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This study is a single-blinded (outcome assessor) and parallel-group non-inferiority RCT. Chinese older adults aged ≥60 years with chronic primary insomnia will be randomized evenly (1:1) to either the brisk walking training group or the CBT-I group. Participants in the brisk walking training group receive an eight-week instructor-led interval brisk walking training (40 minutes/session, three sessions/week). Participants in the CBT-I group receive standard-of-care group-based eight-session CBT-I (one session/week). Self-reported and objective sleep outcomes are measured at baseline (T0), after completion of the intervention (T1), and six (T2), and 12 months after T1 (T3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brisk walking group | Experimental | Participants in the brisk walking training group receive an eight-week instructor-led interval brisk walking training (40 minutes/session, three sessions/week). |
|
| CBT-I group | Active Comparator | Participants in the CBT-I group receive standard-of-care group-based eight-session CBT-I (one session/week). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brisk walking | Behavioral | Participants in the brisk walking training group receive an eight-week instructor-led interval brisk walking training (40 minutes/session, three sessions/week). |
| Measure | Description | Time Frame |
|---|---|---|
| Score of the Insomnia Severity Index (ISI) | Score of the Insomnia Severity Index (ISI) measured at at baseline (T0), after completion of the intervention (T1), and six (T2), and 12 months after T1 (T3). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia remission | Structured clinical interview to confirm insomnia remission based on the DSM-5 criteria at 12 months after completion of the intervention | 12 months |
| Sleep quality | Sleep quality will be measured by the 19-item Pittsburg Sleep Quality Index (PSQI) at baseline (T0), after completion of the intervention (T1), and six (T2), and 12 months after T1 (T3) |
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Inclusion Criteria:
Aged ≥60 years;
Ethnic Chinese; able to read, write and speak Cantonese
Having a Hong Kong ID;
Willing to wear an accelerometer on the wrist for a week to assess sleep parameters at T0, T1, and T2.
Score ≥10 in the Insomnia Severity Index (ISI) (presence of insomnia)
Experiencing any one of the following symptoms for ≥3 days per week
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zixin Wang, PhD | Contact | +852 22528474 | wangzx@cuhk.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Hong Kong | Hong Kong |
The individual participant data contains sensitive behaviors and conditions.
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| Cognitive-behavioral therapy for insomnia | Behavioral | Participants in the CBT-I group receive standard-of-care group-based eight-session CBT-I (one session/week). |
|
| 12 months |
| Seven-day ActiGraph | Seven-day ActiGraph at baseline (T0), after completion of the intervention (T1), and six (T2), and 12 months after T1 (T3) | 12 months |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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