Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From first session to last session at 4 weeks. |
| Pre-sleep Arousal Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yee Man Branda YU | Contact | +852 39173914 | branda.yu@hku.hk | |
| Long Ni WONG | Contact | +852 39173913 | lonniw@hku.hk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Social Work and Social Administration, The University of Hong Kong | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| Background | 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 | ||
| Background | 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 | ||
| Background | 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 | ||
| 39999728 |
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2026 | Mar 13, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Intervention Group | Feb 2, 2026 | Mar 13, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Control Group | Mar 13, 2026 | Mar 12, 2026 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000070263 | Sleep Hygiene |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Booklet on sleep health | Behavioral | Eligible control group participants will receive a booklet on sleep hygiene education. |
|
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. |
| Background |
| 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. |
| 35193046 | Background | 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. |
| 26054060 | Background | 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. |
| 39364910 | Background | 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. |
| 39504928 | Background | 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. |
| 24577847 | Background | 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. |
| 39994983 | Background | 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. |
| 34994272 | Background | 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. |
| 33119375 | Background | 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. |
| 31545084 | Background | 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. |
| 4004706 | Background | 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. |
| 18041487 | Background | Morin CM, Vallieres A, Ivers H. Dysfunctional beliefs and attitudes about sleep (DBAS): validation of a brief version (DBAS-16). Sleep. 2007 Nov;30(11):1547-54. doi: 10.1093/sleep/30.11.1547. |
| 41163515 | Background | Meaklim H, Farrough J, Staben K, Morillo Aguirre AV, Jackson ML, Meltzer LJ, Junge MF, Kennedy GA, Bucks RS, Sweetman A, Phillips LJ, Cunnington DC, Lyons KM, Graco M, Rehm IC. A Qualitative Exploration of Barriers and Facilitators to Implementing Sleep and Cognitive Behavioral Therapy for Insomnia Knowledge Into Graduate Psychology Students' Practice. Behav Sleep Med. 2026 Mar-Apr;24(2):200-218. doi: 10.1080/15402002.2025.2576909. Epub 2025 Oct 30. |
| 29851516 | Background | Lu L, Wang SB, Rao W, Zhang Q, Ungvari GS, Ng CH, Kou C, Jia FJ, Xiang YT. The Prevalence of Sleep Disturbances and Sleep Quality in Older Chinese Adults: A Comprehensive Meta-Analysis. Behav Sleep Med. 2019 Nov-Dec;17(6):683-697. doi: 10.1080/15402002.2018.1469492. Epub 2018 May 31. |
| 35176346 | Background | Li M, Wang N, Dupre ME. Association between the self-reported duration and quality of sleep and cognitive function among middle-aged and older adults in China. J Affect Disord. 2022 May 1;304:20-27. doi: 10.1016/j.jad.2022.02.039. Epub 2022 Feb 14. |
| 34147026 | Background | Lee S, Kim JH, Chung JH. The association between sleep quality and quality of life: a population-based study. Sleep Med. 2021 Aug;84:121-126. doi: 10.1016/j.sleep.2021.05.022. Epub 2021 May 27. |
| 35844091 | Background | Lai VKY, Fung AWT, Lam LCW, Lee ATC. Is sleep quality a potential predictor of neurocognitive disorders? A 6-year follow-up study in Chinese older adults. Int J Geriatr Psychiatry. 2022 Aug;37(8). doi: 10.1002/gps.5783. |
| 40220528 | Background | Hrozanova M, Skarpsno ES, Follestad T, Kallestad H, Pallesen S, Nordstoga AL, Mollerlokken NE, Ronning AS, Meisingset I. Effectiveness of group-delivered cognitive behavioural therapy for insomnia in primary care: a pragmatic, multicentre randomised controlled trial. Sleep Med. 2025 Jul;131:106495. doi: 10.1016/j.sleep.2025.106495. Epub 2025 Apr 2. |
| 33164742 | Background | Edinger JD, Arnedt JT, Bertisch SM, Carney CE, Harrington JJ, Lichstein KL, Sateia MJ, Troxel WM, Zhou ES, Kazmi U, Heald JL, Martin JL. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Feb 1;17(2):255-262. doi: 10.5664/jcsm.8986. |
| 38007301 | Background | Del Brutto OH, Mera RM, Rumbea DA, Sedler MJ, Castillo PR. Poor sleep quality increases mortality risk: A population-based longitudinal prospective study in community-dwelling middle-aged and older adults. Sleep Health. 2024 Feb;10(1):144-148. doi: 10.1016/j.sleh.2023.10.009. Epub 2023 Nov 25. |
| 28463015 | Background | Davidson JR, Dawson S, Krsmanovic A. Effectiveness of Group Cognitive Behavioral Therapy for Insomnia (CBT-I) in a Primary Care Setting. Behav Sleep Med. 2019 Mar-Apr;17(2):191-201. doi: 10.1080/15402002.2017.1318753. Epub 2017 May 2. |
| 21225347 | Background | Crowley K. Sleep and sleep disorders in older adults. Neuropsychol Rev. 2011 Mar;21(1):41-53. doi: 10.1007/s11065-010-9154-6. Epub 2011 Jan 12. |
| 25515275 | Background | Chien MY, Chen HC. Poor sleep quality is independently associated with physical disability in older adults. J Clin Sleep Med. 2015 Mar 15;11(3):225-32. doi: 10.5664/jcsm.4532. |
| 30612061 | Background | Cheung JMY, Jarrin DC, Ballot O, Bharwani AA, Morin CM. A systematic review of cognitive behavioral therapy for insomnia implemented in primary care and community settings. Sleep Med Rev. 2019 Apr;44:23-36. doi: 10.1016/j.smrv.2018.11.001. Epub 2018 Nov 23. |
| 39836656 | Background | Chen SJ, Que JY, Chan NY, Shi L, Li SX, Chan JWY, Huang W, Chen CX, Tsang CC, Ho YL, Morin CM, Zhang JH, Lu L, Wing YK. Effectiveness of app-based cognitive behavioral therapy for insomnia on preventing major depressive disorder in youth with insomnia and subclinical depression: A randomized clinical trial. PLoS Med. 2025 Jan 21;22(1):e1004510. doi: 10.1371/journal.pmed.1004510. eCollection 2025 Jan. |
| 8532986 | Background | Browne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995 Sep 15;14(17):1933-40. doi: 10.1002/sim.4780141709. |
| 28013552 | Background | Becker NB, Jesus SN, Joao KADR, Viseu JN, Martins RIS. Depression and sleep quality in older adults: a meta-analysis. Psychol Health Med. 2017 Sep;22(8):889-895. doi: 10.1080/13548506.2016.1274042. Epub 2016 Dec 26. |
| 35653951 | Background | Alimoradi Z, Jafari E, Brostrom A, Ohayon MM, Lin CY, Griffiths MD, Blom K, Jernelov S, Kaldo V, Pakpour AH. Effects of cognitive behavioral therapy for insomnia (CBT-I) on quality of life: A systematic review and meta-analysis. Sleep Med Rev. 2022 Aug;64:101646. doi: 10.1016/j.smrv.2022.101646. Epub 2022 May 10. |
| D001523 |
| Mental Disorders |
| D015438 | Health Behavior |
| D001519 | Behavior |