N/A
N=63
Implementation of Brief Insomnia Treatments - Clinical Trial
Chronic Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT02724800 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Insomnia Severity Index (ISI) — 9.6; 11.0 score on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CBTI (Behavioral); BBTI (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Pittsburgh Healthcare System
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity Index (ISI) |
9.6; 11.0 | <0.05 sig |
| SECONDARY Patient Health Questionnaire (PHQ-9) |
5.1; 5.1 | — |
| SECONDARY Generalized Anxiety Disorder (GAD-7) |
5.2; 5.0 | — |
| SECONDARY PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) |
14.2; 14.8 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale |
53.4; 54.2 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health |
41.8; 41.4; 45.6; 45.8 | — |
| SECONDARY Work and Social Adjustment Scale (WSAS) |
10.8; 12.5 | — |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
6.8; 8.4 | <0.05 sig |
| SECONDARY Epworth Sleepiness Scale (ESS) |
9.2; 9.4 | — |
| SECONDARY Dysfunctional Beliefs and Attitudes About Sleep (DBAS) |
4.6; 4.4 | — |
| SECONDARY Patient Global Impression of Change (PGIC) |
5.0; 4.7 | <0.05 sig |
| SECONDARY Sleep Diary |
23.5; 20.8; 27.4; 18.5; 10.7; 12.8 | — |
| SECONDARY Sleep Diary - Sleep Efficiency |
83.9; 84.6 | — |
| SECONDARY Sleep Diary - Sleep Quality |
3.4; 2.8 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Age 18 years old and older
- Military Veteran
- Insomnia Severity Index (ISI) ≥15 & Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for insomnia disorder
- 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)
- 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
- Untreated, current, and severe PTSD as determined by the Structured Clinical Interview for DSM-5 (SCID)
- Untreated, current, and severe Major Depressive Disorder as determined by the SCID
- Current/Past Psychotic or Bipolar disorder
- Current substance or alcohol use disorder as determined by the SCID
- Current unstable medical condition
- Hospitalization in the previous 1 month for a medical condition or surgery for which recovery overlaps with the study onset and duration
- Seizure disorder, open skull brain injury, or moderate to severe traumatic brain injury (TBI)
- 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
- 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
- Unstable environment that is not in one's control (e.g., homeless, temporary group home, care taking duties at night)
- 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
Data sourced from ClinicalTrials.gov (NCT02724800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.