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

NCT ID: NCT05929911

Last Updated: 2025-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-26

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Post Traumatic Stress Disorder HIV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trauma-focused psychodynamic psychotherapy

Twice-weekly psychotherapy for 24 sessions

Group Type EXPERIMENTAL

Trauma-focused psychodynamic psychotherapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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TFPP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

American Psychoanalytic Association

UNKNOWN

Sponsor Role collaborator

Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara Milrod, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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John R Keefe, PhD

Role: CONTACT

703-981-7184

Barbara L Milrod, MD

Role: CONTACT

917-593-1377

Facility Contacts

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John R Keefe, PhD

Role: primary

347-391-4189

Barbara L Milrod, MD

Role: backup

References

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Kehn M, Milrod B, Chen CK. Clinical Case of Trauma-Focused Psychodynamic Psychotherapy for a Veteran With PTSD and Race-Based Trauma. Am J Psychother. 2024 Sep 1;77(3):146-150. doi: 10.1176/appi.psychotherapy.20230040. No abstract available.

Reference Type BACKGROUND
PMID: 39277802 (View on PubMed)

Other Identifiers

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P30AI124414

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023-15016

Identifier Type: -

Identifier Source: org_study_id

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