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The current research aims to evaluate the adherence and efficacy of dCBTi with different types of coaching support.
Participants will be randomly assigned to one of the five conditions. C1: Sleep Hygiene and Self-Monitoring Control Condition; C2: dCBTi without coaching; C3; dCBTi with virtual coaching; C4: dCBTi with non-therapist coaching; C5: dCBTi with therapist coaching.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Sleep Hygiene and Self-Monitoring Control | Active Comparator | Participants assigned to this condition will receive an app to track sleep and offers sleep hygiene recommendations |
|
| dCBTi without coaching | Experimental | Participants assigned to this condition will receive a 6-module digital cognitive behavioral therapy for insomnia (dCBTi) with no coaching support |
|
| dCBTi with virtual coaching | Experimental | 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 with non-therapist coaching support | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dCBTi | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Insomnia Severity Index (ISI) | Insomnia symptoms measured by the Insomnia Severity Index (ISI). The score ranges from 0 to 24. Higher scores indicate greater levels of insomnia symptoms | 12 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Sleep Condition Indicator (SCI) | Insomnia symptoms measured by the Sleep Condition Indicator (SCI). The score ranges from 0 to 32. Higher scores indicate lower levels of insomnia symptoms | 12 weeks from baseline |
| Changes in sleep efficiency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wai Sze Chan, PhD | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Hong Kong | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39110971 | Derived | 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. |
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Deidentified individual participant data will be made available for sharing with other researchers for secondary analysis upon request.
From after the study findings have been published to 5 years afterwards.
The request party has a pre-registration of the research that requires data from the present study indicating clearly what data are required and other criteria as the PI deem appropriate.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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All outcome measures will be administered via online surveys
| dCBTi with therapist coaching support | Experimental | 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. |
|
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| Virtual coaching | Behavioral | 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 | Behavioral | 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 | Behavioral | 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 | Behavioral | An app with self-monitoring function and videos and written materials about sleep hygiene will be provided. |
|
Sleep efficiency measured by Consensus Sleep Diary. It ranges from 0 to 100%, the higher indicates better sleep |
| 12 weeks from baseline |
| Changes in sleep onset latency (SOL) | Sleep onset latency (SOL) measured by Consensus Sleep Diary. Its unit is minutes. Longer SOL indicates greater levels of insomnia | 12 weeks from baseline |
| Changes in wake after sleep onset | Wake after sleep onset (WASO) measured by Consensus Sleep Diary. Its unit is minutes. Longer WASO indicates greater levels of insomnia | 12 weeks from baseline |
| Changes in sleep-related cognitions | Sleep-related cognitions measured by the Dysfunctional Beliefs and Attitudes about Sleep 16-item Scale (DBAS-16). Respondents rate their agreement to each of the 16 statements on a Visual Analog Scale (0-100). Higher scores indicate more dysfunctional sleep-related cognitions. | 12 weeks from baseline |
| Changes in sleep-related safety behaviors | Sleep-related safety behaviors measured by the Sleep-Related Behavior Questionnaire - 20 (SRBQ-20). The score ranges from 0 to 80, higher scores indicate greater engagement in sleep-related safety behaviors | 12 weeks from baseline |
| Changes in daytime sleepiness | Sleepiness measured by the Epworth Sleepiness Scale (ESS). The score ranges from 0 to 24, higher scores indicate greater sleepiness. | 12 weeks from baseline |
| Changes in fatigue | Fatigue measured by the Fatigue Assessment Scale (FAS). The score ranges from 10 to 50, the higher the greater levels of fatigue | 12 weeks from baseline |
| Changes in depressive symptoms | Depressive symptoms measured by the Patient Health Questionnaire - 9 (PHQ-9). The score ranges from 0 to 27, the higher the more depressed | 12 weeks from baseline |
| Changes in anxiety symptoms | Anxiety symptoms measured by the Generalized Anxiety Disorder 7-item Scale (GAD-7). The score ranges from 0 to 21, the higher the more anxious | 12 weeks from baseline |
| Changes in psychological wellbeing | Psychological wellbeing measured by the Satisfaction with Life Scale (SWLS). The score ranges from 5 to 35, the higher indicates greater wellbeing | 12 weeks from baseline |
| D001523 |
| Mental Disorders |
| D015438 | Health Behavior |
| D001519 | Behavior |