N/A
N=194
RCT of Brief CBT-I in Primary Care Veterans With Suicidal Thoughts
Insomnia · Suicidal Ideation
Bottom Line
View on ClinicalTrials.gov: NCT03603717 ↗Enrolled (actual)
194
Serious AEs
3.6%
Results posted
Jun 2024
Primary outcome: Primary: Insomnia Severity Index Change — 8.54; 11.88 score on a scale — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Behavioral Therapy for Insomnia (Behavioral); Sleep Hygiene (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity Index Change |
8.54; 11.88 | <0.01 sig |
| SECONDARY Scale for Suicidal Ideation Change |
1.08; 3.10 | 0.03 sig |
| SECONDARY PTSD Symptom Checklist-DSM 5 Change |
29.68; 29.94 | 0.84 |
| SECONDARY Patient Health Questionnaire-Depression Change |
8.92; 11.33 | 0.01 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03603717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.