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

Launched by NGUYEN TRAI HOSPITAL · Dec 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people with chronic insomnia, which is a condition that makes it hard to fall asleep or stay asleep. The researchers at Nguyen Trai Hospital in Ho Chi Minh City want to find out if a shorter version of therapy called Brief Behavioral Therapy for Insomnia (BBT-I) can help improve sleep quality and overall well-being for patients who are already taking medication for insomnia. The trial will look at how effective BBT-I is compared to no additional therapy over one and three months, as well as how much it costs compared to using medication alone.

To participate in the trial, you need to be at least 18 years old and have a diagnosed sleep disorder, such as insomnia. However, if you have certain conditions like cognitive impairment or untreated sleep apnea, you won't be able to join. If you do participate, you can expect to receive therapy sessions designed to help you develop better sleep habits and improve your quality of life. The researchers hope that by using BBT-I, they can reduce the need for sleep medications and help patients feel better overall.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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.
• Exclusion Criteria:
• • 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.