We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Smartwatch-supported Internet-delivered Intervention for Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04568317
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : December 4, 2020
Sponsor:
Collaborators:
University of Dublin, Trinity College
Berkshire Healthcare NHS Foundation Trust
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Space from Depression Device: Mood Monitor watch app Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Integration of a Smartwatch Within an Internet-delivered Intervention for Depression: a Feasibility Randomized Controlled Trial on Acceptance
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Smartwatch group
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
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.

Device: Mood Monitor watch app
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.

Active Comparator: Treatment as usual group
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.




Primary Outcome Measures :
  1. Patient acceptance (questionnaire) [ Time Frame: 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.).

  2. Patient acceptance (interview) [ Time Frame: 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.

  3. Patient acceptance (Satisfaction with Treatment measure) [ Time Frame: 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.



Secondary Outcome Measures :
  1. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 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.


  2. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 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.


  3. Work and Social Adjustment Scale (WSAS) [ Time Frame: 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.


  4. Usage of the program [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568317


Contacts
Layout table for location contacts
Contact: Derek Richards, PhD 00353 1 554 9769 derek.richards@silvercloudhealth.com
Contact: Camille Nadal, MSc 00353 1896 3858 nadalc@tcd.ie

Locations
Layout table for location information
United Kingdom
Berkshire Healthcare NHS Foundation Trust Recruiting
Bracknell, Berkshire, United Kingdom, RG12 1BQ
Contact: Sarah Sollesse, MSc       sarah.sollesse@berkshire.nhs.uk   
Sponsors and Collaborators
Silver Cloud Health
University of Dublin, Trinity College
Berkshire Healthcare NHS Foundation Trust
Investigators
Layout table for investigator information
Study Director: Derek Richards, PhD Silver Cloud Health
Principal Investigator: Sarah Sollesse, MSc Berkshire Healthcare NHS Foundation Trust
Study Chair: Camille Nadal, MSc University of Dublin, Trinity College
Study Chair: Gavin Doherty, PhD University of Dublin, Trinity College
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Silver Cloud Health
ClinicalTrials.gov Identifier: NCT04568317    
Other Study ID Numbers: 20/WA0206
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Silver Cloud Health:
patient acceptance
internet-delivered treatment
depression
self-monitoring
smartwatch
wearable
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders