Chronic Insomnia DisorderNCT06727916
A Randomized, Single-Blind Study Evaluating the Efficacy and Cost-Effectiveness of Brief Behavioral Therapy for Chronic Insomnia Patients Under Medication Treatment At Nguyen Trai Hospital, Ho Chi Minh City
A study testing BBT-I and Non BBT-I in people with Chronic Insomnia Disorder and Chronic Insomnia, run by Nguyen Trai Hospital.
Trial summary
Insomnia disorder is considered quite common and is recognized as a risk factor for psychiatric disorders. In industrialized countries, chronic insomnia disorder is estimated to affect about 5-10% of the population, with some studies indicating that this rate can reach up to 33% among adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Insomnia Disorder, Chronic Insomnia, BBT-I
- What is being tested?
- BBT-I and Non BBT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2024to 30 Sep 2027
- 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
- The study includes patients who fully meet the following criteria:
- Patients with an outpatient prescription diagnosed with "sleep disorder" (ICD-10: G47), insomnia disorder [difficulty initiating and maintaining sleep] (ICD-10: G47.0), nonorganic insomnia (ICD-10: F51.0), or agrypnia [sleep disorder] (ICD-10: U55.621). Diagnoses are based on DSM-5 criteria.
- Patients aged 18 years or older. Agreement to participate in the study.
Who cannot join
- Cognitive impairment (inability to understand counseling content). Presence of a triggering factor during the study period (hospitalization, acute exacerbation of comorbid conditions, or a psychological trauma) as these conditions may induce insomnia.
- Conditions incompatible with sleep restriction therapy:
- Epilepsy. Untreated obstructive sleep apnea (diagnosed or high-risk based on STOP-BANG screening).
- Untreated bipolar disorder. Suicidal intent. Parasomnias related to NREM sleep (sleepwalking, night terrors). Diagnosed with other sleep disorders.
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: Evaluation of Efficacy and Cost-effectiveness of Brief Behavioral Therapy for Chronic Insomnia Patients Under Medication Treatment At Nguyen Trai Hospital, Ho Chi Minh City
Insomnia disorder is considered quite common and is recognized as a risk factor for psychiatric disorders. In industrialized countries, chronic insomnia disorder is estimated to affect about 5-10% of the population, with some studies indicating that this rate can reach up to 33% among adults. Research in the Netherlands has shown that insomnia symptoms increase the risk of developing, relapsing, and prolonging mood disorders in men and are associated with recurrent anxiety disorders in women. Without treatment, insomnia disorders are challenging to improve and can impact patients' economic stability and health. Treating insomnia can support recovery and prevent mental disorders, particularly mood disorders.
One of the commonly referenced non-pharmacological treatments for insomnia worldwide is Cognitive Behavioral Therapy for Insomnia (CBT-I). This therapy has been recognized by the American College of Physicians as a first-line and highly effective treatment for insomnia. However, it still faces several barriers to widespread application in clinical practice, such as resource constraints and the time commitment required from patients. As a result, some studies abroad have shown that physicians may be reluctant to recommend CBT-I alone, even though it is considered the preferred treatment. To address these challenges, numerous international studies have expanded the range of providers (such as pharmacists and nurses) or adopted shortened versions, such as Brief Behavioral Treatment for Insomnia (BBT-I), in hospitals or community pharmacies. BBT-I has been proven effective among older adults with a 2+2 design (two in-person sessions and two follow-up calls) and among younger adults using an electronic format. This is a brief, evidence-based therapy designed to encourage the application of CBT-I techniques in primary healthcare settings, demonstrating effectiveness when performed by healthcare providers with basic training. A significant advantage of combining CBT-I and BBT-I in treating insomnia is the reduction in medication use. When effectively implemented, it can shorten treatment duration, reduce hospitalization rates, decrease adverse effects from drug interactions, and improve patients' quality of life, ultimately reducing the financial burden on healthcare facilities and improving the quality of medical services.
Read more
In Vietnam, CBT-I and BBT-I therapies are not yet widely applied or popularized. Based on the current situation and the desire to apply these therapies in treating chronic insomnia patients to improve quality of life and reduce medication costs, in 2023, Nguyen Trai Hospital collaborated with Thong Nhat Hospital and the Saigon Center for Pharmaceutical Science and Technology to conduct a city-level scientific and technological research program on the application of BBT-I in supporting the treatment of chronic insomnia in the elderly. The research developed a "Sleep Support Guide" as a resource for healthcare workers to counsel patients and provide essential information related to insomnia. Results from the study also showed that BBT-I could help improve sleep-related parameters, life quality, and sleep quality among elderly patients. However, the study had some limitations, such as being conducted only on elderly subjects, with a follow-up period of one month post-intervention for sleep parameters and three months for medication usage metrics, without a cost-effectiveness comparison with medication-only treatments. Therefore, further in-depth research with a wider range of subjects and a comparison with standard hospital treatments is necessary for broader application of this method in practice.
Objective 1: To investigate the characteristics of chronic insomnia patients receiving medication at Nguyen Trai Hospital in Ho Chi Minh City.
Objective 2: To assess the effectiveness of BBT-I in improving sleep quality and quality of life after one and three months compared to non-application in chronic insomnia patients receiving medication at Nguyen Trai Hospital in Ho Chi Minh City.
Objective 3: To evaluate the cost-effectiveness of BBT-I in improving sleep quality and quality of life when applied to chronic insomnia patients receiving medication at Nguyen Trai Hospital in Ho Chi Minh City.
- Conditions
- Chronic Insomnia Disorder, Chronic Insomnia, BBT-I, CBT-I
- Being tested
- BBT-I, Non BBT-I
- Keywords
- Chronic insomnia disorder, chronic insomnia, BBT-I, CBT-I
- 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.
BBT-IBehavioural
Participants in the intervention group will receive BBT-I in 4 consecutive sessions in addition to standard care. Healthcare provider provided BBT-I to the patients.
Non BBT-IOther
Patients in the control group will receive standard care.
| Study group | Role | What they receive |
|---|---|---|
| BBT-I Group | Experimental | Participants in the intervention group will receive BBT-I in 4 consecutive sessions in addition to standard care. Receives: Behavioral: BBT-I |
| Control Group | Other | Patients in the control group will receive standard care. Receives: Other: Non BBT-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PSQI score
The PSQI (developed by Buysse) is a standardized tool used to assess both sleep quantity and quality. It includes 19 items that provide a subjective evaluation of sleep metrics such as total sleep time, perceived restfulness, and sleep disturbances.
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start15 Dec 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Insomnia DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nguyen Trai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727916
- Sponsor's protocol ID
- 2610/ĐHYD-HĐĐĐ
- Other IDs
- 2610/ĐHYD-HĐĐĐ
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Cost-effectiveness of Brief Behavioral Therapy for Chronic Insomnia Patients Under Medication Treatment At Nguyen Trai Hospital, Ho Chi Minh City
- ClinicalTrials.gov ID
- NCT06727916
- Acronym / sponsor ID
- 2610/ĐHYD-HĐĐĐ
- Conditions
- Chronic Insomnia Disorder, Chronic Insomnia, BBT-I, CBT-I
- Keywords
- Chronic insomnia disorder, chronic insomnia, BBT-I, CBT-I
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nguyen Trai HospitalUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 11 Dec 2024 (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.
Insomnia disorder is considered quite common and is recognized as a risk factor for psychiatric disorders. In industrialized countries, chronic insomnia disorder is estimated to affect about 5-10% of the population, with some studies indicating that this rate can reach up to 33% among adults. Research in the Netherlands has shown that insomnia symptoms increase the risk of developing, relapsing, and prolonging mood disorders in men and are associated with recurrent anxiety disorders in women. Without treatment, insomnia disorders are challenging to improve and can impact patients' economic stability and health. Treating insomnia can support recovery and prevent mental disorders, particularly mood disorders.
One of the commonly referenced non-pharmacological treatments for insomnia worldwide is Cognitive Behavioral Therapy for Insomnia (CBT-I). This therapy has been recognized by the American College of Physicians as a first-line and highly effective treatment for insomnia. However, it still faces several barriers to widespread application in clinical practice, such as resource constraints and the time commitment required from patients. As a result, some studies abroad have shown that physicians may be reluctant to recommend CBT-I alone, even though it is considered the preferred treatment. To address these challenges, numerous international studies have expanded the range of providers (such as pharmacists and nurses) or adopted shortened versions, such as Brief Behavioral Treatment for Insomnia (BBT-I), in hospitals or community pharmacies. BBT-I has been proven effective among older adults with a 2+2 design (two in-person sessions and two follow-up calls) and among younger adults using an electronic format. This is a brief, evidence-based therapy designed to encourage the application of CBT-I techniques in primary healthcare settings, demonstrating effectiveness when performed by healthcare providers with basic training. A significant advantage of combining CBT-I and BBT-I in treating insomnia is the reduction in medication use. When effectively implemented, it can shorten treatment duration, reduce hospitalization rates, decrease adverse effects from drug interactions, and improve patients' quality of life, ultimately reducing the financial burden on healthcare facilities and improving the quality of medical services.
In Vietnam, CBT-I and BBT-I therapies are not yet widely applied or popularized. Based on the current situation and the desire to apply these therapies in treating chronic insomnia patients to improve quality of life and reduce medication costs, in 2023, Nguyen Trai Hospital collaborated with Thong Nhat Hospital and the Saigon Center for Pharmaceutical Science and Technology to conduct a city-level scientific and technological research program on the application of BBT-I in supporting the treatment of chronic insomnia in the elderly. The research developed a "Sleep Support Guide" as a resource for healthcare workers to counsel patients and provide essential information related to insomnia. Results from the study also showed that BBT-I could help improve sleep-related parameters, life quality, and sleep quality among elderly patients. However, the study had some limitations, such as being conducted only on elderly subjects, with a follow-up period of one month post-intervention for sleep parameters and three months for medication usage metrics, without a cost-effectiveness comparison with medication-only treatments. Therefore, further in-depth research with a wider range of subjects and a comparison with standard hospital treatments is necessary for broader application of this method in practice.
Objective 1: To investigate the characteristics of chronic insomnia patients receiving medication at Nguyen Trai Hospital in Ho Chi Minh City.
Objective 2: To assess the effectiveness of BBT-I in improving sleep quality and quality of life after one and three months compared to non-application in chronic insomnia patients receiving medication at Nguyen Trai Hospital in Ho Chi Minh City.
Objective 3: To evaluate the cost-effectiveness of BBT-I in improving sleep quality and quality of life when applied to chronic insomnia patients receiving medication at Nguyen Trai Hospital in Ho Chi Minh City.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BBT-I Group | Experimental | Behavioral: BBT-IParticipants in the intervention group will receive BBT-I in 4 consecutive sessions in addition to standard care. |
| Control Group | Other | Other: Non BBT-IPatients in the control group will receive standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with an outpatient prescription diagnosed with "sleep disorder" (ICD-10: G47), insomnia disorder [difficulty initiating and maintaining sleep] (ICD-10: G47.0), nonorganic insomnia (ICD-10: F51.0), or agrypnia [sleep disorder] (ICD-10: U55.621). Diagnoses are based on DSM-5 criteria.
- Patients aged 18 years or older. Agreement to participate in the study.
Key exclusion criteria (4 listed)
- Cognitive impairment (inability to understand counseling content). Presence of a triggering factor during the study period (hospitalization, acute exacerbation of comorbid conditions, or a psychological trauma) as these conditions may induce insomnia.
- Epilepsy. Untreated obstructive sleep apnea (diagnosed or high-risk based on STOP-BANG screening).
- Untreated bipolar disorder. Suicidal intent. Parasomnias related to NREM sleep (sleepwalking, night terrors). Diagnosed with other sleep disorders.
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 |
|---|---|---|
| BBT-IParticipants in the intervention group will receive BBT-I in 4 consecutive sessions in addition to standard care. Healthcare provider provided BBT-I to the patients. | Behavioural | BBT-I Group |
| Non BBT-IPatients in the control group will receive standard care. | Other | Control Group |
Primary outcome
Change in PSQI score
Time frame: 1 and 3 months
The PSQI (developed by Buysse) is a standardized tool used to assess both sleep quantity and quality. It includes 19 items that provide a subjective evaluation of sleep metrics such as total sleep time, perceived restfulness, and sleep disturbances.
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 11 Dec 2024.
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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 BBT-I and Non BBT-I in people with Chronic Insomnia Disorder and Chronic Insomnia, run by Nguyen Trai 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 4 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 11 Dec 2024. 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 Hung Thanh Quach (02839248219, dls.bvnt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PSQI score (time frame: 1 and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2024.