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

ConditionSleep Quality
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorThe University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: The control group (CG)Active comparator 1 intervention
Group B: The emotional support assistant group (ESAG)Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
From first session to last session at 4 weeks.

Secondary outcomes

1

Dysfunctional Beliefs and Attitudes about Sleep

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.

Time frame
From first session to last session at 4 weeks.
2

Pre-sleep Arousal Scale

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.

Time frame
From first session to last session at 4 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: