Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT05866718
Status:
COMPLETED
Last Update Posted:
2024-09-27
First Post:
2023-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can Applying the Science of Habit Formation to Contemplative Practice Improve Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006184', 'term': 'Habits'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Study participants will not be made aware that there are two experimental conditions. All will be told that they are receiving the intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to the SCT or SCT+HABITS using the randomizer elements in Qualtrics.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 486}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-25', 'studyFirstSubmitDate': '2023-05-10', 'studyFirstSubmitQcDate': '2023-05-18', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Barriers and Facilitators', 'timeFrame': 'Assessed at 6-month followup', 'description': 'The investigators will explore first-person experience of using the practice by asking open-ended free-response questions. The investigators will develop a coding system of the barriers and facilitators to forming the habit of practicing SCT daily.'}, {'measure': 'Acceptability and Feasibility (Program Feedback Scale [PFS])', 'timeFrame': 'Assessed at 6-month followup', 'description': '7 Items. 5-point scale (1="really disagree"; 5="totally agree")'}], 'primaryOutcomes': [{'measure': 'Practice Frequency', 'timeFrame': 'Change from baseline to 3-month follow-up, and to 6-month followup', 'description': 'Number of times practiced self-compassion exercise per week since last assessment. 1 item. Higher frequency indicates a better outcome.'}, {'measure': 'Practice Automaticity (Practice Self-Report Behavioral Automaticity Index [SRBAI])', 'timeFrame': 'Change from baseline to 3-month follow-up, and to 6-month follow-up.', 'description': '4 items, 1-9 scale. Higher scores indicate a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Self-Compassion (Sussex-Oxford Compassion for the Self Scale [SOCS-S])', 'timeFrame': 'Change from baseline to 3-month follow-up, and to 6-month followup', 'description': '20-items, 5-point response scale. Scores can range from 20 to 100 (Higher score means higher compassion for self). Sub-scale items included.'}, {'measure': 'Self-Compassion Automaticity (Self-Compassion Self-Report Behavioral Automaticity Index [SRBAI])', 'timeFrame': 'Change from baseline to 3-month follow-up, and to 6-month followup.', 'description': '20 items. 1-9 scale. Higher scores indicate a better outcome.'}, {'measure': 'Perceived Stress (Perceived-Stress Scale [PSS-10])', 'timeFrame': 'Change from baseline to 3-month follow-up, and to 6-month followup', 'description': '10 items, 5 point response scale (from 0 = Never to 4 = Very Often). Lower scores indicate a better outcome.\n\nScoring: Reverse score (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \\& 4 = 0) items 4, 5, 7, \\& 8 and then summing across all scale items.'}, {'measure': 'Psychopathology (DSM-5 Cross-Cutting Measure [DSM-XC])', 'timeFrame': 'Change from baseline to 3-month follow-up, and to 6-month followup', 'description': '22 items (suicidality item Q11 removed). 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearly every day).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Self-Compassion', 'Single-Session Intervention', 'Transdiagnostic', 'Intervention', 'Habits', 'Habit Formation', 'Micropractice', 'Contemplative Micropractice', 'Contemplative Practice', 'Self-Compassionate Touch', 'Compassion'], 'conditions': ['Psychopathology']}, 'descriptionModule': {'briefSummary': 'In the present study, the investigators will conduct a confirmatory efficacy trial to test whether improving practice automaticity (i.e., habit formation) of self-compassionate touch improves outcomes in the predicted direction. Adults (n=440, including 20% for attrition) will be randomly assigned to: (1) the self-compassionate touch intervention plus habit formation tools ("SCT+HABITS") versus (2) the self-compassionate touch intervention alone ("SCT"). The investigators will conduct assessments at baseline, 3-month follow-up, and 6-month follow-up. The SCT+HABITS condition will be used to evaluate whether providing habit formation tools results in superior effects to SCT. The intervention will be delivered entirely online.', 'detailedDescription': 'Specific Aim 1: Evaluate whether SCT+HABITS shows more practice frequency and practice automaticity from baseline to 3-month, and to 6-month follow-up compared to the SCT. Hypothesis 1. The SCT+HABITS group will show greater increases in practice frequency and practice automaticity than SCT from baseline to 3-month, and to 6-month follow-up.\n\nSpecific Aim 2: Determine whether SCT+HABITS, relative to SCT, will experience increased self-compassion and self-compassion automaticity, and reduced stress and psychopathology. Hypothesis 2. SCT+HABITS will promote greater increases in self-compassion and self-compassion automaticity, and greater reductions in stress and psychopathology from baseline to 3-month, to 6-month follow-up.\n\nSpecific Aim 3: Assess whether greater baseline to 3-month follow-up increases in practice automaticity mediate the association between SCT+HABITS and baseline to 6-month follow-up increases in (a) self-compassion and (b) self-compassion automaticity, as well as reductions in (c) stress and (d) psychopathology. Hypothesis 3. Greater baseline to 3-month follow-up increases in practice automaticity will mediate the association between the SCT+HABITS group and baseline to 6-month follow-up increases in (a) self-compassion and (b) self-compassion automaticity, as well as reductions in (c) stress and (d) psychopathology.\n\nExploratory Aim: Evaluate the barriers, facilitators, and acceptability of SCT+HABITS and SCT alone. This aim will be addressed via qualitative analyses to characterize barriers and facilitators to habit formation, and the proportion of participants in each condition (SCT+HABITS and SCT alone) who noted each type of barrier and facilitator. Participants will self-report on acceptability and feasibility via questionnaire. Then, the investigators will examine whether SCT+HABITS and SCT alone will meet or exceed the established criteria for acceptability and feasibility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older.\n* English language proficiency.\n* Able and willing to give informed consent.\n* Resides in the United States of America\n\nExclusion Criteria:\n\n* Does not have email address or access to email.\n* Does not personally own a smartphone device\n* Not able/willing to participate in and/or complete the baseline assessments'}, 'identificationModule': {'nctId': 'NCT05866718', 'briefTitle': 'Can Applying the Science of Habit Formation to Contemplative Practice Improve Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Berkeley'}, 'officialTitle': 'Can Applying the Science of Habit Formation to Contemplative Practice Improve Outcomes? A Randomized Controlled Trial of a Single-Session Habit Formation Intervention for Self-Compassionate Touch', 'orgStudyIdInfo': {'id': '2021-12-14924-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Self-Compassionate Touch Intervention Alone', 'description': 'All participants will receive the self-compassion intervention after completing their baseline assessment, which will contain the same instructions used in the initial study (see NCT05199779).', 'interventionNames': ['Behavioral: Self-Compassionate Touch Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Self-Compassionate Touch Intervention Plus Habit Formation Tools', 'description': 'SCT+HABITS participants will receive the abovementioned procedures, and will also receive evidence-based tools for forming habits.', 'interventionNames': ['Behavioral: Self-Compassionate Touch Intervention', 'Behavioral: Habit Formation Tools']}], 'interventions': [{'name': 'Self-Compassionate Touch Intervention', 'type': 'BEHAVIORAL', 'description': 'Participants will be taught the micropractice (\\<20-second/day personal practice) via video recording.', 'armGroupLabels': ['Self-Compassionate Touch Intervention Alone', 'Self-Compassionate Touch Intervention Plus Habit Formation Tools']}, {'name': 'Habit Formation Tools', 'type': 'BEHAVIORAL', 'description': 'Participants will receive evidence-based tools for promoting habit-formation.', 'armGroupLabels': ['Self-Compassionate Touch Intervention Plus Habit Formation Tools']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94720-1650', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Berkeley', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}], 'overallOfficials': [{'name': 'Eli S Susman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Berkeley'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be shared via the Open Science Framework by time of publication.', 'ipdSharing': 'YES', 'description': 'Data will be shared via the Open Science Framework by time of publication.', 'accessCriteria': 'De-identified data, materials and analytic code will be made publicly available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Berkeley', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mind and Life Institute, Hadley, Massachusetts', 'class': 'OTHER'}, {'name': 'The Greater Good Science Center at the University of California, Berkeley', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}