Clinical trial NCT05780177: Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder
Official title: Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Insomnia Disorder
Keywords: PTSD
Insomnia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-03-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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 45-minute video encounter, and two 30-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.

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 sleep apnea or individuals that are high-risk for sleep apnea. Prior research has found that these individuals can benefit from behavioral interventions for insomnia. Recent research has also established that individuals with untreated mild, moderate or severe sleep apnea or those high-risk for sleep apnea are more likely to receive assessment and treatment for this condition after completing behavioral treatment for insomnia.

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 medical conditions that are known to affect sleep (e.g., restless legs syndrome)
* Veterans with uncontrolled seizure disorder. Sleep restriction is contraindicated for people with uncontrolled seizures due to the possibility of triggering a seizure.
* Veterans who are unable to participate in video treatment sessions or complete online surveys.

Primary outcomes:
measure: Work and Social Adjustment Scale (WSAS) Change
timeFrame: Change from baseline (Week 1) to posttreatment (Week 5)
measure: Work and Social Adjustment Scale (WSAS) Change
timeFrame: Change from baseline (Week 1) to 6-month follow-up--for treatment arm only
Secondary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Change from baseline (Week 1) to posttreatment (Week 5)
measure: Insomnia Severity Index (ISI)
timeFrame: Change from baseline (Week 1) to 6-month follow-up--for treatment arm only
Other outcomes:
measure: Depressive Symptom Index: Suicidality Subscale (DSI-SS)
timeFrame: Change from baseline (Week 1) to 6-month follow-up--for treatment arm only
measure: Depressive Symptom Index: Suicidality Subscale (DSI-SS)
timeFrame: Change from baseline (Week 1) to posttreatment (Week 5)
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
Study officials:
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Shira Maguen, PhD
role: PRINCIPAL_INVESTIGATOR
References: