Clinical trial NCT04568317: Smartwatch-supported Internet-delivered Intervention for Depression
Official title: Integration of a Smartwatch Within an Internet-delivered Intervention for Depression: a Feasibility Randomized Controlled Trial on Acceptance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: patient acceptance
internet-delivered treatment
depression
self-monitoring
smartwatch
wearable
Lead sponsor: Silver Cloud Health
Sponsor class: OTHER
Collaborators: name: University of Dublin, Trinity College
name: Berkshire Healthcare NHS Foundation Trust
First posted: 2020-09-29
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient acceptance (questionnaire)
timeFrame: Upon consent, at 3 weeks, and at 8 weeks
measure: Patient acceptance (interview)
timeFrame: 8 weeks
measure: Patient acceptance (Satisfaction with Treatment measure)
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline - At every meeting between participant and supporter - Immediately after the intervention
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline - At every meeting between participant and supporter - Immediately after the intervention
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Baseline - At every meeting between participant and supporter - Immediately after the intervention
measure: Usage of the program
timeFrame: at treatment completion, in average 8 weeks.
Other outcomes:
Locations:
city: Bracknell
country: United Kingdom
facility: Berkshire Healthcare NHS Foundation Trust
state: Berkshire
Study officials:
affiliation: Silver Cloud Health
name: Derek Richards, PhD
role: STUDY_DIRECTOR
affiliation: Berkshire Healthcare NHS Foundation Trust
name: Sarah Sollesse, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dublin, Trinity College
name: Camille Nadal, MSc
role: STUDY_CHAIR
affiliation: University of Dublin, Trinity College
name: Gavin Doherty, PhD
role: STUDY_CHAIR
References:
citation: 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.