Depression Clinical Trial
Official title:
Feasibility, Acceptability and Effectiveness of a Structured Exercise + Psychoeducation Program for Students With Depression - A Proof of Concept Study
Verified date | April 2023 |
Source | Western University, Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Western University | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Western University, Canada |
Canada,
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
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. |
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