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Exercise + Self-Compassion Intervention for Depression

Not Applicable
Completed
Conditions
Depression
Registration Number
NCT04572035
Lead Sponsor
Western University, Canada
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Feasibility of intervention (compliance)From baseline to 3-month follow-up

Proportion of program sessions attended (and reasons for non-attendance); proportion of participants that complete surveys

Feasibility of intervention (completion)From baseline to 3-month follow-up

Proportion of participants who drop-out prior to program completion

Effectiveness of intervention (depressive symptoms)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

Effectiveness of intervention (exercise behaviour)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

Feasibility of intervention (delivery)From recruitment to post-intervention

Proportion of eligible peer facilitators that maintain their participation in the full intervention

Feasibility of intervention (recruitment)From recruitment to baseline

Proportion of screened individuals choosing to participate (and reasons for not participating)

Acceptability of interventionPost-intervention

Treatment Acceptability Questionnaire - mean score ranging from 1 (low acceptability) to 7 (high acceptability)

Secondary Outcome Measures
NameTimeMethod
Effectiveness of psychological component (depressive symptoms)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)

Effectiveness of psychological component (compliance)From baseline to 3-month follow-up.

Treatment arm difference in compliance (attendance in program sessions)

Effectiveness of psychological component (exercise behaviour)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

Trial Locations

Locations (1)

Western University

🇨🇦

London, Ontario, Canada

Western University
🇨🇦London, Ontario, Canada
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