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

HIV Clinical Trial

— TFPP-PLWH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05929911
• Other study ID #: 2023-15016
• Secondary ID: P30AI124414
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2024
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: Montefiore Medical Center
• Contact: John R Keefe, PhD
• Phone: 703-981-7184
• Email: john.keefe[@]einsteinmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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 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.

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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 5
Primary	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)
Primary	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	Change in Depression Score based on the Hamilton Depression Rating Scale (HDRS)	The HDRS (also known as the Ham-D) scale contains 17 items pertaining to symptoms of depression experienced over the past week. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression, and scores over 24 are indicative of severe depression with the maximum score being 52 on the 17-point scale.	Baseline, Week 12 (treatment termination)
Secondary	Change in Anxiety Score based on the Hamilton Rating Scale for Anxiety (HAM-A)	Severity of anxiety will be assessed using the Hamilton Rating Scale for Anxiety (HAM-A). The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe anxiety.	Baseline, Week 12 (treatment termination)
Secondary	Change in Functional Impairment based on the Sheehan Disability Scale (SDS)	The Sheehan Disability Scale is a composite of three self-rated items designed to measure the extent to which three major domains in the patient's life are functionally impaired by psychiatric or medical symptoms. The SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school (0-10 scoring range), social life (0-10 scoring range), and family life (0-10 scoring range). A composite range of 0-30 is possible. Scores of =5 on any of the 3 individual scales and overall higher totals scores are associated with significant functional impairment.	Baseline, Week 5, Week 12 (treatment termination), 3-month post-treatment follow-up
Secondary	Change in Drug and/or Alcohol Problems based on the Short Inventory of Problems-Alcohol and Drugs (SIP-AD)	The Short Inventory of Problems Alcohol and Drugs is a fifteen item instrument used to assess the self-reported consequences of alcohol and substance abuse. The format establishes whether consequences ever happened to the respondents and the frequency of occurrence of the consequences. Possible responses are scored on a 4-point scale (0 = Never; 1 = Once or a few times; 2 = Once or twice a week; 3 = Daily or almost daily) based on occurrences over the prior 3-month period. A higher composite total is indicative of increasingly severe consequences.	Baseline, Week 5, Week 12 (treatment termination), 3-month post-treatment follow-up
Secondary	Change in Complex PTSD symptoms based on an International Trauma Interview	Additional instrument based off of the CAPS-5, assessing ICD-11 defined Complex PTSD symptoms; additionally meeting for Complex PTSD is defined by having at least one clinically significant symptom in each of the 3 symptom domains.	Baseline, Week 5, Week 12 (treatment termination), 3-month post-treatment follow-up
Secondary	Attrition from treatment by end of therapy duration	Attrition from treatment will be evaluated by the failure to complete experimental psychotherapy intervention defined as attending at least 16 out of 24 TFPP sessions within the 12-week period OR patient declaring intention to not attend any further TFPP sessions during the 12-week period. The specific session in which the patient dropped out will be recorded.	Up to Treatment Termination (Week 12)
Secondary	Change in symptom-specific reflective functioning	Lower scores indicate worse dysregulation, improvement denoted by higher numbers	Baseline, Week 5, Week 12 (treatment termination)
Secondary	Change in HIV Viral Load	Larger numbers are indicative of greater viral load and are worse	Baseline, Week 5, Week 12 (treatment termination)
Secondary	Change in AIDS Clinical Trials Group Adherence Questionnaire	Gives a 3D day for day measure of AIDS drug compliance. Bigger number are better (taking more doses of medicine)	Baseline, Week 5, Week 12 (treatment termination), 3-month post-treatment follow-up
Secondary	Change in salivary cortisol	normal morning cortisol level depends on the lab but is around 0.094-1.551 µg/dL. Interpretations are made with-in person.	Baseline, Week 12 (treatment termination), 3-month post-treatment follow-up
Secondary	Change in salivary cytokines	Multiple cytokines will be assessed: 14-Plex Luminex Panel of cytokines IL-1a, IL-1ß, IL-6, IL-8, IL-17, TNF, IFN-g, MCP-1, MIP-3a, MIP-1a, MIP-1ß, RANTES, GMCSF and CXCL9. Interpretation is joint, complicated, and determined within subject	Baseline, Week 12 (treatment termination), 3-month post-treatment follow-up
Secondary	Number of patients with clinical PTSD response 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, Week 5, Week 12 (treatment termination), 3-month post-treatment follow-up