Insomnia
Conditions
Keywords
brief behavioral treatment of insomnia, insomnia
Brief summary
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.
Detailed description
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 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).
Interventions
BEHAVIORALBrief Behavioral Treatment for Insomnia in chronic mental health
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.
Sponsors
National Taiwan University Hospital
National Taiwan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
participants are assigned to one of 2 groups in parallel for the duration of the study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Insomnia Severity Index (ISI) at end of week 9. | baseline, week4, week9 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Patient Health Questionnaire-4 (PHQ-4) | baseline, week4, week9 |
| Change from baseline in The World Health Organization-Five Well-Being Index (WHO-5) | baseline, week4, week9 |
Contacts
CONTACTJung-Chen Chang, Associate Professor
CONTACTJUNGHUA CHO, Master of Science in Nursing
Outcome results
None listed