Telehealth-Massed Imaginal Exposure for PTSD

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: VVC-delivered Massed Imaginal Exposure

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa M McTeague, PhD; Phone Number: 843 792 8274; Email: mcteague@musc.edu
• Study Contact Backup: Name: Adam R Cobb, PhD; Email: cobbad@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Telehealth Massed Imaginal Exposure Therapy

Behavioral: VVC-delivered Massed Imaginal Exposure; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Ralph H. Johnson VA Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Veterans
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: Pro00106523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No