Exercise + Self-Compassion Intervention for Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04572035
• Other study ID #: 2020-0000-E
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2023
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Behavioural Coaching
behaviour change strategies (i.e., action planning, implementation intentions, relapse prevention, and goal setting)
• Self-compassion psychoeducation
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

Locations

Country	Name	City	State
Canada	Western University	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of intervention (recruitment)	Proportion of screened individuals choosing to participate (and reasons for not participating)	From recruitment to baseline
Primary	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
Primary	Feasibility of intervention (completion)	Proportion of participants who drop-out prior to program completion	From baseline to 3-month follow-up
Primary	Feasibility of intervention (delivery)	Proportion of eligible peer facilitators that maintain their participation in the full intervention	From recruitment to post-intervention
Primary	Acceptability of intervention	Treatment Acceptability Questionnaire - mean score ranging from 1 (low acceptability) to 7 (high acceptability)	Post-intervention
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	Effectiveness of psychological component (compliance)	Treatment arm difference in compliance (attendance in program sessions)	From baseline to 3-month follow-up.