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

NCT03603717 | Completed Results DMC

• 2 other identifiers: IIR 16-055I01HX002183-01A2
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 3

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.

Conditions

Insomnia; Suicidal Ideation

Keywords

insomnia; suicidal ideation; depression; posttraumatic stress disorder; cognitive behavioral therapy for insomnia; sleep; suicide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Scale for Suicidal Ideation Change

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

• 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)

Study Arms (2)

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.

Behavioral: Cognitive Behavioral Therapy for Insomnia

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.

Behavioral: Sleep Hygiene

Interventions

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

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.

CBT-I

Sleep Hygiene BEHAVIORAL

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.

Sleep Hygiene

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, 14215-1129, United States

Location

VA Finger Lakes Healthcare System, Canandaigua, NY

Canandaigua, New York, 14424-1159, United States

Location

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210-2716, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Suicidal Ideation; Depression; Stress Disorders, Post-Traumatic; Suicide

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Wilfred Pigeon, PhD
• Organization: Department of Veterans Affairs, Center of Excellence for Suicide Prevention

wilfred.pigeon2@va.gov

(585) 393-7918

Study Officials

• Wilfred R. Pigeon, PhD

  VA Finger Lakes Healthcare System, Canandaigua, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Two parallel study arms: (1) cognitive behavioral therapy for insomnia (the experimental condition) and (2) sleep hygiene (the control condition).

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 27, 2018
• Study Start: February 18, 2019
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: June 17, 2024
• Results First Posted: June 17, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)