Status:
COMPLETED
Adjunctive Brief Behavioral Treatment of Insomnia (BBTI) for Sleep Intervention (SI)
Lead Sponsor:
VA Office of Research and Development
Conditions:
Insomnia
Depression
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
There is a strong association between sleep disturbance and suicidal thoughts and behaviors. Sleep disturbance is also highly comorbid with other common conditions associated with suicide such as depr...
Detailed Description
Anticipated Benefit to VA Healthcare The proposed study will establish proof of concept that suicidal ideation can be reduced by adjunctively treating insomnia, a common problem that is both a risk fa...
Eligibility Criteria
Inclusion
- English speaking male and female Veterans ages 18-70;
- demonstrate an understanding of the informed consent;
- seeking or receiving services at the Canandaigua VA Medical Center (VAMC) or Rochester Outpatient Clinic;
- endorse death/suicidal ideation on the Columbia Suicide Severity Rating Scale
- either (i) a current diagnosis in their medical record of Major Depressive Disorder, Depression not otherwise specified, PTSD,or (ii) evidence of current depression as indicated by a score of \> 10 on the Patient Health Questionnaire (PHQ-9) or current PTSD as indicated by a score of \> 38 on the PTSD Symptom Checklist (PCL-5)();
- have an Insomnia Severity Index score \> 10 indicating clinically meaningful insomnia with at least 1 insomnia-related daytime consequence (score of 1 on item #3) and trouble sleeping 3 months
Exclusion
- history of serious mental illness such as schizophrenia, Bipolar I or II disorder, or current psychiatric conditions such as psychosis, mania, dementia, cognitive impairment, OR suicidal ideation with plan and intent, a report of a suicide attempt in the past 6 months in the Computerized Patient Record System (CPRS) or via self-report, or a score of 4 on the Columbia-Suicide Severity Rating Scale
- currently engaged in inpatient or partial hospitalization programs or ongoing/pending medical procedures that could inhibit sleep
- recent substance dependence disorder with \< 3 months in remission or abstinence;
- suspicion of or evidence of untreated sleep apnea.
- Diagnosis of a circadian rhythm disorder
- Diagnosis of Narcolepsy
- History of Seizures
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02248675
Start Date
February 1 2015
End Date
January 1 2016
Last Update
April 28 2017
Active Locations (1)
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1
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, United States, 13210