dCBTi With and Without Coaching Support

Study Overview
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Brief Summary
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The current research aims to evaluate the adherence and efficacy of dCBTi with different types of coaching support.

Detailed Description
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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.

Official Title
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A Randomized Controlled Comparative Trial of Digital Cognitive Behavioral Therapy for Insomnia (dCBTi): Comparing Efficacy and Adherence to dCBTi With Virtual and Human Coaching

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: dCBTi
* Behavioral: Virtual coaching
* Behavioral: Non-therapist coaching
* Behavioral: Therapist coaching
* Behavioral: Sleep Hygiene and Self-Monitoring Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (a) Hong Kong resident, (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: (a) significant untreated/unstable mental or medical illness, (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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Digital Sleep Hygiene and Self-Monitoring Control<br>Participants assigned to this condition will receive an app to track sleep and offers sleep hygiene recommendations | Behavioral: Sleep Hygiene and Self-Monitoring Control<br>* An app with self-monitoring function and videos and written materials about sleep hygiene will be provided.<br>|
| Experimental: dCBTi without coaching<br>Participants assigned to this condition will receive a 6-module digital cognitive behavioral therapy for insomnia (dCBTi) with no coaching support | Behavioral: dCBTi<br>* 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.<br>|
| Experimental: dCBTi with virtual coaching<br>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. | Behavioral: dCBTi<br>* 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.<br>Behavioral: Virtual coaching<br>* 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.<br>|
| Experimental: dCBTi with non-therapist coaching support<br>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. | Behavioral: dCBTi<br>* 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.<br>Behavioral: Virtual coaching<br>* 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.<br>Behavioral: Non-therapist coaching<br>* 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.<br>|
| Experimental: dCBTi with therapist coaching support<br>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. | Behavioral: dCBTi<br>* 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.<br>Behavioral: Virtual coaching<br>* 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.<br>Behavioral: Therapist coaching<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavioral Therapy for Insomnia, Treatment efficacy, Treatment adherence, Digital intervention