Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT04460027
Status:
COMPLETED
Last Update Posted:
2022-12-21
First Post:
2020-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
W-SUDs for COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jpro@stanford.edu', 'phone': '650-724-3608', 'title': 'Judith J. Prochaska, PhD', 'organization': 'Stanford Prevention Research Center, Department of Medicine, Stanford University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events were assessed at post-treatment, 8 weeks from baseline.', 'description': 'Serious adverse events occurring during treatment were assessed for hospitalization related to substance use, suicide attempt, alcohol or drug overdose, and severe withdrawal (eg, delirium tremens). Positive endorsements were followed up with questions about the timing, diagnosis, and resolution. If additional details were needed to determine whether the event was study related, a team member reached out to the participant.', 'eventGroups': [{'id': 'EG000', 'title': 'W-SUDs', 'description': 'Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 0, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Wait List Control', 'description': 'Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 0, 'seriousNumAtRisk': 92, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Hospitalization', 'notes': 'Hospitalization for alcohol detoxification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'W-SUDs', 'description': 'Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.'}, {'id': 'OG001', 'title': 'Waitlist Control', 'description': 'Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.1', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Post-treatment at 8 weeks', 'description': 'Change in number of substance use occasions in the past 30 days from Baseline to Post-treatment at 8 weeks', 'unitOfMeasure': 'occasions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'W-SUDs', 'description': 'Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Post-treatment at 8 weeks', 'description': 'Measure of substance use problems. The SIP-AD assesses substance use problems in the past 30 days. Total score consists of of the sum of all 15 items, ranging from 0-45, where greater scores indicate greater substance use problems.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'W-SUDs', 'description': 'Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Post-treatment at 8 weeks', 'description': 'Measure of drug abuse related consequences. The DAST-10 is a brief, 10-item self-report measure that assesses consequences related to drug abuse, excluding alcohol and tobacco. The range is 0-10, where higher scores indicate greater severity. Adapted from past 12 months to past 30 days.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'W-SUDs', 'description': 'Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Post-treatment at 8 weeks', 'description': 'Measure of self-confidence. The 8-item BSCQ is a state dependent measure that assesses self-confidence to resist the urge to drink heavily or use drugs in a variety of situations. Each of the 8 scale situations consists of a 100-mm line, anchored by 0% ("not at all confident") and 100% ("totally confident") where clients are asked to indicate confidence on a scale from 0% to 100%. Higher scores are associated with greater confidence.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Craving Ratings From Baseline to Post-treatment at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'W-SUDs', 'description': 'Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.5', 'spread': '.1', 'groupId': 'OG000'}, {'value': '-.4', 'spread': '.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Post-treatment at 8 weeks', 'description': 'A one-item, self-reported rating of craving intensity to use substances over the past 7 days. Score ranges is from 0-4, where a greater score indicates a more intense urge to use.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'W-SUDs', 'description': 'Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.1', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '-.8', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Post-treatment at 8 Weeks', 'description': 'A one item, self-reported rating of pain. Scores range from 0-100 where higher scores indicate greater levels of pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'W-SUDs', 'description': 'Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '.6', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Post-treatment at 8 weeks', 'description': 'Measure of depression. An 8-item self-report questionnaire that assesses the frequency and severity of depression symptoms. Total scores range from 0 to 24 where higher scores indicate greater levels of depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'W-SUDs', 'description': 'Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '.6', 'groupId': 'OG000'}, {'value': '-.7', 'spread': '.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Post-treatment at 8 weeks', 'description': 'Measure of anxiety. A 7-item brief self-report measure used to assess the frequency and severity of anxious thoughts and behaviors over the past 2 weeks. Total score between 0-21, where higher scores indicate greater levels of anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'W-SUDs', 'description': 'Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.'}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '.5', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Post-treatment at 8 weeks', 'description': 'Assesses impact of the COVID-19 pandemic in terms of exposure to stressors, mental health impact, and growth. Possible total score range from 0-22, where greater scores are related to greater impact.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Client Satisfaction Questionnaire (CSQ) at Post-treatment at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'W-SUDs', 'description': 'Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'spread': '5.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-treatment (8 weeks from Baseline)', 'description': 'Measure of satisfaction. An 8-item measure used to assess client\'s satisfaction with treatment on a 4-point scale. Example questions include, "How would you rate the quality of service you received"? and "Did you get the kind of service you wanted?" Total sums range from 8-32, with high scores indicating greater satisfaction with the W-SUDs mobile application.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.'}, {'type': 'SECONDARY', 'title': 'Usage Rating Profile - Intervention (URPI)-Acceptability at Post-treatment at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'W-SUDs', 'description': 'Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'spread': '4.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-treatment (8 weeks from Baseline)', 'description': 'Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Total scores range from 6-36, where greater scores indicate greater intervention acceptability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.'}, {'type': 'SECONDARY', 'title': 'Usage Rating Profile - Intervention (URPI)-Feasibility at Post-treatment at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'W-SUDs', 'description': 'Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.0', 'spread': '3.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-treatment (8 weeks from Baseline)', 'description': 'Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Total scores range from 6-36, where greater scores indicate greater intervention feasibility.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.'}, {'type': 'SECONDARY', 'title': 'Change in Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'W-SUDs', 'description': 'Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.0', 'spread': '12.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks', 'description': 'Measure of working alliance. A measure of therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Total scores range from 12-60, with higher scores indicating greater alliance. The present study utilized the validated 12-item Short-Revised version (WAI-SR) with minor changes to language, replacing "therapist" with "Woebot".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'W-SUDs', 'description': 'Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.'}, {'id': 'FG001', 'title': 'Waitlist Control', 'description': 'Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'W-SUDs', 'description': 'Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.'}, {'id': 'BG001', 'title': 'Wait List Control', 'description': 'Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.8', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '39.8', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '40.3', 'spread': '11.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '156', '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': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', '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': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-30', 'size': 273641, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-31T09:50', 'hasProtocol': True}, {'date': '2021-10-01', 'size': 91135, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-31T09:51', 'hasProtocol': False}, {'date': '2020-06-19', 'size': 212398, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-10-31T09:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-23', 'studyFirstSubmitDate': '2020-07-01', 'resultsFirstSubmitDate': '2022-07-19', 'studyFirstSubmitQcDate': '2020-07-02', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-23', 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks', 'timeFrame': 'Change from Baseline to Post-treatment at 8 weeks', 'description': 'Change in number of substance use occasions in the past 30 days from Baseline to Post-treatment at 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks', 'timeFrame': 'Change from Baseline to Post-treatment at 8 weeks', 'description': 'Measure of substance use problems. The SIP-AD assesses substance use problems in the past 30 days. Total score consists of of the sum of all 15 items, ranging from 0-45, where greater scores indicate greater substance use problems.'}, {'measure': 'Change in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks', 'timeFrame': 'Change from Baseline to Post-treatment at 8 weeks', 'description': 'Measure of drug abuse related consequences. The DAST-10 is a brief, 10-item self-report measure that assesses consequences related to drug abuse, excluding alcohol and tobacco. The range is 0-10, where higher scores indicate greater severity. Adapted from past 12 months to past 30 days.'}, {'measure': 'Change in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 Weeks', 'timeFrame': 'Change from Baseline to Post-treatment at 8 weeks', 'description': 'Measure of self-confidence. The 8-item BSCQ is a state dependent measure that assesses self-confidence to resist the urge to drink heavily or use drugs in a variety of situations. Each of the 8 scale situations consists of a 100-mm line, anchored by 0% ("not at all confident") and 100% ("totally confident") where clients are asked to indicate confidence on a scale from 0% to 100%. Higher scores are associated with greater confidence.'}, {'measure': 'Change in Craving Ratings From Baseline to Post-treatment at 8 Weeks', 'timeFrame': 'Change from Baseline to Post-treatment at 8 weeks', 'description': 'A one-item, self-reported rating of craving intensity to use substances over the past 7 days. Score ranges is from 0-4, where a greater score indicates a more intense urge to use.'}, {'measure': 'Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks', 'timeFrame': 'Change from Baseline to Post-treatment at 8 Weeks', 'description': 'A one item, self-reported rating of pain. Scores range from 0-100 where higher scores indicate greater levels of pain.'}, {'measure': 'Change in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks', 'timeFrame': 'Change from Baseline to Post-treatment at 8 weeks', 'description': 'Measure of depression. An 8-item self-report questionnaire that assesses the frequency and severity of depression symptoms. Total scores range from 0 to 24 where higher scores indicate greater levels of depression.'}, {'measure': 'Change in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks', 'timeFrame': 'Change from Baseline to Post-treatment at 8 weeks', 'description': 'Measure of anxiety. A 7-item brief self-report measure used to assess the frequency and severity of anxious thoughts and behaviors over the past 2 weeks. Total score between 0-21, where higher scores indicate greater levels of anxiety.'}, {'measure': 'Change in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks', 'timeFrame': 'Change from Baseline to Post-treatment at 8 weeks', 'description': 'Assesses impact of the COVID-19 pandemic in terms of exposure to stressors, mental health impact, and growth. Possible total score range from 0-22, where greater scores are related to greater impact.'}, {'measure': 'Client Satisfaction Questionnaire (CSQ) at Post-treatment at 8 Weeks', 'timeFrame': 'Post-treatment (8 weeks from Baseline)', 'description': 'Measure of satisfaction. An 8-item measure used to assess client\'s satisfaction with treatment on a 4-point scale. Example questions include, "How would you rate the quality of service you received"? and "Did you get the kind of service you wanted?" Total sums range from 8-32, with high scores indicating greater satisfaction with the W-SUDs mobile application.'}, {'measure': 'Usage Rating Profile - Intervention (URPI)-Acceptability at Post-treatment at 8 Weeks', 'timeFrame': 'Post-treatment (8 weeks from Baseline)', 'description': 'Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Total scores range from 6-36, where greater scores indicate greater intervention acceptability.'}, {'measure': 'Usage Rating Profile - Intervention (URPI)-Feasibility at Post-treatment at 8 Weeks', 'timeFrame': 'Post-treatment (8 weeks from Baseline)', 'description': 'Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Total scores range from 6-36, where greater scores indicate greater intervention feasibility.'}, {'measure': 'Change in Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks', 'timeFrame': 'Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks', 'description': 'Measure of working alliance. A measure of therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Total scores range from 12-60, with higher scores indicating greater alliance. The present study utilized the validated 12-item Short-Revised version (WAI-SR) with minor changes to language, replacing "therapist" with "Woebot".'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Substance Use Disorders', 'Alcohol Use Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the efficacy of a substance use disorder intervention delivered via a mobile application in an adult population during the COVID-19 pandemic.\n\nThis study that will test the comparative efficacy of the mobile-app based substance use disorder program to reduce substance use relative to a wait list control condition, and explore between group differences on quality of life indices as well as retention and engagement during COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All genders aged 18-65 years\n* Access to a smartphone\n* Available and committed to engage with app and complete assessments\n* Be willing to provide email address (as this is how assessment incentives will be distributed),\n* Literate in English (as W-SUDs conversational and video materials will be in English).\n\nExclusion Criteria:\n\n* Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)\n* History of severe drug/alcohol use\n* History of opioid misuse without medication-assisted treatment\n* Suicide attempt within the past year\n* Opioid overdose within the past year'}, 'identificationModule': {'nctId': 'NCT04460027', 'briefTitle': 'W-SUDs for COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Woebot Health'}, 'officialTitle': 'Woebot for Substance Use Disorders During COVID-19', 'orgStudyIdInfo': {'id': '56439'}, 'secondaryIdInfos': [{'id': '4R44DA048712-02', 'link': 'https://reporter.nih.gov/quickSearch/4R44DA048712-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'W-SUDs', 'interventionNames': ['Other: Woebot Substance Use Disorder']}, {'type': 'NO_INTERVENTION', 'label': 'Wait List Control'}], 'interventions': [{'name': 'Woebot Substance Use Disorder', 'type': 'OTHER', 'description': 'Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.', 'armGroupLabels': ['W-SUDs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94306', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Woebot Health', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}