Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-28 @ 7:24 PM
Study NCT ID:
NCT04560595
Status:
COMPLETED
Last Update Posted:
2025-01-14
First Post:
2020-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Remote Guided Caffeine Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D006356', 'term': 'Heartburn'}, {'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dlee214@jhmi.edu', 'phone': '410-550-4035', 'title': 'Dr. Dustin C. Lee', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 14 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Caffeine Reduction Manual, Immediate Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the immediate treatment group will receive the guide immediately after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Caffeine Reduction Manual, Delayed Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the delayed treatment group will receive the guide seven weeks after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Retention as Assessed by Number of Participants With Completed Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine Reduction Manual, Immediate Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the immediate treatment group will receive the guide immediately after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}, {'id': 'OG001', 'title': 'Caffeine Reduction Manual, Delayed Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the delayed treatment group will receive the guide seven weeks after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}], 'classes': [{'title': 'Treatment Visit', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': '7-Week Follow-Up', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': '14-Week Follow-Up', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Treatment Visit, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine to what extent participants will engage with a remote caffeine reduction intervention for caffeine-related problems and find it acceptable, we will calculate the percentage of completed assessments for each video visit among eligible participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data analyzed at each timepoint'}, {'type': 'PRIMARY', 'title': 'Treatment Acceptability as Assessed by Treatment Acceptability Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine Reduction Manual, Immediate Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the immediate treatment group will receive the guide immediately after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}, {'id': 'OG001', 'title': 'Caffeine Reduction Manual, Delayed Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the delayed treatment group will receive the guide seven weeks after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.50', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '2.55', 'spread': '0.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks Follow-Up visit', 'description': 'At the 7 Weeks Follow-Up video visit, we will use an internally-developed standardized treatment acceptability questionnaire to determine self-reported agreement with two items on the treatment acceptability survey (i.e., "Overall, was the Guide to Caffeine Reduction and Cessation easy to use?", and "Overall, was the guide to Caffeine reduction and Cessation helpful?"). Each question is scored on a scale from 0-3, for a total score range of 0-6, where lower scores indicate less acceptability (e.g., 0=not at all easy, not at all helpful; 3 = very easy, very helpful).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consists of participants who completed the week 7 end of treatment visit.'}, {'type': 'SECONDARY', 'title': 'Change in Caffeine Consumption (in Milligrams)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine Reduction Manual, Immediate Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the immediate treatment group will receive the guide immediately after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}, {'id': 'OG001', 'title': 'Caffeine Reduction Manual, Delayed Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the delayed treatment group will receive the guide seven weeks after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}], 'classes': [{'title': 'Baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '617.34', 'spread': '354.82', 'groupId': 'OG000'}, {'value': '516.30', 'spread': '218.79', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '602.90', 'spread': '334.29', 'groupId': 'OG000'}, {'value': '553.60', 'spread': '246.62', 'groupId': 'OG001'}]}]}, {'title': '7-Week Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '221.58', 'spread': '235.60', 'groupId': 'OG000'}, {'value': '173.14', 'spread': '161.72', 'groupId': 'OG001'}]}]}, {'title': '14-Week Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '219.61', 'spread': '199.06', 'groupId': 'OG000'}, {'value': '195.56', 'spread': '207.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Treatment Visit, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine to what extent participants are successfully able to reduce their caffeine consumption following the remote intervention, we will assess caffeine consumption as determined by the standardized caffeine assessments at 7 week post-treatment follow-ups and compare this with consumption at the screening televisit. Based on participant responses to the number, type, and amount of caffeinated beverages, caffeine consumption is calculated at each assessment in milligrams (mg).', 'unitOfMeasure': 'milligrams of caffeine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data analyzed at each timepoint'}, {'type': 'SECONDARY', 'title': 'Change in Caffeine-related Problems as Assessed by Past-7 Days Standardized Items', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine Reduction Manual, Immediate Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the immediate treatment group will receive the guide immediately after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}, {'id': 'OG001', 'title': 'Caffeine Reduction Manual, Delayed Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the delayed treatment group will receive the guide seven weeks after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.85', 'spread': '10.57', 'groupId': 'OG000'}, {'value': '19.23', 'spread': '10.88', 'groupId': 'OG001'}]}]}, {'title': '7-Week Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.52', 'spread': '4.89', 'groupId': 'OG000'}, {'value': '6.28', 'spread': '5.92', 'groupId': 'OG001'}]}]}, {'title': '14-Week Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.26', 'spread': '6.25', 'groupId': 'OG000'}, {'value': '4.69', 'spread': '5.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine to what extent participants report improvement in common caffeine-related problems following the remote intervention, we have developed a standardized 19-Item Caffeine Use Disorder measure of the extent to which common problems related to excessive caffeine consumption bothered participants within the past 7 days, e.g., "During the past 7 days, I have consumed caffeine in larger amounts or over a longer period than I intended." Participants rate the extent to which these problems bothered them on a scale from 0-3 where 0 = not at all a problem and 3 = major problem. The total possible scale range is from 0-57 (because the scores of 0-3 are summed for the 19 items). Higher sum scores on the measure indicate greater caffeine-related problems.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data analyzed at each timepoint'}, {'type': 'SECONDARY', 'title': 'Change in Anxiety as Assessed by the PROMIS-Anxiety-8a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine Reduction Manual, Immediate Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the immediate treatment group will receive the guide immediately after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}, {'id': 'OG001', 'title': 'Caffeine Reduction Manual, Delayed Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the delayed treatment group will receive the guide seven weeks after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.31', 'spread': '7.30', 'groupId': 'OG000'}, {'value': '57.38', 'spread': '5.96', 'groupId': 'OG001'}]}]}, {'title': '7-Week Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.78', 'spread': '8.62', 'groupId': 'OG000'}, {'value': '49.55', 'spread': '7.44', 'groupId': 'OG001'}]}]}, {'title': '14-Week Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.82', 'spread': '7.69', 'groupId': 'OG000'}, {'value': '50.6', 'spread': '8.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine whether caffeine reduction is accompanied by a reduction in day-to-day anxiety, we will utilize the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 8a assessment. The questionnaire asks the extent to which anxiety-related items affected the participants over the past 7 days on a scale of 1 (never) to 5 (always) with a total raw score range of 8-40 in which higher scores reflect greater anxiety. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like anxiety, a T-score of 60 is one SD worse than average. By comparison, an anxiety T-score of 40 is one SD better than average. A score of less than 55 is none to slight, 55.0-59.9 is mild, 60.0-69.9 is moderate, and 70 and over is severe.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data analyzed at each timepoint'}, {'type': 'SECONDARY', 'title': 'Change in Anxiety as Assessed by the GAD-7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine Reduction Manual, Immediate Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the immediate treatment group will receive the guide immediately after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}, {'id': 'OG001', 'title': 'Caffeine Reduction Manual, Delayed Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the delayed treatment group will receive the guide seven weeks after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.96', 'spread': '5.79', 'groupId': 'OG000'}, {'value': '6.13', 'spread': '5.39', 'groupId': 'OG001'}]}]}, {'title': '7-Week Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.76', 'spread': '4.84', 'groupId': 'OG000'}, {'value': '3.13', 'spread': '3.20', 'groupId': 'OG001'}]}]}, {'title': '14-Week Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.00', 'spread': '4.34', 'groupId': 'OG000'}, {'value': '3.24', 'spread': '4.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine whether caffeine reduction is accompanied by a reduction in day-to-day anxiety, we will utilize the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 consists of items asking the participant to rate on a scale of 0 (not at all) to 3 (nearly every day) the extent they have experienced anxiety related symptoms. The scoring range is 0-21 and higher scores indicate greater anxiety related symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data analyzed at each timepoint'}, {'type': 'SECONDARY', 'title': 'Change in Sleep Problems as Assessed by the PROMIS Sleep Disturbance 8a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine Reduction Manual, Immediate Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the immediate treatment group will receive the guide immediately after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}, {'id': 'OG001', 'title': 'Caffeine Reduction Manual, Delayed Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the delayed treatment group will receive the guide seven weeks after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.54', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '53.94', 'spread': '6.57', 'groupId': 'OG001'}]}]}, {'title': '7-Week Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.09', 'spread': '9.12', 'groupId': 'OG000'}, {'value': '46.57', 'spread': '6.74', 'groupId': 'OG001'}]}]}, {'title': '14-Week Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.13', 'spread': '7.17', 'groupId': 'OG000'}, {'value': '46.20', 'spread': '6.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine whether caffeine reduction is accompanied by a reduction in sleep problems, we will utilize the PROMIS Sleep Disturbance 8a assessment. The questionnaire asks the extent to which sleep-related items affected the participants over the past 7 days on a scale of 1 (not at all) to 5 (very much). The raw scoring range is 8-40 and higher scores reflect greater sleep disturbance. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like sleep disturbance, a T-score of 60 is one SD worse than average. By comparison, T-score of 40 is one SD better than average. A T-score of 50 or above is often considered a clinically significant level of sleep disturbance.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data analyzed at each timepoint'}, {'type': 'SECONDARY', 'title': 'Change in Sleep Problems as Assessed by the PSQI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine Reduction Manual, Immediate Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the immediate treatment group will receive the guide immediately after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}, {'id': 'OG001', 'title': 'Caffeine Reduction Manual, Delayed Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the delayed treatment group will receive the guide seven weeks after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.21', 'spread': '3.64', 'groupId': 'OG000'}, {'value': '8.96', 'spread': '3.16', 'groupId': 'OG001'}]}]}, {'title': '7-Week Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.80', 'spread': '3.56', 'groupId': 'OG000'}, {'value': '6.15', 'spread': '2.97', 'groupId': 'OG001'}]}]}, {'title': '14-Week Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.60', 'spread': '3.39', 'groupId': 'OG000'}, {'value': '5.76', 'spread': '2.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine whether caffeine reduction is accompanied by a reduction in sleep problems, we will utilize the Pittsburgh Sleep Quality Index (PSQI), which contains 19 self-rated items and 7 sub-scales for different components where a score of 0 indicates no difficulty and a score of 3 indicates severe difficulty. The scoring range is 0-21 and higher global scores indicate greater sleep difficulties.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data analyzed at each timepoint'}, {'type': 'SECONDARY', 'title': 'Change in Gastrointestinal Problems as Assessed by the PROMIS Reflux-13a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine Reduction Manual, Immediate Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the immediate treatment group will receive the guide immediately after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}, {'id': 'OG001', 'title': 'Caffeine Reduction Manual, Delayed Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the delayed treatment group will receive the guide seven weeks after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.35', 'spread': '8.71', 'groupId': 'OG000'}, {'value': '49.32', 'spread': '7.49', 'groupId': 'OG001'}]}]}, {'title': '7-Week Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.57', 'spread': '7.17', 'groupId': 'OG000'}, {'value': '40.73', 'spread': '5.88', 'groupId': 'OG001'}]}]}, {'title': '14-Week Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.28', 'spread': '7.32', 'groupId': 'OG000'}, {'value': '40.73', 'spread': '6.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine whether caffeine reduction is accompanied by a reduction in gastrointestinal problems, we will utilize the PROMIS Reflux-13a. These items ask the extent to which gastrointestinal-related items affected the participants over the past 7 days on a scale of 1 (never) to 5 (always). The scoring range of raw scores is 13-65 and higher scores reflect greater gastrointestinal problems. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like reflux, a T-score of 60 is one SD worse than average. By comparison, an anxiety T-score of 40 is one SD better than average.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data analyzed at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Change in Gastrointestinal Problems as Assessed by the GSRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine Reduction Manual, Immediate Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the immediate treatment group will receive the guide immediately after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}, {'id': 'OG001', 'title': 'Caffeine Reduction Manual, Delayed Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the delayed treatment group will receive the guide seven weeks after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.11', 'spread': '12.84', 'groupId': 'OG000'}, {'value': '17.64', 'spread': '15.60', 'groupId': 'OG001'}]}]}, {'title': '7-Week Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.08', 'spread': '8.28', 'groupId': 'OG000'}, {'value': '8.98', 'spread': '8.86', 'groupId': 'OG001'}]}]}, {'title': '14-Week Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.96', 'spread': '9.36', 'groupId': 'OG000'}, {'value': '9.11', 'spread': '9.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine whether caffeine reduction is accompanied by a reduction in gastrointestinal problems, we will utilize the Gastrointestinal Symptoms Rating Scale (GSRS) which consists of 15 items describing gastrointestinal distress where responses range from 0 (no discomfort at all) to 6 (very severe discomfort). The scoring range is 0-90 and higher scores indicate more severe gastrointestinal symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data analyzed at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Change in Gastrointestinal Problems as Assessed by the PROMIS Diarrhea-6a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine Reduction Manual, Immediate Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the immediate treatment group will receive the guide immediately after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}, {'id': 'OG001', 'title': 'Caffeine Reduction Manual, Delayed Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the delayed treatment group will receive the guide seven weeks after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.31', 'spread': '9.07', 'groupId': 'OG000'}, {'value': '50.70', 'spread': '8.81', 'groupId': 'OG001'}]}]}, {'title': '7-Week Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.55', 'spread': '7.05', 'groupId': 'OG000'}, {'value': '43.61', 'spread': '5.92', 'groupId': 'OG001'}]}]}, {'title': '14-Week Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.35', 'spread': '7.59', 'groupId': 'OG000'}, {'value': '45.02', 'spread': '6.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine whether caffeine reduction is accompanied by a reduction in gastrointestinal problems, we will utilize the PROMIS Diarrhea-6a. These items ask the extent to which gastrointestinal-related items affected the participants over the past 7 days on a scale of 1 (never) to 5 (always). The raw scoring range is 6-30 and higher scores reflect greater gastrointestinal problems. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like diarrhea, a T-score of 60 is one SD worse than average. By comparison, an anxiety T-score of 40 is one SD better than average.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data analyzed at each timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Caffeine Reduction Manual, Immediate Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the immediate treatment group will receive the guide immediately after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}, {'id': 'FG001', 'title': 'Caffeine Reduction Manual, Delayed Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the delayed treatment group will receive the guide seven weeks after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Caffeine Reduction Manual, Immediate Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the immediate treatment group will receive the guide immediately after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}, {'id': 'BG001', 'title': 'Caffeine Reduction Manual, Delayed Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the delayed treatment group will receive the guide seven weeks after screening.\n\nCaffeine Reduction Manual: We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.36', 'spread': '15.42', 'groupId': 'BG000'}, {'value': '41.96', 'spread': '14.14', 'groupId': 'BG001'}, {'value': '43.61', 'spread': '14.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-07', 'size': 307658, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-26T16:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Caffeine consumption and secondary measures will be examined before, during, and after the caffeine reduction intervention and compared between immediate and delayed treatment groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2020-09-08', 'resultsFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2020-09-17', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-10', 'studyFirstPostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Retention as Assessed by Number of Participants With Completed Assessments', 'timeFrame': 'Treatment Visit, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine to what extent participants will engage with a remote caffeine reduction intervention for caffeine-related problems and find it acceptable, we will calculate the percentage of completed assessments for each video visit among eligible participants.'}, {'measure': 'Treatment Acceptability as Assessed by Treatment Acceptability Questionnaire', 'timeFrame': '7 weeks Follow-Up visit', 'description': 'At the 7 Weeks Follow-Up video visit, we will use an internally-developed standardized treatment acceptability questionnaire to determine self-reported agreement with two items on the treatment acceptability survey (i.e., "Overall, was the Guide to Caffeine Reduction and Cessation easy to use?", and "Overall, was the guide to Caffeine reduction and Cessation helpful?"). Each question is scored on a scale from 0-3, for a total score range of 0-6, where lower scores indicate less acceptability (e.g., 0=not at all easy, not at all helpful; 3 = very easy, very helpful).'}], 'secondaryOutcomes': [{'measure': 'Change in Caffeine Consumption (in Milligrams)', 'timeFrame': 'Baseline, Treatment Visit, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine to what extent participants are successfully able to reduce their caffeine consumption following the remote intervention, we will assess caffeine consumption as determined by the standardized caffeine assessments at 7 week post-treatment follow-ups and compare this with consumption at the screening televisit. Based on participant responses to the number, type, and amount of caffeinated beverages, caffeine consumption is calculated at each assessment in milligrams (mg).'}, {'measure': 'Change in Caffeine-related Problems as Assessed by Past-7 Days Standardized Items', 'timeFrame': 'Baseline, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine to what extent participants report improvement in common caffeine-related problems following the remote intervention, we have developed a standardized 19-Item Caffeine Use Disorder measure of the extent to which common problems related to excessive caffeine consumption bothered participants within the past 7 days, e.g., "During the past 7 days, I have consumed caffeine in larger amounts or over a longer period than I intended." Participants rate the extent to which these problems bothered them on a scale from 0-3 where 0 = not at all a problem and 3 = major problem. The total possible scale range is from 0-57 (because the scores of 0-3 are summed for the 19 items). Higher sum scores on the measure indicate greater caffeine-related problems.'}, {'measure': 'Change in Anxiety as Assessed by the PROMIS-Anxiety-8a', 'timeFrame': 'Baseline, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine whether caffeine reduction is accompanied by a reduction in day-to-day anxiety, we will utilize the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 8a assessment. The questionnaire asks the extent to which anxiety-related items affected the participants over the past 7 days on a scale of 1 (never) to 5 (always) with a total raw score range of 8-40 in which higher scores reflect greater anxiety. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like anxiety, a T-score of 60 is one SD worse than average. By comparison, an anxiety T-score of 40 is one SD better than average. A score of less than 55 is none to slight, 55.0-59.9 is mild, 60.0-69.9 is moderate, and 70 and over is severe.'}, {'measure': 'Change in Anxiety as Assessed by the GAD-7', 'timeFrame': 'Baseline, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine whether caffeine reduction is accompanied by a reduction in day-to-day anxiety, we will utilize the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 consists of items asking the participant to rate on a scale of 0 (not at all) to 3 (nearly every day) the extent they have experienced anxiety related symptoms. The scoring range is 0-21 and higher scores indicate greater anxiety related symptoms.'}, {'measure': 'Change in Sleep Problems as Assessed by the PROMIS Sleep Disturbance 8a', 'timeFrame': 'Baseline, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine whether caffeine reduction is accompanied by a reduction in sleep problems, we will utilize the PROMIS Sleep Disturbance 8a assessment. The questionnaire asks the extent to which sleep-related items affected the participants over the past 7 days on a scale of 1 (not at all) to 5 (very much). The raw scoring range is 8-40 and higher scores reflect greater sleep disturbance. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like sleep disturbance, a T-score of 60 is one SD worse than average. By comparison, T-score of 40 is one SD better than average. A T-score of 50 or above is often considered a clinically significant level of sleep disturbance.'}, {'measure': 'Change in Sleep Problems as Assessed by the PSQI', 'timeFrame': 'Baseline, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine whether caffeine reduction is accompanied by a reduction in sleep problems, we will utilize the Pittsburgh Sleep Quality Index (PSQI), which contains 19 self-rated items and 7 sub-scales for different components where a score of 0 indicates no difficulty and a score of 3 indicates severe difficulty. The scoring range is 0-21 and higher global scores indicate greater sleep difficulties.'}, {'measure': 'Change in Gastrointestinal Problems as Assessed by the PROMIS Reflux-13a', 'timeFrame': 'Baseline, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine whether caffeine reduction is accompanied by a reduction in gastrointestinal problems, we will utilize the PROMIS Reflux-13a. These items ask the extent to which gastrointestinal-related items affected the participants over the past 7 days on a scale of 1 (never) to 5 (always). The scoring range of raw scores is 13-65 and higher scores reflect greater gastrointestinal problems. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like reflux, a T-score of 60 is one SD worse than average. By comparison, an anxiety T-score of 40 is one SD better than average.'}, {'measure': 'Change in Gastrointestinal Problems as Assessed by the GSRS', 'timeFrame': 'Baseline, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine whether caffeine reduction is accompanied by a reduction in gastrointestinal problems, we will utilize the Gastrointestinal Symptoms Rating Scale (GSRS) which consists of 15 items describing gastrointestinal distress where responses range from 0 (no discomfort at all) to 6 (very severe discomfort). The scoring range is 0-90 and higher scores indicate more severe gastrointestinal symptoms.'}, {'measure': 'Change in Gastrointestinal Problems as Assessed by the PROMIS Diarrhea-6a', 'timeFrame': 'Baseline, 7-Week Follow-Up, 14-Week Follow-Up', 'description': 'To determine whether caffeine reduction is accompanied by a reduction in gastrointestinal problems, we will utilize the PROMIS Diarrhea-6a. These items ask the extent to which gastrointestinal-related items affected the participants over the past 7 days on a scale of 1 (never) to 5 (always). The raw scoring range is 6-30 and higher scores reflect greater gastrointestinal problems. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like diarrhea, a T-score of 60 is one SD worse than average. By comparison, an anxiety T-score of 40 is one SD better than average.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['caffeine', 'caffeine reduction', 'online study', 'manualized treatment', 'caffeine fading', 'remote intervention', 'remote trial'], 'conditions': ['Caffeine Dependence', 'Anxiety', 'Sleep Disturbance', 'Gastrointestinal Dysfunction', 'Sleep Initiation and Maintenance Disorders', 'Caffeine; Sleep Disorder', 'Caffeine', 'Caffeine-Induced Anxiety Disorder', 'Caffeine Withdrawal', 'Caffeine-Induced Sleep Disorder, Without Use Disorder', 'Caffeine Abuse', 'Insomnia', 'Anxiety Disorders', 'Sleep Disorder', 'Heartburn', 'Diarrhea']}, 'descriptionModule': {'briefSummary': 'The purpose of this online research study is to determine whether or not a gradual caffeine reduction program developed at Johns Hopkins can help people reduce their caffeine use. The investigators will provide materials to help guide caffeine reduction and ask questions to track caffeine use over several weeks. The investigators will also assess how reducing caffeine may benefit common caffeine-related problems such as anxiety, sleep disturbances, and gastrointestinal distress. The study will also determine whether or not people like participating in this caffeine reduction program in an online format.', 'detailedDescription': "There is emerging evidence that some individuals have difficulty cutting down or eliminating caffeine consumption in spite of clinically significant problems exacerbated by caffeine use. This study will evaluate whether a caffeine reduction program developed at Johns Hopkins can help people reduce their caffeine use in an online format. Volunteers will participate in an intervention study conducted entirely online, including video visits for screening, instructions for caffeine reduction, and follow up. The study also involves filling out online surveys sent via email and text message. During screening, participants will be asked questions about their personal characteristics including demographic information, weekly caffeine consumption, and general medical history. Participants who are determined to be eligible after screening will be randomized to either the immediate or delayed treatment group. Those in the immediate treatment group will have their next session immediately after screening while those in the delayed treatment group will have their next session 7 weeks after screening. At this session, participants receive a digital copy of a caffeine reduction manual and instructions on how to gradually cut down caffeine. After this, participants will complete weekly online surveys over six weeks. Participants will complete two follow-up video visits at 7 and 14 weeks after participants received the caffeine reduction instructions. The investigators will measure caffeine consumption over time using the online surveys and interview questions during video visits, and the investigators will also measure how various caffeine related problems may improve during caffeine reduction, such as sleep problems, gastrointestinal issues, and anxiety. During the end of study sessions, participants will answer questions related to acceptability of the online format and report on participants' current caffeine use."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-75 years old\n* Reside in the United States\n* Read, write, and speak English fluently\n* Able to access a video camera on a smart phone, tablet, or other computer\n* Able to receive text messages or emails (or both)\n* Suitable caffeine consumption\n* Indicate suitable reason for caffeine reduction\n* Interested in getting help to gradually reduce or eliminate caffeine consumption as part of a research study\n\nExclusion Criteria:\n\n* Any current medical or psychiatric disorder or symptoms that, in the opinion of the investigators, may interfere with or preclude completion of the study \\[many psychiatric or medical concerns such as insomnia or anxiety are not anticipated to interfere with study participation and will not generally be exclusionary\\]'}, 'identificationModule': {'nctId': 'NCT04560595', 'briefTitle': 'Remote Guided Caffeine Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Remote Guided Caffeine Reduction', 'orgStudyIdInfo': {'id': 'IRB00250925'}, 'secondaryIdInfos': [{'id': 'R01DA003890', 'link': 'https://reporter.nih.gov/quickSearch/R01DA003890', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caffeine Reduction Manual, Immediate Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the immediate treatment group will receive the guide immediately after screening.', 'interventionNames': ['Behavioral: Caffeine Reduction Manual']}, {'type': 'EXPERIMENTAL', 'label': 'Caffeine Reduction Manual, Delayed Treatment Group', 'description': 'Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the delayed treatment group will receive the guide seven weeks after screening.', 'interventionNames': ['Behavioral: Caffeine Reduction Manual']}], 'interventions': [{'name': 'Caffeine Reduction Manual', 'type': 'BEHAVIORAL', 'otherNames': ['Johns Hopkins Guide to Caffeine Reduction and Cessation'], 'description': 'We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.', 'armGroupLabels': ['Caffeine Reduction Manual, Delayed Treatment Group', 'Caffeine Reduction Manual, Immediate Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Dustin Lee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not currently a plan to make individual participant data available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}