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Adjunctive Brief Behavioral Treatment of Insomnia (BBTI) for Sleep Intervention (SI)

An Adjunctive Behavioral Sleep Intervention to Prevent Veteran Suicides

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02248675
Enrollment
54
Registered
2014-09-25
Start date
2015-02-28
Completion date
2016-01-31
Last updated
2017-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Insomnia, Posttraumatic Stress Disorder, Suicidal Ideation

Keywords

sleep disorders, insomnia, suicidal ideation, Depression, Depressive disorders, PTSD, anxiety disorders, suicide, cognitive behavioral therapy

Brief summary

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.

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.

Interventions

BEHAVIORALCBT-I

Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.

OTHERTAU

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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Columbia Suicide Severity Rating Scale (C-SSRS)post-treatment (~6-8 weeks)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.

Secondary

MeasureTime frameDescription
Patient Health Questionnaire-9 (PHQ-9)post-treatment (~6-8 weeks)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).
Perceived Treatment Beliefs (PTS)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.
Insomnia Severity Index (ISI)post-treatment (~6-8 weeks)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).

Countries

United States

Participant flow

Recruitment details

581 potential participants were identified from medical records and received a recruitment letter from their current treatment provider; 420 were reachable and screened by phone with 71 meeting initial eligibility criteria, completing written informed consent and baseline interview. 54 participants met all eligibility criteria and were randomized.

Participants by arm

ArmCount
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). CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions. 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.
26
TAU Control
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. 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.
28
Total54

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up31

Baseline characteristics

CharacteristicCBT-I + TAUTotalTAU Control
Age, Continuous53.9 years
STANDARD_DEVIATION 14.1
55.4 years
STANDARD_DEVIATION 12.5
57.2 years
STANDARD_DEVIATION 10.8
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants2 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants52 Participants27 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
5 Participants9 Participants4 Participants
Race (NIH/OMB)
More than one race
3 Participants5 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
17 Participants38 Participants21 Participants
Region of Enrollment
United States
26 participants54 participants28 participants
Sex: Female, Male
Female
6 Participants11 Participants5 Participants
Sex: Female, Male
Male
20 Participants43 Participants23 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 230 / 27
serious
Total, serious adverse events
0 / 230 / 27

Outcome results

Primary

Columbia Suicide Severity Rating Scale (C-SSRS)

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.

Time frame: post-treatment (~6-8 weeks)

ArmMeasureValue (MEAN)Dispersion
CBT-I + TAUColumbia Suicide Severity Rating Scale (C-SSRS)5.4 units on a scaleStandard Deviation 6.8
TAU ControlColumbia Suicide Severity Rating Scale (C-SSRS)8.4 units on a scaleStandard Deviation 6.3
p-value: 0.153Regression, Linear
Secondary

Insomnia Severity Index (ISI)

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).

Time frame: post-treatment (~6-8 weeks)

ArmMeasureValue (MEAN)Dispersion
CBT-I + TAUInsomnia Severity Index (ISI)7.9 units on a scaleStandard Deviation 5.5
TAU ControlInsomnia Severity Index (ISI)17.8 units on a scaleStandard Deviation 5.2
p-value: <0.001Regression, Linear
Secondary

Patient Health Questionnaire-9 (PHQ-9)

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).

Time frame: post-treatment (~6-8 weeks)

ArmMeasureValue (MEAN)Dispersion
CBT-I + TAUPatient Health Questionnaire-9 (PHQ-9)6.4 units on a scaleStandard Deviation 4.6
TAU ControlPatient Health Questionnaire-9 (PHQ-9)12.3 units on a scaleStandard Deviation 5.4
p-value: <0.001Regression, Linear
Secondary

Perceived Treatment Beliefs (PTS)

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.

Time frame: post-treatment (~6-8 weeks)

ArmMeasureValue (MEAN)Dispersion
CBT-I + TAUPerceived Treatment Beliefs (PTS)135.7 units on a scaleStandard Deviation 18
TAU ControlPerceived Treatment Beliefs (PTS)133.04 units on a scaleStandard Deviation 28.8
p-value: 0.627Regression, Linear

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026