Telehealth-Massed Imaginal Exposure for PTSD

Not Applicable

Withdrawn

• Conditions: Posttraumatic Stress Disorder
• Interventions: Behavioral: VVC-delivered Massed Imaginal Exposure

• Registration Number: NCT05450224
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-08
• Study Start: 2023-01-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telehealth Massed Imaginal Exposure Therapy	VVC-delivered Massed Imaginal Exposure	-

Primary Outcome Measures

Name	Time	Method
Rate of treatment completion and pre-mature dropout.	from pre-treatment to 1-month follow-up	Total percent of patients retained from initial patients.
PTSD symptom checklist	from pre-treatment to 1-month follow-up	PCL-5: PTSD Symptom Checklist for DSM-5. Scores range from 0 to 80, with higher scores indicating greater PTSD severity and impairment.
Satisfaction with treatment - provider	1 week post-treatment	PETQ: Prolonged exposure therapist questionnaire; scores range 0-30 with higher scores suggesting patient is more engaged in treatment.
Satisfaction with treatment - patient	1 week post-treatment	STTSR: Satisfaction with Therapy and Therapist Scale-Revised; scores range 0-60 with higher scores indicating higher satisfaction
Adverse events	from admission to 1 month follow up	Potential adverse events will be assessed with a structured as well as open-ended interview daily during treatment and at follow up.
Satisfaction with telehealth - patient	1 week post-treatment	Technology Treatment Satisfaction Questionnaire; scores range 0-60 with higher scores indicating higher satisfaction.
Satisfaction with telehealth - provider	1 week post-treatment	TTSQ-Provider: Technology Treatment Satisfaction Questionnaire; scores range 0-30 with higher scores suggesting patient is more engaged in treatment
CAPS: Clinician-Administered PTSD Scale for DSM-5	from pre-treatment to 1-month follow-up	Structured interview for DSM-5 PTSD severity and impairment; Scores range from 0 to 80 with higher scores indicating greater PTSD severity and impairment.
Number of sessions attended per patient	from pre-treatment to 1-month follow-up	Number of telehealth therapy appointments attended per patient.

Secondary Outcome Measures

Name	Time	Method
Facial emotional expressivity	Pre-treatment, 1-week post-treatment, and 1-month follow-up.	Video-based derivation of facial emotional expressivity.
Remote photoplethysmography	Pre-treatment, 1-week post-treatment, and 1-month follow-up.	Video-based derivation of psychophysiology including heart rate and respiratory rate
Vocal and linguistic emotional expressivity	Pre-treatment, 1-week post-treatment, and 1-month follow-up.	Audio-based derivation of vocal and linguistic emotional expressivity.