Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-31 @ 1:33 AM
Study NCT ID:
NCT05407935
Status:
COMPLETED
Last Update Posted:
2025-08-20
First Post:
2022-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults With Depressive Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2022-05-31', 'studyFirstSubmitQcDate': '2022-06-03', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Physical activity values clarification (valuing questionnaire)', 'timeFrame': 'Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months', 'description': "Measures how a person's values align with physical activity"}, {'measure': 'Change in Acceptance of physical activity-related distress (Physical Activity Acceptance Questionnaire)', 'timeFrame': 'Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months', 'description': 'Measures the extent to which a person can tolerate any distress associated with physical activity'}, {'measure': 'Change in Physical activity-related motivation (Treatment Self-Regulation Questionnaire - Exercise Version)', 'timeFrame': 'Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months', 'description': 'Measures the extent to which a person is motivated to engage in physical activity'}, {'measure': 'Change in Discomfort intolerance (Discomfort Intolerance Scale)', 'timeFrame': 'Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months', 'description': 'Measures the extent to which a person can tolerate uncomfortable experiences'}, {'measure': 'Change in Physical activity enjoyment (PACES questionnaire)', 'timeFrame': 'Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months', 'description': 'Measures the extent to which a person enjoys physical activity'}, {'measure': 'Change in Credibility and expectancy questionnaire', 'timeFrame': 'Week 1 (After the first treatment session)', 'description': 'Measures perceived credibility and expected benefits of treatment'}, {'measure': 'Change in Client satisfaction questionnaire', 'timeFrame': 'Post-Treatment (8 weeks) and following the booster session (12 weeks)', 'description': 'Measures satisfaction with treatment'}, {'measure': 'Change in Group cohesion questionnaire', 'timeFrame': 'Post-Treatment (8 weeks)', 'description': 'Measures perceived cohesiveness of the treatment group'}], 'primaryOutcomes': [{'measure': 'Change in Accelerometry', 'timeFrame': 'Baseline, Post-Treatment (8 weeks), 6-months', 'description': 'Minutes of physical activity weighted by intensity, expressed in metabolic equivalent (MET) minutes per week as determined by accelerometers (Actigraph \\[model wGT3x-BT\\]) worn during one-week periods.'}], 'secondaryOutcomes': [{'measure': 'Change in Self-report physical activity (Godin)', 'timeFrame': 'Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months', 'description': 'Self-reported minutes of leisure time physical activity per week weighted by intensity'}, {'measure': 'Change in Self-reported depression symptoms (CES-D)', 'timeFrame': 'Baseline, Mid-Treatment (4 weeks) Post-Treatment (8 weeks), 6-months', 'description': 'Score on the Center for Epidemiological Studies Depression Scale (CES-D)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Inactivity']}, 'descriptionModule': {'briefSummary': 'The goal of the proposed project is to conduct a feasibility clinical trial comparing group-based acceptance and commitment therapy for physical activity, (ACT; ACTivity) to a time- and attention-matched standard PA intervention (i.e., PA education, goal-setting, and self-monitoring) plus relaxation training comparison condition (Relaxercise) among 60 low-active adults (ages 18-65) with elevated depressive symptoms. Participants will be randomized to treatment condition, followed for 6 months, including the 8-week treatment. Participants will be randomized 1:1 to treatment condition, followed for 6 months, including the 8-week treatment, and receive a 6-month YMCA membership to equate access to PA facilities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elevated depressive symptoms (CES-D score of greater than or equal to 10)\n* Low-active (less than 60 minutes per week of moderate intensity PA)\n* Willing and able to attend weekly virtual video sessions via Zoom\n\nExclusion Criteria:\n\n* Regular mindfulness meditation practice (more than once per week)\n* Body Mass Index (BMI) less than 18.5 or greater than 40\n* History or presence of any condition that may limit or substantially increase the risks of physical activity\n* Active suicidal thoughts or behaviors\n* Currently participating in any exercise or weight-loss research studies\n* Household member is participating in this study\n* Does not have a Rhode Island mailing address OR if only Rhode Island mailing address is a PO box\n* Unable to receive materials in the mail at residential mailing address\n* Does not plan to live in Rhode Island for the next 6 months\n* Unable to speak, read, and/or write fluently in English'}, 'identificationModule': {'nctId': 'NCT05407935', 'briefTitle': 'Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults With Depressive Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults With Depressive Symptoms', 'orgStudyIdInfo': {'id': 'R34AT011302', 'link': 'https://reporter.nih.gov/quickSearch/R34AT011302', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACTivity', 'description': 'Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)', 'interventionNames': ['Behavioral: ACTivity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Relaxercise', 'description': 'Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)', 'interventionNames': ['Behavioral: Relaxercise']}], 'interventions': [{'name': 'ACTivity', 'type': 'BEHAVIORAL', 'description': 'Acceptance and Commitment Therapy for physical activity promotion plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)', 'armGroupLabels': ['ACTivity']}, {'name': 'Relaxercise', 'type': 'BEHAVIORAL', 'description': 'Relaxation training plus standard physical activity promotion strategies (i.e., goal-setting, self-monitoring)', 'armGroupLabels': ['Relaxercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02912', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Da M Wil, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University School of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}