Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

Conditions
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Posttraumatic Stress Disorder, Insomnia Disorder

Intervention / Treatment
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* Behavioral: Brief Behavioral Treatment for Insomnia (BBTI)
* Behavioral: Progressive Muscle Relaxation Training (PMRT)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BBTI<br>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. | Behavioral: Brief Behavioral Treatment for Insomnia (BBTI)<br>* 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.<br>|
| Active Comparator: PMRT<br>Participants in this arm will receive 4 sessions (20-60 minutes) of progressive muscle relaxation training (PMRT). | Behavioral: Progressive Muscle Relaxation Training (PMRT)<br>* Participants in this arm will receive 4 sessions (20-60 minutes) of progressive muscle relaxation training called PMRT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline (Week 1) to posttreatment (Week 5) | 
| 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. | Change from baseline (Week 1) to 6-month follow-up--for treatment arm only | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline (Week 1) to posttreatment (Week 5) | 
| 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. | Change from baseline (Week 1) to 6-month follow-up--for treatment arm only | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Insomnia