Smartwatch-supported Internet-delivered Intervention for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Space from Depression; Mood Monitor watch app
Intervention type(s): Behavioral; Device
Intervention description(s): This is a 7-module internet-based CBT program. The structure and content of the modules follow evidence-based CBT principles; they are structured to incorporate quizzes, videos, psychoeducational content and interactive tools, personalised homework suggestions and summaries. One of the interactive tools is the mood monitor, where users are encouraged to monitor their mood and reflect on several factors that might had influenced it. Clients are allocated to a psychological wellbeing practitioner (PWP). The PWP is responsible for monitoring and guiding the client's progress throughout the intervention. Over the course of the 8 week supported intervention period, on 6 separate occasions the PWP will review participants progress, leaving feedback for them and responding to the work they have completed. The basic share level allows PWP is to view users' goals for the week, key messages and progress points. Each PWP will provide post-session feedback of between 10 and 15 minutes per session.; The Mood Monitor watch app will allow in-the-moment self-report of patients' mood and automated monitoring of their sleep and activity level. This data will be integrated into the existing Mood Monitor tool within the participant's Space from Depression program. During the intervention, prompts to record mood data will appear on the watch app; participants will be encourage to choose the frequency and time ranges to receive prompts. The watch app main screen will provide a daily and weekly visualisation of participant's mood, bedtime, hours slept and steps count, and visual cues on their progress. Participants will receive encouragement prompts to reward frequent and consistent self-report of mood over time and a good sleep hygiene. Finally, the app "Tips to Stay Well" feature will allow participants to go through a list of lifestyle-related tips extracted from the Space from Depression program.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Upon giving consent, participants will be randomised in two arms: iCBT intervention (n=35) and iCBT intervention with smartwatch (n=35). Participants who decline consent will be excluded from the study and will receive iCBT treatment as usual. The sample size of 70 aligns with the literature around desired sample sizes for feasibility and acceptability studies (Teare et al., 2014). Participants will be recruited regardless of whether they own a smartwatch. As the smartwatch is a new addition to the iCBT intervention, this will be the first time for all participants using a smartwatch within the 'Space from Depression' program. The degree to which participants' experience/familiarity with the smartwatch technology influenced acceptance outcomes will be investigated in a secondary analysis.
Masking: None (Open Label)
Primary purpose: Other
Keywords: patient acceptance; internet-delivered treatment; depression; self-monitoring; smartwatch; wearable