Trauma-focused Psychodynamic Psychotherapy for LGBT Patients With Post-traumatic Stress Disorder

October 5, 2021 updated by: Weill Medical College of Cornell University
This is a pilot, open trial of trauma-focused psychodynamic psychotherapy for LGBT-identifying individuals who meet for DSM-5 defined post-traumatic stress disorder and are interested in receiving a research psychotherapy intervention. A sample of at least 15 therapy completers will be collected.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite high prevalence of PTSD among LGBT individuals, there are no data characterizing the disorder in this population, nor its treatment. This represents an important under-researched area in LGBT care and treatment. The purpose of this study is: (a) to preliminarily characterize PTSD within an LGBT sample; and (b) to test out the preliminary effects and acceptability of a novel PTSD psychotherapy, trauma-focused psychodynamic psychotherapy, in this group. Participants identifying as LGBT and meeting DSM-5 criteria for PTSD per a structured, reliable clinical interview for PTSD will receive 20-24 sessions of twice-weekly TFPP at no cost. Participants will receive four detailed clinical research assessments, at baseline/study entry, Week 5 of treatment, treatment termination/end (Week 12), and 3-months after the end of treatment.

TFPP is adapted from the only empirically supported, non-exposure focused psychodynamic therapy for panic disorder and anxiety disorders, panic-focused psychodynamic psychotherapy. TFPP aims to improve patients' ability to understand and manage strong, intense emotions that appear seemingly "out of the blue," which links to their tendency to reexperience traumatic events in the here-and-now. TFPP addresses the psychological meanings of symptoms and their relationship to traumatic events to help the patient understand underlying emotions triggering their symptoms and the ways in which trauma influences their current experiences. TFPP was developed for patients with complex PTSD, who often have multiple prior trauma exposures with no clear "index" trauma. Moreover, TFPP also explicitly considers opportunities for patients to explore the broader context of their symptoms and difficulties, including but not limited to LGBT identity or experiences of oppression.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10075
        • Weill Medical College of Cornell University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Identify as LGBTQ
  • CAPS-5 diagnosed PTSD per DSM-5 criteria
  • Stable medication for >=2 months and ongoing during treatment

Exclusion Criteria:

  • Psychosis or bipolar disorder
  • Primary substance use disorder
  • Severe suicidality
  • Severe depression per a reconstructed Hamilton Rating Scale for Depression score of >=24
  • Organic mental syndromes interfering with trial demands

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trauma-focused psychodynamic psychotherapy
Twice-weekly psychotherapy for 20-24 sessions.
Behavioral: Trauma-focused psychodynamic psychotherapy

This psychotherapy addresses disruptions in narrative coherence and affective dysregulation 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.

Other Names:
  • TFPP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Treatment Response on Clinician Administered PTSD Scale for DSM-5
Time Frame: Baseline (to calculate what is defined as a 30% change from initial CAPS severity score), Mid-Treatment (Week 5), Termination (Week 12), Follow-Up (3 Months Post Treatment)
The CAPS is the gold-standard measure for PTSD symptoms and diagnosis given by trained research assistants; 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.
Baseline (to calculate what is defined as a 30% change from initial CAPS severity score), Mid-Treatment (Week 5), Termination (Week 12), Follow-Up (3 Months Post Treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attrition from treatment by end of therapy duration (Week 12)
Time Frame: Anytime between Baseline and Termination (Week 12)
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.
Anytime between Baseline and Termination (Week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: John R Keefe, PhD, Weill Medical College of Cornell University / NYP-Weill Cornell

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2020

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 31, 2020

Study Record Updates

Last Update Posted (Actual)

October 7, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-05022019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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