Primary Insomnia
Conditions
Brief summary
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).
Interventions
BEHAVIORALBrisk walking
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).
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥60 years; 2. Ethnic Chinese; able to read, write and speak Cantonese 3. Having a Hong Kong ID; 4. Willing to wear an accelerometer on the wrist for a week to assess sleep parameters at T0, T1, and T2. 5. Score ≥10 in the Insomnia Severity Index (ISI) (presence of insomnia) 6. Experiencing any one of the following symptoms for ≥3 days per week 1. Difficulty initiating sleep; OR 2. Difficulty maintaining sleep; OR 3. Early-morning awakening with inability to return to sleep
Exclusion criteria
1. Score ≥1 in the Chinese version of the Physical Activity Readiness Questionnaire (PAR-Q); 2. Currently regularly practicing a moderate-intensity PA program such as brisk walking or Tai Chi (≥3 times a week, ≥30 minutes/session); 3. Currently receiving or scheduled to receive CBT-I during the study period; 4. Score ≤16 in the validated telephone version of the Cantonese Mini-Mental State Examination (T-CMMSE). 5. Working nightshifts and unable/unwilling to discontinue such work pattern; 6. Having a diagnosis of a major depressive disorder, anxiety disorders or other severe mental disorder (bipolar disorders, psychosis). Those with mild depression or anxiety disorders will not be excluded; 7. Use of antidepressant or antipsychotic medication or under treatment of other serious diseases (e.g., cancer chemotherapy) known to affect sleep; 8. Presence of any serious chronic diseases which affect sleep (e.g., cancer, autoimmune diseases). 9. Having a serious somatic condition preventing the participation of brisk walking training/CBT-I.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score of the Insomnia Severity Index (ISI) | 12 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia remission | 12 months | Structured clinical interview to confirm insomnia remission based on the DSM-5 criteria at 12 months after completion of the intervention |
| Sleep quality | 12 months | 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) |
| Seven-day ActiGraph | 12 months | Seven-day ActiGraph at baseline (T0), after completion of the intervention (T1), and six (T2), and 12 months after T1 (T3) |
Countries
Hong Kong
Contacts
Primary ContactZixin Wang, PhD
Outcome results
None listed