NCT04532996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 12, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 7, 2021

Status Verified

October 1, 2021

Enrollment Period

1.1 years

First QC Date

August 26, 2020

Last Update Submit

October 5, 2021

Conditions

Complex Post-Traumatic Stress DisorderPost-traumatic Stress Disorder

Keywords

PTSDpsychotherapypsychodynamicLGBTQ

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 Outcomes (1)

  • Attrition from treatment by end of therapy duration (Week 12)

    Anytime between Baseline and Termination (Week 12)

Study Arms (1)

Trauma-focused psychodynamic psychotherapy

EXPERIMENTAL

Twice-weekly psychotherapy for 20-24 sessions.

Behavioral: Trauma-focused psychodynamic psychotherapy

Interventions

Trauma-focused psychodynamic psychotherapyBEHAVIORAL

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.

Also known as: TFPP
Trauma-focused psychodynamic psychotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10075, United States

Location

Related Publications (3)

  • 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.

    PMID: 32097526BACKGROUND

  • 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.

    PMID: 30786735BACKGROUND

  • 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.

    PMID: 29739526BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

2,2,3,3-tetrafluoroputrescine

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • John R Keefe, PhD

    Weill Medical College of Cornell University / NYP-Weill Cornell

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2020

First Posted

August 31, 2020

Study Start

August 12, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

October 7, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)