Telehealth-Massed Imaginal Exposure for PTSD

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05450224
• Other study ID #: Pro00106523
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: March 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Ralph H. Johnson VA Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Satisfaction with telehealth - patient	Technology Treatment Satisfaction Questionnaire; scores range 0-60 with higher scores indicating higher satisfaction.	1 week post-treatment
Primary	Number of sessions attended per patient	Number of telehealth therapy appointments attended per patient.	from pre-treatment to 1-month follow-up
Primary	Rate of treatment completion and pre-mature dropout.	Total percent of patients retained from initial patients.	from pre-treatment to 1-month follow-up
Primary	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
Primary	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	Remote photoplethysmography	Video-based derivation of psychophysiology including heart rate and respiratory rate	Pre-treatment, 1-week post-treatment, and 1-month follow-up.
Secondary	Facial emotional expressivity	Video-based derivation of facial emotional expressivity.	Pre-treatment, 1-week post-treatment, and 1-month follow-up.
Secondary	Vocal and linguistic emotional expressivity	Audio-based derivation of vocal and linguistic emotional expressivity.	Pre-treatment, 1-week post-treatment, and 1-month follow-up.