Implementation of Brief Insomnia Treatments - Clinical Trial
iBIT
2 other identifiers
interventional
92
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2016
CompletedFirst Posted
Study publicly available on registry
March 31, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedResults Posted
Study results publicly available
August 11, 2020
CompletedAugust 11, 2020
July 1, 2020
2.9 years
March 21, 2016
May 7, 2020
July 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insomnia Severity Index (ISI)
Insomnia Severity Index (ISI) 0-28; 0-7 (no symptoms), 8-14 (sub-threshold symptoms), 15-21 (moderately severe), 22-28 (severe) high scores indicate worse outcome/greater severity
post-treatment (BBTI: week 5; CBTI: week 6-9)
Secondary Outcomes (13)
Patient Health Questionnaire (PHQ-9)
post-treatment (BBTI: week 5; CBTI: week 6-9)
Generalized Anxiety Disorder (GAD-7)
post-treatment (BBTI: week 5; CBTI: week 6-9)
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
post-treatment (BBTI: week 5; CBTI: week 6-9)
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
post-treatment (BBTI: week 5; CBTI: week 6-9)
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
post-treatment (BBTI: week 5; CBTI: week 6-9)
- +8 more secondary outcomes
Study Arms (2)
CBTI
ACTIVE COMPARATORCBTI 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.
BBTI
ACTIVE COMPARATORBBTI 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
Related Publications (2)
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.
PMID: 32586428DERIVEDBramoweth 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.
PMID: 29373993DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
In general, higher than expected dropout leading to smaller number of participants analyzed. For sleep diaries, higher than expected dropout and poor completion at post-treatment resulted in small number analyzed.
Results Point of Contact
- Title
- Adam Bramoweth, PhD
- Organization
- VA Pittsburgh Healthcare System
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Health Scientist
Study Record Dates
First Submitted
March 21, 2016
First Posted
March 31, 2016
Study Start
April 1, 2016
Primary Completion
March 1, 2019
Study Completion
March 1, 2020
Last Updated
August 11, 2020
Results First Posted
August 11, 2020
Record last verified: 2020-07