Adjunctive Brief Behavioral Treatment of Insomnia (BBTI) for Sleep Intervention (SI)
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Insomnia Sleep Studies, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | February 2015 |
| End Date: | January 2016 |
An Adjunctive Behavioral Sleep Intervention to Prevent Veteran Suicides
There is a strong association between sleep disturbance and suicidal thoughts and behaviors.
Sleep disturbance is also highly comorbid with other common conditions associated with
suicide such as depression and posttraumatic stress disorder. Accordingly, this application
focuses on improving sleep as a novel suicide prevention strategy that can be delivered to a
broad range of Veterans. This pilot proposal specifically examines how Cognitive Behavioral
Therapy for Insomnia, an efficacious treatment for insomnia, may reduce suicidal ideation in
Veterans who also suffer from additional conditions. The proposal further suggests that
adding this sleep intervention to usual care may further enhance overall care by increasing
the utilization of recommended treatments for depression and posttraumatic stress disorder.
Sleep disturbance is also highly comorbid with other common conditions associated with
suicide such as depression and posttraumatic stress disorder. Accordingly, this application
focuses on improving sleep as a novel suicide prevention strategy that can be delivered to a
broad range of Veterans. This pilot proposal specifically examines how Cognitive Behavioral
Therapy for Insomnia, an efficacious treatment for insomnia, may reduce suicidal ideation in
Veterans who also suffer from additional conditions. The proposal further suggests that
adding this sleep intervention to usual care may further enhance overall care by increasing
the utilization of recommended treatments for depression and posttraumatic stress disorder.
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.
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.
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
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