The Self-Compassion Online - Preventing Depression Trial

NCT ID: NCT04350814

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2024-05-01

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Self-Compassion Step by Step

Intervention Type: BEHAVIORAL

This is a 6-lesson self-guided audio program by Dr. Kristen Neff (2013)

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.

Group Type: ACTIVE_COMPARATOR

Self-Reflection Active Control

Intervention Type: BEHAVIORAL

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.

Interventions

Self-Compassion Step by Step

This is a 6-lesson self-guided audio program by Dr. Kristen Neff (2013)

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saskatchewan Health Research Foundation

OTHER

Sponsor Role: collaborator

University of Amsterdam

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: collaborator

University of Regina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shadi Beshai, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Regina

Locations

University of Regina

Regina, Saskatchewan, Canada

DCC Lab

Regina, , Canada

Countries

Canada

Other Identifiers

2018-229

Identifier Type: -

Identifier Source: org_study_id