Integration of a Smartwatch Within an Internet-delivered Intervention for Depression: a Feasibility Randomized Controlled Trial on Acceptance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Patient acceptance (Satisfaction with Treatment measure)
研究概览
简要总结
The current study seeks to investigate the acceptance of the use of a smartwatch in an internet-delivered Cognitive Behavioural Therapy (CBT) based intervention for depression.
详细描述
Eligible patients (n=70) will be invited to use the supported intervention over an 8-week period. Participants who have indicated consent will be randomised in two arms: iCBT intervention - treatment as usual (n=35) and iCBT intervention with smartwatch (n=35). Participants in the smartwatch group will be lent a smartwatch for the duration of treatment, with an app allowing them to monitor their mood in the moment, and keep track of their daily sleep and activity level. All participants will be asked to complete an acceptance questionnaire regarding the technology at three time points: before first use, at 3 weeks, and 8 weeks. This study will contribute to the growing literature on acceptance of technology supporting mental health interventions worldwide. The results may help to establish criteria for patient acceptance of the smartwatch technology as a treatment enhancer in the context of mental health interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for the internet-delivered CBT intervention 'Space from Depression'
- •Own a compatible mobile device (iPhone 6 or upper)
排除标准
- •Suicidal intent/ideation; score >2 on PHQ-9 question 9
- •Psychotic illness
- •Alcohol or drug misuse
- •Previous diagnosis of an organic mental health disorder
- •Currently in psychological treatment for depression symptoms
- •Unstable medication regimens
结局指标
主要结局
Patient acceptance (Satisfaction with Treatment measure)
时间窗: Immediately after the intervention
The SAT (Richards et al, 2013) will be used to assess patient satisfaction with the intervention. This 5-item questionnaire has been used previously to evaluate different aspects of patient satisfaction and experience with the 'Space from Depression' intervention (Richards et al, 2013). Score varies from 0 to 20; a higher score indicates a better outcome. The score is informed by 2 open-ended questions at the end of the questionnaire.
Patient acceptance (questionnaire)
时间窗: Upon consent, at 3 weeks, and at 8 weeks
All participants will be asked to fill in the Acceptability Questionnaire (AQ) upon consent, at 3 weeks, and at 8 weeks. These measurement points are aligned with Nadal et al. (2020) Technology Acceptance Lifecycle model. The questionnaire is based on the acceptance factors identified by Kim \& Park (2012). The wording of the AQ is adapted to the technology in question (smartwatch vs mobile/desktop app). Participants will rate each statement on a 5-point Likert Scale. The 8-week AQ contains a series of open-ended questions for the smartwatch group to explore additional factors that might influence the watch app acceptance (privacy protection, resistance to change, etc.).
Patient acceptance (interview)
时间窗: 8 weeks
Participants in the smartwatch group who have indicated consent in taking part in the follow-up interview will be contacted after answering the final acceptance questionnaire.
次要结局
- Patient Health Questionnaire-9 (PHQ-9)(Baseline - At every meeting between participant and supporter - Immediately after the intervention)
- Work and Social Adjustment Scale (WSAS)(Baseline - At every meeting between participant and supporter - Immediately after the intervention)
- Generalized Anxiety Disorder-7 (GAD-7)(Baseline - At every meeting between participant and supporter - Immediately after the intervention)
- Usage of the program(at treatment completion, in average 8 weeks.)