Can Applying the Science of Habit Formation to Contemplative Practice Improve Outcomes

Not Applicable

Active, not recruiting

• Conditions: Psychopathology

• Registration Number: NCT05866718
• Lead Sponsor: University of California, Berkeley

Brief Summary

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.

Detailed Description

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.

Specific 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.

Specific 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.

Exploratory 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.

Study Timeline

• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-18
• Study First Posted: 2023-05-19
• Study Start: 2023-06-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

• 18 years of age or older.
• English language proficiency.
• Able and willing to give informed consent.
• Resides in the United States of America

Exclusion Criteria

• Does not have email address or access to email.
• Does not personally own a smartphone device
• Not able/willing to participate in and/or complete the baseline assessments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Practice Frequency	Change from baseline to 3-month follow-up, and to 6-month followup	Number of times practiced self-compassion exercise per week since last assessment. 1 item. Higher frequency indicates a better outcome.
Practice Automaticity (Practice Self-Report Behavioral Automaticity Index [SRBAI])	Change from baseline to 3-month follow-up, and to 6-month follow-up.	4 items, 1-9 scale. Higher scores indicate a better outcome.

Secondary Outcome Measures

Name	Time	Method
Perceived Stress (Perceived-Stress Scale [PSS-10])	Change from baseline to 3-month follow-up, and to 6-month followup	10 items, 5 point response scale (from 0 = Never to 4 = Very Often). Lower scores indicate a better outcome.; Scoring: 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.
Psychopathology (DSM-5 Cross-Cutting Measure [DSM-XC])	Change from baseline to 3-month follow-up, and to 6-month followup	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).
Self-Compassion Automaticity (Self-Compassion Self-Report Behavioral Automaticity Index [SRBAI])	Change from baseline to 3-month follow-up, and to 6-month followup.	20 items. 1-9 scale. Higher scores indicate a better outcome.
Self-Compassion (Sussex-Oxford Compassion for the Self Scale [SOCS-S])	Change from baseline to 3-month follow-up, and to 6-month followup	20-items, 5-point response scale. Scores can range from 20 to 100 (Higher score means higher compassion for self). Sub-scale items included.

Trial Locations

Locations (1)

University of California at Berkeley; 🇺🇸 Berkeley, California, United States