Implementation of Brief Insomnia Treatments

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-03-31

Brief Summary

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The purpose of this study is to directly compare the effectiveness of two interventions for insomnia: Brief Behavioral Treatment for Insomnia (BBTI) vs. Cognitive Behavioral Therapy for Insomnia (CBTI).

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Detailed Description

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Cognitive Behavioral Therapy for Insomnia (CBTI) is the evidence-based first line treatment for chronic insomnia. Randomized controlled trials and meta-analyses have established that CBTI is efficacious and effective. Despite the strong evidence for CBTI, chronic insomnia remains under-treated among Veterans because of several barriers that limit access to behavioral treatments. In recent years, the VA has taken substantial measures to train more clinicians to provide insomnia treatment; however, a deficit in treatment availability remains. In 2011, the VA began to train clinicians in CBTI as part of the VA's Evidence Based Psychotherapy (EBP) training program, with a goal to train 1000 clinicians. Even with 1000 VA clinicians trained in CBTI, a shortage of clinicians will likely remain due to the high prevalence of insomnia. High prevalence and a shortage of clinicians prevent the VA from meeting the care demand of Veterans with insomnia. While the CBTI roll-out is a significant investment from the VA, additional mechanisms, such as dissemination and implementation of other evidence-based treatments for insomnia with fewer implementation barriers, must be considered to address the high prevalence of insomnia.

The in-person delivery and length of treatment for CBTI may be one of barriers to accessing care. Briefer protocols that use multiple delivery modalities have recently been developed and may help to increase session attendance and treatment completion. These shorter insomnia treatments are often referred to as Brief Behavioral Treatment for Insomnia (BBTI) and consist of ≤4 sessions. Besides fewer and briefer sessions, and utilizing both in-person and phone delivery of treatment, BBTI also emphasizes the behavioral components of CBTI (i.e., stimulus control and sleep restriction) rather than a combined approach focusing on both behavioral and cognitive components. BBTI is efficacious in adults-studies with older adults and Veterans found BBTI resulted in a significant decrease in insomnia severity with Cohen's d effect sizes in the moderate to large range. Like CBTI, BBTI significantly improves insomnia severity and may also help to improve secondary outcomes like depression and anxiety.

Integration of newer insomnia treatments, like BBTI, will first depend on establishing its evidence directly compared to CBTI. Effectiveness trials of BBTI, especially those conducted with military Veterans in typical VA settings, have yet to be conducted. Before BBTI can be broadly implemented and integrated into the VA, it needs to be established as a clinically effective treatment for insomnia among Veterans and a statistically non-inferior treatment (not necessarily better or worse) for Veterans compared to CBTI.

Conditions

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Chronic Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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CBTI

CBTI consists of five in-person sessions within an eight week period. Topics covered include: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene.

Group Type ACTIVE_COMPARATOR

CBTI

Intervention Type BEHAVIORAL

28 Veterans with chronic insomnia will be randomized to CBTI. The intervention will be delivered in 5 face-to-face session within an 8 week time period. The intervention will be delivered at the VA Pittsburgh Healthcare System. Treatment visits will last approximately 45 minutes.

BBTI

BBTI consists of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered include: sleep education, stimulus control, and sleep restriction.

Group Type ACTIVE_COMPARATOR

BBTI

Intervention Type BEHAVIORAL

28 Veterans with chronic insomnia will be randomized to BBTI. The intervention will be delivered over 4 consecutive weeks, which include individual face-to-face visits on Weeks 1 and 3 (option for telephone), and telephone appointments on Weeks 2 and 4. Interventions will be delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit is approximately 45-minutes, and the follow-up visit on Week 3 will last no more than 30 minutes. Brief (\<20 minutes) telephone sessions will be conducted on Weeks 2 and 4.

Interventions

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CBTI

28 Veterans with chronic insomnia will be randomized to CBTI. The intervention will be delivered in 5 face-to-face session within an 8 week time period. The intervention will be delivered at the VA Pittsburgh Healthcare System. Treatment visits will last approximately 45 minutes.

Intervention Type BEHAVIORAL

BBTI

28 Veterans with chronic insomnia will be randomized to BBTI. The intervention will be delivered over 4 consecutive weeks, which include individual face-to-face visits on Weeks 1 and 3 (option for telephone), and telephone appointments on Weeks 2 and 4. Interventions will be delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit is approximately 45-minutes, and the follow-up visit on Week 3 will last no more than 30 minutes. Brief (\<20 minutes) telephone sessions will be conducted on Weeks 2 and 4.

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive Behavioral Therapy for Insomnia Brief Behavioral Treatment for Insomnia

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years old and older
2. Military Veteran
3. Insomnia Severity Index (ISI) ≥15 \& Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for insomnia disorder
4. If using sleep medications, medication and dosage have not been changed in the past month, and will remain unchanged for the duration of the treatment phase of the study (i.e., 4-8 weeks)
5. If using other psychotropic medications, medication and dosage have not been changed in the past 2 months, and will remain unchanged for the duration of the treatment phase of the study (i.e., 4-8 weeks)

Exclusion Criteria

1. Untreated, current, and severe PTSD as determined by the Structured Clinical Interview for DSM-5 (SCID)
2. Untreated, current, and severe Major Depressive Disorder as determined by the SCID
3. Current/Past Psychotic or Bipolar disorder
4. Current substance or alcohol use disorder as determined by the SCID
5. Current unstable medical condition
6. Hospitalization in the previous 1 month for a medical condition or surgery for which recovery overlaps with the study onset and duration
7. Seizure disorder, open skull brain injury, or moderate to severe traumatic brain injury (TBI)
8. Current, untreated, sleep disorders such as nightmare disorder, restless legs syndrome, circadian rhythm disorder (or shift work), or a suspected sleep disorder requiring polysomnographic assessment, such as obstructive sleep apnea or periodic leg movements as determined by the South Texas Research Organizational Network Guiding Studies on Trauma and Resilience (STRONG STAR) Clinical Interview for DSM-5 Sleep-Wake Disorders and/or the STOP-BANG questionnaire
9. Moderate to severe cognitive impairment (St. Louis University Mental Status \[SLUMS\] exam ≤20) and/or diagnosis in medical record indicative of moderate to severe cognitive impairment
10. Unstable environment that is not in one's control (e.g., homeless, temporary group home, care taking duties at night)
11. Pregnancy and/or breast-feeding

STOP-BANG is not a true acronym but indicates the symptoms each item assess:

* S-snores T-tired/sleepy O-observed apneas P-high blood pressure
* B-body mass index A-age N-neck circumference G-gender

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No