RCT of Brief CBT-I in Primary Care Veterans With Suicidal Thoughts
Completed · Not applicable
Conditions studied: Insomnia, Suicidal Ideation
In brief
There is a strong association between insomnia and suicidal thoughts and behaviors. Insomnia also frequently co-occurs with other common conditions associated with suicide such as depression and posttraumatic stress disorder. This project focuses on improving sleep as a novel suicide prevention strategy that can be delivered to a broad range of Veterans. The study will examine how Cognitive Behavioral Therapy for Insomnia, an efficacious treatment for insomnia, may reduce suicidal thoughts in Veterans who also suffer from co-occurring conditions when delivered by integrated primary care clinicians.
Key facts
- Study ID
- NCT03603717
- Run by
- VA Office of Research and Development
- People needed
- 283
- Starts
- 2019-02-18
- Expected to finish
- 2023-06-30
- Last updated by the study team
- 2024-06-17
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- English speaking
- Veteran seeking or receiving services at the Canandaigua, Buffalo or Syracuse VA Medical Centers
- Demonstrate understanding of informed consent
- Endorse current death/suicidal ideation on item 9 of the Patient Health Questionnaire-9
- An Insomnia Severity Index score > 10 with trouble sleeping 3 months and at least 1 insomnia-related daytime consequence
- Either:
- [a] a current diagnosis of Major Depressive Disorder, Depression not otherwise specified or PTSD
- [b] a score of > 16 on the Patient Health Questionnaire for Depression (PHQ-9) or a score > 46 on the PTSD Symptom Checklist
- If using psychotropic medications the dosage must be stable
You may not qualify if…
- History of serious mental illness such as schizophrenia, Bipolar I or II disorder, or current psychiatric conditions such as psychosis, mania, dementia or cognitive impairment
- A suicide attempt within the last 6 months or [report of SI with active plan or intent in the past month]
- Currently engaged in inpatient or partial hospitalization programs
- Recent substance dependence disorder with < 6 months abstinence
- Narcolepsy
- Circadian rhythm disorders
- Restless legs syndrome
- Untreated sleep apnea based upon chart review
- A sleep disorders screening questionnaire and the STOP-BANG sleep apnea questionnaire
- Sleep medications are not exclusionary, but participants using them must still meet insomnia criteria
Where it is running
- VA Western New York Healthcare System, Buffalo, NY — Buffalo, New York, United States
- VA Finger Lakes Healthcare System, Canandaigua, NY — Canandaigua, New York, United States
- Syracuse VA Medical Center, Syracuse, NY — Syracuse, New York, United States
Full record on ClinicalTrials.gov
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