InsomniaNCT07779499
Group-Based Brief Behavioral Therapy for Insomnia for Patients With Chronic Mental Illness
A study testing Brief Behavioral Treatment for Insomnia in chronic mental health in people with Insomnia, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Brief Behavioral Treatment for Insomnia in chronic mental health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2026to 10 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of a 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:
- 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 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.
Read more
Participants will:
- Attend four sessions that cover sleep structure education, relaxation techniques (including acupressure), sleep-promoting diet principles, and the proper use of sedative-hypnotic medications.
- Write a daily sleep diary.
- Complete three times of structured self-report questionnaires.
- Undergo physiological and physical function assessments.
Read the 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:
- 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).
- Conditions
- Insomnia
- Being tested
- Brief Behavioral Treatment for Insomnia in chronic mental health
- Keywords
- brief behavioral treatment of insomnia, insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Treatment for Insomnia in chronic mental healthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | the first group to have intervention Receives: 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 Receives: Behavioral: Brief Behavioral Treatment for Insomnia in chronic mental health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Insomnia Severity Index (ISI) at end of week 9.
Measured: baseline, week4, week9
Secondary outcomes (2)
Change from baseline in Patient Health Questionnaire-4 (PHQ-4)
Measured: baseline, week4, week9
Change from baseline in The World Health Organization-Five Well-Being Index (WHO-5)
Measured: baseline, week4, week9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start31 Aug 2026 (estimated)
- Primary completion10 Nov 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants are assigned to one of 2 groups in parallel for the duration of the study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779499
- Sponsor's protocol ID
- 202607017RINC
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21263078Maguen 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.
PubMed 33022048
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Group-Based Brief Behavioral Therapy for Insomnia for Patients With Chronic Mental Illness
- ClinicalTrials.gov ID
- NCT07779499
- Acronym / sponsor ID
- 202607017RINC
- Conditions
- Insomnia
- Keywords
- brief behavioral treatment of insomnia, insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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:
- Attend four sessions that cover sleep structure education, relaxation techniques (including acupressure), sleep-promoting diet principles, and the proper use of sedative-hypnotic medications.
- Write a daily sleep diary.
- Complete three times of structured self-report questionnaires.
- 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:
- 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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- participants are assigned to one of 2 groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Brief Behavioral Treatment for Insomnia in chronic mental healththe first group to have intervention |
| waiting-list control group | Other | Behavioral: Brief Behavioral Treatment for Insomnia in chronic mental healththe group will accept the same intervention after the experimental group finished |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Behavioral Treatment for Insomnia in chronic mental healthThe 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. | Behavioural | experimental group, waiting-list control group |
Primary outcome
Change from baseline in Insomnia Severity Index (ISI) at end of week 9.
Time frame: baseline, week4, week9
2 secondary outcomes
Change from baseline in Patient Health Questionnaire-4 (PHQ-4)
Time frame: baseline, week4, week9
Change from baseline in The World Health Organization-Five Well-Being Index (WHO-5)
Time frame: baseline, week4, week9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 21263078Buysse 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.
- Background: PubMed 33022048Maguen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Treatment for Insomnia in chronic mental health in people with Insomnia, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung-Chen Chang, Associate Professor (＋886-2-23123456 ext. 288905, jungchenchang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Insomnia Severity Index (ISI) at end of week 9. (time frame: baseline, week4, week9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07779499, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.