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

Primary Purpose

Complex Post-Traumatic Stress Disorder, Post-traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma-focused psychodynamic psychotherapy
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Post-Traumatic Stress Disorder focused on measuring PTSD, psychotherapy, psychodynamic, LGBTQ

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weill Medical College of Cornell University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trauma-focused psychodynamic psychotherapy

Arm Description

Twice-weekly psychotherapy for 20-24 sessions.

Outcomes

Primary Outcome Measures

Change in Treatment Response on Clinician Administered PTSD Scale for DSM-5
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.

Secondary Outcome Measures

Attrition from treatment by end of therapy duration (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.

Full Information

First Posted
August 26, 2020
Last Updated
October 5, 2021
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT04532996
Brief Title
Trauma-focused Psychodynamic Psychotherapy for LGBT Patients With Post-traumatic Stress Disorder
Official Title
Trauma-focused Psychodynamic Psychotherapy for LGBT Patients With Post-traumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 12, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Post-Traumatic Stress Disorder, Post-traumatic Stress Disorder
Keywords
PTSD, psychotherapy, psychodynamic, LGBTQ

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trauma-focused psychodynamic psychotherapy
Arm Type
Experimental
Arm Description
Twice-weekly psychotherapy for 20-24 sessions.
Intervention Type
Behavioral
Intervention Name(s)
Trauma-focused psychodynamic psychotherapy
Other Intervention Name(s)
TFPP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Treatment Response on Clinician Administered PTSD Scale for DSM-5
Description
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.
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)
Secondary Outcome Measure Information:
Title
Attrition from treatment by end of therapy duration (Week 12)
Description
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.
Time Frame
Anytime between Baseline and Termination (Week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R Keefe, PhD
Organizational Affiliation
Weill Medical College of Cornell University / NYP-Weill Cornell
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32097526
Citation
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.
Results Reference
background
PubMed Identifier
30786735
Citation
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.
Results Reference
background
PubMed Identifier
29739526
Citation
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.
Results Reference
background

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

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