Lay-led Brief Cognitive Behavioural Therapy for Insomnia (CBT-I) Group for Older Adults in Hong Kong: A Pilot Study (LayLedCBTIG)

March 17, 2026 updated by: YU Yee Man Branda, The University of Hong Kong
The goal of this clinical trial is to study whether a Cognitive Behavioural Therapy for Insomnia (CBT-I) group led by laypersons serves as an effective tool for alleviating insomnia in older Chinese adults in Hong Kong. The main questions it aims to answer are: 1) Can the group improve subjective sleep quality? 2) What is the feasibility and acceptability of the group? Researchers will compare the intervention group with a control group. Participants will either join the intervention group or receive a self-help booklet, depending on their assignment. Both groups will complete two questionnaires over a four-week period: Baseline and Week-4 data.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Long Ni WONG
  • Phone Number: +852 39173913
  • Email: lonniw@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Social Work and Social Administration, The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 45 or older
  • Have a PHQ-9 score between 5-9, and item 3 must be scored at 2 or higher
  • Experiencing existing symptoms of depression and sleep disturbance
  • Capable of providing informed consent for their participation in the study

Exclusion Criteria:

  • Known history of intellectual disabilities, schizophrenia spectrum disorders, bipolar disorder, Parkinson's disease, or dementia
  • Assessed to be at active suicidal risk
  • Significant difficulties in communication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: The control group (CG)
Participants will receive a booklet on sleep hygiene education and will be asked to follow the instruction for 4 weeks for the same duration as the intervention group.
Behavioral: Booklet on sleep health
Eligible control group participants will receive a booklet on sleep hygiene education.
Experimental: The emotional support assistant group (ESAG)
A brief in-person group for CBT-I, consisting of four sessions, with each session lasting approximately 1.5 hours and expected to be completed within a month. The sessions will cover four treatment components: sleep hygiene, stimulus control, cognitive restructuring, and relaxation exercises, all facilitated by trained Emotional Support Assistants.
Behavioral: Lay-led CBT-I brief group
Participants will participate in a brief in-person group for CBT-I, consisting of four sessions, with each session lasting approximately 1.5 hours and expected to be completed within a month. The sessions will cover four treatment components: sleep hygiene, stimulus control, cognitive restructuring, and relaxation exercises, all facilitated by trained Emotional Support Assistants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective sleep quality
Time Frame: From first session to last session at 4 weeks.
Brief Version of the Pittsburgh Sleep Quality Index (B-PSQI): Likert scale with a global scoring ranging from 0 to 15. A higher score indicates worse sleep quality.
From first session to last session at 4 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysfunctional Beliefs and Attitudes about Sleep
Time Frame: From first session to last session at 4 weeks.
A 16-items scale ranging from 0 (Strongly Disagree) to 10 (Strongly Agree). Stronger endorsement of these beliefs indicates greater maladaptation in detecting therapeutic changes and effectiveness.
From first session to last session at 4 weeks.
Pre-sleep Arousal Scale
Time Frame: From first session to last session at 4 weeks.
Rated on a 5-point Likert scale, ranging from 1 (Not at all) to 5 (Extremely), with total scores ranging from 8 to 40 for both subscales. Higher scores indicate an increased level of pre-sleep arousal.
From first session to last session at 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA260143

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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