NCT05136638

dCBTi With and Without Coaching Support

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	dCBTi	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.
BEHAVIORAL	Virtual coaching	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.
BEHAVIORAL	Non-therapist coaching	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.
BEHAVIORAL	Therapist coaching	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.
BEHAVIORAL	Sleep Hygiene and Self-Monitoring Control	An app with self-monitoring function and videos and written materials about sleep hygiene will be provided.

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-11-29
• Last updated: 2023-08-09

Locations

1 site across 1 country: Hong Kong