NCT06573125

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable depression

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

August 22, 2024

Last Update Submit

August 25, 2024

Conditions

Keywords

mHealthPhysical ActivityBehavior ChangeMental HealtheHealth

Outcome Measures

Primary Outcomes (7)

  • 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%.

    After recruitment is completed (up to 6 months)

  • 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.

    Post-intervention (week 10)

  • 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.

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

  • 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.

    Post-intervention (week 10)

  • 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.

    Post-intervention (week 10)

  • 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".

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

  • 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.

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

Secondary Outcomes (15)

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

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

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

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

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

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

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

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

  • Sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)

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

  • +10 more secondary outcomes

Study Arms (1)

MoodMover

EXPERIMENTAL

Participants engage with MoodMover regularly as instructed over a period of 9 weeks, along with a 9-week follow-up.

Behavioral: MoodMover

Interventions

MoodMoverBEHAVIORAL

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.

MoodMover

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 39906877BACKGROUND
  • 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.

    PMID: 27852251BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 12054320BACKGROUND
  • 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.

MeSH Terms

Conditions

DepressionMotor ActivityPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Guy Faulkner

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-Arm, Pre-Post Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2024

First Posted

August 27, 2024

Study Start

October 1, 2024

Primary Completion

April 30, 2025

Study Completion

June 30, 2025

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share