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

Psychopathology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05866718
• Other study ID #: 2021-12-14924-2
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 14, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 440
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psychopathology

Intervention

Behavioral:
• Self-Compassionate Touch Intervention
Participants will be taught the micropractice (<20-second/day personal practice) via video recording.
• Habit Formation Tools
Participants will receive evidence-based tools for promoting habit-formation.

Locations

Country	Name	City	State
United States	University of California at Berkeley	Berkeley	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Berkeley	Mind and Life Institute, Hadley, Massachusetts, The Greater Good Science Center at the University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Acceptability and Feasibility (Program Feedback Scale [PFS])	7 Items. 5-point scale (1="really disagree"; 5="totally agree")	Assessed at 6-month followup
Primary	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
Primary	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	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
Secondary	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.
Secondary	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
Secondary	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