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

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

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Sleep Hygiene and Self-Monitoring Control; Behavioral: dCBTi; Behavioral: Virtual coaching; Behavioral: Non-therapist coaching; Behavioral: Therapist coaching

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.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Wai Sze Chan, PhD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 29, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Treatment efficacy; Digital intervention; Cognitive Behavioral Therapy for Insomnia; Treatment adherence
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: EA210458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data will be made available for sharing with other researchers for secondary analysis upon request.
• IPD Sharing Time Frame: From after the study findings have been published to 5 years afterwards.
• IPD Sharing Access Criteria: The request party has a pre-registration of the research that requires data from the present study indicating clearly what data are required and other criteria as the PI deem appropriate.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No