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Telehealth-Massed Imaginal Exposure for PTSD

Primary Purpose

Posttraumatic Stress Disorder

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

VVC-delivered Massed Imaginal Exposure

About this trial

This is an interventional other trial for Posttraumatic Stress Disorder focused on measuring Veterans

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; based on MINI, DMSC, and chart review; see measures).
Current, or history of bipolar I disorder (based on MINI; see measures).
Current, or history of psychotic symptoms (based on MINI; see measures).
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 (based on MINI, DMSC, and chart review; see measures)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Telehealth Massed Imaginal Exposure Therapy

Arm Description

Outcomes

Primary Outcome Measures

Adverse events

Potential adverse events will be assessed with a structured as well as open-ended interview daily during treatment and at 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.

Satisfaction with telehealth - provider

TTSQ-Provider: Technology Treatment Satisfaction Questionnaire; scores range 0-30 with higher scores suggesting patient is more engaged in treatment

Satisfaction with treatment - patient

STTSR: Satisfaction with Therapy and Therapist Scale-Revised; scores range 0-60 with higher scores indicating higher satisfaction

Satisfaction with telehealth - patient

Technology Treatment Satisfaction Questionnaire; scores range 0-60 with higher scores indicating higher satisfaction.

Number of sessions attended per patient

Number of telehealth therapy appointments attended per patient.

Rate of treatment completion and pre-mature dropout.

Total percent of patients retained from initial patients.

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.

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.

Secondary Outcome Measures

Remote photoplethysmography

Video-based derivation of psychophysiology including heart rate and respiratory rate

Facial emotional expressivity

Video-based derivation of facial emotional expressivity.

Vocal and linguistic emotional expressivity

Audio-based derivation of vocal and linguistic emotional expressivity.

Full Information

NCT ID

NCT05450224

First Posted

November 29, 2021

Last Updated

March 27, 2023

Sponsor

Medical University of South Carolina

Collaborators

Ralph H. Johnson VA Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05450224

Brief Title

Telehealth-Massed Imaginal Exposure for PTSD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Veteran's Affairs Research and Development Office delays.

Study Start Date

January 1, 2023 (Anticipated)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of South Carolina

Collaborators

Ralph H. Johnson VA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posttraumatic Stress Disorder

Keywords

Veterans

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Telehealth Massed Imaginal Exposure Therapy

Arm Type

Other

Intervention Type

Behavioral

Intervention Name(s)

VVC-delivered Massed Imaginal Exposure

Intervention Description

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.

Primary Outcome Measure Information:

Title

Adverse events

Description

Potential adverse events will be assessed with a structured as well as open-ended interview daily during treatment and at follow up.

Time Frame

from admission to 1 month follow up

Title

Satisfaction with treatment - provider

Description

PETQ: Prolonged exposure therapist questionnaire; scores range 0-30 with higher scores suggesting patient is more engaged in treatment.

Time Frame

1 week post-treatment

Title

Satisfaction with telehealth - provider

Description

TTSQ-Provider: Technology Treatment Satisfaction Questionnaire; scores range 0-30 with higher scores suggesting patient is more engaged in treatment

Time Frame

1 week post-treatment

Title

Satisfaction with treatment - patient

Description

STTSR: Satisfaction with Therapy and Therapist Scale-Revised; scores range 0-60 with higher scores indicating higher satisfaction

Time Frame

1 week post-treatment

Title

Satisfaction with telehealth - patient

Description

Technology Treatment Satisfaction Questionnaire; scores range 0-60 with higher scores indicating higher satisfaction.

Time Frame

1 week post-treatment

Title

Number of sessions attended per patient

Description

Number of telehealth therapy appointments attended per patient.

Time Frame

from pre-treatment to 1-month follow-up

Title

Rate of treatment completion and pre-mature dropout.

Description

Total percent of patients retained from initial patients.

Time Frame

from pre-treatment to 1-month follow-up

Title

CAPS: Clinician-Administered PTSD Scale for DSM-5

Description

Structured interview for DSM-5 PTSD severity and impairment; Scores range from 0 to 80 with higher scores indicating greater PTSD severity and impairment.

Time Frame

from pre-treatment to 1-month follow-up

Title

PTSD symptom checklist

Description

PCL-5: PTSD Symptom Checklist for DSM-5. Scores range from 0 to 80, with higher scores indicating greater PTSD severity and impairment.

Time Frame

from pre-treatment to 1-month follow-up

Secondary Outcome Measure Information:

Title

Remote photoplethysmography

Description

Video-based derivation of psychophysiology including heart rate and respiratory rate

Time Frame

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

Title

Facial emotional expressivity

Description

Video-based derivation of facial emotional expressivity.

Time Frame

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

Title

Vocal and linguistic emotional expressivity

Description

Audio-based derivation of vocal and linguistic emotional expressivity.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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)

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Telehealth-Massed Imaginal Exposure for PTSD

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