Feasibility Study of an Online Physical Activity Intervention for Youth With Depression

NCT05386745 | Completed

• 1 other identifier: 21-0301
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Physical activity (PA) has recently been established as both a primary intervention for mild to moderate, and a secondary therapy for moderate to severe Major Depressive Disorder (MDD; Fortier et al., 2020). Those with mental health disorders do not on average achieve recommended levels of PA (Hallgren et al., 2016), and exercise prescription is extremely lacking in clinical care (Stanton, Reaburn, \& Happell, 2015; Stanton et al., 2018). Theory-based behavioural interventions have proven to be an effective tool for improving physical activity levels in clinical populations (Glowacki, et al., 2017; Stanton et al., 2015). More research is needed to understand PA intervention effectiveness for MDD patients (Glowacki et al., 2017), support integration of such behavioural treatments with primary care (Lederman et al., 2017), and address growing concerns regarding mental health during the global pandemic and beyond (Boyce, 2021). This community-based study examines the feasibility of a co-designed, 10-week, asynchronous, web-based beta platform PA intervention for patients with experience of low mood and/or mild to moderate depression, and will provide important parameters for a future randomized-controlled trial (RCT). Primary outcome measures will focus on acceptability and feasibility, including recruitment and retention rates. Secondary measures will include physical activity and depression symptom severity. Behavioural predictors of PA are to be evaluated as tertiary outcomes. Questionnaires will include an adapted participant experience measure, Godin Leisure-Time Exercise Questionnaire, and the Patient Health Questionnaire-9. This study features a controlled baseline, post-intervention evaluative design with an embedded quantitative process evaluation with a waitlist control. Participants will be young adults with experience of low mood and/or mild to moderate depression, 19-30 years of age, with access to a device with internet, English speaking, living within British Columbia, CAN., and falling below the minimum Canadian recommendations for PA. Study recruitment will primarily be facilitated by multiple youth mental health primary and community care clinics. This study will contribute to understanding of acceptable, efficacious, behaviour-based and mobile health intervention approaches for young adults with depression. It will also provide young people with a platform to share invaluable feedback to direct innovations in their own alternative care and mental health treatment. If outcome benchmarks set based on previous literature are met or exceeded for each of recruitment, retention, and acceptability, and depressive symptoms trend downwards for intervention participants, then a future randomized controlled trial exploring principally mental health outcomes will be recommended.

Conditions

Low Mood; Mild Depression; Moderate Depression; Inactivity, Physical

Outcome Measures

Primary Outcomes (3)

• Recruitment Rate

  outcome related to trial feasibility

  10 weeks

• Retention Rate

  outcome related to trial feasibility

  10 weeks

• Experience Measure

  outcome related to trial acceptability

  10 weeks

Secondary Outcomes (2)

• Depression Severity

  10 weeks

• Physical Activity Levels

  10 weeks

Other Outcomes (1)

• Psychosocial Factors Predicting Physical Activity Behaviour

  10 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

An online, asynchronous, self-paced, 10-week long, physical activity intervention.

Behavioral: physical activity

Control

NO INTERVENTION

A waitlist control; continue with life/activity as usual. Control participants will receive access to the intervention at 10 weeks following all measurements.

Interventions

physical activity BEHAVIORAL

A series of 10 weekly psychoeducational modules including information on psychosocial determinants of physical activity engagement, adherence and maintenance, as well as a number of other behaviour change tools, like reflection activities.

Intervention

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• between the ages of 19-30 years
• experience of low mood and/or mild to moderate depression (no diagnosis required)
• report falling below minimum Canadian public health recommendations for PA consistently over the past 6 months
• report no contraindications to physical activity (based on the completion of the Physical Activity Readiness Questionnaire administered at screening)
• do not report any manic or psychotic episodes within the past 6 months
• do not report any substance or alcohol abuse within the past 6 months
• have access to a device with an internet connection
• reside in British Columbia currently
• fluent in English

You may not qualify if:

• be young adults, 19-30 years of age,
• currently reside in British Columbia,
• self-identify as someone with experience of depression (ranging from low mood and/or depressive symptoms to a formal mild to moderate Major Depressive Disorder diagnosis according to the Diagnostic and Statistical Manual of Mental Health Disorders-V)
• report no manic episode(s) or psychosis in the past 6 months,
• fall below the minimum Canadian public health recommendations for PA (Ross et al., 2020) for at least six months prior to screening,
• have access to a device with internet access, AND
• English speaking.

Sponsors & Collaborators

• University of Victoria: lead

Study Sites (1)

University of Victoria

Victoria, British Columbia, V8P 5C2, Canada

Location

MeSH Terms

Conditions

Consciousness Disorders; Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Aleah B Ross, BSc

  University of Victoria

  STUDY DIRECTOR

• Ryan E Rhodes, PhD

  University of Victoria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 23, 2022
• Study Start: February 22, 2022
• Primary Completion: November 24, 2023
• Study Completion: November 24, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)