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

Primary Purpose

Low Mood, Mild Depression, Moderate Depression

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
physical activity
Sponsored by
University of Victoria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Mood

Eligibility Criteria

19 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

No exclusion criteria for sex, gender, medications, race or religion will be applied. There will be no contraindications to PA after screening with the Physical Activity Readiness Questionnaire (PAR-Q).

Sites / Locations

  • University of VictoriaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Recruitment Rate
outcome related to trial feasibility
Retention Rate
outcome related to trial feasibility
Experience Measure
outcome related to trial acceptability

Secondary Outcome Measures

Depression Severity
measured with the Patient Health Questionnaire-9 (min.=0, max.=27, lower scores indicate fewer symptoms of depression)
Physical Activity Levels
measured with the Godin Leisure Time Exercise Questionnaire (min.=0, max.=N/A, higher scores indicate increased physical activity)

Full Information

First Posted
May 18, 2022
Last Updated
November 4, 2022
Sponsor
University of Victoria
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1. Study Identification

Unique Protocol Identification Number
NCT05386745
Brief Title
Feasibility Study of an Online Physical Activity Intervention for Youth With Depression
Official Title
A Feasibility Study Evaluating an Online Physical Activity Intervention for Young Adults With Low Mood and/or Depression Engaged in Community Primary Clinical Care
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Victoria

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Mood, Mild Depression, Moderate Depression, Inactivity, Physical

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
An online, asynchronous, self-paced, 10-week long, physical activity intervention.
Arm Title
Control
Arm Type
No Intervention
Arm Description
A waitlist control; continue with life/activity as usual. Control participants will receive access to the intervention at 10 weeks following all measurements.
Intervention Type
Behavioral
Intervention Name(s)
physical activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment Rate
Description
outcome related to trial feasibility
Time Frame
10 weeks
Title
Retention Rate
Description
outcome related to trial feasibility
Time Frame
10 weeks
Title
Experience Measure
Description
outcome related to trial acceptability
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Depression Severity
Description
measured with the Patient Health Questionnaire-9 (min.=0, max.=27, lower scores indicate fewer symptoms of depression)
Time Frame
10 weeks
Title
Physical Activity Levels
Description
measured with the Godin Leisure Time Exercise Questionnaire (min.=0, max.=N/A, higher scores indicate increased physical activity)
Time Frame
10 weeks
Other Pre-specified Outcome Measures:
Title
Psychosocial Factors Predicting Physical Activity Behaviour
Description
measured with the Multi-Process Action Control Framework which included various constructs and measurements scales, e.g., affective and instrumental attitude (min.=1, max.=7, higher scores indicate increased positively-valenced attitude; Ajzen 2002; Rhodes and Courneya 2003)
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. No exclusion criteria for sex, gender, medications, race or religion will be applied. There will be no contraindications to PA after screening with the Physical Activity Readiness Questionnaire (PAR-Q).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleah B Ross, BSc
Phone
1-778-679-3379
Email
rossa382@uvic.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleah B Ross, BSc
Organizational Affiliation
University of Victoria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ryan E Rhodes, PhD
Organizational Affiliation
University of Victoria
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Victoria
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8P 5C2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleah B Ross, BSc
Phone
1-778-679-3379
Email
rossa382@uvic.ca
First Name & Middle Initial & Last Name & Degree
Ryan E Rhodes, PhD
Email
rhodes@uvic.ca
First Name & Middle Initial & Last Name & Degree
Aleah B Ross, BSc
First Name & Middle Initial & Last Name & Degree
Ryan E Rhodes, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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