Exercise + Self-Compassion Intervention for Depression

April 24, 2023 updated by: Dr. Eva Pila, Western University, Canada

Feasibility, Acceptability and Effectiveness of a Structured Exercise + Psychoeducation Program for Students With Depression - A Proof of Concept Study

An alarming number of students report depressive symptoms that make it difficult to function academically. Previous research has indicated that exercise can be effective in treating mild-moderate depression. However, individuals with depression may struggle psychologically to adhere to exercise programs. Researchers have highlighted the potential role of self-compassion, a psychological approach that is useful in dealing with personal inadequacies, to facilitate health behaviour regulation. Behavioural coaching is another approach that consists of self-regulatory strategies such as action planning and less emphasis on emotion-focused strategies. The purpose of this study is to test the effectiveness of a structured exercise and psychoeducation program on improving depressive symptoms among inactive students with depression and to evaluate if the addition of psychological components (self-compassion or behavioural coaching) affects this effectiveness. Students with mild-to-moderate depression will refer themselves to participate or be referred/recommended by Student Health Services at Western University. The study will consist of attending 3 exercise + psychoeducation sessions per week for 10-weeks. Study participants will be randomly allocated to one of three groups; exercise only, exercise + self-compassion, or exercise + behavioral coaching. All will complete questionnaires before, after, and 3-months following the end of their sessions. It is expected that participants in the exercise + self-compassion or exercise + behaviour coaching groups will show greater improvements in their depressive symptoms, program adherence and follow-up exercise behaviour and depression after 3 months than the exercise only group and that the exercise + self-compassion group will be superior to the exercise + behavioural coaching group in those measurements.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a 10-week randomized parallel study assessing the effectiveness of exercise in reducing depressive symptoms among students with mild-to-moderate depression. This study has three treatment arms: exercise; exercise + self-compassion; exercise + behavioral coaching. Each participant will be invited to attend 3 supervised group-based sessions each week either virtually through Zoom or in-person at the Exercise and Health Psychology Lab for 10 weeks. Senior undergraduate Kinesiology students will facilitate a personalized exercise program adapted to the participant's abilities, teach participants how to exercise, and gauge exercise intensity in a safe manner. The CANMAT guidelines will be implemented, with the program consisting of supervised moderate-intensity exercise sessions lasting 30-minutes (plus 10-minutes for warm-up and cool-down), 3 times weekly, for a period of 10-weeks. Participants will start exercising at a low intensity and progressively increase until they are consistently exercising at a moderate intensity. The exercise intervention will integrate moderate intensity aerobic and resistance training activities while accounting for the physical abilities and interests of the individual participant and theh group.The exercise + psychoeducation groups will receive equal contact supplemental individual manualized strategies each session (+15-20 minutes) centered either on behaviour change strategies (i.e., action planning, implementation intentions, relapse prevention, and goal setting) or self-compassion strategies (i.e., mindfulness, self-directed kindness meditations, and writing tasks). The manualized psychoeducation sessions will be group-based with the trainer that is supervising the exercise sessions. Participants will fill out surveys before, after and three months following the intervention period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Eva Pila, PhD
  • Phone Number: 519-661-2111
  • Email: epila@uwo.ca

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 3K7
        • Western University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Informed of the nature of the study and have agreed to and are able to read, review, and sign the informed consent form. The informed consent document will be written in English; therefore, the volunteer must have the ability to read and communicate in English.

  • Student participants 17 to 30 years of age, inclusive, at the time of screening.
  • Available and able to attend 3x group-based exercise training sessions per week.
  • Patient Health Questionnaire (PHQ)-9 score of >5
  • Godin Leisure-Time Exercise Questionnaire score of <14
  • Able to engage in physical activity as assessed by the PAR-Q
  • For Virtual Intervention Only: access to reliable internet connection and computer with a camera for the purpose of the Zoom Video calls

Exclusion criteria:

  • Participant receives pharmacological (i.e. medications listed in list of prohibited medications document) or psychotherapy treatment for depression or anxiety
  • Reports of suicide ideation (e.g., PHQ-9 item) and scores on the PHQ-9 >20 demonstrating severe depression
  • Failed safety screening for exercise without physician clearance
  • Participant initiates pharmacological or psychotherapy treatments for depression while in the study and/or participates in any other research that aims to target depression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise only
Undergraduate peer-facilitators part of a curricular kinesiology program will facilitate a personalized group-based exercise program adapted to the participant's abilities, teach participants how to exercise, and gauge exercise intensity in a safe manner (26). The CANMAT guidelines will be implemented, with the program consisting of supervised group-based moderate-intensity exercise sessions lasting 30-minutes (plus 10-minutes for warm-up and cool-down), 3 times weekly, for a period of 10-weeks. Participants will start exercising at a low intensity and progressively increase until they are consistently exercising at a moderate intensity. As a result of the uncertainty surrounding the pandemic, the intervention will be conducted either via a virtual platform or in-person at the Exercise and Health Psychology Lab, depending on the health and safety restrictions applicable to when the student enrolls and begins their program.
Other: Exercise
aerobic exercise program either delivered in a laboratory setting or via Zoom
Experimental: Exercise + Self-compassion
Participants will undergo the same exercise program as described in the exercise only treatment arm. Participants will receive equal contact supplemental individual manualized strategies each session (+15-20 minutes) centered on self-compassion strategies (i.e., mindfulness, self-directed kindness meditations, and writing tasks).
Other: Exercise
aerobic exercise program either delivered in a laboratory setting or via Zoom
Behavioral: Self-compassion psychoeducation
self-compassion strategies (i.e., mindfulness, self-directed kindness meditations, and writing tasks)
Experimental: Exercise + Behavioural Coaching
Participants will undergo the same exercise program as described in the exercise only treatment arm. Participants will receive equal contact supplemental individual manualized strategies each session (+15-20 minutes) centered on behaviour change strategies (i.e., action planning, implementation intentions, relapse prevention, and goal setting).
Other: Exercise
aerobic exercise program either delivered in a laboratory setting or via Zoom
Behavioral: Behavioural Coaching
behaviour change strategies (i.e., action planning, implementation intentions, relapse prevention, and goal setting)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of intervention (recruitment)
Time Frame: From recruitment to baseline
Proportion of screened individuals choosing to participate (and reasons for not participating)
From recruitment to baseline
Feasibility of intervention (compliance)
Time Frame: From baseline to 3-month follow-up
Proportion of program sessions attended (and reasons for non-attendance); proportion of participants that complete surveys
From baseline to 3-month follow-up
Feasibility of intervention (completion)
Time Frame: From baseline to 3-month follow-up
Proportion of participants who drop-out prior to program completion
From baseline to 3-month follow-up
Feasibility of intervention (delivery)
Time Frame: From recruitment to post-intervention
Proportion of eligible peer facilitators that maintain their participation in the full intervention
From recruitment to post-intervention
Acceptability of intervention
Time Frame: Post-intervention
Treatment Acceptability Questionnaire - mean score ranging from 1 (low acceptability) to 7 (high acceptability)
Post-intervention
Effectiveness of intervention (depressive symptoms)
Time Frame: From baseline to 3-month follow-up.
Change in depressive symptoms measured by Patient Health Questionnaire 9 - total score ranges from 0 (no symptoms) to 27 (severe symptoms) for all treatment arms
From baseline to 3-month follow-up.
Effectiveness of intervention (exercise behaviour)
Time Frame: From baseline to 3-month follow-up.
Change in exercise measured by Leisure Time Exercise Questionnaire - calculate Leisure Score Index with higher values indicating higher exercise frequency/intensity for all treatment arms
From baseline to 3-month follow-up.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effectiveness of psychological component (depressive symptoms)
Time Frame: From baseline to 3-month follow-up.
Treatment arm difference in changes in depressive symptoms measured by Patient Health Questionnaire 9 - total score ranges from 0 (no symptoms) to 27 (severe symptoms)
From baseline to 3-month follow-up.
Effectiveness of psychological component (exercise behaviour)
Time Frame: From baseline to 3-month follow-up.
Treatment arm difference in changes in exercise behaviour measured by Leisure Time Exercise Questionnaire - calculate Leisure Score Index with higher values indicating higher exercise frequency/intensity
From baseline to 3-month follow-up.
Effectiveness of psychological component (compliance)
Time Frame: From baseline to 3-month follow-up.
Treatment arm difference in compliance (attendance in program sessions)
From baseline to 3-month follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-0000-E

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

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.

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