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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Psychopathology

Intervention / Treatment
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* Behavioral: Self-Compassionate Touch Intervention
* Behavioral: Habit Formation Tools


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to the SCT or SCT+HABITS using the randomizer elements in Qualtrics.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self-Compassionate Touch Intervention Alone<br>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). | Behavioral: Self-Compassionate Touch Intervention<br>* Participants will be taught the micropractice (<20-second/day personal practice) via video recording.<br>|
| Experimental: Self-Compassionate Touch Intervention Plus Habit Formation Tools<br>SCT+HABITS participants will receive the abovementioned procedures, and will also receive evidence-based tools for forming habits. | Behavioral: Self-Compassionate Touch Intervention<br>* Participants will be taught the micropractice (<20-second/day personal practice) via video recording.<br>Behavioral: Habit Formation Tools<br>* Participants will receive evidence-based tools for promoting habit-formation.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Compassion (Sussex-Oxford Compassion for the Self Scale [SOCS-S]) | 20-items, 5-point response scale. Scores can range from 20 to 100 (Higher score means higher compassion for self). Sub-scale items included. | Change from baseline to 3-month follow-up, and to 6-month followup | 
| Self-Compassion Automaticity (Self-Compassion Self-Report Behavioral Automaticity Index [SRBAI]) | 20 items. 1-9 scale. Higher scores indicate a better outcome. | Change from baseline to 3-month follow-up, and to 6-month followup. | 
| Perceived Stress (Perceived-Stress Scale [PSS-10]) | 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. | Change from baseline to 3-month follow-up, and to 6-month followup | 
| Psychopathology (DSM-5 Cross-Cutting Measure [DSM-XC]) | 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). | Change from baseline to 3-month follow-up, and to 6-month followup | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-Compassion, Single-Session Intervention, Transdiagnostic, Intervention, Habits, Habit Formation, Micropractice, Contemplative Micropractice, Contemplative Practice, Self-Compassionate Touch, Compassion