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

NCT07779499 | Not Yet Recruiting

• 1 other identifier: 202607017RINC
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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. 1.Does the BBTI-based group intervention improve subjective sleep quality and reduce the severity of insomnia?
2. 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.
3. 3.Attend four sessions that cover sleep structure education, relaxation techniques (including acupressure), sleep-promoting diet principles, and the proper use of sedative-hypnotic medications.
4. 4.Write a daily sleep diary.
5. 5.Complete three times of structured self-report questionnaires.
6. 6.Undergo physiological and physical function assessments.

Conditions

Insomnia

Keywords

brief behavioral treatment of insomnia; insomnia

Outcome Measures

Primary Outcomes (1)

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

  baseline, week4, week9

Secondary Outcomes (2)

• 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

Other Outcomes (2)

• Change from baseline in Body Mass Index (BMI)

  baseline, week4, week9

• Change from baseline in waist circumference(WC)

  baseline, week 4, week9

Study Arms (2)

experimental group

EXPERIMENTAL

the first group to have intervention

Behavioral: Brief Behavioral Treatment for Insomnia in chronic mental health

waiting-list control group

OTHER

the group will accept the same intervention after the experimental group finished

Behavioral: Brief Behavioral Treatment for Insomnia in chronic mental health

Interventions

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.

experimental group; waiting-list control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University: collaborator

Related Publications (2)

• Buysse DJ, Germain A, Moul DE, Franzen PL, Brar LK, Fletcher ME, Begley A, Houck PR, Mazumdar S, Reynolds CF 3rd, Monk TH. Efficacy of brief behavioral treatment for chronic insomnia in older adults. Arch Intern Med. 2011 May 23;171(10):887-95. doi: 10.1001/archinternmed.2010.535. Epub 2011 Jan 24.

  PMID: 21263078 BACKGROUND

• Maguen S, Gloria R, Huggins J, Goldstein LA, Kanady JC, Straus LD, Metzler TJ, Lujan C, Neylan TC. Brief behavioral treatment for insomnia improves psychosocial functioning in veterans: results from a randomized controlled trial. Sleep. 2021 Mar 12;44(3):zsaa205. doi: 10.1093/sleep/zsaa205.

  PMID: 33022048 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Jung-Chen Chang, Associate Professor

CONTACT

＋886-2-23123456; jungchenchang@ntu.edu.tw

JUNGHUA CHO, Master of Science in Nursing

CONTACT

+886-927786950; saradora8894@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: participants are assigned to one of 2 groups in parallel for the duration of the study

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 21, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share