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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Low Mood, Mild Depression, Moderate Depression, Inactivity, Physical
- 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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | An online, asynchronous, self-paced, 10-week long, physical activity intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
outcome related to trial feasibility
Measured: 10 weeks
Retention Rate
outcome related to trial feasibility
Measured: 10 weeks
Experience Measure
outcome related to trial acceptability
Measured: 10 weeks
Secondary outcomes (2)
Depression Severity
measured with the Patient Health Questionnaire-9 (min.=0, max.=27, lower scores indicate fewer symptoms of depression)
Measured: 10 weeks
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.
- First posted23 May 2022
- Study start22 Feb 2022
- Primary completion24 Nov 2023
- Study completion24 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Victoria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleah B Ross, BSc, Study director, University of VictoriaRyan E Rhodes, PhD, Principal investigator, University of Victoria
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05386745
- Acronym / sponsor ID
- 21-0301
- Conditions
- Low Mood, Mild Depression, Moderate Depression, Inactivity, Physical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of VictoriaUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: physical activityAn online, asynchronous, self-paced, 10-week long, physical activity intervention. |
| 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. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical activityA 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. | Behavioural | Intervention |
Primary outcome
Recruitment Rate
Time frame: 10 weeks
outcome related to trial feasibility
Retention Rate
Time frame: 10 weeks
outcome related to trial feasibility
Experience Measure
Time frame: 10 weeks
outcome related to trial acceptability
2 secondary outcomes
Depression Severity
Time frame: 10 weeks
Physical Activity Levels
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleah B Ross, BSc study director
University of Victoria
Ryan E Rhodes, PhD principal investigator
University of Victoria
1 site in 1 country: see every site and its status.
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.