Smartwatch-supported Internet-delivered Intervention for Depression

NCT04568317 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2022-11-18

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Dublin, Trinity College

    collaborator OTHER
  • Berkshire Healthcare NHS Foundation Trust

    collaborator OTHER
  • Silver Cloud Health

    lead OTHER

Principal Investigators

  • Derek Richards, PhD · Silver Cloud Health

  • Sarah Sollesse, MSc · Berkshire Healthcare NHS Foundation Trust

  • Camille Nadal, MSc · University of Dublin, Trinity College

  • Gavin Doherty, PhD · University of Dublin, Trinity College

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2021-09-01
Completion
2021-09-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04568317 on ClinicalTrials.gov