dCBTi With and Without Coaching Support
- Conditions
- Insomnia
- Interventions
- Behavioral: dCBTiBehavioral: Sleep Hygiene and Self-Monitoring ControlBehavioral: Virtual coachingBehavioral: Therapist coachingBehavioral: Non-therapist coaching
- Registration Number
- NCT05136638
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
The current research aims to evaluate the adherence and efficacy of dCBTi with different types of coaching support.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- (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
- (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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dCBTi with virtual coaching dCBTi 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 dCBTi 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. Digital Sleep Hygiene and Self-Monitoring Control Sleep Hygiene and Self-Monitoring Control Participants assigned to this condition will receive an app to track sleep and offers sleep hygiene recommendations dCBTi without coaching dCBTi 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 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 with therapist coaching support Therapist coaching 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 with non-therapist coaching support Virtual coaching 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 with non-therapist coaching support Non-therapist coaching 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 with therapist coaching support dCBTi 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 with therapist coaching support Virtual coaching 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.
- Primary Outcome Measures
Name Time Method Changes in Insomnia Severity Index (ISI) 12 weeks from baseline Insomnia symptoms measured by the Insomnia Severity Index (ISI). The score ranges from 0 to 24. Higher scores indicate greater levels of insomnia symptoms
- Secondary Outcome Measures
Name Time Method Changes in sleep-related cognitions 12 weeks from baseline 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.
Changes in Sleep Condition Indicator (SCI) 12 weeks from baseline Insomnia symptoms measured by the Sleep Condition Indicator (SCI). The score ranges from 0 to 32. Higher scores indicate lower levels of insomnia symptoms
Changes in sleep onset latency (SOL) 12 weeks from baseline Sleep onset latency (SOL) measured by Consensus Sleep Diary. Its unit is minutes. Longer SOL indicates greater levels of insomnia
Changes in fatigue 12 weeks from baseline Fatigue measured by the Fatigue Assessment Scale (FAS). The score ranges from 10 to 50, the higher the greater levels of fatigue
Changes in sleep efficiency 12 weeks from baseline Sleep efficiency measured by Consensus Sleep Diary. It ranges from 0 to 100%, the higher indicates better sleep
Changes in anxiety symptoms 12 weeks from baseline 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
Changes in wake after sleep onset 12 weeks from baseline Wake after sleep onset (WASO) measured by Consensus Sleep Diary. Its unit is minutes. Longer WASO indicates greater levels of insomnia
Changes in psychological wellbeing 12 weeks from baseline Psychological wellbeing measured by the Satisfaction with Life Scale (SWLS). The score ranges from 5 to 35, the higher indicates greater wellbeing
Changes in sleep-related safety behaviors 12 weeks from baseline 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
Changes in daytime sleepiness 12 weeks from baseline Sleepiness measured by the Epworth Sleepiness Scale (ESS). The score ranges from 0 to 24, higher scores indicate greater sleepiness.
Changes in depressive symptoms 12 weeks from baseline Depressive symptoms measured by the Patient Health Questionnaire - 9 (PHQ-9). The score ranges from 0 to 27, the higher the more depressed
Trial Locations
- Locations (1)
The University of Hong Kong
🇭🇰Hong Kong, Hong Kong
The University of Hong Kong🇭🇰Hong Kong, Hong Kong