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Brief Behavioral Insomnia Treatment Study (BBTI)

Primary Purpose

Insomnia Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Behavioral Treatment for Insomnia
Progressive Muscle Relaxation
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia Disorder focused on measuring Veteran, Insomnia, Primary Healthcare

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • San Francisco VA Medical Center, San Francisco, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brief Behavioral Treatment for Insomnia

Progressive Muscle Relaxation

Arm 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.

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.

Outcomes

Primary Outcome Measures

Work and Social Adjustment Scale (WSAS)
The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others. Scores range from 0-40, with higher scores meaning greater impairment. The measure was administered at Baseline (week 0), Mid-treatment (week 3) & Post-treatment (week 5).
Work and Social Adjustment Scale (WSAS)
The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others. Scores range from 0-40, with higher scores meaning greater impairment. The WSAS was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.

Secondary Outcome Measures

Insomnia Severity (ISI)
The ISI 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 quality of life; and worry about sleep problems. Scores range from 0-28, with higher scores meaning greater impairment. The measure was administered at Baseline (week 0), Mid-treatment (week 3) & Post-treatment (week 5).
Insomnia Severity (ISI)
Insomnia Severity Index (ISI) 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 quality of life; and worry about sleep problems. Scores range from 0-28, with higher scores meaning greater impairment. The ISI was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.

Full Information

First Posted
October 2, 2015
Last Updated
January 28, 2020
Sponsor
VA Office of Research and Development
Collaborators
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02571452
Brief Title
Brief Behavioral Insomnia Treatment Study
Acronym
BBTI
Official Title
Telephone-Facilitated Insomnia Treatment in Primary Care for OEF/OIF/OND Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 6, 2016 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Disorder
Keywords
Veteran, Insomnia, Primary Healthcare

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Behavioral Treatment for Insomnia
Arm Type
Experimental
Arm 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 Title
Progressive Muscle Relaxation
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Behavioral Treatment for Insomnia
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Muscle Relaxation
Intervention 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.
Primary Outcome Measure Information:
Title
Work and Social Adjustment Scale (WSAS)
Description
The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others. Scores range from 0-40, with higher scores meaning greater impairment. The measure was administered at Baseline (week 0), Mid-treatment (week 3) & Post-treatment (week 5).
Time Frame
Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
Title
Work and Social Adjustment Scale (WSAS)
Description
The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others. Scores range from 0-40, with higher scores meaning greater impairment. The WSAS was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.
Time Frame
Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
Secondary Outcome Measure Information:
Title
Insomnia Severity (ISI)
Description
The ISI 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 quality of life; and worry about sleep problems. Scores range from 0-28, with higher scores meaning greater impairment. The measure was administered at Baseline (week 0), Mid-treatment (week 3) & Post-treatment (week 5).
Time Frame
Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
Title
Insomnia Severity (ISI)
Description
Insomnia Severity Index (ISI) 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 quality of life; and worry about sleep problems. Scores range from 0-28, with higher scores meaning greater impairment. The ISI was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.
Time Frame
Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shira Maguen, PhD
Organizational Affiliation
San Francisco VA Medical Center, San Francisco, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco VA Medical Center, San Francisco, CA
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35393934
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.
Results Reference
derived
PubMed Identifier
33022048
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.
Results Reference
derived

Learn more about this trial

Brief Behavioral Insomnia Treatment Study

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