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

NCT07486973 | Not Yet Recruiting

• 1 other identifier: EA260143
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Quality

Keywords

Cognitive Behavioural Therapy for Insomnia; Task-shifting; Sleep hygiene; Stimulus control; Sleep health; Lay-led psychotherapy; lay-led psychotherapy group; Subjective sleep quality; Cognitive restructuring

Outcome Measures

Primary Outcomes (1)

• Subjective sleep quality

  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 Outcomes (2)

• Dysfunctional Beliefs and Attitudes about Sleep

  From first session to last session at 4 weeks.

• Pre-sleep Arousal Scale

  From first session to last session at 4 weeks.

Study Arms (2)

The control group (CG)

ACTIVE COMPARATOR

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

The emotional support assistant group (ESAG)

EXPERIMENTAL

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

Interventions

Lay-led CBT-I brief group BEHAVIORAL

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.

The emotional support assistant group (ESAG)

Booklet on sleep health BEHAVIORAL

Eligible control group participants will receive a booklet on sleep hygiene education.

The control group (CG)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, Hong Kong

Location

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Hygiene

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yee Man Branda YU

CONTACT

+852 39173914; branda.yu@hku.hk

Long Ni WONG

CONTACT

+852 39173913; lonniw@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-02

Locations

HK (1)