Depression Clinical Trial
Official title:
Integration of a Smartwatch Within an Internet-delivered Intervention for Depression: a Feasibility Randomized Controlled Trial on Acceptance
Verified date | November 2022 |
Source | Silver Cloud Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 71 |
Est. completion date | September 1, 2021 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Berkshire Healthcare NHS Foundation Trust | Bracknell | Berkshire |
Lead Sponsor | Collaborator |
---|---|
Silver Cloud Health | Berkshire Healthcare NHS Foundation Trust, University of Dublin, Trinity College |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Patient Health Questionnaire-9 (PHQ-9) | 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. |
Baseline - At every meeting between participant and supporter - Immediately after the intervention | |
Secondary | Generalized Anxiety Disorder-7 (GAD-7) | 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. |
Baseline - At every meeting between participant and supporter - Immediately after the intervention | |
Secondary | Work and Social Adjustment Scale (WSAS) | 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. |
Baseline - At every meeting between participant and supporter - Immediately after the intervention | |
Secondary | Usage of the program | 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. | at treatment completion, in average 8 weeks. |
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