Clinical trial NCT05929911: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
HIV
Keywords: PTSD
HIV
psychotherapy
trauma
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: American Psychoanalytic Association
First posted: 2023-07-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
timeFrame: Baseline
measure: Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
timeFrame: Week 6
measure: Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
timeFrame: Week 12 (treatment termination)
measure: Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
timeFrame: 3-month post-treatment follow-up
Secondary outcomes:
measure: Change in Depression Score based on the Hamilton Depression Rating Scale (HDRS)
timeFrame: Baseline, Week 12 (treatment termination)
measure: Change in Anxiety Score based on the Hamilton Rating Scale for Anxiety (HAM-A)
timeFrame: Baseline, Week 12 (treatment termination)
measure: Change in Functional Impairment based on the Sheehan Disability Scale (SDS)
timeFrame: Baseline, Week 6, Week 12 (treatment termination), 3-month post-treatment follow-up
Other outcomes:
measure: Change in Drug and/or Alcohol Problems based on the Short Inventory of Problems-Alcohol and Drugs (SIP-AD)
timeFrame: Baseline, Week 6, Week 12 (treatment termination), 3-month post-treatment follow-up
measure: Attrition from treatment by end of therapy duration
timeFrame: Up to Treatment Termination (Week 12)
measure: Change in AIDS Clinical Trials Group Adherence Questionnaire
timeFrame: Baseline, Week 6, Week 12 (treatment termination), 3-month post-treatment follow-up
measure: Number of patients with clinical PTSD response based on the Clinician Administered PTSD Scale for DSM-5
timeFrame: Baseline, Week 6, Week 12 (treatment termination), 3-month post-treatment follow-up
measure: Change in salivary cytokines
timeFrame: Baseline, Week 12 (treatment termination), 3-month post-treatment follow-up
measure: Change in salivary cortisol
timeFrame: Baseline, Week 12 (treatment termination), 3-month post-treatment follow-up
measure: Change in HIV Viral Load
timeFrame: Baseline, Week 6, Week 12 (treatment termination)
measure: Change in Complex PTSD symptoms based on an International Trauma Interview
timeFrame: Baseline, Week 6, Week 12 (treatment termination), 3-month post-treatment follow-up
measure: Change in symptom-specific reflective functioning
timeFrame: Baseline, Week 6, Week 12 (treatment termination)
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Barbara Milrod, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.