A Randomized Controlled Comparative Trial of Digital Cognitive Behavioral Therapy for Insomnia (dCBTi): Comparing Efficacy and Adherence to dCBTi With Virtual and Human Coaching
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The University of Hong Kong
- Enrollment
- 129
- Locations
- 1
- Primary Endpoint
- Changes in Insomnia Severity Index (ISI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
All outcome measures will be administered via online surveys
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Digital Sleep Hygiene and Self-Monitoring Control
Participants assigned to this condition will receive an app to track sleep and offers sleep hygiene recommendations
Intervention: Sleep Hygiene and Self-Monitoring Control (Behavioral)
dCBTi without coaching
Participants assigned to this condition will receive a 6-module digital cognitive behavioral therapy for insomnia (dCBTi) with no coaching support
Intervention: dCBTi (Behavioral)
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.
Intervention: dCBTi (Behavioral)
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.
Intervention: Virtual coaching (Behavioral)
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.
Intervention: dCBTi (Behavioral)
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.
Intervention: Virtual coaching (Behavioral)
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.
Intervention: Non-therapist coaching (Behavioral)
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.
Intervention: dCBTi (Behavioral)
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.
Intervention: Virtual coaching (Behavioral)
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.
Intervention: Therapist coaching (Behavioral)
Outcomes
Primary Outcomes
Changes in Insomnia Severity Index (ISI)
Time Frame: 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 Outcomes
- Changes in sleep-related cognitions(12 weeks from baseline)
- Changes in Sleep Condition Indicator (SCI)(12 weeks from baseline)
- Changes in sleep onset latency (SOL)(12 weeks from baseline)
- Changes in fatigue(12 weeks from baseline)
- Changes in sleep efficiency(12 weeks from baseline)
- Changes in anxiety symptoms(12 weeks from baseline)
- Changes in wake after sleep onset(12 weeks from baseline)
- Changes in psychological wellbeing(12 weeks from baseline)
- Changes in sleep-related safety behaviors(12 weeks from baseline)
- Changes in daytime sleepiness(12 weeks from baseline)
- Changes in depressive symptoms(12 weeks from baseline)
Investigators
Dr. Chan Wai Sze
Assistant Professor
The University of Hong Kong