NCT04568317

Smartwatch-supported Internet-delivered Intervention for Depression

Integration of a Smartwatch Within an Internet-delivered Intervention for Depression: a Feasibility Randomized Controlled Trial on Acceptance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Silver Cloud Health · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Space from Depression	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.
DEVICE	Mood Monitor watch app	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.

Timeline

• Start date: 2020-11-30
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2020-09-29
• Last updated: 2022-11-18

Locations

1 site across 1 country: United Kingdom