Exercise + Self-Compassion Intervention for Depression

NCT04572035 | Completed

• 1 other identifier: 2020-0000-E
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (7)

• Feasibility of intervention (recruitment)

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

  From recruitment to baseline

• 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

• Feasibility of intervention (completion)

  Proportion of participants who drop-out prior to program completion

  From baseline to 3-month follow-up

• Feasibility of intervention (delivery)

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

  From recruitment to post-intervention

• Acceptability of intervention

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

  Post-intervention

• 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.

• 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 Outcomes (3)

• Effectiveness of psychological component (depressive symptoms)

  From baseline to 3-month follow-up.

• Effectiveness of psychological component (exercise behaviour)

  From baseline to 3-month follow-up.

• Effectiveness of psychological component (compliance)

  From baseline to 3-month follow-up.

Study Arms (3)

Exercise only

EXPERIMENTAL

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.

Other: Exercise

Exercise + Self-compassion

EXPERIMENTAL

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).

Behavioral: Self-compassion psychoeducation; Other: Exercise

Exercise + Behavioural Coaching

EXPERIMENTAL

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).

Behavioral: Behavioural Coaching; Other: Exercise

Interventions

Behavioural Coaching BEHAVIORAL

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

Exercise + Behavioural Coaching

Self-compassion psychoeducation BEHAVIORAL

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

Exercise + Self-compassion

Exercise OTHER

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

Exercise + Behavioural Coaching; Exercise + Self-compassion; Exercise only

Eligibility Criteria

• Age: 17 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Western University

London, Ontario, N6A 3K7, Canada

Location

Related 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.

  PMID: 13470504 BACKGROUND

• 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.

  PMID: 26791022 BACKGROUND

• 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.

  PMID: 19666194 BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 1, 2020
• Study Start: October 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)