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Sleep QualityLayLedCBTIGNCT07486973

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

A study testing Lay-led CBT-I brief group and Booklet on sleep health in people with Sleep Quality, run by The University of Hong Kong at 1 site in Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Sleep Quality
What is being tested?
Lay-led CBT-I brief group and Booklet on sleep health
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteHong Kong
Study dates
Mar 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yee Man Branda YU contact

+852 39173914

branda.yu@hku.hk

Long Ni WONG contact

+852 39173913

lonniw@hku.hk

Hong Kong1 site

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

    Hong Kong

Other trials in Hong Kong

About this 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.

Conditions
Sleep Quality
Being tested
Lay-led CBT-I brief group, Booklet on sleep health
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
Medical subject headings
Sleep Initiation and Maintenance Disorders, Sleep Hygiene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lay-led CBT-I brief groupBehavioural

    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 healthBehavioural

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

Study groups in NCT07486973
Study groupRoleWhat they receive
The control group (CG)Active comparatorParticipants 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.
Receives: Behavioral: Booklet on sleep health
The emotional support assistant group (ESAG)ExperimentalA 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.
Receives: Behavioral: Lay-led CBT-I brief group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From first session to last session at 4 weeks.

Secondary outcomes (2)

  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.

    Measured: 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.

    Measured: From first session to last session at 4 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2026
  2. Study startMar 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07486973
Sponsor's protocol ID
EA260143
Acronym
LayLedCBTIG
Status last verified
Feb 2026
First submitted
17 Mar 2026
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Frishammar, J., Essén, A., Bergström, F., & Ekman, T. (2023). Digital health platforms for the elderly? Key adoption and usage barriers and ways to address them. Technological Forecasting and Social Change, 189, 122319. https://doi.org/10.1016/j.techfore.2023.122319

  • Julious, S. A. (2005). Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics, 4(4), 287-291. https://doi.org/10.1002/pst.185

  • Wing, Y. K., CHAN, N. Y. R., Xie, C., Chen, S., Yu, D., & Chan, J. W. Y. (2024). Determinants of help-seeking behaviors for insomnia in Hong Kong Chinese: Community-based survey. Journal of Sleep Research, 33(S1), 503-504. https://doi.org/10.1111/jsr.14291

  • World Health Organization, PEPFAR & UNAIDS (2007). Task shifting : rational redistribution of tasks among health workforce teams : global recommendations and guidelines. World Health Organization. https://iris.who.int/handle/10665/43821

  • Yeung WF, Lai AY, Yu BY, Ho FY, Chung KF, Ho JY, Suen LK, Ho LM, Lam TH. Effect of zero-time exercise on physically inactive adults with insomnia disorder: A randomized controlled trial. Int J Nurs Stud. 2025 May;165:105033. doi: 10.1016/j.ijnurstu.2025.105033. Epub 2025 Feb 18.

    PubMed 39999728

  • Yeung WF, Yu BY, Chung KF, Zhang ZJ, Lao L, Ho FY, Suen LK, Ho LM. Self-administered acupressure for insomnia disorder: A randomized controlled trial. Phytomedicine. 2022 May;99:153993. doi: 10.1016/j.phymed.2022.153993. Epub 2022 Feb 15.

    PubMed 35193046

  • Trauer JM, Qian MY, Doyle JS, Rajaratnam SM, Cunnington D. Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Aug 4;163(3):191-204. doi: 10.7326/M14-2841.

    PubMed 26054060

  • Sweetman A, McEvoy RD, Frommer MS, Adams R, Chai-Coetzer CL, Newell S, Moxham-Hall V, Redman S. Promoting sustained access to cognitive behavioral therapy for insomnia in Australia: a system-level implementation program. J Clin Sleep Med. 2025 Feb 1;21(2):325-335. doi: 10.5664/jcsm.11374.

    PubMed 39364910

  • Steinmetz L, Simon L, Feige B, Riemann D, Johann AF, Ell J, Ebert DD, Baumeister H, Benz F, Spiegelhalder K. Network meta-analysis examining efficacy of components of cognitive behavioural therapy for insomnia. Clin Psychol Rev. 2024 Dec;114:102507. doi: 10.1016/j.cpr.2024.102507. Epub 2024 Oct 28.

    PubMed 39504928

  • Stanley MA, Wilson NL, Amspoker AB, Kraus-Schuman C, Wagener PD, Calleo JS, Cully JA, Teng E, Rhoades HM, Williams S, Masozera N, Horsfield M, Kunik ME. Lay providers can deliver effective cognitive behavior therapy for older adults with generalized anxiety disorder: a randomized trial. Depress Anxiety. 2014 May;31(5):391-401. doi: 10.1002/da.22239. Epub 2014 Feb 27.

    PubMed 24577847

  • Simon L, Steinmetz L, Berghoff N, Rehm C, Neumann LM, Kuchler AM, Riemann D, Ebert DD, Spiegelhalder K, Baumeister H. Barriers and Facilitators of Sleep Restriction Therapy in Internet-Delivered CBT-I: A Qualitative Content Analysis and the Development of a Treatment Path Model. J Sleep Res. 2025 Dec;34(6):e70018. doi: 10.1111/jsr.70018. Epub 2025 Feb 24.

    PubMed 39994983

  • Shorey S, Chua JYX. Effectiveness of peer support interventions for adults with depressive symptoms: a systematic review and meta-analysis. J Ment Health. 2023 Apr;32(2):465-479. doi: 10.1080/09638237.2021.2022630. Epub 2022 Jan 7.

    PubMed 34994272

  • Sancho-Domingo C, Carballo JL, Coloma-Carmona A, Buysse DJ. Brief version of the Pittsburgh Sleep Quality Index (B-PSQI) and measurement invariance across gender and age in a population-based sample. Psychol Assess. 2021 Feb;33(2):111-121. doi: 10.1037/pas0000959. Epub 2020 Oct 29.

    PubMed 33119375

  • Puzino K, Amatrudo G, Sullivan A, Vgontzas AN, Fernandez-Mendoza J. Clinical Significance and Cut-Off Scores for the Pre-Sleep Arousal Scale in Chronic Insomnia Disorder: A Replication in a Clinical Sample. Behav Sleep Med. 2020 Nov-Dec;18(6):705-718. doi: 10.1080/15402002.2019.1669604. Epub 2019 Sep 23.

    PubMed 31545084

  • Nicassio PM, Mendlowitz DR, Fussell JJ, Petras L. The phenomenology of the pre-sleep state: the development of the pre-sleep arousal scale. Behav Res Ther. 1985;23(3):263-71. doi: 10.1016/0005-7967(85)90004-x. No abstract available.

    PubMed 4004706

Questions about this trial

What is this clinical trial studying?

A study testing Lay-led CBT-I brief group and Booklet on sleep health in people with Sleep Quality, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yee Man Branda YU (+852 39173914, branda.yu@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective sleep quality (time frame: From first session to last session at 4 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07486973, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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