Smartwatch-supported Internet-delivered Intervention for Depression

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Space from Depression; Device: Mood Monitor watch app

• Registration Number: NCT04568317
• Lead Sponsor: Silver Cloud Health

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.

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.

Study Timeline

• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-29
• Study Start: 2020-11-30
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smartwatch group	Space from Depression	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).
Smartwatch group	Mood Monitor watch app	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).
Treatment as usual group	Space from Depression	iCBT intervention 'Space from Depression' (n=35).

Primary Outcome Measures

Name	Time	Method
Patient acceptance (Satisfaction with Treatment measure)	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9 (PHQ-9)	Baseline - At every meeting between participant and supporter - Immediately after the intervention	The PHQ-9 is a nine-item self-report measure of depression (Kroenke et al, 2001; Spitzer et al, 1999) that has been widely used in research and is employed as a clinical outcome measure in IAPT as part of its minimum dataset. The PHQ-9 items reflect the diagnostic criteria for depression outlined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (A.P. Association, 2013).; Score varies from 0 to 27; a higher score indicates a worse outcome.
Work and Social Adjustment Scale (WSAS)	Baseline - At every meeting between participant and supporter - Immediately after the intervention	This is a five-item self-report questionnaire of functional impairment (Mundt et al, 2002) that is employed nationally as an outcome measure in IAPT. It examines the experiential impact of a disorder across different life domains from the perspective of the service users. The questionnaire examines the degree of impairment caused by a disorder on a daily basis across five dimensions: work, social life, home life, private life, and close relationships.; Score varies from 0 to 40; a higher score indicates a worse outcome.
Generalized Anxiety Disorder-7 (GAD-7)	Baseline - At every meeting between participant and supporter - Immediately after the intervention	The GAD-7 (Spitzer et al, 2006) is used nationally as a screening and outcome measure in IAPT and is part of the minimum dataset. The seven items measuring anxiety symptoms and severity reflect the DSM-Fifth Edition diagnostic criteria for GAD (A.P. Association, 2013).; Score varies from 0 to 21; a higher score indicates a worse outcome.
Usage of the program	at treatment completion, in average 8 weeks.	Usage data in terms of time spent in the platform, number of logins, number of tools used, percentage viewed, and number of reviews will be collected. Also, the amount of mood monitor entries, sleep and activity data will be extracted. Approximate activity levels (graded 1 to 5) and sleep patterns will be analyzed to explore the changes over time.

Trial Locations

Locations (1)

Berkshire Healthcare NHS Foundation Trust; 🇬🇧 Bracknell, Berkshire, United Kingdom