- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05199779
Single Session Intervention for Building Self-Compassion Habits-RCT
A Single Session Intervention Leveraging an Ultra-Brief Exercise for Building Self-Compassion Habits-A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
The broad aims of the proposed research is to examine the outcomes of a single session psychological intervention and to further understand processes and factors associated with habit formation. undergraduate students at a large university will be randomly assigned to a self-compassion intervention (SCI), or an active control (AC), and complete assessments at baseline (pre-treatment) and 4 weeks later (post-treatment).
The investigators seek to examine the following: (A1) Determine whether the group who receives the SCI, relative to the AC, will experience increased self-compassion, growth mindset and positive affect, as well as reduced stress and psychopathology. (A2) Evaluate whether the SCI group shows greater increases in automaticity of self-compassion compared to the AC pre- to post-treatment. (A3) Assess whether greater pre- to post-treatment increases in automaticity of self-compassionate are associated with increased self-compassion, growth mindset, and positive affect, as well as reductions in stress and psychopathology.
The investigators hypothesize the following: (H1) SCI will promote greater increases in self-compassion, growth mindset, and positive affect, as well as greater reductions in stress and psychopathology from pre- to post-treatment, relative to AC. (H2) The SCI group will show greater increases in the automaticity of self-compassion than AC from pre- to post-treatment. (H3) Greater increases in the automaticity of self-compassion from pre- to post-treatment will be predicted by greater increases in self-compassion, growth mindset, and positive affect, as well as greater decreases in psychopathology and stress, from pre- to post treatment. To further understand the results obtained, the investigators will evaluate participants' frequency, adherence, and impressions of using the intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Berkeley, California, United States, 94720-1650
- University of California at Berkeley
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years of age or older.
- English language proficiency.
- Able and willing to give informed consent.
Exclusion Criteria:
- Does not have email address or access to email.
- Not able/willing to participate in and/or complete the pre-treatment assessments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Self-Compassion Intervention (SCI)
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.
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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.
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Active Comparator: Finger-Tapping Active Control (AC)
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Time Frame: Change from baseline to post-treatment (week 4)
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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)
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Kind of Person' Implicit Theory Scale (KOPITS)
Time Frame: Change from baseline to post-treatment (week 4)
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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)
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Positive and Negative Affect Schedule (PANAS)
Time Frame: Change from baseline to post-treatment (week 4)
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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)
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10-item Perceived-Stress Scale (PSS-10)
Time Frame: Change from baseline to post-treatment (week 4)
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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)
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DSM-5 Cross-Cutting Measure (DSM-XC)
Time Frame: Change from baseline to post-treatment (week 4)
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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).
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Change from baseline to post-treatment (week 4)
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Self-Report Behavioral Automaticity Index for Self-Compassion
Time Frame: Change from baseline to post-treatment (week 4)
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20 items. 1-9 scale.
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Change from baseline to post-treatment (week 4)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
State Self-Compassion Scale Long Form (SSCS-L)
Time Frame: 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)
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9 items.
1-5 scale.
Scores range from 9-45.
Mindfulness, common humanity, and self-kindness sub-scales only.
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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)
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Self-Report Behavioral Automaticity Index for Exercise
Time Frame: Change from baseline to post-treatment (week 4)
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4 items. 1-9 scale.
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Change from baseline to post-treatment (week 4)
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Real Self Overlap Scale
Time Frame: Change from baseline to post-treatment (week 4)
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1 item. 1-8 scale.
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Change from baseline to post-treatment (week 4)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Practice Frequency
Time Frame: Assessed at Post-treatment (week 4)
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Number of times practiced self-compassion exercise per day. 1 item.
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Assessed at Post-treatment (week 4)
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Overall Practice Frequency
Time Frame: Assessed at Post-treatment (week 4)
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Number of days in the past two months that did not practice the exercise at all. 1 item.
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Assessed at Post-treatment (week 4)
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Practice Duration
Time Frame: Assessed at Post-treatment (week 4)
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1 item, number of days practiced exercise but for less than 10 seconds.
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Assessed at Post-treatment (week 4)
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Adherence Report Scale
Time Frame: Assessed at Post-treatment (week 4)
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10 items on a five-point scale, where 5 = never, 4 = rarely, 3 = sometimes, 2 = often and 1 = always.
Scores for each item were summed to give a total score, with higher scores indicating higher levels of reported adherence.
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Assessed at Post-treatment (week 4)
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General impressions of exercise
Time Frame: Assessed at Post-treatment (week 4)
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Exploratory qualitative assessment.
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Assessed at Post-treatment (week 4)
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Collaborators and Investigators
Investigators
- Principal Investigator: Eli S Susman, BA, University of California, Berkeley
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021-12-14924
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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