Clinical trial NCT06073990: Brief Behavioral Therapy for Insomnia(BBTi) in Middle-aged and Older Adults With Chronic Insomnia
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Insomnia
Older Adults
Sleep Hygiene
Keywords: Brief Behavioral Treatment for Insomnia
Chronic Insomnia
Older adults
Sleep Hygiene
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* individuals aged 40 years and above,
* experiencing sleep disturbances,
* willing to participate in the research project and provide informed consent

Exclusion Criteria:

●Cognitive impairment

Primary outcomes:
measure: Insomnia severity (T1)
timeFrame: the first week
measure: Insomnia severity (T2)
timeFrame: the second week
measure: Insomnia severity (T3)
timeFrame: the third week
measure: Insomnia severity (T4)
timeFrame: the fourth week
measure: Sleep health (T1)
timeFrame: the first week
measure: Sleep health (T2)
timeFrame: the second week
measure: Sleep health (T3)
timeFrame: the third week
measure: Sleep health (T4)
timeFrame: the fourth week
measure: Sleep Diary_Sleep efficacy (%) (T1)
timeFrame: the first week
measure: Sleep Diary_Sleep efficacy (%) (T2)
timeFrame: the second week
measure: Sleep Diary_Sleep efficacy (%) (T3)
timeFrame: the third week
measure: Sleep Diary_Sleep efficacy (%) (T4)
timeFrame: the fourth week
measure: Anxiety (T1)
timeFrame: the first week
measure: Anxiety (T2)
timeFrame: the second week
measure: Anxiety (T3)
timeFrame: the third week
measure: Anxiety (T4)
timeFrame: the fourth week
measure: Depression (T1)
timeFrame: the first week
measure: Depression (T2)
timeFrame: the second week
measure: Depression (T3)
timeFrame: the third week
measure: Depression (T4)
timeFrame: the fourth week
measure: Stress index (ms2) (T1)
timeFrame: the first week
measure: Stress index (ms2) (T3)
timeFrame: the third week
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
Study officials:
References: