NCT05866718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
497

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

June 14, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2024

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

1.3 years

First QC Date

May 10, 2023

Last Update Submit

December 23, 2025

Conditions

Keywords

Self-CompassionSingle-Session InterventionTransdiagnosticInterventionHabitsHabit FormationMicropracticeContemplative MicropracticeContemplative PracticeSelf-Compassionate TouchCompassion

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

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

    Change from baseline to 3-month follow-up, and to 6-month followup

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

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

  • Perceived Stress (Perceived-Stress Scale [PSS-10])

    Change from baseline to 3-month follow-up, and to 6-month followup

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

    Change from baseline to 3-month follow-up, and to 6-month followup

Other Outcomes (2)

  • Barriers and Facilitators

    Assessed at 6-month followup

  • Acceptability and Feasibility (Program Feedback Scale [PFS])

    Assessed at 6-month followup

Study Arms (2)

Self-Compassionate Touch Intervention Alone

ACTIVE COMPARATOR

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

Self-Compassionate Touch Intervention Plus Habit Formation Tools

EXPERIMENTAL

SCT+HABITS participants will receive the abovementioned procedures, and will also receive evidence-based tools for forming habits.

Behavioral: Self-Compassionate Touch InterventionBehavioral: Habit Formation Tools

Interventions

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

Self-Compassionate Touch Intervention AloneSelf-Compassionate Touch Intervention Plus Habit Formation Tools

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

Self-Compassionate Touch Intervention Plus Habit Formation Tools

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older.
  • English language proficiency.
  • Able and willing to give informed consent.
  • Resides in the United States of America

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California at Berkeley

Berkeley, California, 94720-1650, United States

Location

MeSH Terms

Conditions

Habits

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Eli S Susman

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Study participants will not be made aware that there are two experimental conditions. All will be told that they are receiving the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to the SCT or SCT+HABITS using the randomizer elements in Qualtrics.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 19, 2023

Study Start

June 14, 2023

Primary Completion

September 22, 2024

Study Completion

September 22, 2024

Last Updated

December 31, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Data will be shared via the Open Science Framework by time of publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will be shared via the Open Science Framework by time of publication.
Access Criteria
De-identified data, materials and analytic code will be made publicly available

Locations