An interventional study of Space from Depression and Mood Monitor watch app in Depression, sponsored by Silver Cloud Health. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-11-18.
Sponsored by Silver Cloud Health · Not applicable, Interventional, and Other
Among 282 studies in Depression with a site in United Kingdom — 49 open to participants now, 52 under way, 6 of them phase 3. Depression · United Kingdom.
Among the 282 studies in Depression with a site in United Kingdom, this one is the 107th largest by enrollment of the 232 interventional ones, is one of 20 that started in 2020, is one of 180 with no phase, and was the 152nd registered.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 71 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →49 of the 282 studies in Depression with a site in United Kingdom are open now, in 12 countries. Each count lists the studies.
Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →282 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 20 started in 2020.
Median enrollment 62 across the 232 interventional studies, 185 across the 50 observational. Of the 186 that completed or were terminated, 19 (10%) have results posted.
39 of 282 have an industry lead sponsor. The 10 most frequent:
Silver Cloud Health is the lead sponsor of 7 studies on the registry; none are open to participants now.
Silver Cloud Health has 7 studies filed under Depression — fewer than ten, so there is no comparison to draw.
17 of the studies in Depression with a site in United Kingdom that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06793397Phase 3Cybin IRL LimitedA Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder | 2027-06-07 |
| NCT06963021Phase 3Neurocrine BiosciencesNBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) | 2027-07 |
| NCT07599930King's College LondonImpact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being | 2026-12 |
| NCT07398365University of EdinburghMedical Phenotyping of NHS General Adult Psychiatry (GAP) Inpatients | 2026-12-31 |
| NCT07424781University of OxfordFluoxetine on Emotional Experience (FLEX) Study | 2026-12-31 |
Among the 282 studies in Depression with a site in United Kingdom, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
iCBT intervention 'Space from Depression' (n=35).
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.
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.
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.).
Time frame: 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.
Time frame: 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.
Time frame: Immediately after the intervention
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.
Time frame: Baseline - At every meeting between participant and supporter - Immediately after the intervention
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.
Time frame: Baseline - At every meeting between participant and supporter - Immediately after the intervention
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.
Time frame: Baseline - At every meeting between participant and supporter - Immediately after the intervention
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.
Time frame: at treatment completion, in average 8 weeks.
Plan to share: No
Ran from Nov 2020 to primary completion in Sep 2021, 9 months.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 9 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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