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The Self-Compassion Online - Preventing Depression Trial (SCOPE)

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Self-Compassion Step by Step
Self-Reflection Active Control
Sponsored by
University of Regina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of ReginaRecruiting
  • DCC LabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-Compassion Intervention Arm

Self-Reflection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
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).
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)

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
April 14, 2020
Last Updated
April 14, 2020
Sponsor
University of Regina
Collaborators
Saskatchewan Health Research Foundation, University of Amsterdam, University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT04350814
Brief Title
The Self-Compassion Online - Preventing Depression Trial
Acronym
SCOPE
Official Title
Efficacy of a Self-Compassion Intervention to Prevent Relapse and Recurrence of Depression: Fostering Trait Resilience to Disrupt the Cycle of Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Regina
Collaborators
Saskatchewan Health Research Foundation, University of Amsterdam, University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators will randomly assign participants to one of two conditions, and monitor their symptoms for 12 months. After the 12-months assessment period is complete, the investigators will offer the intervention to participants assigned to the active control condition to use at their own discretion.
Masking
Investigator
Masking Description
No research assistants involved in participant assessment, nor is the primary investigator, aware of which condition participants are assigned to. This masking will be monitored and conducted by a lab staff member not directly involved in the study.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-Compassion Intervention Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Self-Reflection
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-Compassion Step by Step
Intervention Description
This is a 6-lesson self-guided audio program by Dr. Kristen Neff (2013)
Intervention Type
Behavioral
Intervention Name(s)
Self-Reflection Active Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Longitudinal Interval Follow-UP Evaluation - Structured Clinical Interview (LIFE-SCID)
Description
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)
Time Frame
12 Months
Title
Weeks to Relapse
Description
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).
Time Frame
12 Months
Title
Scores on the Patient Health Questionnaire - 9 over 12-months
Description
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)
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Self-Compassion Scale (SCS)
Description
This is a measure of dispositional self-compassion. Scores range from 12-60, with higher scores indicative of greater dispositional self-compassion.
Time Frame
Post-intervention, 3, 6, 9, and 12 Months
Title
Five-Facet Mindfulness Questionnaire-15
Description
This is a measure of dispositional mindfulness skills. Scores range from 15-75, with higher scores indicative of greater dispositional mindfulness.
Time Frame
Post-intervention, 3, 6, 9, and 12 Months
Title
Experiences Questionnaire-Decentering
Description
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.
Time Frame
Post-intervention, 3, 6, 9, and 12 Months
Title
Fears of Compassion Scales (FCS)
Description
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.
Time Frame
Post-intervention, 3, 6, 9, and 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shadi Beshai, PhD
Phone
306-585-4026
Email
shadi.beshai@uregina.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mabel Yu, MA
Phone
306-585-4459
Email
m.mabelyu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shadi Beshai, PhD
Organizational Affiliation
University of Regina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Regina
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S0A2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shadi Beshai, Ph.D
First Name & Middle Initial & Last Name & Degree
Mabel Yu, M.Sc.
Facility Name
DCC Lab
City
Regina
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shadi Beshai
Phone
306-585-4026

12. IPD Sharing Statement

Plan to Share IPD
No

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The Self-Compassion Online - Preventing Depression Trial

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