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

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ClinicalTrials.gov Identifier: NCT03603717
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Insomnia Suicidal Ideation Behavioral: Cognitive Behavioral Therapy for Insomnia Behavioral: Sleep Hygiene Not Applicable

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 HSR&D 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two parallel study arms: (1) cognitive behavioral therapy for insomnia (the experimental condition) and (2) sleep hygiene (the control condition).
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.
Primary Purpose: Treatment
Official Title: Improving Sleep as a Strategy to Reduce Suicide Risk Among At-Risk Veterans: A Real World Clinical Trial
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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: SH
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.




Primary Outcome Measures :
  1. 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.

  2. Scale for Suicidal ideation Change [ Time Frame: 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.


Secondary Outcome Measures :
  1. PTSD Symptom Checklist-DSM 5 Change [ Time Frame: 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.

  2. Patient Health Questionnaire-Depression Change [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English speaking
  • Veteran seeking or receiving services at the Canandaigua, Buffalo or Syracuse VAMCs
  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603717


Contacts
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Contact: Wilfred R Pigeon, PhD (585) 393-7918 Wilfred.Pigeon2@va.gov
Contact: Jennifer S Funderburk, PhD (315) 425-4400 ext 54703 Jennifer.Funderburk@va.gov

Locations
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United States, New York
VA Western New York Healthcare System, Buffalo, NY Recruiting
Buffalo, New York, United States, 14215
Contact: Laura O Wray, PhD    716-862-8598    Laura.Wray@va.gov   
Contact: Jennifer S Funderburk, PhD    (315) 425-4400 ext 54703    Jennifer.Funderburk@va.gov   
Sub-Investigator: Gregory P. Beehler, PhD         
Canandaigua VA Medical Center, Canandaigua, NY Recruiting
Canandaigua, New York, United States, 14424
Contact: Wilfred R Pigeon, PhD    585-393-7918    Wilfred.Pigeon2@va.gov   
Principal Investigator: Wilfred R. Pigeon, PhD         
Syracuse VA Medical Center, Syracuse, NY Recruiting
Syracuse, New York, United States, 13210
Contact: Wilfred R Pigeon, PhD    (585) 393-7918    Wilfred.Pigeon2@va.gov   
Contact: Jennifer S Funderburk, PhD    (315) 425-4400 ext 54703    Jennifer.Funderburk@va.gov   
Sub-Investigator: Jennifer Schum Funderburk, PhD         
Sub-Investigator: Wilfred R. Pigeon, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Wilfred R. Pigeon, PhD Canandaigua VA Medical Center, Canandaigua, NY

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03603717     History of Changes
Other Study ID Numbers: IIR 16-055
I01HX002183-01A2 ( U.S. NIH Grant/Contract )
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by VA Office of Research and Development:
insomnia
suicidal ideation
depression
posttraumatic stress disorder
cognitive behavioral therapy for insomnia
sleep
suicide

Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Suicidal Ideation
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Suicide
Self-Injurious Behavior
Behavioral Symptoms