Exercise + Self-Compassion Intervention for Depression

NCT ID: NCT04572035

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-06-30

Brief Summary

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.

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

aerobic exercise program either delivered in a laboratory setting or via Zoom

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).

Group Type: EXPERIMENTAL

Self-compassion psychoeducation

Intervention Type: BEHAVIORAL

self-compassion strategies (i.e., mindfulness, self-directed kindness meditations, and writing tasks)

Exercise

Intervention Type: OTHER

aerobic exercise program either delivered in a laboratory setting or via Zoom

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).

Group Type: EXPERIMENTAL

Behavioural Coaching

Intervention Type: BEHAVIORAL

behaviour change strategies (i.e., action planning, implementation intentions, relapse prevention, and goal setting)

Exercise

Intervention Type: OTHER

aerobic exercise program either delivered in a laboratory setting or via Zoom

Interventions

Behavioural Coaching

behaviour change strategies (i.e., action planning, implementation intentions, relapse prevention, and goal setting)

Intervention Type: BEHAVIORAL

Self-compassion psychoeducation

self-compassion strategies (i.e., mindfulness, self-directed kindness meditations, and writing tasks)

Intervention Type: BEHAVIORAL

Exercise

aerobic exercise program either delivered in a laboratory setting or via Zoom

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Dr. Eva Pila

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Western University

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 13470504 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26791022 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19666194 (View on PubMed)

Other Identifiers

2020-0000-E

Identifier Type: -

Identifier Source: org_study_id