Recruiting

Psychotherapy

Sponsor:

Montefiore Medical Center

Code:

NCT05929911

Conditions

Post Traumatic Stress Disorder (PTSD)

HIV

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Trauma-focused psychodynamic psychotherapy

Study Details

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.

Conditions

Post Traumatic Stress Disorder (PTSD)

HIV

Study ID

NCT05929911

Start date

Apr 26, 2024

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Trauma-focused psychodynamic psychotherapy

Twice-weekly psychotherapy for 24 sessions

Interventions

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 measure

  • Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5 [ Time Frame: Baseline ]
  • Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5 [ Time Frame: Week 6 ]
  • Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5 [ Time Frame: Week 12 (treatment termination) ]
  • Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5 [ Time Frame: 3-month post-treatment follow-up ]

Central Contacts and Locations

Central contacts

John R Keefe, PhD

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

Barbara L Milrod, MD

917-593-1377bmilrod@montefiore.edu

Locations

Albert Einstein College of Medicine

Recruiting

The Bronx, New York, United States, 10461

Contacts

John R Keefe, PhD

347-391-4189john.keefe@einsteinmed.edu

Barbara L Milrod, MD

bmilrod@montefiore.org

Principal Investigator:

Barbara L Milrod, MD

More Information

Sponsor

Montefiore Medical Center

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • HIV
  • psychotherapy
  • trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-06-12.