Telehealth-Massed Imaginal Exposure for PTSD

NCT05450224 | Withdrawn

• 1 other identifier: Pro00106523
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Veterans

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (3)

• Remote photoplethysmography

  Pre-treatment, 1-week post-treatment, and 1-month follow-up.

• Facial emotional expressivity

  Pre-treatment, 1-week post-treatment, and 1-month follow-up.

• Vocal and linguistic emotional expressivity

  Pre-treatment, 1-week post-treatment, and 1-month follow-up.

Study Arms (1)

Telehealth Massed Imaginal Exposure Therapy

OTHER

Behavioral: VVC-delivered Massed Imaginal Exposure

Interventions

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.

Telehealth Massed Imaginal Exposure Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Ralph H. Johnson VA Medical Center: collaborator

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: July 8, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share