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

Official title

Pilot Feasibility Proposal to Adapt Trauma-focused Psychodynamic Psychotherapy (TFPP) for PLWH and PTSD

Overview

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 author

Primary outcome measures

• 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]

Secondary outcome measures (3)

• Change in Depression Score based on the Hamilton Depression Rating Scale (HDRS) [Time frame: Baseline, Week 12 (treatment termination)]
• Change in Anxiety Score based on the Hamilton Rating Scale for Anxiety (HAM-A) [Time frame: Baseline, Week 12 (treatment termination)]
• Change in Functional Impairment based on the Sheehan Disability Scale (SDS) [Time frame: Baseline, Week 6, Week 12 (treatment termination), 3-month post-treatment follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Albert Einstein College of Medicine — The Bronx

Publications

• 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

Identifiers

NCT: NCT05929911 · 2023-15016 · P30AI124414

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗