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Low MoodNCT05386745

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

A study testing physical activity in people with Low Mood and Mild Depression, run by University of Victoria at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 19 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Low Mood, Mild Depression, Moderate Depression
What is being tested?
physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
22 Feb 2022to 24 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • have access to a device with an internet connection
  • reside in British Columbia currently
  • fluent in English

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Victoria

    Victoria, British Columbia, V8P 5C2

Other trials in Canada

About this study

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

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.

Being tested
physical activity
Medical subject headings
Consciousness Disorders, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • physical activityBehavioural

    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.

Study groups in NCT05386745
Study groupRoleWhat they receive
InterventionExperimentalAn online, asynchronous, self-paced, 10-week long, physical activity intervention.
Receives: Behavioral: physical activity
ControlNo interventionA waitlist control; continue with life/activity as usual. Control participants will receive access to the intervention at 10 weeks following all measurements.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate

    outcome related to trial feasibility

    Measured: 10 weeks

  2. Retention Rate

    outcome related to trial feasibility

    Measured: 10 weeks

  3. Experience Measure

    outcome related to trial acceptability

    Measured: 10 weeks

Secondary outcomes (2)
  1. Depression Severity

    measured with the Patient Health Questionnaire-9 (min.=0, max.=27, lower scores indicate fewer symptoms of depression)

    Measured: 10 weeks

  2. Physical Activity Levels

    measured with the Godin Leisure Time Exercise Questionnaire (min.=0, max.=N/A, higher scores indicate increased physical activity)

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2022
  2. Study start22 Feb 2022
  3. Primary completion24 Nov 2023
  4. Study completion24 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05386745
Sponsor's protocol ID
21-0301
Status last verified
Nov 2023
First submitted
18 May 2022
Last updated
26 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing physical activity in people with Low Mood and Mild Depression, run by University of Victoria at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.

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