Brief Behavioral Therapy for Insomnia(BBTi) in Middle-aged and Older Adults With Chronic Insomnia

NCT ID: NCT06073990

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-13

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Insomnia Older Adults Sleep Hygiene

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Brief Behavioral Treatment for Insomnia (BBTi)

In the post-intervention group, the investigators collected data at the 1-week, 2-week, and 3-week marks following the intervention.

Group Type EXPERIMENTAL

Brief Behavioral Treatment for Insomnia (BBTi)

Intervention Type BEHAVIORAL

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.

Interventions

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Brief Behavioral Treatment for Insomnia (BBTi)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen, Yen-Chin

Vice Head Nurse and Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University

Tainan City, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yen-Chin Chen

Role: CONTACT

+886-6-2353535 ext. 2019

Facility Contacts

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YenChin Chen

Role: primary

+886-6-2353535 ext. 2019

Other Identifiers

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A-ER-112-175

Identifier Type: -

Identifier Source: org_study_id

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