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

NCT ID: NCT04532996

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-12
• Study Completion Date: 2021-10-01

Brief Summary

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.

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.

Conditions

Complex Post-Traumatic Stress Disorder; Post-traumatic Stress Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trauma-focused psychodynamic psychotherapy

Twice-weekly psychotherapy for 20-24 sessions.

Group Type: EXPERIMENTAL

Trauma-focused psychodynamic psychotherapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

TFPP

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John R Keefe, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University / NYP-Weill Cornell

Locations

Weill Medical College of Cornell University

New York, New York, United States

Countries

United States

References

Milrod B, Keefe JR, Choo TH, Arnon S, Such S, Lowell A, Neria Y, Markowitz JC. Separation anxiety in PTSD: A pilot study of mechanisms in patients undergoing IPT. Depress Anxiety. 2020 Apr;37(4):386-395. doi: 10.1002/da.23003. Epub 2020 Feb 25.

Reference Type: BACKGROUND

PMID: 32097526 (View on PubMed)

Busch FN, Nehrig N, Milrod B. Trauma-Focused Psychodynamic Psychotherapy of a Patient With PTSD in a Veterans Affairs Setting. Am J Psychother. 2019 Mar 1;72(1):24-28. doi: 10.1176/appi.psychotherapy.20180019. Epub 2019 Feb 21.

Reference Type: BACKGROUND

PMID: 30786735 (View on PubMed)

Busch FN, Milrod BL. Trauma-Focused Psychodynamic Psychotherapy. Psychiatr Clin North Am. 2018 Jun;41(2):277-287. doi: 10.1016/j.psc.2018.01.005.

Reference Type: BACKGROUND

PMID: 29739526 (View on PubMed)

Other Identifiers

20-05022019

Identifier Type: -

Identifier Source: org_study_id