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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
129
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.
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.
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.
The University of Hong Kong
Hong Kong, Hong Kong
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
Time frame: 12 weeks from baseline
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 12 weeks from baseline
Changes in sleep-related safety behaviors
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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.
An app with self-monitoring function and videos and written materials about sleep hygiene will be provided.
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 weeks from baseline