NCT05929911 Open Trial of Trauma-focused Psychodynamic Psychotherapy for People Living With HIV and PTSD
| NCT ID | NCT05929911 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montefiore Medical Center |
| Condition | Post Traumatic Stress Disorder (PTSD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-04-26 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-04-26 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
People living with HIV (PLWH) have a higher rate of post-traumatic stress disorder (PTSD) diagnosis than the general population. Comorbid PTSD is also associated with negative HIV-related health outcomes. Unfortunately, little outcome research has examined the usefulness of PTSD treatments for PTSD. This pilot study adapts for PLWH a non-exposure based psychotherapy for PTSD focused on reflecting on one's emotions and relationships and understanding and working through how trauma may have disrupted them. The study team is interested in better understanding the needs of PLWH with PTSD, learning whether PLWH with PTSD find this treatment acceptable and helpful, and beginning to understand the relationship between HIV-related health factors (e.g., inflammation and stress biology) and PTSD, and how these health factors may improve during treatment.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of DSM-5 defined PTSD, per the Clinician Administered PTSD Scale \& CAPS-5 total severity score greater than or equal to 25 * HIV diagnosis (by medical records or HIV testing) * Stable psychiatric/psychotropic medication for \>=2 months and ongoing during treatment Exclusion Criteria: * Psychosis * Bipolar I * Acute suicidality * Current substance use disorder * Organic mental syndrome or intellectual disability * Unstable non-HIV medical conditions
Contact & Investigator
Barbara Milrod, MD
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT05929911 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Post Traumatic Stress Disorder (PTSD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05929911 currently recruiting?
Yes, NCT05929911 is actively recruiting participants. Contact the research team at john.keefe@einsteinmed.edu for enrollment information.
Where is the NCT05929911 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT05929911 clinical trial?
NCT05929911 is sponsored by Montefiore Medical Center. The principal investigator is Barbara Milrod, MD at Montefiore Medical Center. The trial plans to enroll 20 participants.
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