Clinical trial NCT02724800: Implementation of Brief Insomnia Treatments - Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Insomnia
Keywords: Insomnia
Veterans
Cognitive Behavioral Therapy for Insomnia
Brief Behavioral Treatment for Insomnia
Comparative Effectiveness Research
Lead sponsor: VA Pittsburgh Healthcare System
Sponsor class: FED
Collaborators: name: VA Office of Research and Development
First posted: 2016-03-31
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: post-treatment (BBTI: week 5; CBTI: week 6-9)
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: post-treatment (BBTI: week 5; CBTI: week 6-9)
measure: PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
timeFrame: post-treatment (BBTI: week 5; CBTI: week 6-9)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
timeFrame: post-treatment (BBTI: week 5; CBTI: week 6-9)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
timeFrame: post-treatment (BBTI: week 5; CBTI: week 6-9)
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: post-treatment (BBTI: week 5; CBTI: week 6-9)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: post-treatment (BBTI: week 5; CBTI: week 6-9)
measure: Epworth Sleepiness Scale (ESS)
timeFrame: post-treatment (BBTI: week 5; CBTI: week 6-9)
measure: Dysfunctional Beliefs and Attitudes About Sleep (DBAS)
timeFrame: post-treatment (BBTI: week 5; CBTI: week 6-9)
measure: Patient Global Impression of Change (PGIC)
timeFrame: post-treatment (BBTI: week 5; CBTI: week 6-9)
measure: Sleep Diary
timeFrame: post-treatment (BBTI: week 5; CBTI: week 6-9)
measure: Sleep Diary - Sleep Efficiency
timeFrame: post-treatment (BBTI: week 5; CBTI: week 6-9)
measure: Sleep Diary - Sleep Quality
timeFrame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
Study officials:
References:
citation: Bramoweth AD, Lederer LG, Youk AO, Germain A, Chinman MJ. Brief Behavioral Treatment for Insomnia vs. Cognitive Behavioral Therapy for Insomnia: Results of a Randomized Noninferiority Clinical Trial Among Veterans. Behav Ther. 2020 Jul;51(4):535-547. doi: 10.1016/j.beth.2020.02.002. Epub 2020 Feb 20.
citation: Bramoweth AD, Germain A, Youk AO, Rodriguez KL, Chinman MJ. A hybrid type I trial to increase Veterans' access to insomnia care: study protocol for a randomized controlled trial. Trials. 2018 Jan 26;19(1):73. doi: 10.1186/s13063-017-2437-y.