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| ID | Type | Description | Link |
|---|---|---|---|
| NIMH: 1 R34 MH080696 |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to adapt and test the effects of a 4-week behavioral treatment that targets chronic insomnia (lasting >1 month) in service members returning from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF).
Insomnia is one of the most common reasons for referral to mental health services in active duty personnel. Chronic insomnia often persists post-deployment, contributes to poor mental and physical health outcomes, and requires targeted interventions. Effective behavioral treatments of insomnia have not been adapted and tested for the treatment of chronic insomnia comorbid to combat-related mental disorders and stress reactions. In addition, effective behavioral insomnia treatments are typically delivered over an 8-week period. This format may not be easily exportable to primary and community care settings where military returnees and veterans seek help. The goal of this R34 Exploratory Clinical Research Grant is to adapt and test the effects of a 4-week behavioral treatment that targets chronic insomnia (lasting >1 month) in service members returning from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), and who present with the typical psychiatric comorbidities associated of combat-related anxiety and mood disorders and stress reactions. We call this intervention the Brief Behavioral Treatment of Insomnia for Military Veterans (BBTI-MV). The proposed study includes two phases. Phase I aims at iteratively adapting and refining a treatment manual for insomnia in OIF/OEF military returnees. Outcomes of interest include self-report, diary, and actigraphic sleep measures, as well as measures of PTSD, anxiety, and depression, and perceived physical health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Brief Behavioral Treatment for Insomnia |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Behavioral Treatment for Insomnia | Behavioral | Effective behavioral insomnia treatments are typically delivered over an 8-week period. This format may not be easily exportable to primary and community care settings where military returnees and veterans seek help. The goal here is to test the effects of a 4-week behavioral treatment that targets chronic insomnia (lasting >1 month) in service members returning from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), and who present with the typical psychiatric comorbidities associated of combat-related anxiety and mood disorders and stress reactions. |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Diary | Weekly during entire participation | |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline and Post Intervention | |
| PSQI Addendum for PTSD (PSQIA) | Baseline and Post Intervention | |
| Sleep quality defined by:PIRS 20 and the ISI | Screening, Baseline, and Post Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD symptom severity as measured by the CAPS | Screening | |
| Depression: BDI | Baseline and Post Intervention | |
| Anxiety: BAI |
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Inclusion Criteria:
Age is 18 and older.
Military returnees from OIF/OEF
Meet diagnostic criteria for chronic insomnia as defined by:
If using sleep medications, medication and dosage have not been changed in the past month, and will remain unchanged for the duration of the acute treatment phase of the study (i.e., 4 weeks)
If using other psychotropic medications, medication and dosage have not been changed in the past 2 months, and will remain unchanged for the duration of the acute treatment phase of the study (i.e., 4 weeks)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Germain, PhD. | University of Pittsburgh, Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Baseline and Post Intervention |
| Medical History: MHQ, MEDHIST_2WK, MOS | Screening, Baseline, and Post Intervention |
| Trauma History: THQ,CES,PCL-C,ICG | Screening, Baseline, and Post Intervention |
| Post Sleep Self Report: PSEQ-SV and POST | Screening |
| Sleepiness: EPWORTH, BASS | Screening, Baseline, and Post Intervention |
| Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey | Baseline and Post Intervention |
| D001523 |
| Mental Disorders |