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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BBTI | Experimental | Participants in this arm will receive 4 sessions (30-60 minutes) of a brief behavioral treatment for insomnia (BBTI). Relaxation techniques are not a component of BBTI. |
|
| PMRT | Active Comparator | Participants in this arm will receive 4 sessions (30-60 minutes) of progressive muscle relaxation training (PMRT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Behavioral Treatment for Insomnia (BBTI) | Behavioral | Participants 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. |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shira Maguen, PhD | Contact | (415) 221-4810 | 2511 | shira.maguen@va.gov |
| Joy Huggins, MA | Contact | (415) 221-4810 | 4850 | Joy.Huggins@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Shira Maguen, PhD | San Francisco VA Medical Center, San Francisco, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco VA Medical Center, San Francisco, CA | Recruiting | San Francisco | California | 94121-1563 | United States |
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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.
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The clinical evaluator will be kept blind to treatment condition throughout the study period.
| Progressive Muscle Relaxation Training (PMRT) | Behavioral | Participants in this arm will receive 4 sessions (30-60 minutes) of progressive muscle relaxation training called PMRT. |
|
| 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 |
| 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) |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D001326 | Autogenic Training |
| ID | Term |
|---|---|
| D006990 | Hypnosis |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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