NCT05929911 · Montefiore Medical Center
Open Trial of Trauma-focused Psychodynamic Psychotherapy for People Living With HIV and PTSD
(TFPP-PLWH)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Trauma-focused psychodynamic psychotherapy
This psychotherapy addresses disruptions in the ability to reflect and affective regulation by exploring the psychological meanings of symptoms and their relation to traumatic events. The therapist works to identify intrapsychic conflicts, intense negative affects, and defense mechanisms related to the PTSD syndrome using a psychodynamic formulation that provides a framework for intervention. The transference provides a forum for patients to address feelings of mistrust, difficulties with authority, fears of abuse, angry and guilty feelings, and fantasies. This treatment will be provided in-person or over teletherapy as the public health situation demands.
Primary outcome measures
Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
Time frame: Baseline
Lower scores denote less severe PTSD symptoms; a decline of at least 30% from an individual's baseline CAPS score is defined as a treatment response on the CAPS; diagnostic remission will be defined as achieving response plus failing to meet for DSM-5 defined PTSD per the CAPS after treatment.
Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
Time frame: Week 6
Lower scores denote less severe PTSD symptoms; a decline of at least 30% from an individual's baseline CAPS score is defined as a treatment response on the CAPS; diagnostic remission will be defined as achieving response plus failing to meet for DSM-5 defined PTSD per the CAPS after treatment.
Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
Time frame: Week 12 (treatment termination)
Lower scores denote less severe PTSD symptoms; a decline of at least 30% from an individual's baseline CAPS score is defined as a treatment response on the CAPS; diagnostic remission will be defined as achieving response plus failing to meet for DSM-5 defined PTSD per the CAPS after treatment.
Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
Time frame: 3-month post-treatment follow-up
Lower scores denote less severe PTSD symptoms; a decline of at least 30% from an individual's baseline CAPS score is defined as a treatment response on the CAPS; diagnostic remission will be defined as achieving response plus failing to meet for DSM-5 defined PTSD per the CAPS after treatment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Acute suicidality
- Current substance use disorder
- Organic mental syndrome or intellectual disability
- Unstable non-HIV medical conditions
Where
- The Bronx, New York
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), American Psychoanalytic Association (APsA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 12, 2026 · Source of record for eligibility and locations