Viewing Study NCT04572035



Ignite Creation Date: 2024-05-06 @ 3:16 PM
Last Modification Date: 2024-10-26 @ 1:46 PM
Study NCT ID: NCT04572035
Status: COMPLETED
Last Update Posted: 2023-04-25
First Post: 2020-09-22

Brief Title: Exercise Self-Compassion Intervention for Depression
Sponsor: Western University Canada
Organization: Western University Canada

Study Overview

Official Title: Feasibility Acceptability and Effectiveness of a Structured Exercise Psychoeducation Program for Students With Depression - A Proof of Concept Study
Status: COMPLETED
Status Verified Date: 2023-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 referredrecommended 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 participants 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 groupThe exercise psychoeducation groups will receive equal contact supplemental individual manualized strategies each session 15-20 minutes centered either on behaviour change strategies ie action planning implementation intentions relapse prevention and goal setting or self-compassion strategies ie 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None