The Self-Compassion Online - Preventing Depression Trial (SCOPE)
Efficacy of a Self-Compassion Intervention to Prevent Relapse and Recurrence of Depression: Fostering Trait Resilience to Disrupt the Cycle of Depression
Purpose: Depression affects 12.6% of Canadians at some point in their life. Depression is associated with staggering personal and economic costs. There are several treatments that have been shown to treat episodes of depression when they occur. Unfortunately, more than half who respond to these treatments go on to re-experience an episode of depression. Even with psychological and pharmacological interventions designed to prevent future episodes, relapse and recurrence of the disorder remain alarmingly high. A patient-focused and self-directed intervention that harnesses the effects of an Eastern-influenced concept, called self-compassion, has shown tremendous promise in treating acute depression. Self-compassion is being moved by one's own suffering, and a desire to alleviate such suffering.
Objectives: In the proposed project, the investigators will examine whether a self-compassion intervention is effective in preventing relapse/recurrence of depression over a 12-month period among people who are at high risk for relapse. The investigators will also examine whether the intervention works to prevent depression by increasing the innate ability to bounce back from stress, a concept known as resilience.
Methodology: 120 participants with a history of depression will be randomly assigned to the self-compassion intervention or a self-assessment reflection condition, and their respective relapse rates will be examined over a period of 12 months.
Importance to Research: This will be the first study to examine the effects of self-compassion as a preventive intervention for depression.
Impact on health: If successful, this new intervention can be used by thousands of people in Saskatchewan and Canada who are at risk for depression relapse.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Regina, Canada
- DCC Lab
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4S0A2
- University of Regina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- To be eligible to participate in the study, participants must be: a) 18 years old or older; b) have experienced at least one episode of depression; and c) exhibit elevated residual symptoms of depression-as indicated by a score of 5 or more on the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001). As the majority of people experience both depression and anxiety symptoms concurrently, participants experiencing elevated anxiety symptoms will not be excluded from the study.
Exclusion Criteria:
- Participants will be excluded from the study if they indicate: a) a current diagnosis MDD, substance use disorder, psychosis, or mania in accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5; American Psychiatric Association, 2013); b) the presence of major health conditions (e.g., cardiovascular diseases, cancer, hypothyroidism, etc.); and c) currently undergoing psychological or pharmacological treatment at the time of recruitment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-Compassion Intervention Arm
Participants randomized to this condition will receive access to the audio Mindful Self-Compassion self-help intervention.
The intervention is 7 weeks in duration (with a pacing of one lesson per week) and participants are asked to complete study measures once each week of the intervention.
|
This is a 6-lesson self-guided audio program by Dr. Kristen Neff (2013)
|
|
Active Comparator: Self-Reflection
Participants randomized to this active control condition will be asked to complete study measures at the same assessment intervals as those in the experimental arm.
In addition to completing the measures, participants in the Self-Reflection Active Control condition will be asked to reflect on their self-reported symptoms and changes they may have experienced between assessment intervals.
|
Participants randomized to this active control condition will be asked to complete study measures at the same intervals as those assigned to the intervention condition.
In addition to completing study questionnaires, participants in this arm will also be invited to reflect on their weekly reported symptoms, whether they experienced changed, what they believe these changes are attributed to, etc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Longitudinal Interval Follow-UP Evaluation - Structured Clinical Interview (LIFE-SCID)
Time Frame: 12 Months
|
Proportional rates of individuals meeting criteria for major depression episode in accordance with the LIFE-SCID post randomization over 12-months across two conditions. This measure is a diagnostic interview: Outcomes are binary (diagnosis vs. no diagnosis) |
12 Months
|
|
Weeks to Relapse
Time Frame: 12 Months
|
Time in weeks to confirmed MDE relapse during the assessment period This is a linear calculation of how many weeks participants stayed diagnosis free (higher is more weeks without a depressive relapse/recurrence). |
12 Months
|
|
Scores on the Patient Health Questionnaire - 9 over 12-months
Time Frame: 12 Months
|
Differences in depressive symptoms among those randomized to the intervention or active control condition at the 12-month assessment period This measure is a diagnostic interview: Outcomes are binary (diagnosis vs. no diagnosis) |
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Compassion Scale (SCS)
Time Frame: Post-intervention, 3, 6, 9, and 12 Months
|
This is a measure of dispositional self-compassion.
Scores range from 12-60, with higher scores indicative of greater dispositional self-compassion.
|
Post-intervention, 3, 6, 9, and 12 Months
|
|
Five-Facet Mindfulness Questionnaire-15
Time Frame: Post-intervention, 3, 6, 9, and 12 Months
|
This is a measure of dispositional mindfulness skills.
Scores range from 15-75, with higher scores indicative of greater dispositional mindfulness.
|
Post-intervention, 3, 6, 9, and 12 Months
|
|
Experiences Questionnaire-Decentering
Time Frame: Post-intervention, 3, 6, 9, and 12 Months
|
This is a measure of dispositional decentring abilities (viewing all experiences, including internal experiences, as passing events).
Scores range from 12-48, with higher scores indicative of greater decentring.
|
Post-intervention, 3, 6, 9, and 12 Months
|
|
Fears of Compassion Scales (FCS)
Time Frame: Post-intervention, 3, 6, 9, and 12 Months
|
This is a measure of the fear of showing one's self compassion.
Scores range from 10 to 50, with higher scores indicative of greater fears of self compassion.
|
Post-intervention, 3, 6, 9, and 12 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shadi Beshai, PhD, University of Regina
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-229
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.