Telehealth-Massed Imaginal Exposure for PTSD

Study Overview
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Brief Summary
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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.

Official Title
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Telehealth-delivered Massed Imaginal Exposure for PTSD: Toward Increasing Access to Alternative, Evidence-based Treatment Schedules for Virtual Care

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: VVC-delivered Massed Imaginal Exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65. Ability to speak, read, and write English. Diagnosis of PTSD based on CAPS-5 (> 3 mo. post-trauma). Seeking treatment for PTSD at the Charleston VA. Willingness and ability to engage in assessment and treatment visits through VVC, or another VA-approved telehealth videoconferencing platform. Exclusion Criteria: Currently receiving psychotherapy for another anxiety- or stress-related condition. Current substance use disorder diagnosis with repeated abuse or dependence within 3 months of study entry and unwillingness to abstain for 24 hours prior to study visits. Unstable dose of psychotropic medications within 6 weeks prior to baseline assessment (based on the DMSC; see measures). Medical condition that would contraindicate participation in treatment or assessment activities (e.g., severe cardiovascular problems; DMSC, and chart review; see measures). Current, or history of bipolar I disorder Current, or history of psychotic symptoms Serious suicidal risk or a suicide attempt in the past year, as determined by self-report (PHQ-9) and clinical interview (C-SSRS; see measures). Active neurological conditions, e.g., seizures, stroke, loss of consciousness or concussion (DMSC, and chart review; see measures)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Telehealth Massed Imaginal Exposure Therapy<br> | Behavioral: VVC-delivered Massed Imaginal Exposure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Veterans