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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Nursing Research (NINR) | NIH |
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Exposure to trauma, especially when it manifests as Posttraumatic Stress Disorder (PTSD), results in numerous negative consequences for patients, families, and society. Some of the most frequent, disturbing, and treatment resistant symptoms of PTSD are nightmares and insomnia. This study will examine whether treatments specifically targeted at those sleep disorders can improve clinical outcomes and increase health-related quality of life in individuals recently exposed to war-related trauma. Hypotheses are that treating nightmares and insomnia will improve both nighttime and daytime symptoms of PTSD, as well as quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT for Insomnia | Experimental | Patients change their sleep times and habits in order to reduce alertness and "over thinking" when they are trying to sleep. This helps them learn how to sleep overnight in one solid block of time |
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| Imagery Rehearsal Therapy | Experimental | Patients "rescript" the narrative of a nightmare to eliminate the distressing elements and create a new pleasant dream scene. They then rehearse this scene in their imagination at least twice each day. This reduces the frequency and intensity of the target nightmare and often reduces other nightmares, too. |
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| Prolonged Exposure | Experimental | This behavioral treatment for PTSD involves 1) systematic and repeated exposure to objects and situations that are avoided due to trauma-related distress, 2) prolonged, repeated recounting of trauma memories through visualization, and 3)therapist-guided discussions of thoughts and emotions related to the exposure exercises. The goals of PE are to reduce the anxiety and distress elicited by trauma-related memories and situations, show patients these memories and situations are distinct from the trauma, and teach patients they can tolerate the distress caused by these memories and situations. |
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| Suportive Care Therapy | Active Comparator | This is an active therapy where the focus of the intervention is on helping patients better understand their emotional response to their PTSD and sleep symptoms. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTSD + IRT/CBT-I | Behavioral | 6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia |
|
| Measure | Description | Time Frame |
|---|---|---|
| nightmares and insomnia symptoms | pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| daytime (non-sleep) PTSD symptoms | pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment | |
| health-related quality of life | pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean PA Drummond, PhD | Veterans Medical Research Foundation & University of California San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs San Diego Healthcare System | San Diego | California | 92161 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33472513 | Derived | Mascaro L, Phillips AJK, Clark JW, Straus LD, Drummond SPA. Diurnal Rhythm Robustness in Individuals With PTSD and Insomnia and The Association With Sleep. J Biol Rhythms. 2021 Apr;36(2):185-195. doi: 10.1177/0748730420984563. Epub 2021 Jan 20. | |
| 31246050 | Derived | Walters EM, Jenkins MM, Nappi CM, Clark J, Lies J, Norman SB, Drummond SPA. The impact of prolonged exposure on sleep and enhancing treatment outcomes with evidence-based sleep interventions: A pilot study. Psychol Trauma. 2020 Feb;12(2):175-185. doi: 10.1037/tra0000478. Epub 2019 Jun 27. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007171 | Implosive Therapy |
| D015928 | Cognitive Behavioral Therapy |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| PTSD + Supportive Care Therapy | Behavioral | 6 weeks of prolonged exposure + 12 weeks of supportive care therapy |
|
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| D040921 |
| Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |