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Veteran's Affairs Research and Development Office delays.
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| Name | Class |
|---|---|
| Ralph H. Johnson VA Medical Center | FED |
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The purpose of this study is to establish the safety, feasibility, and acceptability of very brief imaginal exposure therapy for post-traumatic stress disorder (PTSD) delivered by telehealth over the course of six-daily 60-minute sessions within a 10-day window. All study visits occur remotely, by telehealth. You will be asked to complete a pre-treatment assessment involving a clinical interview, video-based measures of emotional and physical reactions, such as heart rate and breathing rate, and self-report questionnaires to measure the severity and impact of trauma-related symptoms. These assessments are completed again 1-week, and 1-month after completing treatment. The researchers propose that massed exposure-based therapy delivered via telehealth will advance telemental health treatment options and personalized care for Veterans with PTSD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telehealth Massed Imaginal Exposure Therapy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VVC-delivered Massed Imaginal Exposure | Behavioral | Consistent with Zoellner et al., (2017), six, 60-minute daily sessions of imaginal exposure will be conducted based on the PE manual (Foa et al., 2007). No in vivo exposure or homework will be included. Session 1 will include rationale for imaginal exposure and common reactions to trauma. Sessions 2-6 will focus on imaginal exposure (45 minutes) and processing (15 minutes), with later sessions focused on the most distressing aspect of the trauma memory. The final session will include relapse prevention. All sessions will be delivered within a 10-day window. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Potential adverse events will be assessed with a structured as well as open-ended interview daily during treatment and at follow up. | from admission to 1 month follow up |
| Satisfaction with treatment - provider | PETQ: Prolonged exposure therapist questionnaire; scores range 0-30 with higher scores suggesting patient is more engaged in treatment. | 1 week post-treatment |
| Satisfaction with telehealth - provider | TTSQ-Provider: Technology Treatment Satisfaction Questionnaire; scores range 0-30 with higher scores suggesting patient is more engaged in treatment | 1 week post-treatment |
| Satisfaction with treatment - patient | STTSR: Satisfaction with Therapy and Therapist Scale-Revised; scores range 0-60 with higher scores indicating higher satisfaction | 1 week post-treatment |
| Satisfaction with telehealth - patient | Technology Treatment Satisfaction Questionnaire; scores range 0-60 with higher scores indicating higher satisfaction. | 1 week post-treatment |
| Number of sessions attended per patient | Number of telehealth therapy appointments attended per patient. | from pre-treatment to 1-month follow-up |
| Rate of treatment completion and pre-mature dropout. | Total percent of patients retained from initial patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Remote photoplethysmography | Video-based derivation of psychophysiology including heart rate and respiratory rate | Pre-treatment, 1-week post-treatment, and 1-month follow-up. |
| Facial emotional expressivity |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2022 | Mar 27, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 7, 2022 | Mar 15, 2023 | ICF_001.pdf |
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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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| from pre-treatment to 1-month follow-up |
| CAPS: Clinician-Administered PTSD Scale for DSM-5 | Structured interview for DSM-5 PTSD severity and impairment; Scores range from 0 to 80 with higher scores indicating greater PTSD severity and impairment. | from pre-treatment to 1-month follow-up |
| PTSD symptom checklist | PCL-5: PTSD Symptom Checklist for DSM-5. Scores range from 0 to 80, with higher scores indicating greater PTSD severity and impairment. | from pre-treatment to 1-month follow-up |
Video-based derivation of facial emotional expressivity.
| Pre-treatment, 1-week post-treatment, and 1-month follow-up. |
| Vocal and linguistic emotional expressivity | Audio-based derivation of vocal and linguistic emotional expressivity. | Pre-treatment, 1-week post-treatment, and 1-month follow-up. |