- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02248675
Adjunctive Brief Behavioral Treatment of Insomnia (BBTI) for Sleep Intervention (SI)
An Adjunctive Behavioral Sleep Intervention to Prevent Veteran Suicides
Study Overview
Status
Intervention / Treatment
Detailed Description
Anticipated Benefit to VA Healthcare The proposed study will establish proof of concept that suicidal ideation can be reduced by adjunctively 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 PTSD. In addition, to the extent that insomnia is improved, the investigators expect to both enhance Veteran's quality of life and increase their engagement with treatments for co-occurring conditions.
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, depression, substance abuse and chronic pain 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. This application focuses on an intervention target that co-occurs in each of the listed conditions at high rates and is itself an independent risk factor for suicidal thoughts and behaviors: the sleep disturbance of insomnia. Therefore, this proposal examines the use of cognitive-behavioral therapy for insomnia (CBT-I), an efficacious intervention that targets insomnia, as a novel way to reduce suicidal ideation in at-risk Veterans. Importantly, CBT-I has been successfully used in patients with PTSD and depression. Preliminary evidence from an uncontrolled trial in civilians suggests that CBT-I may also decrease suicidal ideation, but this has not been tested in Veterans, in the context of treatments for co-occurring conditions, or in a controlled trial.
Project Objectives The ultimate goal of the broader program of research is to reduce suicide among Veterans, while the proposed pilot project will provide data to guide the development of a larger trial. The primary objectives of this pilot project are to test whether using CBT-I as an adjunctive treatment: (1) is feasible to deliver in the context of other ongoing care and acceptable to participants; (2) can reduce the severity of suicidal ideation among Veterans at risk for suicide; and (3) can increase rates of engagement in treatments that address the co-morbid conditions that also put them at risk for suicide. The latter objective will help refine the study methods, design, and intervention in anticipation of a larger trial.
Project Methods In order to achieve these proof-of-concept objectives the investigators will conduct a small randomized clinical trial. Veterans who are either flagged as high risk for suicide or who have depression or PTSD will be recruited from VA sites only. Approximately 56 such Veterans who also endorse current suicidal ideation and current insomnia will be randomized to receive either treatment-as-usual or a 4-session CBT-I treatment in addition to treatment-as-usual. All participants will be encouraged to continue or to seek treatment for co-occurring conditions as recommended by their VA treatment providers. Assessments of suicidal ideation, insomnia, depression, PTSD, and quality of life will be conducted at baseline and following the treatment period. In addition, the investigators will collect provider and participant feedback at an exit interview immediately following the post-treatment assessment. The investigators will use multiple linear and logistic regression models to assess the effect of treatment on outcome measures across the study assessment time points.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
New York
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Syracuse, New York, United States, 13210
- Syracuse VA Medical Center, Syracuse, NY
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- English speaking male and female Veterans ages 18-70;
- demonstrate an understanding of the informed consent;
- seeking or receiving services at the Canandaigua VA Medical Center (VAMC) or Rochester Outpatient Clinic;
- endorse death/suicidal ideation on the Columbia Suicide Severity Rating Scale
- either (i) a current diagnosis in their medical record of Major Depressive Disorder, Depression not otherwise specified, PTSD,or (ii) evidence of current depression as indicated by a score of > 10 on the Patient Health Questionnaire (PHQ-9) or current PTSD as indicated by a score of > 38 on the PTSD Symptom Checklist (PCL-5)();
- have an Insomnia Severity Index score > 10 indicating clinically meaningful insomnia with at least 1 insomnia-related daytime consequence (score of 1 on item #3) and trouble sleeping 3 months
Exclusion Criteria:
- history of serious mental illness such as schizophrenia, Bipolar I or II disorder, or current psychiatric conditions such as psychosis, mania, dementia, cognitive impairment, OR suicidal ideation with plan and intent, a report of a suicide attempt in the past 6 months in the Computerized Patient Record System (CPRS) or via self-report, or a score of 4 on the Columbia-Suicide Severity Rating Scale
- currently engaged in inpatient or partial hospitalization programs or ongoing/pending medical procedures that could inhibit sleep
- recent substance dependence disorder with < 3 months in remission or abstinence;
- suspicion of or evidence of untreated sleep apnea.
- Diagnosis of a circadian rhythm disorder
- Diagnosis of Narcolepsy
- History of Seizures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBT-I + TAU
Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment.
In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).
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Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment.
In this study it will be delivered in four individual sessions.
Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers.
This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health.
Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.
|
Active Comparator: TAU
Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers.
This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health.
Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.
|
Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers.
This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health.
Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: post-treatment (~6-8 weeks)
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The entire Columbia Suicide Severity Rating Scale (C-SSRS) will be administered, but the investigators will use its' Suicidal Ideation Intensity scale (0-25 score range summed from five items, with higher scores indicating more severe suicidal ideation) as the primary outcome.
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post-treatment (~6-8 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Treatment Beliefs (PTS)
Time Frame: post-treatment (~6-8 weeks)
|
A 21-item measure (with items ranging from 1-7) based on the theory of planned behavior and designed to assess beliefs about treatment and plans to engage in treatment in military populations.
This measure will focus on engagement in PTSD and depression treatments.
The total score has a range of 21-147 with higher scores indicating higher likelihood of engaging in care.
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post-treatment (~6-8 weeks)
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Patient Health Questionnaire-9 (PHQ-9)
Time Frame: post-treatment (~6-8 weeks)
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A well-validated 9-item self-report measure developed to assess depression severity; higher scores are associated with greater severity (range of 0-27 with higher scores indicating more severe depression severity).
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post-treatment (~6-8 weeks)
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Insomnia Severity Index (ISI)
Time Frame: post-treatment (~6-8 weeks)
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A well-validated 7-item self-report measure developed to assess insomnia severity; higher scores are associated with greater severity (range of 0-28 with higher scores indicating greater insomnia severity).
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post-treatment (~6-8 weeks)
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Collaborators and Investigators
Investigators
- Principal Investigator: Wilfred R Pigeon, PhD, Syracuse VA Medical Center, Syracuse, NY
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Trauma and Stressor Related Disorders
- Self-Injurious Behavior
- Stress Disorders, Traumatic
- Suicide
- Depression
- Sleep Initiation and Maintenance Disorders
- Stress Disorders, Post-Traumatic
- Suicidal Ideation
Other Study ID Numbers
- PPO 13-373
- I21HX001473 (U.S. NIH Grant/Contract)
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