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NCT Number: NCT07779499

Group-Based Brief Behavioral Therapy for Insomnia for Patients With Chronic Mental Illness

The goal of this clinical trial is to evaluate the effectiveness of a short-term, group-based Brief Behavioral Therapy for Insomnia (BBTI) intervention in chronic psychiatric patients at a hospital day ward.The main questions it aims to answer are:

1. Does the BBTI-based group intervention improve subjective sleep quality and reduce the severity of insomnia? 2. Does the intervention have a positive effect on psychological well-being and cardiometabolic/physical functions? Researchers will compare an experimental group to a waitlist control group to see if the intervention improves sleep quality, reduces insomnia-perpetuating behaviors, and enhances overall health status across various timeframes.

Participants will:

1. Attend four sessions that cover sleep structure education, relaxation techniques (including acupressure), sleep-promoting diet principles, and the proper use of sedative-hypnotic medications. 2. Write a daily sleep diary. 3. Complete three times of structured self-report questionnaires. 4. Undergo physiological and physical function assessments.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The goal of this clinical trial is to evaluate the effectiveness of a short-term, group-based Brief Behavioral Therapy for Insomnia (BBTI) intervention in chronic psychiatric patients at a hospital day ward.The main questions it aims to answer are:

  • Does the BBTI-based group intervention improve subjective sleep quality and reduce the severity of insomnia?
  • Does the intervention have a positive effect on psychological well-being and cardiometabolic/physical functions? Researchers will compare an experimental group receiving the immediate 4-week intervention to a waitlist control group, who receive the intervention starting in week five, to see if the intervention improves sleep quality, reduces insomnia-perpetuating behaviors, and enhances overall health status across various timeframes.

Participants will:

1.Attend four weekly 1-hour group intervention sessions that cover sleep structure education, relaxation techniques (including acupressure), sleep-promoting diet principles, and the proper use of sedative-hypnotic medications. 2.Maintain a daily sleep diary to track their subjective sleep quality, daily nutritional intake, and physical activity levels.

3.Complete structured self-report questionnaires assessing insomnia severity (ISI), psychological distress (PHQ-4), and well-being (WHO-5) at baseline (T0), post-program (T1), and during a 9-week follow-up (T2).

4.Undergo physiological and physical function assessments, including measurements for Body Mass Index (BMI), waist circumference, blood pressure, a 10-Meter Walk Test (normal and fast pace), a Timed Up and Go (TUG) test, and a Five-Times Sit-to-Stand Test (FTSST).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years and older.
  • Diagnosed with a psychiatric disorder.
  • Experiencing self-reported sleep disturbances, such as difficulty initiating sleep, difficulty maintaining sleep, early morning awakening, prolonged sleep latency, short sleep duration, poor sleep efficiency, or the current use of sedative-hypnotic medications.

Exclusion criteria

  • Severe intellectual disability resulting in the inability to complete the assessment questionnaires.
  • Severe cognitive impairment (e.g., dementia) that prevents cooperation and participation in the intervention activities.
  • Recent clinical instability, high suicide risk, or deemed unsuitable for participation by the primary attending physician.

Treatment and study plan

Brief Behavioral Treatment for Insomnia in chronic mental health

Behavioral

The intervention is a short-term group therapy based on Brief Behavioral Treatment for Insomnia (BBTI). Participants will undergo a 4-week program, consisting of one 60-minute group session held once a week. The core content of the sessions focuses on personalized behavioral prescriptions designed to rebuild sleep regularity, aiming to improve insomnia symptoms and regulate related physiological and psychological indicators in chronic psychiatric patients.

Primary outcomes

  1. Change from baseline in Insomnia Severity Index (ISI) at end of week 9.

    Time frame: baseline, week4, week9

Secondary outcomes

  1. Change from baseline in Patient Health Questionnaire-4 (PHQ-4)

    Time frame: baseline, week4, week9

  2. Change from baseline in The World Health Organization-Five Well-Being Index (WHO-5)

    Time frame: baseline, week4, week9

Other outcomes

  1. Change from baseline in Body Mass Index (BMI)

    Time frame: baseline, week4, week9

  2. Change from baseline in waist circumference(WC)

    Time frame: baseline, week 4, week9

Study contacts

Contact information is provided by the study sponsor or research team.

JUNGHUA CHO, Master of Science in Nursing

CONTACT

[email protected]

+886-927786950

Jung-Chen Chang, Associate Professor

CONTACT

[email protected]

+886-2-23123456 ext. 288905

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • National Taiwan University

Registry information

Official study title

Effectiveness of a Group-Based Brief Behavioral Therapy for Insomnia for Patients With Chronic Mental Illness

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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