Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

Posttraumatic Stress Disorder Clinical Trial

— BBTI & PTSD  

Official title:

Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780177
• Other study ID #: D4243-R
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: April 30, 2027

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: Shira Maguen, PhD
• Phone: (415) 221-4810
• Email: shira.maguen[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Insomnia Disorder
• Posttraumatic Stress Disorder
• Sleep Initiation and Maintenance Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Brief Behavioral Treatment for Insomnia (BBTI)
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.
• Progressive Muscle Relaxation Training (PMRT)
Participants in this arm will receive 4 sessions (20-60 minutes) of progressive muscle relaxation training called PMRT.

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center, San Francisco, CA	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depressive Symptom Index: Suicidality Subscale (DSI-SS)	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.	Change from baseline (Week 1) to 6-month follow-up--for treatment arm only
Other	Depressive Symptom Index: Suicidality Subscale (DSI-SS)	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.	Change from baseline (Week 1) to posttreatment (Week 5)
Primary	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)
Primary	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	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)
Secondary	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