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: Unknown
• Conditions: Depression
• Intervention / Treatment: Behavioral: Self-Compassion Step by Step; Behavioral: Self-Reflection Active Control

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shadi Beshai, PhD; Phone Number: 306-585-4026; Email: shadi.beshai@uregina.ca
• Study Contact Backup: Name: Mabel Yu, MA; Phone Number: 306-585-4459; Email: m.mabelyu@gmail.com

Study Locations

• Canada
  • Regina, Canada
    • Recruiting
    • DCC Lab
    • Contact: Shadi Beshai; Phone Number: 306-585-4026
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4S0A2
      • Recruiting
      • University of Regina
      • Contact: Shadi Beshai, Ph.D
      • Contact: Mabel Yu, M.Sc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

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.	Behavioral: Self-Compassion Step by Step; 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.	Behavioral: Self-Reflection Active Control; 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)	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 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	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)	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	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	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)	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: University of Regina
• Collaborators: University of Oxford; University of Amsterdam; Saskatchewan Health Research Foundation
• Investigators: Principal Investigator: Shadi Beshai, PhD, University of Regina

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 2018-229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No