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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Psychopathology
• Intervention / Treatment: Behavioral: Self-Compassionate Touch Intervention; Behavioral: Habit Formation Tools

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 Type: Interventional
• Enrollment (Estimated): 440
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720-1650
      • University of California at Berkeley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability and Feasibility (Program Feedback Scale [PFS])	7 Items. 5-point scale (1="really disagree"; 5="totally agree")	Assessed at 6-month followup
Barriers and Facilitators	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.	Assessed at 6-month followup

Collaborators and Investigators

• Sponsor: University of California, Berkeley
• Collaborators: Mind and Life Institute, Hadley, Massachusetts; The Greater Good Science Center at the University of California, Berkeley
• Investigators: Principal Investigator: Eli S Susman, University of California, Berkeley

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Intervention; Self-Compassion; Habits; Transdiagnostic; Compassion; Habit Formation; Single-Session Intervention; Micropractice; Contemplative Micropractice; Contemplative Practice; Self-Compassionate Touch
• Other Study ID Numbers: 2021-12-14924-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared via the Open Science Framework by time of publication.
• IPD Sharing Time Frame: Data will be shared via the Open Science Framework by time of publication.
• IPD Sharing Access Criteria: De-identified data, materials and analytic code will be made publicly available
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No