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A Quasi-experimental Study Design of Evaluation the Effects of Brief Behavioral Therapy for Insomnia on Regulating Stress and Sleep Quality in Middle-aged and Older Adults With Chronic Insomnia
This study aims to investigate whether a four-week BBTi program can effectively improve chronic insomnia and reduce overall stress in middle-aged and elderly individuals.
This study will be conducted a single-group pre-test and post-test design, aiming to recruit 80 subjects who will undergo a four-week BBTi intervention. Participants will be selected from sleep counseling patients referred by sleep specialists. Inclusion criteria include: 1) individuals aged 40 years and above; 2) experiencing sleep disturbances; 3) willing to participate in the research project and provide informed consent. Cognitive impairment will exclude. The intervention consists of four weeks of BBTi. During the first week, participants will receive face-to-face sleep assessments and sleep hygiene education. In the second week, a phone interview will be conducted to assess the patient's progress and provide appropriate relaxation techniques. Unsatisfactory responses to sleep restriction therapy or stimulation control methods will be addressed through face-to-face interviews in the third week. The fourth week will involve an overall review and evaluation conducted via a telephone interview.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
Yes
National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
Tainan, Taiwan, Taiwan
Start Date
July 13, 2023
Primary Completion Date
December 31, 2025
Completion Date
July 31, 2026
Last Updated
March 13, 2026
80
ESTIMATED participants
Brief Behavioral Treatment for Insomnia (BBTi)
BEHAVIORAL
Lead Sponsor
National Cheng-Kung University Hospital
NCT07429578
NCT06791356
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07379099