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NCT Number: NCT06850272

Brisk Walking Training Compared with Cognitive Behavioral Therapy for the Treatment of Chronic Primary Insomnia in People Aged 60 Years or Above: a Randomized, Partially Blinded, Non-inferiority Trial

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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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Difficulty initiating sleep; OR
  • Difficulty maintaining sleep; OR
  • Early-morning awakening with inability to return to sleep

Exclusion criteria

  • Score ≥1 in the Chinese version of the Physical Activity Readiness Questionnaire (PAR-Q);
  • Currently regularly practicing a moderate-intensity PA program such as brisk walking or Tai Chi (≥3 times a week, ≥30 minutes/session);
  • Currently receiving or scheduled to receive CBT-I during the study period;
  • Score ≤16 in the validated telephone version of the Cantonese Mini-Mental State Examination (T-CMMSE).
  • Working nightshifts and unable/unwilling to discontinue such work pattern;
  • 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;
  • Use of antidepressant or antipsychotic medication or under treatment of other serious diseases (e.g., cancer chemotherapy) known to affect sleep;
  • Presence of any serious chronic diseases which affect sleep (e.g., cancer, autoimmune diseases).
  • Having a serious somatic condition preventing the participation of brisk walking training/CBT-I.

Treatment and study plan

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).

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).

Primary outcomes

  1. Score of the Insomnia Severity Index (ISI)

    Time frame: 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 outcomes

  1. Insomnia remission

    Time frame: 12 months

    Structured clinical interview to confirm insomnia remission based on the DSM-5 criteria at 12 months after completion of the intervention

  2. Sleep quality

    Time frame: 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)

  3. Seven-day ActiGraph

    Time frame: 12 months

    Seven-day ActiGraph at baseline (T0), after completion of the intervention (T1), and six (T2), and 12 months after T1 (T3)

Study contacts

Contact information is provided by the study sponsor or research team.

Zixin Wang, PhD

CONTACT

[email protected]

+852 22528474

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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