Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
129 participants
INTERVENTIONAL
2021-12-01
2022-12-31
Brief Summary
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Detailed Description
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Question 1:
Does dCBTi work better than the active control?
Hypothesis 1:
Participants in C2, C3, C4, and C5 will have greater improvement in insomnia than those in C1.
Question 2:
Does coaching support, virtual or human, improve treatment adherence and outcome?
Hypothesis 2:
Participants in C3, C4, and C5 will have greater improvement in insomnia and greater adherence to treatment recommendations than those in C2.
Question 3:
Does human coaching enhance treatment adherence and outcome?
Hypothesis 3:
Participants in C4 and C5 will have greater improvement in primary outcome than those in C3.
Question 4:
Does therapist-coaching-support enhance treatment adherence and outcome to a greater extent than virtual and non-therapist coaching support?
Hypothesis 4:
Participants in C5 will have greater improvement in primary outcome than those in C3 and C4.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Digital Sleep Hygiene and Self-Monitoring Control
Participants assigned to this condition will receive an app to track sleep and offers sleep hygiene recommendations
Sleep Hygiene and Self-Monitoring Control
An app with self-monitoring function and videos and written materials about sleep hygiene will be provided.
dCBTi without coaching
Participants assigned to this condition will receive a 6-module digital cognitive behavioral therapy for insomnia (dCBTi) with no coaching support
dCBTi
The dCBTi adopts a multi-module approach, consisted of 6 weekly modules including psychoeducational on sleep, insomnia, sleep hygiene, sleep restriction and prescription, stimulus control, relaxation and worry time, cognitive restructuring, and relapse prevention. In each module, participants will watch short videos to learn strategies to improve their sleep.
dCBTi with virtual coaching
Participants assigned to this condition will receive a 6-module digital cognitive behavioral therapy for insomnia (dCBTi) with a virtual coach in the form of a text-based force-choice conversation coach. The virtual coach will check participants' understanding of the treatment materials and lead them to come up with action plans to implement CBTi strategies.
dCBTi
The dCBTi adopts a multi-module approach, consisted of 6 weekly modules including psychoeducational on sleep, insomnia, sleep hygiene, sleep restriction and prescription, stimulus control, relaxation and worry time, cognitive restructuring, and relapse prevention. In each module, participants will watch short videos to learn strategies to improve their sleep.
Virtual coaching
A virtual coach will be added to the app functionality. It will be in the form of a text-based forced-choice conversation bot. It will initiate conversations with the users to check their understanding of treatment materials and guide them to come up with specific action plans to implement the treatment strategies.
dCBTi with non-therapist coaching support
Participants assigned to this condition will receive a 6-module digital cognitive behavioral therapy for insomnia (dCBTi) with the virtual coach. They will get additional support from a non-therapist support person who provides support after modules 1, 3, and 6 to address any questions or concerns.
dCBTi
The dCBTi adopts a multi-module approach, consisted of 6 weekly modules including psychoeducational on sleep, insomnia, sleep hygiene, sleep restriction and prescription, stimulus control, relaxation and worry time, cognitive restructuring, and relapse prevention. In each module, participants will watch short videos to learn strategies to improve their sleep.
Virtual coaching
A virtual coach will be added to the app functionality. It will be in the form of a text-based forced-choice conversation bot. It will initiate conversations with the users to check their understanding of treatment materials and guide them to come up with specific action plans to implement the treatment strategies.
Non-therapist coaching
A research intern will answer questions and address concerns raised by the participant at the end of modules 1, 3, and 6 by phone. The contact time will be within 30 minutes on each occasion.
dCBTi with therapist coaching support
Participants assigned to this condition will receive a 6-module digital cognitive behavioral therapy for insomnia (dCBTi) with the virtual coach. They will get additional support from a clinical psychology trainee who provides therapeutic support that aims to enhance the usage of CBTi treatment strategies.
dCBTi
The dCBTi adopts a multi-module approach, consisted of 6 weekly modules including psychoeducational on sleep, insomnia, sleep hygiene, sleep restriction and prescription, stimulus control, relaxation and worry time, cognitive restructuring, and relapse prevention. In each module, participants will watch short videos to learn strategies to improve their sleep.
Virtual coaching
A virtual coach will be added to the app functionality. It will be in the form of a text-based forced-choice conversation bot. It will initiate conversations with the users to check their understanding of treatment materials and guide them to come up with specific action plans to implement the treatment strategies.
Therapist coaching
A clinical psychology trainee will provide therapeutic support to enhance the use and adherence to CBTi treatment strategies at the end of modules 1, 3, and 6 by phone. The contact time will be within 30 minutes on each occasion.
Interventions
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dCBTi
The dCBTi adopts a multi-module approach, consisted of 6 weekly modules including psychoeducational on sleep, insomnia, sleep hygiene, sleep restriction and prescription, stimulus control, relaxation and worry time, cognitive restructuring, and relapse prevention. In each module, participants will watch short videos to learn strategies to improve their sleep.
Virtual coaching
A virtual coach will be added to the app functionality. It will be in the form of a text-based forced-choice conversation bot. It will initiate conversations with the users to check their understanding of treatment materials and guide them to come up with specific action plans to implement the treatment strategies.
Non-therapist coaching
A research intern will answer questions and address concerns raised by the participant at the end of modules 1, 3, and 6 by phone. The contact time will be within 30 minutes on each occasion.
Therapist coaching
A clinical psychology trainee will provide therapeutic support to enhance the use and adherence to CBTi treatment strategies at the end of modules 1, 3, and 6 by phone. The contact time will be within 30 minutes on each occasion.
Sleep Hygiene and Self-Monitoring Control
An app with self-monitoring function and videos and written materials about sleep hygiene will be provided.
Eligibility Criteria
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Inclusion Criteria
* (b) Aged 18 or above,
* (c) Able to read and write Chinese,
* (d) Has regular access to a smart phone and internet,
* (e) insomnia severity index ⩾10;
* (f) Willing and can be contacted by experimenter via phone between 9 am - 9 pm
Exclusion Criteria
* (b) known factor to interfere with participation in this research,
* (c) serious medical, neurological, or psychiatric illness that may affect participation in this research,
* (d) sleep apnea,
* (e) concurrent treatment for insomnia,
* (f) unstablized medication that can affect sleep
18 Years
65 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Dr. Chan Wai Sze
Assistant Professor
Principal Investigators
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Wai Sze Chan, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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The University of Hong Kong
Hong Kong, , Hong Kong
Countries
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References
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Chan WS, Cheng WY, Lok SHC, Cheah AKM, Lee AKW, Ng ASY, Kowatsch T. Assessing the Short-Term Efficacy of Digital Cognitive Behavioral Therapy for Insomnia With Different Types of Coaching: Randomized Controlled Comparative Trial. JMIR Ment Health. 2024 Aug 7;11:e51716. doi: 10.2196/51716.
Other Identifiers
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EA210458
Identifier Type: -
Identifier Source: org_study_id
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