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

Обзор

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).

Вмешательства

• Поведенческое Brisk walking
  Participants in the brisk walking training group receive an eight-week instructor-led interval brisk walking training (40 minutes/session, three sessions/week).
• Поведенческое Cognitive-behavioral therapy for insomnia
  Participants in the CBT-I group receive standard-of-care group-based eight-session CBT-I (one session/week).

Первичные конечные точки

• Score of the Insomnia Severity Index (ISI) [Срок оценки: 12 months]

Вторичные конечные точки (3)

• Insomnia remission [Срок оценки: 12 months]
• Sleep quality [Срок оценки: 12 months]
• Seven-day ActiGraph [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Chinese University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT06850272 · ECS24610123

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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