A Feasibility and Preliminary Efficacy Study of an App-Based Physical Activity Intervention (MoodMover) for Depression
NCT Number: NCT06573125
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression
Interventions: BEHAVIORAL: MoodMover
Sponsor: University of British Columbia
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-06-30

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.

Primary Outcome Measures: 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 Outcome Measures: 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., 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), 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., Enrollment (week 0) and post-intervention (week 10)|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., Enrollment (week 0) and post-intervention (week 10)|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., Enrollment (week 0) and post-intervention (week 10)|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., Enrollment (week 0) and post-intervention (week 10)|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., Enrollment (week 0) and post-intervention (week 10)|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., Enrollment (week 0) and post-intervention (week 10)|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., Enrollment (week 0) and post-intervention (week 10)|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., Enrollment (week 0) and post-intervention (week 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., Enrollment (week 0) and post-intervention (week 10)|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., Enrollment (week 0) and post-intervention (week 10)|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)., Enrollment (week 0) and post-intervention (week 10)|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., Enrollment (week 0) and post-intervention (week 10)|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., Enrollment (week 0) and post-intervention (week 10)|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., Enrollment (week 0) and post-intervention (week 10)