Clinical trial NCT05450224: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Veterans
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Ralph H. Johnson VA Medical Center
First posted: 2022-07-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Adverse events
timeFrame: from admission to 1 month follow up
measure: Satisfaction with treatment - provider
timeFrame: 1 week post-treatment
measure: Satisfaction with telehealth - provider
timeFrame: 1 week post-treatment
measure: Satisfaction with treatment - patient
timeFrame: 1 week post-treatment
measure: Satisfaction with telehealth - patient
timeFrame: 1 week post-treatment
measure: Number of sessions attended per patient
timeFrame: from pre-treatment to 1-month follow-up
measure: Rate of treatment completion and pre-mature dropout.
timeFrame: from pre-treatment to 1-month follow-up
measure: CAPS: Clinician-Administered PTSD Scale for DSM-5
timeFrame: from pre-treatment to 1-month follow-up
measure: PTSD symptom checklist
timeFrame: from pre-treatment to 1-month follow-up
Secondary outcomes:
measure: Remote photoplethysmography
timeFrame: Pre-treatment, 1-week post-treatment, and 1-month follow-up.
measure: Facial emotional expressivity
timeFrame: Pre-treatment, 1-week post-treatment, and 1-month follow-up.
measure: Vocal and linguistic emotional expressivity
timeFrame: Pre-treatment, 1-week post-treatment, and 1-month follow-up.
Other outcomes:
Locations:
Study officials:
References: