Clinical trial NCT02571452: Brief Behavioral Insomnia Treatment Study
Official title: Telephone-Facilitated Insomnia Treatment in Primary Care for OEF/OIF/OND Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Disorder
Keywords: Veteran
Insomnia
Primary Healthcare
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of California, San Francisco
First posted: 2015-10-08
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 determine whether a brief, behavioral treatment for insomnia is effective in addressing social and occupational functioning and overall health among Veterans with insomnia disorder.

Detailed description: This study is a randomized, controlled trial of a telephone-based, brief insomnia treatment in primary care in order to accomplish the goal of improving psychosocial functioning in Veterans who meet criteria for Insomnia Disorder. The primary outcome for the trial will be psychosocial functioning, with insomnia severity serving as the secondary outcome. Additional goals include evaluating durability of treatment gains and obtaining feedback from participants about the utility and feasibility of the proposed insomnia treatment.

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).

Primary outcomes:
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
Secondary outcomes:
measure: Insomnia Severity (ISI)
timeFrame: Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
measure: Insomnia Severity (ISI)
timeFrame: Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
Study officials:
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Shira Maguen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ranney RM, Gloria R, Metzler TJ, Huggins J, Neylan TC, Maguen S. Brief behavioral treatment for insomnia decreases trauma-related nightmare frequency in veterans. J Clin Sleep Med. 2022 Jul 1;18(7):1831-1839. doi: 10.5664/jcsm.10002.
citation: Maguen S, Gloria R, Huggins J, Goldstein LA, Kanady JC, Straus LD, Metzler TJ, Lujan C, Neylan TC. Brief behavioral treatment for insomnia improves psychosocial functioning in veterans: results from a randomized controlled trial. Sleep. 2021 Mar 12;44(3):zsaa205. doi: 10.1093/sleep/zsaa205.