Exercise + Self-Compassion Intervention for Depression

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: Completed
• Conditions: Depression
• Intervention / Treatment: Other: Exercise; Behavioral: Self-compassion psychoeducation; Behavioral: Behavioural Coaching

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: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Feasibility of intervention (recruitment)	Proportion of screened individuals choosing to participate (and reasons for not participating)	From recruitment to baseline
Feasibility of intervention (compliance)	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)	Proportion of participants who drop-out prior to program completion	From baseline to 3-month follow-up
Feasibility of intervention (delivery)	Proportion of eligible peer facilitators that maintain their participation in the full intervention	From recruitment to post-intervention
Acceptability of intervention	Treatment Acceptability Questionnaire - mean score ranging from 1 (low acceptability) to 7 (high acceptability)	Post-intervention
Effectiveness of intervention (depressive symptoms)	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)	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

Outcome Measure	Measure Description	Time Frame
Effectiveness of psychological component (depressive symptoms)	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)	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)	Treatment arm difference in compliance (attendance in program sessions)	From baseline to 3-month follow-up.

Collaborators and Investigators

• Sponsor: Western University, Canada

Publications and helpful links

General Publications

• KARVONEN MJ, KENTALA E, MUSTALA O. The effects of training on heart rate; a longitudinal study. Ann Med Exp Biol Fenn. 1957;35(3):307-15. No abstract available.
• Prapavessis H, De Jesus S, Fitzgeorge L, Faulkner G, Maddison R, Batten S. Exercise to Enhance Smoking Cessation: the Getting Physical on Cigarette Randomized Control Trial. Ann Behav Med. 2016 Jun;50(3):358-69. doi: 10.1007/s12160-015-9761-9.
• Ravindran AV, Lam RW, Filteau MJ, Lesperance F, Kennedy SH, Parikh SV, Patten SB; Canadian Network for Mood and Anxiety Treatments (CANMAT). Canadian Network for Mood and Anxiety Treatments (CANMAT) Clinical guidelines for the management of major depressive disorder in adults. V. Complementary and alternative medicine treatments. J Affect Disord. 2009 Oct;117 Suppl 1:S54-64. doi: 10.1016/j.jad.2009.06.040. Epub 2009 Aug 8.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 27, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

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