dCBTi With and Without Coaching Support

NCT05136638 | Completed

• 1 other identifier: EA210458
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insomnia

Keywords

Digital intervention; Cognitive Behavioral Therapy for Insomnia; Treatment efficacy; Treatment adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Changes in Sleep Condition Indicator (SCI)

  12 weeks from baseline

• Changes in sleep efficiency

  12 weeks from baseline

• Changes in sleep onset latency (SOL)

  12 weeks from baseline

• Changes in wake after sleep onset

  12 weeks from baseline

• Changes in sleep-related cognitions

  12 weeks from baseline

Study Arms (5)

Digital Sleep Hygiene and Self-Monitoring Control

ACTIVE COMPARATOR

Participants assigned to this condition will receive an app to track sleep and offers sleep hygiene recommendations

Behavioral: Sleep Hygiene and Self-Monitoring Control

dCBTi without coaching

EXPERIMENTAL

Participants assigned to this condition will receive a 6-module digital cognitive behavioral therapy for insomnia (dCBTi) with no coaching support

Behavioral: dCBTi

dCBTi with virtual coaching

EXPERIMENTAL

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; Behavioral: Virtual coaching

dCBTi with non-therapist coaching support

EXPERIMENTAL

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; Behavioral: Virtual coaching; Behavioral: Non-therapist coaching

dCBTi with therapist coaching support

EXPERIMENTAL

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; Behavioral: Virtual coaching; Behavioral: Therapist coaching

Interventions

dCBTi BEHAVIORAL

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.

dCBTi with non-therapist coaching support; dCBTi with therapist coaching support; dCBTi with virtual coaching; dCBTi without coaching

Virtual coaching BEHAVIORAL

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.

dCBTi with non-therapist coaching support; dCBTi with therapist coaching support; dCBTi with virtual coaching

Non-therapist coaching BEHAVIORAL

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.

dCBTi with non-therapist coaching support

Therapist coaching BEHAVIORAL

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.

dCBTi with therapist coaching support

Sleep Hygiene and Self-Monitoring Control BEHAVIORAL

An app with self-monitoring function and videos and written materials about sleep hygiene will be provided.

Digital Sleep Hygiene and Self-Monitoring Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• Chan WS, Cheng WY, Lok SHC, Cheah AKM, Lee AKW, Ng ASY, Kowatsch T. Assessing the Short-Term Efficacy of Digital Cognitive Behavioral Therapy for Insomnia With Different Types of Coaching: Randomized Controlled Comparative Trial. JMIR Ment Health. 2024 Aug 7;11:e51716. doi: 10.2196/51716.

  PMID: 39110971 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Health Behavior; Behavior

Study Officials

• Wai Sze Chan, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All outcome measures will be administered via online surveys
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 29, 2021
• Study Start: December 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From after the study findings have been published to 5 years afterwards.
• 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.

Locations

HK (1)