Cognitive Behavioral Therapy for Insomnia in Veterans with Psychosis
Cognitive Behavioral Therapy For Insomnia (CBT-I) to Improve Functional Outcomes in Veterans With Psychosis
NA · VA Office of Research and Development · NCT04646200
This study is testing whether Cognitive Behavioral Therapy for Insomnia can help veterans with both psychosis and sleep problems feel better and function well in their daily lives.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT04646200 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of Cognitive Behavioral Therapy for Insomnia (CBT-I) in improving sleep quality and overall functioning in Veterans suffering from both psychosis and insomnia. The study will compare outcomes between participants receiving CBT-I and those in an active control group, measuring insomnia severity and health functioning at post-treatment and six months later. Additionally, the study will explore the underlying processes linking insomnia severity to functional outcomes and how psychiatric symptoms may influence the effectiveness of CBT-I.
Who should consider this trial
Good fit: Ideal candidates are Veterans aged 18 to 80 with severe mental illness and insomnia who are actively engaged in outpatient mental health services.
Not a fit: Patients currently undergoing CBT-I treatment or those planning to relocate during the study period may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance sleep quality and overall health functioning in Veterans with psychosis.
How similar studies have performed: Previous studies have shown positive outcomes for CBT-I in various populations, suggesting potential success in this specific group of Veterans.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * meet criteria for SMI: Schizophrenic disorder, affective psychosis, major depression with psychotic features, delusional disorder, brief psychotic disorder, unspecified psychotic disorder, schizotypal personality disorder * be between the ages of 18 and 80 * be actively participating in outpatient mental health services at designated site Exclusion Criteria: * currently in CBT-I treatment * planning to move out of the area during the study period
Where this trial is running
Baltimore, Maryland and 1 other locations
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States (RECRUITING)
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Elizabeth A. Klingaman, PhD — Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
- Study coordinator: Elizabeth A Klingaman, PhD
- Email: Elizabeth.Klingaman@va.gov
- Phone: (410) 637-1875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Insomnia, Psychosis, Mental Disorders, Insomnia Disorder