Clinical trial NCT04572035: Exercise + Self-Compassion Intervention for Depression
Official title: Feasibility, Acceptability and Effectiveness of a Structured Exercise + Psychoeducation Program for Students With Depression - A Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility of intervention (recruitment)
timeFrame: From recruitment to baseline
measure: Feasibility of intervention (compliance)
timeFrame: From baseline to 3-month follow-up
measure: Feasibility of intervention (completion)
timeFrame: From baseline to 3-month follow-up
measure: Feasibility of intervention (delivery)
timeFrame: From recruitment to post-intervention
measure: Acceptability of intervention
timeFrame: Post-intervention
measure: Effectiveness of intervention (depressive symptoms)
timeFrame: From baseline to 3-month follow-up.
measure: Effectiveness of intervention (exercise behaviour)
timeFrame: From baseline to 3-month follow-up.
Secondary outcomes:
measure: Effectiveness of psychological component (depressive symptoms)
timeFrame: From baseline to 3-month follow-up.
measure: Effectiveness of psychological component (exercise behaviour)
timeFrame: From baseline to 3-month follow-up.
measure: Effectiveness of psychological component (compliance)
timeFrame: From baseline to 3-month follow-up.
Other outcomes:
Locations:
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
References:
citation: 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.
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.
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.