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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
92
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).
The Chinese University of Hong Kong
Hong Kong, Hong Kong
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).
Time frame: 12 months
Insomnia remission
Structured clinical interview to confirm insomnia remission based on the DSM-5 criteria at 12 months after completion of the intervention
Time frame: 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)
Time frame: 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)
Time frame: 12 months
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