Telehealth-Massed Imaginal Exposure for PTSD

NCT ID: NCT05450224

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-01-01

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Telehealth Massed Imaginal Exposure Therapy

Group Type: OTHER

VVC-delivered Massed Imaginal Exposure

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ralph H. Johnson VA Medical Center

FED

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00106523

Identifier Type: -

Identifier Source: org_study_id