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

Launched by CHINESE UNIVERSITY OF HONG KONG · Feb 23, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring two different approaches to help older adults, aged 60 and above, who are struggling with chronic primary insomnia (difficulty sleeping). The study compares brisk walking training with cognitive behavioral therapy for insomnia (CBT-I) to see which method is more effective. Participants will be randomly assigned to either join a brisk walking program led by an instructor for eight weeks or attend group sessions of CBT-I over eight weeks. The goal is to determine if brisk walking can help improve sleep just as well as the therapy.

To be eligible for the trial, participants must be ethnic Chinese, able to read, write, and speak Cantonese, and have a Hong Kong ID. They should also report difficulties with sleep at least three times a week and score 10 or higher on the Insomnia Severity Index. However, those who are currently exercising regularly, have certain mental health issues, or are dealing with serious chronic illnesses may not qualify. Throughout the study, participants will wear a device on their wrist to track their sleep patterns and will have their sleep assessed at different points—before the program starts, right after it ends, and again six and twelve months later. This trial aims to find accessible and effective ways to improve sleep for older adults.

Gender

ALL

Eligibility criteria

• 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.