Clinical trial NCT04350814: The Self-Compassion Online - Preventing Depression Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Saskatchewan Health Research Foundation
name: University of Amsterdam
name: University of Oxford
First posted: 2020-04-17
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Longitudinal Interval Follow-UP Evaluation - Structured Clinical Interview (LIFE-SCID)
timeFrame: 12 Months
measure: Weeks to Relapse
timeFrame: 12 Months
measure: Scores on the Patient Health Questionnaire - 9 over 12-months
timeFrame: 12 Months
Secondary outcomes:
measure: Self-Compassion Scale (SCS)
timeFrame: Post-intervention, 3, 6, 9, and 12 Months
measure: Five-Facet Mindfulness Questionnaire-15
timeFrame: Post-intervention, 3, 6, 9, and 12 Months
measure: Experiences Questionnaire-Decentering
timeFrame: Post-intervention, 3, 6, 9, and 12 Months
measure: Fears of Compassion Scales (FCS)
timeFrame: Post-intervention, 3, 6, 9, and 12 Months
Other outcomes:
Locations:
city: Regina
country: Canada
facility: University of Regina
state: Saskatchewan
city: Regina
country: Canada
facility: DCC Lab
Study officials:
affiliation: University of Regina
name: Shadi Beshai, PhD
role: PRINCIPAL_INVESTIGATOR
References: