NCT03603717

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

Completed NA Results posted Last updated 17 June 2024

What this trial tests

NA trial testing Cognitive Behavioral Therapy for Insomnia in Insomnia in 283 participants. Completed in 30 June 2023.

Timeline

18 February 2019

Primary endpoint
31 December 2022

30 June 2023

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	283
Start date	18 February 2019
Primary completion	31 December 2022
Estimated completion	30 June 2023
Sites	3 locations across United States

Drugs / interventions tested

• Cognitive Behavioral Therapy for Insomnia
• Sleep Hygiene

Conditions studied

• Insomnia — all drugs for Insomnia →
• Suicidal Ideation — all drugs for Suicidal Ideation →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 70, any sex, with Insomnia or Suicidal Ideation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Insomnia Severity Index Change Primary · 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.

Group	Value	95% CI
CBT-I	8.54	± 6.03
Sleep Hygiene	11.88	± 6.36

Scale for Suicidal Ideation Change Secondary · Baseline (Week 0) and 6 Month follow-up (Week 30)

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.

Group	Value	95% CI
CBT-I	1.08	± 2.08
Sleep Hygiene	3.10	± 5.12

PTSD Symptom Checklist-DSM 5 Change Secondary · Baseline (Week 0) and 6 Month follow-up (Week 30)

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.

Group	Value	95% CI
CBT-I	29.68	± 18.02
Sleep Hygiene	29.94	± 17.62

Patient Health Questionnaire-Depression Change Secondary · Baseline (Week 0) and 6 Month follow-up (Week 30)

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.

Group	Value	95% CI
CBT-I	8.92	± 6.03
Sleep Hygiene	11.33	± 6.48

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 weeks. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CBT-I

Serious: 3/98 (3%)

Deaths: 0/98

Sleep Hygiene

Serious: 4/96 (4%)

Deaths: 0/96

Serious adverse events (5 terms)

Reaction	System	CBT-I	Sleep Hygiene
Hospitalization	Cardiac disorders	—	—
Hospitalization	Musculoskeletal and connective tissue disorders	—	—
Hospitalization	Respiratory, thoracic and mediastinal disorders	—	—
Hospitalization	Psychiatric disorders	—	—
hospitalization	Skin and subcutaneous tissue disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	CBT-I	Sleep Hygiene
Emergency room visit for migraine headache	Nervous system disorders	—	—

Most-reported serious reactions: Hospitalization, Hospitalization, Hospitalization, Hospitalization, hospitalization.

Data from ClinicalTrials.gov NCT03603717 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cognitive behavioral therapy for insomnia modified for adults with hazardous alcohol use: an open-label pilot study.
   Pigeon WR, Bishop TM, Arnedt JT, Duberstein Z, et al · · 2026 · PMID 41768371 · DOI 10.1093/sleepadvances/zpag002
2. The effect and safety of sleep interventions on suicidal thoughts and behavior - A systematic review and meta-analyses.
   von Spreckelsen P, Schouten D, Waslam NG, Katuin P, et al · · 2025 · PMID 40688431 · DOI 10.1016/j.sleepx.2025.100145
3. Open Clinical Trials for Veterans With Suicidal Ideation.
   · 2019 · PMID 31772493
4. The darkest hours: McCarthy et al. (2019) report increased risk for suicide from midnight to 3 am for U.S. veterans and civilians.
   Cunningham TJ, Bowman MA. · · 2020 · PMID 31634911 · DOI 10.1093/sleep/zsz258