N/A
N=93
Brief Behavioral Insomnia Treatment Study
Insomnia Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02571452 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Work and Social Adjustment Scale (WSAS) — 20.1; 19.7; 14.1; 15.8 score on a scale — p=.021
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brief Behavioral Treatment for Insomnia (Behavioral); Progressive Muscle Relaxation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Work and Social Adjustment Scale (WSAS) |
10.8; 11.2 | .568 |
| PRIMARY Work and Social Adjustment Scale (WSAS) |
10.8; 11.2 | .568 |
| SECONDARY Insomnia Severity (ISI) |
8.1; 7.5 | .173 |
| SECONDARY Insomnia Severity (ISI) |
8.1; 7.5 | .173 |
Summary
The purpose of this study is to determine whether a brief, behavioral treatment for insomnia is effective in addressing social and occupational functioning and overall health among Veterans with insomnia disorder.
Eligibility Criteria
Inclusion Criteria
- Veterans between the ages of 18-75 years.
- Meet DSM-5 Criteria for Insomnia Disorder.
- Able attend in-person appointments at the San Francisco VA Medical Center
- The investigators will not exclude individuals who are taking insomnia or antidepressant medications, provided they have been stable on these medications for at least one month and still meet criteria for Insomnia Disorder as described above.
- Specifically, individuals receiving benzodiazepine or benzodiazepine receptor agonists, anticonvulsants, atypical antipsychotic medication, or non-SSRI antidepressant medications such as trazodone will not be excluded provided they meet the criteria described above.
- The investigators will not exclude Veterans receiving any type of psychotherapy, provided they have received this treatment for at least three months and do not plan to discontinue this treatment during the BBTI trial.
- However, individual who need to start a new type of psychotherapy during the course of the treatment will be excluded, or they will need to wait three months in order to enroll in the trial.
- The investigators will not exclude individuals with TBI.
- The investigators will not exclude individuals with chronic pain.
- The investigators will not exclude individuals based on any other mental health condition, including posttraumatic stress disorder and depression.
Exclusion Criteria
- Conditions that may be associated with comorbid insomnia, including a lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, and alcohol or drug dependence within the past year.
- Individuals who meet criteria for alcohol or drug abuse will be asked to reduce alcohol to recommended limits during the course of the study and/or refrain from drug use in order to be included.
- Veterans with suicidal or homicidal ideation.
- Veterans who are pregnant, due to the biological impact of pregnancy on sleep.
- Veterans who work night or rotating shifts.
- Veterans with untreated moderate to severe sleep apnea (those receiving treatment will not be excluded from the study).
Data sourced from ClinicalTrials.gov (NCT02571452). 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.