Brief Behavioral Insomnia Treatment Study



Status:Active, not recruiting
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 75
Updated:11/16/2018
Start Date:January 12, 2016
End Date:March 31, 2019

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Telephone-Facilitated Insomnia Treatment in Primary Care for OEF/OIF/OND Veterans

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.

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.

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.

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.

- The investigators also will not exclude individuals based on any other mental health
condition, including posttraumatic stress disorder and depression.

- 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 sleep apnea (those receiving treatment will not be
excluded from the study).
We found this trial at
1
site
San Francisco, California 94121
Principal Investigator: Shira Maguen, PhD
Phone: 415-221-4810
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mi
from
San Francisco, CA
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