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| ID | Type | Description | Link |
|---|---|---|---|
| 1 I01 CX001136-01 | Other Grant/Funding Number | Veterans Affairs |
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| Name | Class |
|---|---|
| The University of Texas Health Science Center at San Antonio | OTHER |
| South Texas Veterans Health Care System | FED |
| Duke University | OTHER |
| Durham VA Medical Center |
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The primary objective of the current study is to determine if providing cognitive-behavioral therapy of Insomnia and nightmares (CBTin) and Cognitive Processing Therapy of PTSD (CPT) results in greater PTSD and sleep symptom reduction than CPT only. A secondary objective is to determine if the sequencing of CBTl&N before or after CPT results in differential effects on PTSD and sleep symptom reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPT | Active Comparator | Cognitive Processing Therapy-cognitive only version (typically labeled CPT-C, but labeled CPT in this grant for simplicity) is a type of Cognitive Therapy addressing daytime symptoms of PTSD. This arm will have 12 twice-weekly sessions, followed by 6 weekly sessions. |
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| CBTin+CPT | Active Comparator | Cognitive Behavioral Therapy of Insomnia and nightmares (CBTin) will be used to address nighttime symptoms of PTSD during 6 weekly sessions, followed by 12 twice-weekly sessions of CPT. |
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| CPT+CBTin | Active Comparator | 12 twice-weekly sessions of CPT followed by 6 sessions of CBTin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Processing Therapy-Cognitive Only (CPT) | Behavioral | Twice weekly CPT over 6 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS-5) | The CAPS-5 (Weathers, Litz, et al., 2013) is a structured diagnostic interview and gold standard for assessing PTSD. The scale also assesses social and occupational functioning, dissociation, and the validity of symptom reports. The CAPS was revised to match DSM-5. The CAPS was revised to accommodate the changes made in DSM-5, to reduce administration time, and to facilitate learning administration and scoring procedures. The CAPS-5 will be the primary outcome of PTSD symptom severity. | Change from baseline to 1-month post-treatment (i.e., after the completion of all 18 sessions, not to exceed 22 weeks from baseline). |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Checklist -DSM-5 (PCL-5) | The PCL-5 (Weathers, Blake, et al., 2013) is a 20-item self-report measure designed to assess PSTSD symptoms as defined by the DSM-5. The PCL-5 will be the secondary outcome of PTSD symptom severity. | Change from baseline to 1-month post-treatment (i.e., after the completion of all 18 sessions, not to exceed 22 weeks from baseline). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel J Taylor, Ph.D. | University of North Texas Health Science Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carl R. Darnall Army Medical Center | Fort Hood | Texas | 76544 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37322836 | Derived | Taylor DJ, Pruiksma KE, Mintz J, Slavish DC, Wardle-Pinkston S, Dietch JR, Dondanville KA, Young-McCaughan S, Nicholson KL, Litz BT, Keane TM, Peterson AL, Resick PA; Consortium to Alleviate PTSD. Treatment of comorbid sleep disorders and posttraumatic stress disorder in U.S. active duty military personnel: A pilot randomized clinical trial. J Trauma Stress. 2023 Aug;36(4):712-726. doi: 10.1002/jts.22939. Epub 2023 Jun 15. | |
| 35197191 |
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| FED |
| Boston VA Research Institute, Inc. | OTHER |
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| Cognitive Behavioral Therapy of Insomnia and Nightmares (CBTin) | Behavioral | Cognitive behavioral therapy of insomnia and nightmares weekly over 6 weeks. |
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| Continuation Cognitive Processing Therapy-Cognitive Only (CPT) | Behavioral | Once weekly continuation CPT over 6 weeks. |
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| Sleep Diary Sleep Efficiency | Sleep diaries will be used for seven days to measure subjective sleep patterns (Carney et al., 2012). Participants will be asked to make daily diary entries with an estimate of their sleep the night before (e.g., bedtime, sleep onset). Questions will also assess nightmare frequency and severity. Average sleep efficiency ((total sleep time/time in bed) x 100) derived from the sleep diaries will be the primary outcome of insomnia symptom severity. | Change from baseline to 1-month post-treatment (i.e., after the completion of all 18 sessions, not to exceed 22 weeks from baseline). |
| Derived |
| Miles SR, Pruiksma KE, Slavish D, Dietch JR, Wardle-Pinkston S, Litz BT, Rodgers M, Nicholson KL, Young-McCaughan S, Dondanville KA, Nakase-Richardson R, Mintz J, Keane TM, Peterson AL, Resick PA, Taylor DJ; Consortium to Alleviate PTSD. Sleep disorder symptoms are associated with greater posttraumatic stress and anger symptoms in US Army service members seeking treatment for posttraumatic stress disorder. J Clin Sleep Med. 2022 Jun 1;18(6):1617-1627. doi: 10.5664/jcsm.9926. |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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