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Completed

NCT Number: NCT05866718

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

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.

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Key information

Conditions

Psychopathology Behavior Habits

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California at Berkeley

Berkeley, California, 94720-1650, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-Compassionate Touch Intervention

Behavioral

Participants will be taught the micropractice (<20-second/day personal practice) via video recording.

Habit Formation Tools

Behavioral

Participants will receive evidence-based tools for promoting habit-formation.

Primary outcomes

  1. Practice Frequency

    Time frame: 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.

  2. Practice Automaticity (Practice Self-Report Behavioral Automaticity Index [SRBAI])

    Time frame: 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 outcomes

  1. Self-Compassion (Sussex-Oxford Compassion for the Self Scale [SOCS-S])

    Time frame: 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.

  2. Self-Compassion Automaticity (Self-Compassion Self-Report Behavioral Automaticity Index [SRBAI])

    Time frame: Change from baseline to 3-month follow-up, and to 6-month followup.

    20 items. 1-9 scale. Higher scores indicate a better outcome.

  3. Perceived Stress (Perceived-Stress Scale [PSS-10])

    Time frame: 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.

  4. Psychopathology (DSM-5 Cross-Cutting Measure [DSM-XC])

    Time frame: 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).

Other outcomes

  1. Barriers and Facilitators

    Time frame: Assessed at 6-month followup

    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.

  2. Acceptability and Feasibility (Program Feedback Scale [PFS])

    Time frame: Assessed at 6-month followup

    7 Items. 5-point scale (1="really disagree"; 5="totally agree")

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 19, 2023
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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