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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Intervention adherence assessed by the proportion of participants who complete the majority of major lessons.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Intervention adherence assessed by the proportion of participants who complete the majority of major lessons.
时间窗: Post-intervention (week 10)
An adherence rate of 70% will be deemed as acceptable.
User Engagement: Time spent on each module will be downloaded from the Pathverse admin web portal.
时间窗: Post-intervention (week 10) and up to 18 weeks
Time spent on each module will be generated by Pathverse and reported in seconds.
Usability assessed by the adapted, patient version of the mHealth app usability questionnaire (MAUQ) for standalone apps.
时间窗: Post-intervention (week 10)
An average score of 5 and over will be deemed as acceptable.
Recruitment rate assessed by the proportion of enrolled participants to those who are eligible and interested.
时间窗: After recruitment is completed (up to 6 months)
Successful recruitment will be defined as achieving a rate of 65%.
User satisfaction assessed by Melin et al.'s mHealth Satisfaction Questionnaire (14-item)
时间窗: Post-intervention (week 10) and 9-week follow-up (week 18)
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.
Retention rates indicated by the proportion of participants completing both pre- and post-intervention questionnaires.
时间窗: Post-intervention (week 10)
An attrition rate of 30% will be defined as acceptable.
Compliance to the graded goal setting indicated by the proportion of participants who successfully set their step goals as instructed.
时间窗: During the intervention (weeks 2-9) and Post-intervention (week 10)
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".
次要结局
- Depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9)(Enrollment (week 0) and post-intervention (week 10))
- Instrumental attitudes assessed using items derived from Tang et al. (2023)(Enrollment (week 0) and post-intervention (week 10))
- Perceived opportunity assessed using items derived from Tang et al. (2023)(Enrollment (week 0) and post-intervention (week 10))
- Affective attitudes assessed using items derived from Tang et al. (2023)(Enrollment (week 0) and post-intervention (week 10))
- Intention strength assessed using items derived from Tang et al. (2023)(Enrollment (week 0) and post-intervention (week 10))
- Identity assessed using items modified from Rhodes and Lim (2016)(Enrollment (week 0) and post-intervention (week 10))
- Subjective physical activity assessed by the Canadian Physical Activity Adult Questionnaire (PAAQ)(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))
- Functional disability assessed by the short-version of the World Health Organization Disability Assessment Schedule 2.0(Enrollment (week 0) and post-intervention (week 10))
- Perceived capability assessed using items derived from Tang et al. (2023)(Enrollment (week 0) and post-intervention (week 10))
- Habit assessed using items modified from Rhodes and Lim (2016)(Enrollment (week 0) and post-intervention (week 10))
- 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))
- Decisional intention assessed using item "I intend to increase 3000 steps above my baseline daily steps for most days per week."(Enrollment (week 0) and post-intervention (week 10))
- Regulations assessed using items derived from Rovniak et al. 2002.(Enrollment (week 0) and post-intervention (week 10))
研究者
Guy Faulkner
Principal Investigator
University of British Columbia