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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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This study examines clinical and process outcomes following variable length prolonged exposure (PE) for posttraumatic stress disorder (PTSD) delivered by one of three treatment modalities: home-based telehealth (HBT), office-based telehealth (OBT), or in-home-in-person (IHIP).
This study will provide a certain type of exposure therapy, called prolonged exposure therapy (PE), to military Veterans with Post Traumatic Stress Disorder (PTSD). One hundred and seventy-five Veterans will participate in the study. The main study goal is to compare PE conducted in three different ways: (1) PE that is office-based (OB; Veterans come to a VA clinic and meet with a therapist via telehealth, using videoconferencing technology), (2) PE delivered via home-based telehealth (HBT; Veterans stay at home and meet with the therapist via telehealth, using videoconferencing technology), and (3) PE delivered in home, in person (IHIP; the therapist goes to the Veterans' homes to provide the psychotherapy). Symptoms of PTSD, depression, and anxiety will be examined at pre-treatment, post-treatment and at six-month follow up to determine if symptoms change over time. Study hypotheses state that the IHIP approach, compared to the other two approaches, will be more effective at reducing the PTSD symptoms experienced by these Veterans because it will help Veterans attend each session and complete the therapy "homework" assigned by the therapists (such as doing feared, but safe, activities around the house or the neighborhood). However, the delivery of IHIP may cost more than the delivery of PE via the other modalities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Office-based telehealth (OBT) | Active Comparator | Veterans come to a VA clinic and meet with a therapist via telehealth, using videoconferencing technology |
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| Home-based telehealth (HBT) | Active Comparator | Veterans stay at home and meet with the therapist via telehealth, using videoconferencing technology |
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| In home, in person (IHIP) | Experimental | Therapist goes to the Veterans' homes to provide the psychotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged exposure | Behavioral | PE is a manualized treatment developed by Dr. Edna Foa and her colleagues. In all three treatment modalities, 7-15 weekly, 90 minute individual sessions of PE will be provided. PE is based on emotional processing theory, which proposes that avoidance and negative thoughts about the self and the world maintain PTSD symptoms over time. According to emotional processing theory, effective treatment requires repeated activation of the trauma memory (as through memory and in vivo exposure) and incorporation of corrective information into the trauma fear structure. PE has several primary components: (1) psychoeducation about PTSD and avoidance; (2) imaginal exposure with processing, wherein the participant describes the traumatic memory aloud many times and discusses it with the therapist afterward; and (3) in-vivo exposure, wherein the participant engages in feared, but safe, activities that have been avoided since the traumatic event (e.g., crowded places, driving). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | The CAPS is a clinician-administered interview that assesses PTSD severity and diagnostic threshold. CAPS questions are designed to assess DSM-5 PTSD diagnostic criteria. CAPS has become the "gold standard" semistructured interview for assessing PTSD in the general population. | From baseline to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Beck Depression Inventory (BDI-II) | The BDI is a well-established, 21-item self-report inventory designed to measure depressive symptomatology, including suicidality. | From baseline to 9 months |
| Change in PTSD Checklist (PCL-5) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Morland, PsyD | VA San Diego and University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System | San Diego | California | 92161 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42313651 | Derived | Khalifian CE, Glassman L, Mackintosh M, Grubbs K, Herbert M, Morland L. Improvement in mindful awareness during prolonged exposure treatment leads to reduction in posttraumatic stress disorder (PTSD) symptoms and anger expression. Psychol Trauma. 2026 Jun 18. doi: 10.1037/tra0002212. Online ahead of print. | |
| 31872563 | Derived |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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The PCL-5 is a gold-standard self-report questionnaire designed to assess PTSD symptom severity; there are 20 questions.
| From baseline to 9 months |
| Change in Client Satisfaction Questionnaire (CSQ) - Short form | This well-validated questionnaire consists of 8 items rated on a 5-point Likert scale ranging from "Not at all" to "Very much" and one free response question. The CSQ is designed to measure patient satisfaction with interpersonal and communication behaviors. | From baseline to 3 months |
| Change in Therapist Satisfaction Questionnaire (TSQ) | The TSQ is a validated instrument filled out by the therapist and used to measure provider satisfaction with therapy. This questionnaire consists of 20 items that are rated on a 5-point likert scale raning from "Strongly agree" to "Strongly disagree." | From baseline to 3 months |
| Change in Working Alliance Inventory - Short form (WAI-S) | The WAI measures therapeutic alliance between the therapist and patient. Both the patient and the therapist fill out the WAI. This 12-item inventory has 3 subscales: (1) Goals (agreement about therapy goals), (2) Tasks (agreement about issues to be worked on), and (3) Bonds (comfort level between participant and therapist). | From baseline to 3 months |
| Morland LA, Mackintosh MA, Glassman LH, Wells SY, Thorp SR, Rauch SAM, Cunningham PB, Tuerk PW, Grubbs KM, Golshan S, Sohn MJ, Acierno R. Home-based delivery of variable length prolonged exposure therapy: A comparison of clinical efficacy between service modalities. Depress Anxiety. 2020 Apr;37(4):346-355. doi: 10.1002/da.22979. Epub 2019 Dec 24. |