RCT of Brief CBT-I in Primary Care Veterans With Suicidal Thoughts

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Suicidal Ideation
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: Sleep Hygiene

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.

Project Methods In order to achieve these objectives the investigators will conduct a real-world, randomized clinical trial among 240 Veterans experiencing either co-occurring depression or PTSD recruited from primary clinics at three VA sites. These Veterans, who will also endorse SI and insomnia, will be randomized to receive either a brief course of CBT-I or a sleep hygiene intervention of similar length. Assessments of suicidal thoughts and behaviors, insomnia, depression, and PTSD will be conducted at baseline, post-treatment, and every 6 weeks thereafter until 6 months post-treatment. Mixed effects modeling and structured equation modeling will be applied to determine how improvements in sleep and other symptoms (e.g. depression, PTSD) contribute to reductions in SI severity. In addition, the investigators will collect, code and analyze participant and provider feedback to assess barriers and facilitators of implementation in real-world clinical practice.

• Study Type: Interventional
• Enrollment (Actual): 283
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14215-1129
      • VA Western New York Healthcare System, Buffalo, NY
    • Canandaigua, New York, United States, 14424-1159
      • VA Finger Lakes Healthcare System, Canandaigua, NY
    • Syracuse, New York, United States, 13210-2716
      • Syracuse VA Medical Center, Syracuse, NY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT-I; 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.	Behavioral: Cognitive Behavioral Therapy for Insomnia; The intervention will consist of a standard, structured, multi-component intervention for insomnia that includes sleep education, sleep hygiene, sleep restriction, stimulus control, and cognitive therapy.
Active Comparator: Sleep Hygiene; 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.	Behavioral: Sleep Hygiene; The intervention will include basic psychoeducation about sleep, discussion of sleep hygiene factors that disrupt and improve sleep, setting sleep hygiene goals, and developing action steps to achieve those goals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index Change	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.	Baseline (Week 0) and 6 Month follow-up (Week 30)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Symptom Checklist-DSM 5 Change	The PTSD Symptom Checklist-DSM 5 version is a 20-item self-report measure of PTSD symptoms. Each item is rated on a 0-4 point scale with a total score range of 0-80 where higher scores indicate greater severity.	Baseline (Week 0) and 6 Month follow-up (Week 30)
Patient Health Questionnaire-Depression Change	The Patient Health Questionnaire-Depression is a 9-item self-report measure of depression symptoms. Each item is rated on a 0-3 point scale with a total score range of 0-27 where higher scores indicate greater severity.	Baseline (Week 0) and 6 Month follow-up (Week 30)
Scale for Suicidal Ideation Change	The Scale for Suicidal Ideation is a clinician administered scale with 19-items related to suicidal ideation. Each item is rated on a 0-2 point scale with a total score range of 0-38 where higher scores indicate greater severity.	Baseline (Week 0) and 6 Month follow-up (Week 30)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Wilfred R. Pigeon, PhD, VA Finger Lakes Healthcare System, Canandaigua, NY

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2019
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: sleep; depression; insomnia; suicide; suicidal ideation; posttraumatic stress disorder; cognitive behavioral therapy for insomnia
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Self-Injurious Behavior; Suicide; Sleep Initiation and Maintenance Disorders; Suicidal Ideation
• Other Study ID Numbers: IIR 16-055; I01HX002183-01A2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No