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Exercise + Self-Compassion Intervention for Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Behavioural Coaching
Self-compassion psychoeducation
Exercise
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

17 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Western University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Exercise only

Exercise + Self-compassion

Exercise + Behavioural Coaching

Arm Description

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.

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).

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).

Outcomes

Primary Outcome Measures

Feasibility of intervention (recruitment)
Proportion of screened individuals choosing to participate (and reasons for not participating)
Feasibility of intervention (compliance)
Proportion of program sessions attended (and reasons for non-attendance); proportion of participants that complete surveys
Feasibility of intervention (completion)
Proportion of participants who drop-out prior to program completion
Feasibility of intervention (delivery)
Proportion of eligible peer facilitators that maintain their participation in the full intervention
Acceptability of intervention
Treatment Acceptability Questionnaire - mean score ranging from 1 (low acceptability) to 7 (high acceptability)
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
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

Secondary Outcome Measures

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)
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
Effectiveness of psychological component (compliance)
Treatment arm difference in compliance (attendance in program sessions)

Full Information

First Posted
September 22, 2020
Last Updated
April 24, 2023
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT04572035
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise only
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise + Self-compassion
Arm Type
Experimental
Arm Description
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).
Arm Title
Exercise + Behavioural Coaching
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Behavioural Coaching
Intervention Description
behaviour change strategies (i.e., action planning, implementation intentions, relapse prevention, and goal setting)
Intervention Type
Behavioral
Intervention Name(s)
Self-compassion psychoeducation
Intervention Description
self-compassion strategies (i.e., mindfulness, self-directed kindness meditations, and writing tasks)
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
aerobic exercise program either delivered in a laboratory setting or via Zoom
Primary Outcome Measure Information:
Title
Feasibility of intervention (recruitment)
Description
Proportion of screened individuals choosing to participate (and reasons for not participating)
Time Frame
From recruitment to baseline
Title
Feasibility of intervention (compliance)
Description
Proportion of program sessions attended (and reasons for non-attendance); proportion of participants that complete surveys
Time Frame
From baseline to 3-month follow-up
Title
Feasibility of intervention (completion)
Description
Proportion of participants who drop-out prior to program completion
Time Frame
From baseline to 3-month follow-up
Title
Feasibility of intervention (delivery)
Description
Proportion of eligible peer facilitators that maintain their participation in the full intervention
Time Frame
From recruitment to post-intervention
Title
Acceptability of intervention
Description
Treatment Acceptability Questionnaire - mean score ranging from 1 (low acceptability) to 7 (high acceptability)
Time Frame
Post-intervention
Title
Effectiveness of intervention (depressive symptoms)
Description
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
Time Frame
From baseline to 3-month follow-up.
Title
Effectiveness of intervention (exercise behaviour)
Description
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
Time Frame
From baseline to 3-month follow-up.
Secondary Outcome Measure Information:
Title
Effectiveness of psychological component (depressive symptoms)
Description
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)
Time Frame
From baseline to 3-month follow-up.
Title
Effectiveness of psychological component (exercise behaviour)
Description
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
Time Frame
From baseline to 3-month follow-up.
Title
Effectiveness of psychological component (compliance)
Description
Treatment arm difference in compliance (attendance in program sessions)
Time Frame
From baseline to 3-month follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
13470504
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.
Results Reference
background
PubMed Identifier
26791022
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.
Results Reference
background
PubMed Identifier
19666194
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.
Results Reference
background

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Exercise + Self-Compassion Intervention for Depression

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