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

NCT05929911 | Recruiting

• 2 other identifiers: 2023-15016P30AI124414
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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; HIV

Keywords

PTSD; HIV; psychotherapy; trauma

Outcome Measures

Primary Outcomes (4)

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

  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.

  Baseline

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

  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.

  Week 6

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

  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.

  Week 12 (treatment termination)

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

  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.

  3-month post-treatment follow-up

Secondary Outcomes (3)

• Change in Depression Score based on the Hamilton Depression Rating Scale (HDRS)

  Baseline, Week 12 (treatment termination)

• Change in Anxiety Score based on the Hamilton Rating Scale for Anxiety (HAM-A)

  Baseline, Week 12 (treatment termination)

• Change in Functional Impairment based on the Sheehan Disability Scale (SDS)

  Baseline, Week 6, Week 12 (treatment termination), 3-month post-treatment follow-up

Other Outcomes (9)

• Change in Drug and/or Alcohol Problems based on the Short Inventory of Problems-Alcohol and Drugs (SIP-AD)

  Baseline, Week 6, Week 12 (treatment termination), 3-month post-treatment follow-up

• Attrition from treatment by end of therapy duration

  Up to Treatment Termination (Week 12)

• Change in AIDS Clinical Trials Group Adherence Questionnaire

  Baseline, Week 6, Week 12 (treatment termination), 3-month post-treatment follow-up

Study Arms (1)

Trauma-focused psychodynamic psychotherapy

EXPERIMENTAL

Twice-weekly psychotherapy for 24 sessions

Behavioral: Trauma-focused psychodynamic psychotherapy

Interventions

Trauma-focused psychodynamic psychotherapy 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.

Also known as: TFPP

Trauma-focused psychodynamic psychotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Psychosis
• Bipolar I
• Acute suicidality
• Current substance use disorder
• Organic mental syndrome or intellectual disability
• Unstable non-HIV medical conditions

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• American Psychoanalytic Association: collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39277802 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Interventions

2,2,3,3-tetrafluoroputrescine

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Barbara Milrod, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John R Keefe, PhD

CONTACT

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

Barbara L Milrod, MD

CONTACT

917-593-1377; bmilrod@montefiore.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 3, 2023
• Study Start: April 26, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)