Expired Study
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San Francisco, California 94121


Purpose:

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.


Study summary:

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.


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. 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).


Study is Available At:


Original ID:

D1539-I


NCT ID:

NCT02571452


Secondary ID:


Study Acronym:

BBTI


Brief Title:

Brief Behavioral Insomnia Treatment Study


Official Title:

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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

VA Office of Research and Development


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

110


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Shira Maguen, PhD
Principal Investigator
San Francisco VA Medical Center, San Francisco, CA

Study Dates

Start Date:January 12, 2016
Completion Date:June 30, 2019
Completion Type:Anticipated
Primary Completion Date:March 31, 2019
Primary Completion Type:Actual
Verification Date:April 2019
Last Changed Date:April 10, 2019
First Received Date:October 2, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Psychosocial functioning (WSAS)
Time Frame:change from pre-treatment to post-treatment (after 5 weeks)
Safety Issues:False
Description:Work and social adjustment scale (WSAS) assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others.
Outcome Type:Secondary Outcome
Measure:Insomnia severity (ISI)
Time Frame:Change from pre-treatment to 6 months post-treatment (treatment arm only)
Safety Issues:False
Description:Insomnia Severity Index is a specific index of perceived insomnia severity. Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on qualit
Outcome Type:Secondary Outcome
Measure:Insomnia severity (ISI)
Time Frame:Change from pre-treatment to post treatment (after 5 weeks)
Safety Issues:False
Description:Insomnia Severity Index is a specific index of perceived insomnia severity. Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on qualit
Outcome Type:Primary Outcome
Measure:Psychosocial functioning (WSAS)
Time Frame:Change from pre-treatment to follow up (after 6 months)--for treatment arm only
Safety Issues:False
Description:Work and social adjustment scale (WSAS) assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others. The WSAS will be administered 6 months post-treatment for participants receiving

Study Interventions

Intervention Type:Behavioral
Name:Brief Behavioral Treatment for Insomnia
Description:Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
Arm Name:Brief Behavioral Treatment for Insomnia
Intervention Type:Behavioral
Name:Progressive Muscle Relaxation
Description:Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
Arm Name:Progressive Muscle Relaxation

Study Arms

Study Arm Type:Experimental
Arm Name:Brief Behavioral Treatment for Insomnia
Description:Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
Study Arm Type:Active Comparator
Arm Name:Progressive Muscle Relaxation
Description:Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:VA Office of Research and Development
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of California, San Francisco

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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