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

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.

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.

Inclusion Criteria:

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)

Exclusion Criteria:

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