Transdiagnostic PsychopathologyNCT05199779
Single Session Intervention for Building Self-Compassion Habits-RCT
A study testing Single Session Intervention Leveraging an Ultra-Brief Self-Compassion Exercise in people with Transdiagnostic Psychopathology, run by University of California, Berkeley at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transdiagnostic Psychopathology
- What is being tested?
- Single Session Intervention Leveraging an Ultra-Brief Self-Compassion Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2022to 29 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- English language proficiency.
- Able and willing to give informed consent.
Who cannot join
- Does not have email address or access to email.
- Not able/willing to participate in and/or complete the pre-treatment assessments
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California at Berkeley
Berkeley, California, 94720-1650
About this study
Official title: A Single Session Intervention Leveraging an Ultra-Brief Exercise for Building Self-Compassion Habits-A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Transdiagnostic Psychopathology
- Being tested
- Single Session Intervention Leveraging an Ultra-Brief Self-Compassion Exercise, Finger-Tapping Active Control
- Keywords
- Self-Compassion, Habits, Transdiagnostic, Intervention
- Medical subject headings
- Habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Session Intervention Leveraging an Ultra-Brief Self-Compassion ExerciseBehavioural
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.
Finger-Tapping Active ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Finger-Tapping Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Change from baseline to post-treatment (week 4)
Self-Report Behavioral Automaticity Index for Self-Compassion
20 items. 1-9 scale.
Measured: Change from baseline to post-treatment (week 4)
Secondary outcomes (3)
State Self-Compassion Scale Long Form (SSCS-L)
9 items. 1-5 scale. Scores range from 9-45. Mindfulness, common humanity, and self-kindness sub-scales only.
Measured: 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
4 items. 1-9 scale.
Measured: Change from baseline to post-treatment (week 4)
Real Self Overlap Scale
1 item. 1-8 scale.
Measured: Change from baseline to post-treatment (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start13 Feb 2022
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transdiagnostic PsychopathologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to the SCI or AC control using the randomizer elements in Qualtrics.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Harvey, University of California, Berkeley
- Investigators
- Allison Harvey, PhD, Principal investigator, University of California, BerkeleyEli S Susman, BA, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199779
- Sponsor's protocol ID
- 2021-12-14924
- Status last verified
- May 2022
- First submitted
- 5 Jan 2022
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38412573
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Session Intervention Leveraging an Ultra-Brief Exercise for Building Self-Compassion Habits-A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05199779
- Acronym / sponsor ID
- 2021-12-14924
- Conditions
- Transdiagnostic Psychopathology
- Keywords
- Self-Compassion, Habits, Transdiagnostic, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- 13 Feb 2022 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized to the SCI or AC control using the randomizer elements in Qualtrics.
| Arm | Type | Receives |
|---|---|---|
| Self-Compassion Intervention (SCI) | Experimental | Behavioral: Single Session Intervention Leveraging an Ultra-Brief Self-Compassion ExerciseFirst, 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. |
| Finger-Tapping Active Control (AC) | Active comparator | Behavioral: Finger-Tapping Active ControlThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older.
- English language proficiency.
- Able and willing to give informed consent.
Key exclusion criteria (2 listed)
- Does not have email address or access to email.
- Not able/willing to participate in and/or complete the pre-treatment assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Session Intervention Leveraging an Ultra-Brief Self-Compassion ExerciseThis 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. | Behavioural | Self-Compassion Intervention (SCI) |
| Finger-Tapping Active ControlThis 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. | Behavioural | Finger-Tapping Active Control (AC) |
Primary outcome
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Time frame: Change from baseline to post-treatment (week 4)
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.
Kind of Person' Implicit Theory Scale (KOPITS)
Time frame: Change from baseline to post-treatment (week 4)
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)
Positive and Negative Affect Schedule (PANAS)
Time frame: Change from baseline to post-treatment (week 4)
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.
10-item Perceived-Stress Scale (PSS-10)
Time frame: Change from baseline to post-treatment (week 4)
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.
DSM-5 Cross-Cutting Measure (DSM-XC)
Time frame: Change from baseline to post-treatment (week 4)
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).
Self-Report Behavioral Automaticity Index for Self-Compassion
Time frame: Change from baseline to post-treatment (week 4)
20 items. 1-9 scale.
3 secondary outcomes
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)
Self-Report Behavioral Automaticity Index for Exercise
Time frame: Change from baseline to post-treatment (week 4)
Real Self Overlap Scale
Time frame: Change from baseline to post-treatment (week 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 38412573Susman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Harvey, PhD principal investigator
University of California, Berkeley
Eli S Susman, BA principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Session Intervention Leveraging an Ultra-Brief Self-Compassion Exercise in people with Transdiagnostic Psychopathology, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sussex-Oxford Compassion for the Self Scale (SOCS-S) (time frame: Change from baseline to post-treatment (week 4)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05199779, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.