NCT05199779

Brief Summary

The study will test a single session self-compassion intervention that leverages an ultra-brief contemplative exercise. It will evaluate the effect of this intervention on psychopathology, stress, growth mindset, positive affect, self-compassion and the automaticity of self-compassion, as well as the relationships between these constructs and the automaticity of self-compassion. The participants will be undergraduate students at a large public university.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

February 13, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2022

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

January 5, 2022

Last Update Submit

May 14, 2022

Conditions

Keywords

Self-CompassionHabitsTransdiagnosticIntervention

Outcome Measures

Primary Outcomes (6)

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

    Sum of 20-item, 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 post-treatment (week 4)

  • Kind of Person' Implicit Theory Scale (KOPITS)

    8 items. 6-point response scale (1 = strongly agree; 6 = strongly disagree) Higher scores indicate a more growth mindset. Lower scores indicate a more fixed mindset. Score is sum of all items, with Q3, Q5, Q7, and Q8 reverse-scored. The formula for reverse-scoring an item is: ((Number of scale points) + 1) - (Respondent's answer)

    Change from baseline to post-treatment (week 4)

  • Positive and Negative Affect Schedule (PANAS)

    10 items with a 6 point response scale. Positive affect sub-scale only. Scoring: Positive Affect Score: Sum score of 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores range from 10 - 50. Higher scores = higher levels of positive affect. Negative Affect Score: Sum score of 2, 4, 6, 7, 8, 11, 13, 15, 18, and 20. Scores range from 10 - 50. Lower scores = lower levels of negative affect.

    Change from baseline to post-treatment (week 4)

  • 10-item Perceived-Stress Scale (PSS-10)

    10 items, 5 point response scale (from 0 = Never to 4 = Very Often) 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 post-treatment (week 4)

  • 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 post-treatment (week 4)

  • Self-Report Behavioral Automaticity Index for Self-Compassion

    20 items. 1-9 scale.

    Change from baseline to post-treatment (week 4)

Secondary Outcomes (3)

  • State Self-Compassion Scale Long Form (SSCS-L)

    Change from pre-induction to post-induction at baseline and at post-treatment (week 4). Change in pre to post-induction changes in state self-compassion from baseline to post-treatment (week 4)

  • Self-Report Behavioral Automaticity Index for Exercise

    Change from baseline to post-treatment (week 4)

  • Real Self Overlap Scale

    Change from baseline to post-treatment (week 4)

Other Outcomes (5)

  • Practice Frequency

    Assessed at Post-treatment (week 4)

  • Overall Practice Frequency

    Assessed at Post-treatment (week 4)

  • Practice Duration

    Assessed at Post-treatment (week 4)

  • +2 more other outcomes

Study Arms (2)

Self-Compassion Intervention (SCI)

EXPERIMENTAL

First, participants will be taught to implement a 20-second self-compassion induction via video recording. Second, participants will be taught to choose a cue that will precede their daily use of the self-compassion induction. Participants will document the cue they chose, and will be emailed a record of their selected cue, along with the recording and transcript of the self-compassion induction that they can refer back to for reference. Third, participants will be asked to use the self-compassion induction as much as they can and at least once during their daily routine following exposure to their chosen cue.

Behavioral: Single Session Intervention Leveraging an Ultra-Brief Self-Compassion Exercise

Finger-Tapping Active Control (AC)

ACTIVE COMPARATOR

The active control will receive the same procedures as described above, except for receiving a different video containing different instructions describing a finger-tapping exercise. The videos will be virtually identical in length, quality, instructor/their outfit, and lighting.

Behavioral: Finger-Tapping Active Control

Interventions

This 20-second contemplative exercise includes draws from the science of habit formation and includes elements of self-soothing touch, somatic experiencing, and mindful self-compassion.

Self-Compassion Intervention (SCI)

This 20-second finger tapping exercise involves touching each finger to the thumb on one hand and repeating for twenty seconds. This intervention was designed to control for the potential effect of assessment on outcomes, the effect of having an activity to do for the duration of the intervention (4 weeks), regression to the mean, time, or other nonspecific factors.

Finger-Tapping Active Control (AC)

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.

You may not qualify if:

  • Does not have email address or access to email.
  • Not able/willing to participate in and/or complete the pre-treatment 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

Related Publications (1)

  • Susman ES, Chen S, Kring AM, Harvey AG. Daily micropractice can augment single-session interventions: A randomized controlled trial of self-compassionate touch and examining their associations with habit formation in US college students. Behav Res Ther. 2024 Apr;175:104498. doi: 10.1016/j.brat.2024.104498. Epub 2024 Feb 21.

MeSH Terms

Conditions

Habits

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Allison Harvey, PhD

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR
  • Eli S Susman, BA

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
To reduce bias in the assessments, none of the constructs of interest to this study (e.g., "stress", "self-compassion") will be included in the language used to describe the intervention or in any materials used to advertise the study. Study participants will be told they are participating in a study on "fostering emotional well-being". No further information about the intervention will be provided.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to the SCI or AC control using the randomizer elements in Qualtrics.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Psychology

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 20, 2022

Study Start

February 13, 2022

Primary Completion

April 29, 2022

Study Completion

April 29, 2022

Last Updated

May 17, 2022

Record last verified: 2022-05

Locations