Clinical trial NCT05866718: Can Applying the Science of Habit Formation to Contemplative Practice Improve Outcomes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychopathology
Keywords: Self-Compassion
Single-Session Intervention
Transdiagnostic
Intervention
Habits
Habit Formation
Micropractice
Contemplative Micropractice
Contemplative Practice
Self-Compassionate Touch
Compassion
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: Mind and Life Institute, Hadley, Massachusetts
name: The Greater Good Science Center at the University of California, Berkeley
First posted: 2023-05-19
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to the SCT or SCT+HABITS using the randomizer elements in Qualtrics.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Practice Frequency
timeFrame: Change from baseline to 3-month follow-up, and to 6-month followup
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.
Secondary outcomes:
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
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.
measure: Perceived Stress (Perceived-Stress Scale [PSS-10])
timeFrame: Change from baseline to 3-month follow-up, and to 6-month followup
measure: Psychopathology (DSM-5 Cross-Cutting Measure [DSM-XC])
timeFrame: Change from baseline to 3-month follow-up, and to 6-month followup
Other outcomes:
measure: Barriers and Facilitators
timeFrame: Assessed at 6-month followup
measure: Acceptability and Feasibility (Program Feedback Scale [PFS])
timeFrame: Assessed at 6-month followup
Locations:
city: Berkeley
country: United States
facility: University of California at Berkeley
state: California
Study officials:
affiliation: University of California, Berkeley
name: Eli S Susman
role: PRINCIPAL_INVESTIGATOR
References: