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Clinical Trials/NCT03603717
NCT03603717CompletedNot Applicable

Improving Sleep as a Strategy to Reduce Suicide Risk Among At-Risk Veterans: A Real World Clinical Trial

VA Office of Research and Development3 sites in 1 country283 target enrollmentStarted: February 18, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
283
Locations
3
Primary Endpoint
Insomnia Severity Index Change

Study Overview

Brief 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.

Detailed Description

Anticipated Benefit to VA Healthcare The proposed study will establish the feasibility and effectiveness of treating insomnia in the primary care environment as a suicide prevention strategy. By treating insomnia, a common problem that is both a risk factor for suicide and highly prevalent in common conditions associated with suicide such as depression and posttraumatic stress disorder (PTSD), the investigators expect to reduce the severity of suicidal ideation (SI) among Veterans experiencing SI, insomnia and a co-occurring condition.

Project Background Suicide is the tenth leading cause of death in the U.S., is a major concern of the Department of Veterans Affairs (VA) and occurs at elevated rates among Veterans. Veterans with common chronic conditions such as PTSD and depression are at increased risk for suicide. Although evidence-based treatments exist for these conditions, a significant number of Veterans do not engage in or complete such treatments leaving them at higher risk for suicide.

This application builds upon VA funded pilot work that demonstrated the feasibility of delivering a brief version of cognitive-behavioral therapy for insomnia (CBT-I) within primary care to Veterans experiencing SI. The pilot data suggest that the investigators' brief, primary-care based insomnia treatment was delivered with high fidelity, acceptable to Veterans and associated with significant reductions in insomnia and depression symptoms, and reduced SI intensity. The next stage of this program of research is to establish the feasibility of delivering the brief, primary care based, insomnia intervention utilizing primary care-mental health integration (PC-MHI) clinicians (as opposed to research staff) and to establish the effectiveness of the intervention on reducing the severity of factors that contribute to suicide risk and to improve other clinical markers in a definitive trial.

Project Objectives The ultimate goal of the broader program of research is to reduce suicide among Veterans by intervening upon sleep disturbance as a modifiable risk factor for suicide. In this application the investigators focus on insomnia, which is the most common sleep disorder among Veterans and is robustly associated with suicidal thoughts and behaviors.

The primary objective of this proposed clinical trial is to test whether (and how) using brief behavioral insomnia treatment can not only improve sleep, but reduce other risk factors for suicide including the severity of depression, PTSD and suicidal ideation among Veterans at risk for suicide. Secondary objectives are to: (1) gather initial data on barriers and facilitators to implementation to aid future implementation efforts in VA primary care and (2) determine if the intervention improves attitudes towards psychotherapy treatments that address the co-morbid conditions.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Participants will be informed that they are receiving one of two non-medication sleep interventions. Assessors are blinded to study condition. Study staff entering data will be blinded to condition. It is not possible to blind staff delivering the interventions. The PI's are providing some supervision of the interventionists, so they will be unblinded for those participants they supervise interventionists on.

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •[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

Arms & Interventions

CBT-I

Experimental

Four individual sessions that will last approximately 15-30 minutes each across a 6-week time period, with the option to deliver sessions over the telephone as necessary.

Intervention: Cognitive Behavioral Therapy for Insomnia (Behavioral)

Sleep Hygiene

Active Comparator

Four individual sessions that will last 15-30 minutes each across a 6-week time period, with the option to deliver sessions over the telephone as necessary.

Intervention: Sleep Hygiene (Behavioral)

Outcomes

Primary Outcomes

Insomnia Severity Index Change

Time Frame: Baseline (Week 0) and 6 Month follow-up (Week 30)

The Insomnia Severity Index (ISI) is a 7-item self-report measure of insomnia symptoms. Each item is rated on a 0-4-point scale with a total score range of 0-28 where higher scores indicate greater severity.

Secondary Outcomes

  • PTSD Symptom Checklist-DSM 5 Change(Baseline (Week 0) and 6 Month follow-up (Week 30))
  • Patient Health Questionnaire-Depression Change(Baseline (Week 0) and 6 Month follow-up (Week 30))
  • Scale for Suicidal Ideation Change(Baseline (Week 0) and 6 Month follow-up (Week 30))

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (3)

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