Smartwatch-supported Internet-delivered Intervention for Depression

NCT04568317 | Completed

• 1 other identifier: 20/WA0206
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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

Depression

Keywords

patient acceptance; internet-delivered treatment; depression; self-monitoring; smartwatch; wearable

Outcome Measures

Primary Outcomes (3)

• Patient acceptance (questionnaire)

  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.).

  Upon consent, at 3 weeks, and at 8 weeks

• Patient acceptance (interview)

  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.

  8 weeks

• Patient acceptance (Satisfaction with Treatment measure)

  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.

  Immediately after the intervention

Secondary Outcomes (4)

• Patient Health Questionnaire-9 (PHQ-9)

  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

• Work and Social Adjustment Scale (WSAS)

  Baseline - At every meeting between participant and supporter - Immediately after the intervention

• Usage of the program

  at treatment completion, in average 8 weeks.

Study Arms (2)

Smartwatch group

EXPERIMENTAL

iCBT intervention 'Space from Depression' with smartwatch as an additional means to self-report data on mood, sleep and physical activity in the 'Space from Depression' program (n=35).

Behavioral: Space from Depression; Device: Mood Monitor watch app

Treatment as usual group

ACTIVE COMPARATOR

iCBT intervention 'Space from Depression' (n=35).

Behavioral: Space from Depression

Interventions

Space from Depression BEHAVIORAL

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.

Smartwatch group; Treatment as usual group

Mood Monitor watch app DEVICE

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.

Smartwatch group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible for the internet-delivered CBT intervention 'Space from Depression'
• Own a compatible mobile device (iPhone 6 or upper)

You may not qualify if:

• 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

Sponsors & Collaborators

• Silver Cloud Health: lead
• University of Dublin, Trinity College: collaborator
• Berkshire Healthcare NHS Foundation Trust: collaborator

Study Sites (1)

Berkshire Healthcare NHS Foundation Trust

Bracknell, Berkshire, RG12 1BQ, United Kingdom

Location

Related Publications (1)

• Nadal C, Earley C, Enrique A, Vigano N, Sas C, Richards D, Doherty G. Integration of a smartwatch within an internet-delivered intervention for depression: Protocol for a feasibility randomized controlled trial on acceptance. Contemp Clin Trials. 2021 Apr;103:106323. doi: 10.1016/j.cct.2021.106323. Epub 2021 Feb 20.

  PMID: 33621632 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Derek Richards, PhD

  Silver Cloud Health

  STUDY DIRECTOR

• Sarah Sollesse, MSc

  Berkshire Healthcare NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Camille Nadal, MSc

  University of Dublin, Trinity College

  STUDY CHAIR

• Gavin Doherty, PhD

  University of Dublin, Trinity College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 29, 2020
• Study Start: November 30, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)