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Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder (BBTI & PTSD)

Primary Purpose

Posttraumatic Stress Disorder, Insomnia Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Behavioral Treatment for Insomnia (BBTI)
Progressive Muscle Relaxation Training (PMRT)
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 Posttraumatic Stress Disorder focused on measuring PTSD, Insomnia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Individuals between the ages of 18-75 years who served in the military Veterans who meet DSM-5 Criteria for Insomnia Disorder. Veterans who meet DSM-5 Criteria for current PTSD If currently taking insomnia, PTSD or other psychotropic medications, must be stable on these medications for at least one month and not make any changes to medications during the active treatment phase of the study. If currently receiving any type of psychotherapy, must have received this treatment for at least one month and do not plan to discontinue treatment during the BBTI trial. Individuals planning to start a new type of psychotherapy will be required to wait one month prior to study enrollment. Individuals currently engaged or planning to engage in evidence-based treatments that are recognized by the VA as directly targeting insomnia or PTSD (i.e., Cognitive Behavioral Therapy for Insomnia, Cognitive Processing Therapy, or Prolonged Exposure Therapy) must complete treatment and wait one month prior to screening for the trial. The investigators will not exclude individuals with TBI, given that prior studies have found that individuals with mild to severe TBI can benefit from behavioral interventions for insomnia. The investigators will not exclude individuals with chronic pain, given that prior studies have found that these individuals can benefit from behavioral interventions for insomnia. The investigators will not exclude individuals with treated sleep apnea or untreated mild sleep apnea. Exclusion Criteria: Veterans with a lifetime history of psychotic disorder or manic episodes. Veterans with moderate to severe alcohol or substance use disorder. Veterans with recent homicidal behaviors. Veterans with suicidal ideation will not be excluded. However, Veterans with recent suicidal behaviors or hospitalization or those who report prominent suicidal ideation with intent or a plan will be excluded. Veterans who are pregnant Veterans who work night or rotating shifts Veterans with unstable housing Veterans with untreated moderate to severe obstructive sleep apnea (OSA) Veterans with untreated medical conditions that are known to affect sleep (e.g., restless legs syndrome)

Sites / Locations

  • San Francisco VA Medical Center, San Francisco, CARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BBTI

PMRT

Arm Description

Participants in this arm will receive 4 sessions (20-60 minutes) of a brief behavioral treatment for insomnia (BBTI). Relaxation techniques are not a component of BBTI.

Participants in this arm will receive 4 sessions (20-60 minutes) of progressive muscle relaxation training (PMRT).

Outcomes

Primary Outcome Measures

Work and Social Adjustment Scale (WSAS) Change
Assesses functioning in work, home management, social leisure activities, private leisure activities and relationships with others. It is a five-item measure with each item rated on a 0 to 8 scale, with higher scores reflecting greater impairment.
Work and Social Adjustment Scale (WSAS) Change
Assesses functioning in work, home management, social leisure activities, private leisure activities and relationships with others. It is a five-item measure with each item rated on a 0 to 8 scale, with higher scores reflecting greater impairment.

Secondary Outcome Measures

Insomnia Severity Index (ISI)
The ISI is a valid and reliable self-report measure that is a specific index of perceived insomnia severity. The ISI is a 7-item measure that is scored on a five-point Likert scale. 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 of 15 to 21 represent moderate clinical insomnia, and scores of 22 to 28 represent severe clinical insomnia.
Insomnia Severity Index (ISI)
The ISI is a valid and reliable self-report measure that is a specific index of perceived insomnia severity. The ISI is a 7-item measure that is scored on a five-point Likert scale. 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 of 15 to 21 represent moderate clinical insomnia, and scores of 22 to 28 represent severe clinical insomnia.

Full Information

First Posted
March 9, 2023
Last Updated
June 27, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05780177
Brief Title
Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder
Acronym
BBTI & PTSD
Official Title
Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
April 30, 2027 (Anticipated)
Study Completion Date
April 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

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
This study will investigate treatments for insomnia in Veterans who have posttraumatic stress disorder (PTSD). The purpose of this study is to compare a brief behavioral treatment for insomnia (BBTI) to a treatment that helps promote relaxation (progressive muscle relaxation training or PMRT). The investigators will examine improvements in psychosocial functioning and insomnia severity. The investigators will also examine whether treatment gains last over time and whether suicidal ideation decreases following insomnia treatment.
Detailed Description
This is a randomized, controlled trial of a video- and telephone-based, brief insomnia treatment in Veterans who meet criteria for Insomnia Disorder and Posttraumatic Stress Disorder (PTSD) to accomplish the goal of improving psychosocial functioning. The primary outcome for the trial will be psychosocial functioning, with insomnia severity serving as the secondary outcome. Additional goals include assessing durability of treatment gains and evaluating whether suicidal ideation decreases after insomnia treatment. Eighty Veterans with Insomnia Disorder and PTSD will be randomly assigned to either Brief Behavioral Treatment for Insomnia (BBTI; one 60-minute and one 30-minute video encounter, and two 20-minute phone-based encounters) or a Progressive Muscle Relaxation Training control group (manualized relaxation training delivered by two video and two phone sessions, matched to the BBTI condition for therapist time). Prior to randomization, participants will complete clinician-administered, mental health diagnostic interviews at baseline (and post-treatment). Self-report measures of psychosocial functioning, insomnia severity, and other mental health symptoms will be completed at baseline (pretreatment), mid-treatment, post-treatment, and at 6-month follow-up (BBTI group only). Sleep parameters will be completed with a self-report sleep diary. One week of sleep parameters data will be collected at baseline and continuously to the post-treatment appointment (and at 6-month follow-up for the BBTI group only). The investigators also will explore whether BBTI decreases suicidal ideation, which often occurs in Veterans with PTSD and insomnia, using the Depressive Symptom Index: Suicidality Subscale and the Columbia Suicide Severity Rating Scale, the latter which is used clinically in VA to assess suicide risk.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Insomnia Disorder
Keywords
PTSD, Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators will conduct a randomized, controlled trial of a video- and telephone-based, brief insomnia treatment in Veterans who meet criteria for Insomnia Disorder and Posttraumatic Stress Disorder (PTSD) to accomplish the goal of improving psychosocial functioning.
Masking
Outcomes Assessor
Masking Description
The clinical evaluator will be kept blind to treatment condition throughout the study period.
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BBTI
Arm Type
Experimental
Arm Description
Participants in this arm will receive 4 sessions (20-60 minutes) of a brief behavioral treatment for insomnia (BBTI). Relaxation techniques are not a component of BBTI.
Arm Title
PMRT
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive 4 sessions (20-60 minutes) of progressive muscle relaxation training (PMRT).
Intervention Type
Behavioral
Intervention Name(s)
Brief Behavioral Treatment for Insomnia (BBTI)
Intervention Description
Participants in this arm will receive 4 sessions (20-60 minutes) of a brief behavioral treatment for insomnia called BBTI. Relaxation techniques are not a component of BBTI.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Muscle Relaxation Training (PMRT)
Intervention Description
Participants in this arm will receive 4 sessions (20-60 minutes) of progressive muscle relaxation training called PMRT.
Primary Outcome Measure Information:
Title
Work and Social Adjustment Scale (WSAS) Change
Description
Assesses functioning in work, home management, social leisure activities, private leisure activities and relationships with others. It is a five-item measure with each item rated on a 0 to 8 scale, with higher scores reflecting greater impairment.
Time Frame
Change from baseline (Week 1) to posttreatment (Week 5)
Title
Work and Social Adjustment Scale (WSAS) Change
Description
Assesses functioning in work, home management, social leisure activities, private leisure activities and relationships with others. It is a five-item measure with each item rated on a 0 to 8 scale, with higher scores reflecting greater impairment.
Time Frame
Change from baseline (Week 1) to 6-month follow-up--for treatment arm only
Secondary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
The ISI is a valid and reliable self-report measure that is a specific index of perceived insomnia severity. The ISI is a 7-item measure that is scored on a five-point Likert scale. 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 of 15 to 21 represent moderate clinical insomnia, and scores of 22 to 28 represent severe clinical insomnia.
Time Frame
Change from baseline (Week 1) to posttreatment (Week 5)
Title
Insomnia Severity Index (ISI)
Description
The ISI is a valid and reliable self-report measure that is a specific index of perceived insomnia severity. The ISI is a 7-item measure that is scored on a five-point Likert scale. 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 of 15 to 21 represent moderate clinical insomnia, and scores of 22 to 28 represent severe clinical insomnia.
Time Frame
Change from baseline (Week 1) to 6-month follow-up--for treatment arm only
Other Pre-specified Outcome Measures:
Title
Depressive Symptom Index: Suicidality Subscale (DSI-SS)
Description
The DSI-SS is a 4-item self-report questionnaire designed to identify the frequency and intensity of suicidal ideation and impulses in the past two weeks. Scores range from 0-12, with higher scores reflecting greater severity of suicidal ideation. The DSI-SS is a reliable and valid measure of severity of SI in psychiatric patients.
Time Frame
Change from baseline (Week 1) to 6-month follow-up--for treatment arm only
Title
Depressive Symptom Index: Suicidality Subscale (DSI-SS)
Description
The DSI-SS is a 4-item self-report questionnaire designed to identify the frequency and intensity of suicidal ideation and impulses in the past two weeks. Scores range from 0-12, with higher scores reflecting greater severity of suicidal ideation. The DSI-SS is a reliable and valid measure of severity of SI in psychiatric patients.
Time Frame
Change from baseline (Week 1) to posttreatment (Week 5)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals between the ages of 18-75 years who served in the military Veterans who meet DSM-5 Criteria for Insomnia Disorder. Veterans who meet DSM-5 Criteria for current PTSD If currently taking insomnia, PTSD or other psychotropic medications, must be stable on these medications for at least one month and not make any changes to medications during the active treatment phase of the study. If currently receiving any type of psychotherapy, must have received this treatment for at least one month and do not plan to discontinue treatment during the BBTI trial. Individuals planning to start a new type of psychotherapy will be required to wait one month prior to study enrollment. Individuals currently engaged or planning to engage in evidence-based treatments that are recognized by the VA as directly targeting insomnia or PTSD (i.e., Cognitive Behavioral Therapy for Insomnia, Cognitive Processing Therapy, or Prolonged Exposure Therapy) must complete treatment and wait one month prior to screening for the trial. The investigators will not exclude individuals with TBI, given that prior studies have found that individuals with mild to severe TBI can benefit from behavioral interventions for insomnia. The investigators will not exclude individuals with chronic pain, given that prior studies have found that these individuals can benefit from behavioral interventions for insomnia. The investigators will not exclude individuals with treated sleep apnea or untreated mild sleep apnea. Exclusion Criteria: Veterans with a lifetime history of psychotic disorder or manic episodes. Veterans with moderate to severe alcohol or substance use disorder. Veterans with recent homicidal behaviors. Veterans with suicidal ideation will not be excluded. However, Veterans with recent suicidal behaviors or hospitalization or those who report prominent suicidal ideation with intent or a plan will be excluded. Veterans who are pregnant Veterans who work night or rotating shifts Veterans with unstable housing Veterans with untreated moderate to severe obstructive sleep apnea (OSA) Veterans with untreated medical conditions that are known to affect sleep (e.g., restless legs syndrome)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shira Maguen, PhD
Phone
(415) 221-4810
Ext
2511
Email
shira.maguen@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Joy Huggins, MA
Phone
(415) 221-4810
Ext
4850
Email
Joy.Huggins@va.gov
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
94121-1563
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shira Maguen, PhD
Phone
415-221-4810
Ext
2511
Email
shira.maguen@va.gov
First Name & Middle Initial & Last Name & Degree
Shira Maguen, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

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