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NCT Number: NCT07486973

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

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.

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Key information

Conditions

Sleep Quality Behavior Dyssomnias Health Behavior Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Hygiene Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Booklet on sleep health

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Long Ni WONG

CONTACT

[email protected]

+852 39173913

Yee Man Branda YU

CONTACT

[email protected]

+852 39173914

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Acronym: LayLedCBTIG

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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