Posttraumatic Stress DisorderNCT05450224
Telehealth-Massed Imaginal Exposure for PTSD
A study testing VVC-delivered Massed Imaginal Exposure in people with Posttraumatic Stress Disorder, run by Medical University of South Carolina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- VVC-delivered Massed Imaginal Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
About this study
Official title: 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- VVC-delivered Massed Imaginal Exposure
- Keywords
- Veterans
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VVC-delivered Massed Imaginal ExposureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Massed Imaginal Exposure Therapy | Other | Not described Receives: Behavioral: VVC-delivered Massed Imaginal Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Potential adverse events will be assessed with a structured as well as open-ended interview daily during treatment and at follow up.
Measured: 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.
Measured: 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
Measured: 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
Measured: 1 week post-treatment
Satisfaction with telehealth - patient
Technology Treatment Satisfaction Questionnaire; scores range 0-60 with higher scores indicating higher satisfaction.
Measured: 1 week post-treatment
Number of sessions attended per patient
Number of telehealth therapy appointments attended per patient.
Measured: from pre-treatment to 1-month follow-up
Rate of treatment completion and pre-mature dropout.
Total percent of patients retained from initial patients.
Measured: 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.
Measured: 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.
Measured: from pre-treatment to 1-month follow-up
Secondary outcomes (3)
Remote photoplethysmography
Video-based derivation of psychophysiology including heart rate and respiratory rate
Measured: Pre-treatment, 1-week post-treatment, and 1-month follow-up.
Facial emotional expressivity
Video-based derivation of facial emotional expressivity.
Measured: 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.
Measured: Pre-treatment, 1-week post-treatment, and 1-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Why it stopped: Veteran's Affairs Research and Development Office delays.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Ralph H. Johnson VA Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450224
- Sponsor's protocol ID
- Pro00106523
- Status last verified
- Jul 2025
- First submitted
- 29 Nov 2021
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth-delivered Massed Imaginal Exposure for PTSD: Toward Increasing Access to Alternative, Evidence-based Treatment Schedules for Virtual Care
- ClinicalTrials.gov ID
- NCT05450224
- Acronym / sponsor ID
- Pro00106523
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Veterans
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Veteran's Affairs Research and Development Office delays.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Ralph H. Johnson VA Medical Center
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telehealth Massed Imaginal Exposure Therapy | Other | Behavioral: VVC-delivered Massed Imaginal Exposure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VVC-delivered Massed Imaginal ExposureConsistent 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. | Behavioural | Telehealth Massed Imaginal Exposure Therapy |
Primary outcome
Adverse events
Time frame: 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 treatment - provider
Time frame: 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 telehealth - provider
Time frame: 1 week post-treatment
TTSQ-Provider: Technology Treatment Satisfaction Questionnaire; scores range 0-30 with higher scores suggesting patient is more engaged in treatment
Satisfaction with treatment - patient
Time frame: 1 week post-treatment
STTSR: Satisfaction with Therapy and Therapist Scale-Revised; scores range 0-60 with higher scores indicating higher satisfaction
Satisfaction with telehealth - patient
Time frame: 1 week post-treatment
Technology Treatment Satisfaction Questionnaire; scores range 0-60 with higher scores indicating higher satisfaction.
Number of sessions attended per patient
Time frame: from pre-treatment to 1-month follow-up
Number of telehealth therapy appointments attended per patient.
Rate of treatment completion and pre-mature dropout.
Time frame: from pre-treatment to 1-month follow-up
Total percent of patients retained from initial patients.
CAPS: Clinician-Administered PTSD Scale for DSM-5
Time frame: 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.
PTSD symptom checklist
Time frame: 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.
3 secondary outcomes
Remote photoplethysmography
Time frame: Pre-treatment, 1-week post-treatment, and 1-month follow-up.
Facial emotional expressivity
Time frame: Pre-treatment, 1-week post-treatment, and 1-month follow-up.
Vocal and linguistic emotional expressivity
Time frame: Pre-treatment, 1-week post-treatment, and 1-month follow-up.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing VVC-delivered Massed Imaginal Exposure in people with Posttraumatic Stress Disorder, run by Medical University of South Carolina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: from admission to 1 month follow up). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.