RecruitingNot Applicable

Open Trial of Trauma-focused Psychodynamic Psychotherapy for People Living With HIV and PTSD

United States20 participantsStarted 2024-04-26

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5

Timeframe: Baseline

Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5

Timeframe: Week 6

Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5

Timeframe: Week 12 (treatment termination)

Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5

Timeframe: 3-month post-treatment follow-up

Trial details

NCT IDNCT05929911

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

John R Keefe, PhD

703-981-7184 john.keefe@einsteinmed.edu

View on ClinicalTrials.gov More Post Traumatic Stress Disorder (PTSD) trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5

Timeframe: Baseline

Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5

Timeframe: Week 6

Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5

Timeframe: Week 12 (treatment termination)

Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5

Timeframe: 3-month post-treatment follow-up