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DepressionNCT06573125

A Feasibility and Preliminary Efficacy Study of an App-Based Physical Activity Intervention (MoodMover) for Depression

A study testing MoodMover in people with Depression, run by University of British Columbia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Exercise is recommended as a standalone treatment for mild-to-moderate depression in Canada. However, it's unclear how mental health practitioners can guide patients to structured, in-person exercise programs. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Depression
What is being tested?
MoodMover
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
1 Oct 2024to 30 Jun 2025
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 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • AGE: 18-64 years DIAGNOSIS: A self-reported current diagnosis of major depressive disorder and/or at least mild depressive symptoms (>= 5) on the Patient Health Questionnaire, 9-Item (PHQ-9).
  • DEVICE: Possess an iPhone or Android smartphone with internet access to download the app.
  • LANGUAGE: Read, write understand, and communicate in the English language (or as appropriate)

Who cannot join

  • Are experiencing acute risk of harm to self or others
  • Have an active alcohol or substance use disorder
  • Physical disability preventing exercise
  • Active psychosis or mania
  • Severe cognitive impairment
  • Current pregnancy
Show all 10Show fewer
  • Patients whose depression is directly linked to another major primary psychiatric disorder, such as psychosis or bipolar disorder
  • Exercise >= 90 min moderate-vigorous physical activity per week or >= 3 times/week
  • Anticipate a major absence (e.g., long vacation, surgery) in the next 3 months
  • Anticipate a major change to participants' current antidepressant treatment regimen (if any, e.g., medications, psychotherapy) in the next 3 months

Trial locations and contacts

No sites are listed yet.

Yiling Tang contact

2369677785

yilingtt@student.ubc.ca

About this study

Official title: Feasibility and Preliminary Efficacy of an App-Based Physical Activity Intervention for Individuals With Depression (MoodMover): A Protocol for a Single-Arm, Pre-Post Intervention Study

Exercise is recommended as a standalone treatment for mild-to-moderate depression in Canada. However, it's unclear how mental health practitioners can guide patients to structured, in-person exercise programs. In cases where such programs are not available or are unattractive to some, self-guided mobile health physical activity interventions could be a potential alternative. The investigators have been following a behavioural intervention development framework to create a 9-week, app-based physical activity intervention called MoodMover for people with depression. To evaluate the feasibility and preliminary efficacy of MoodMover, this study will employ a single-arm, pre-post experimental trial.

Read the detailed description

MoodMover is a 9-week, app-based physical activity intervention, comprising a one-week run-in period, followed by eight major lessons, each complemented by an optional lesson, with new lessons becoming available on a weekly basis. Each major lesson addresses a specific topic designed to enhance physical activity engagement, covering topics including 1) feeling better through daily activity, 2) making physical activity enjoyable, 3) building self-confidence, 4) building physical activity opportunities, 5) developing self-regulatory skills, 6) drawing on social support, 7) forming an exercise habit, and 8) building exercise identity. Key features include step tracker, exercise logging with mood monitoring, action planning, gamification, and anonymized communications among users.

PRIMARY OBJECTIVE: This trial primarily aims to evaluate the feasibility and acceptability of MoodMover. In addition, the study will preliminarily assess the efficacy of MoodMover by monitoring changes in daily step counts, the main behavioral outcome of interest. Furthermore, the study will assess alterations in depressive symptoms and explore the association between these changes.

RESEARCH METHODOLOGY: All participants will begin by completing baseline assessments on REDCap. They will then participate in a 15-minute orientation session via Zoom with a researcher on the program's start date. The first five orientation sessions will be recorded and evaluated by an independent researcher using a fidelity checklist, allowing for immediate improvements in treatment fidelity. Following the orientation, participants will use MoodMover as directed for the duration of the 9-week program. No additional support will be offered except for technical issues. After completing the intervention, participants will undergo a follow-up assessment on REDCap. Participants will be encouraged to keep the app on their smartphones and continue using it after the program concludes. If they choose not to uninstall the app, this will be considered implied consent for the researcher to monitor their ongoing user engagement and physical activity data for an additional 9-week follow-up period. At the end of this period, participants will be contacted to sync their step data with MoodMover, enabling the collection of physical activity data throughout the follow-up. Additionally, participants will be asked to complete a satisfaction survey on REDCap.

STATISTICAL ANALYSIS: The analysis will involve (1) Descriptive statistics, (2) Regression-based analyses to evaluate the relationships between feasibility outcomes and other variables, and (3) Random effects mixed modeling to assess the impact of MoodMover on secondary outcomes and the relationship between changes in physical activity and depressive symptoms. As an underpowered single-arm feasibility study, the reporting of efficacy outcomes will focus on estimation.

Conditions
Depression
Being tested
MoodMover
Keywords
mHealth, Physical Activity, Behavior Change, Mental Health, eHealth
Medical subject headings
Depression, Motor Activity, Psychological Well-Being

What participants receive

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

  • MoodMoverBehavioural

    MoodMover is a 9-week app-based program aimed at increasing physical activity (PA) among individuals with depression, delivered via Pathverse. The current version of MoodMover includes one introductory module for baseline self-monitoring, eight primary modules, and eight optional supplementary modules. The program uses a variety of formats to deliver educational content, including videos, podcasts, and illustrated articles. In addition to its structured psychoeducational content, the app provides a range of behavioral features.

Study groups in NCT06573125
Study groupRoleWhat they receive
MoodMoverExperimentalParticipants engage with MoodMover regularly as instructed over a period of 9 weeks, along with a 9-week follow-up.
Receives: Behavioral: MoodMover

What is being measured

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

  1. Recruitment rate assessed by the proportion of enrolled participants to those who are eligible and interested.

    Successful recruitment will be defined as achieving a rate of 65%.

    Measured: After recruitment is completed (up to 6 months)

  2. Intervention adherence assessed by the proportion of participants who complete the majority of major lessons.

    An adherence rate of 70% will be deemed as acceptable.

    Measured: Post-intervention (week 10)

  3. User Engagement: Time spent on each module will be downloaded from the Pathverse admin web portal.

    Time spent on each module will be generated by Pathverse and reported in seconds.

    Measured: Post-intervention (week 10) and up to 18 weeks

  4. Usability assessed by the adapted, patient version of the mHealth app usability questionnaire (MAUQ) for standalone apps.

    An average score of 5 and over will be deemed as acceptable.

    Measured: Post-intervention (week 10)

  5. Retention rates indicated by the proportion of participants completing both pre- and post-intervention questionnaires.

    An attrition rate of 30% will be defined as acceptable.

    Measured: Post-intervention (week 10)

  6. Compliance to the graded goal setting indicated by the proportion of participants who successfully set their step goals as instructed.

    The proportion of participants who successfully set their step goal in week 2, and those who modified their step goals in week 4 and week 6, will be reported separately. Participants who followed all the instructions across these time points will be deemed as having achieved "full compliance", while those who followed instructions at one or two time points will be deemed as having achieved "partial compliance". Participants who did not follow instructions at any time points will be deemed as having achieved "no compliance".

    Measured: During the intervention (weeks 2-9) and Post-intervention (week 10)

  7. User satisfaction assessed by Melin et al.'s mHealth Satisfaction Questionnaire (14-item)

    Melin et al.'s mHealth Satisfaction Questionnaire is a 14-item questionnaire. Scores range from 0 to 60, with higher scores indicating better satisfaction levels.

    Measured: Post-intervention (week 10) and 9-week follow-up (week 18)

Secondary outcomes (15)

  1. Device-based physical activity assessed by the smartphone's built-in step counting function

    Daily step counts will be collected using the smartphone's built-in step counting function.

    Measured: Baseline (week 1), during the intervention (weeks 1- 9), post-intervention (week 10), and follow-up (week 18)

  2. Subjective physical activity assessed by the Canadian Physical Activity Adult Questionnaire (PAAQ)

    This questionnaire is designed in accordance with the Canadian Physical Activity Guidelines, which recommend a minimum of 150 minutes of MVPA per week for adults. It has been widely employed for monitoring PA in Canadian adults.

    Measured: Enrollment (week 0) and post-intervention (week 10)

  3. Depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9)

    The Patient Health Questionnaire-9 (PHQ-9) is a validated, self-administered tool for assessing depression. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.

    Measured: Enrollment (week 0) and post-intervention (week 10)

  4. Anxiety assessed by the Generalized Anxiety Disorder 7 scale (GAD-7)

    The Generalized Anxiety Disorder 7 scale (GAD-7) is a seven-item validated instrument for measuring the severity of anxiety. Scores range from 0 to 21, with higher scores indicating more severe anxiety.

    Measured: Enrollment (week 0) and post-intervention (week 10)

  5. Sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)

    Pittsburgh Sleep Quality Index (PSQI) is a self-rated, 19-item questionnaire that assess sleep-related problems. Scores range from 0 to 21, with higher scores indicating poorer sleep quality.

    Measured: Enrollment (week 0) and post-intervention (week 10)

  6. Functional disability assessed by the short-version of the World Health Organization Disability Assessment Schedule 2.0

    The short-version of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) will be utilized. Scores range from 0 to 100, with higher scores indicating more severe disability.

    Measured: Enrollment (week 0) and post-intervention (week 10)

  7. Affective attitudes assessed using items derived from Tang et al. (2023)

    Affective attitudes will be measured on three 7-point bipolar scales (Unenjoyable (1) to enjoyable (7); Boring (1) to very exciting (7); Unpleasant (1) to very pleasant (7)). All items share the same stem: "For me, participating in regular PA over the next month would be ..." Higher scores indicate more positive attitudes.

    Measured: Enrollment (week 0) and post-intervention (week 10)

  8. Instrumental attitudes assessed using items derived from Tang et al. (2023)

    Instrumental attitudes will be measured on three 7-point bipolar scales (Unwise (1) to very wise (7); Not beneficial (1) to very beneficial (7); Useless (1) to very useful (7)). All items share the same stem: "For me, participating in regular PA over the next month would be ..." Higher scores indicate more positive attitudes.

    Measured: Enrollment (week 0) and post-intervention (week 10)

  9. Perceived opportunity assessed using items derived from Tang et al. (2023)

    Perceived opportunity will be assessed using three 5-point Likert scales, ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate higher perceived opportunity.

    Measured: Enrollment (week 0) and post-intervention (week 10)

  10. Perceived capability assessed using items derived from Tang et al. (2023)

    Perceived capability will be assessed using three 5-point Likert scales, ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate higher perceived capability.

    Measured: Enrollment (week 0) and post-intervention (week 10)

  11. Intention strength assessed using items derived from Tang et al. (2023)

    Intention strength will be measured using three items (e.g., I am committed to engage in physical activity over the next month). Participants will rate these items on 5-point Likert scales ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate higher intention strength.

    Measured: Enrollment (week 0) and post-intervention (week 10)

  12. Decisional intention assessed using item "I intend to increase 3000 steps above my baseline daily steps for most days per week."

    Participants will be asked to provide binary responses (Yes/No).

    Measured: Enrollment (week 0) and post-intervention (week 10)

  13. Regulations assessed using items derived from Rovniak et al. 2002.

    Regulations will be measured using 5-point Likert scales with three items pertaining to self-monitoring, goal-setting, and action planning. Higher scores indicate stronger regulatory skills.

    Measured: Enrollment (week 0) and post-intervention (week 10)

  14. Habit assessed using items modified from Rhodes and Lim (2016)

    Habit will be assessed using 5-point Likert scales with three items (e.g., "I engage in regular physical activity without having to consciously remember it"). Higher scores indicate stronger habit.

    Measured: Enrollment (week 0) and post-intervention (week 10)

  15. Identity assessed using items modified from Rhodes and Lim (2016)

    Identity will be measured using 5-point Likert scales with three items (e.g., "When I describe myself to others, I usually include my involvement in physical activity"). Higher scores indicate a stronger exercise identity.

    Measured: Enrollment (week 0) and post-intervention (week 10)

Timeline

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

  1. First posted27 Aug 2024
  2. Study start1 Oct 2024 (estimated)
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

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
Not applicable
Intervention model
Single group
Model description
Single-Arm, Pre-Post Study
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06573125
Sponsor's protocol ID
H24-01820
Status last verified
Aug 2024
First submitted
22 Aug 2024
Last updated
27 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tang Y, Gierc M, La H, Kim J, Liu S, Lam RW, Puterman E, Faulkner G. MoodMover: Development and usability testing of an mHealth physical activity intervention for depression. Digit Health. 2025 Feb 3;11:20552076251317756. doi: 10.1177/20552076251317756. eCollection 2025 Jan-Dec.

    PubMed 39906877

  • Rhodes RE, Lim C. Understanding action control of daily walking behavior among dog owners: a community survey. BMC Public Health. 2016 Nov 16;16(1):1165. doi: 10.1186/s12889-016-3814-2.

    PubMed 27852251

  • Tang Y, Gierc M, Whiteford V, Rhodes RE, Faulkner G. Exploring correlates of physical activity using the multi-process action control framework: is there a moderating role for mental health? International Journal of Sport and Exercise Psychology. 2023:1-19. doi: https://doi.org/10.1080/1612197X.2023.2225515.

  • Rovniak LS, Anderson ES, Winett RA, Stephens RS. Social cognitive determinants of physical activity in young adults: a prospective structural equation analysis. Ann Behav Med. 2002 Spring;24(2):149-56. doi: 10.1207/S15324796ABM2402_12.

    PubMed 12054320

  • Tang Y, Gierc M, Liu S, Lam RW, Puterman E, Faulkner G. App-Based Physical Activity Intervention for Individuals With Depression (MoodMover): Single-Arm, Pre-Post Proof-of-Concept and Feasibility Study. JMIR Form Res. 2026 Jun 11;10:e79033. doi: 10.2196/79033.

    PubMed 42275461

  • Tang Y, Gierc M, La H, Liu S, Lam RW, Puterman E, Faulkner G. Feasibility and preliminary effects of an app-based physical activity intervention for individuals with depression (MoodMover): A protocol for a single-arm, pre-post intervention study. PLoS One. 2025 Apr 22;20(4):e0321958. doi: 10.1371/journal.pone.0321958. eCollection 2025.

    PubMed 40261856

Questions about this trial

What is this clinical trial studying?

A study testing MoodMover in people with Depression, run by University of British Columbia.

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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact Yiling Tang (2369677785, yilingtt@student.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate assessed by the proportion of enrolled participants to those who are eligible and interested. (time frame: After recruitment is completed (up to 6 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06573125, which also lists 6 linked publications.

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 27 Aug 2024.

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