Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Brief Behavioral Treatment for Insomnia (BBTI)
BehavioralParticipants in this arm will receive 4 sessions (30-60 minutes) of a brief behavioral treatment for insomnia called BBTI. Relaxation techniques are not a component of BBTI.
Progressive Muscle Relaxation Training (PMRT)
BehavioralParticipants in this arm will receive 4 sessions (30-60 minutes) of progressive muscle relaxation training called PMRT.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: BBTIExperimental treatment 1 intervention
Group B: PMRTActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Change from baseline (Week 1) to posttreatment (Week 5)2
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.
Time frame
Change from baseline (Week 1) to 6-month follow-up--for treatment arm onlySecondary outcomes
1
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.
Time frame
Change from baseline (Week 1) to posttreatment (Week 5)2
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.
Time frame
Change from baseline (Week 1) to 6-month follow-up--for treatment arm onlyOther outcomes
1
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.
Time frame
Change from baseline (Week 1) to 6-month follow-up--for treatment arm only2
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.
Time frame
Change from baseline (Week 1) to posttreatment (Week 5)Sponsors and contacts
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Source ClinicalTrials.gov