Post-Traumatic Stress Disorder Focused Psychodynamic Psychotherapy

NCT ID: NCT03755401

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-02

Study Completion Date

2027-05-31

Brief Summary

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This is a randomized controlled trial of Trauma-Focused Psychodynamic Psychotherapy (TFPP) in comparison with TAU (at the VA) in a 2:1 ratio in 75 Veterans with PTSD who have not responded to standard treatment at the VA.

Detailed Description

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Veterans with PTSD are a highly vulnerable population with tremendous disability and unmet needs. Few VA patients with PTSD now actually receive evidence-based psychotherapy because current exposure-based treatments have low uptake. The project goal is to expand the range of PTSD psychotherapy treatments available at Veterans Administration Medical Centers. This pilot trauma recovery proposal takes the next step in translating a brief efficacious psychotherapy developed and tested for panic disorder, Panic Focused Psychodynamic Psychotherapy (PFPP) for Veterans with PTSD at the VA New York Harbor Healthcare System (VA NYHHCS). PFPP was developed, manualized, and studied in RCTs over the past two decades. We hope that Trauma-Focused Psychodynamic Psychotherapy (TFPP), an adaptation of PFPP, with its high response rates in panic disorder with/without agoraphobia, and non-exposure protocol, will fill crucial gaps in Veteran care. A major challenge facing psychotherapy research is translating and implementing efficacious therapies to the community. No psychodynamic psychotherapy for anxiety or PTSD has achieved this in the US. This pilot RCT represents a paradigm shift in its approach to trauma. TFPP will be the only PTSD treatment for Veterans to incorporate Veterans' input into refinement of the treatment as this project progresses. TFPP targets aspects of traumatic experience and approaches Veterans' lives more broadly than the symptom-focused treatments the VA currently offers our traumatized Veterans.

Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial of psychosocial interventions
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
All assessments will be performed by blinded clinical assessors; randomization accomplished by computer algorhythm

Study Groups

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TFPP

TFPP is a manualized 16-24 session psychodynamic psychotherapy targeted on trauma symptoms of PTSD

Group Type EXPERIMENTAL

TFPP

Intervention Type OTHER

Trauma-Focused Psychodynamic Psychotherapy

TAU

TAU in this study is treatment for PTSD as currently delivered at the VA

Group Type ACTIVE_COMPARATOR

TAU

Intervention Type OTHER

treatment as usual at the VA for PTSD

Interventions

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TFPP

Trauma-Focused Psychodynamic Psychotherapy

Intervention Type OTHER

TAU

treatment as usual at the VA for PTSD

Intervention Type OTHER

Other Intervention Names

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psychodynamic psychotherapy

Eligibility Criteria

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Inclusion Criteria

* Reporting moderate PTSD, as defined by a CAPS score of \>40
* Have at least one of the following history with CPT and/or PE:

* offered and declined
* dropped out of treatment
* been determined unsuitable by their treatment team
* received treatment but continue to experience symptoms meeting entrance criteria.
* Require stabilization on psychiatric medication for 2 month period prior to entry into study to avoid confounding treatments

Exclusion Criteria

* Presence of SCID-5 assessed psychotic disorder, bipolar disorder, or substance use that would interfere with trial demands
* Severe suicidality that would require immediate crisis management
* Organic mental syndromes, delirium, or unstable medical conditions that would interfere with trial demands
* Inability to meet trial demands.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA New York Harbor Healthcare System

FED

Sponsor Role collaborator

Weill Medical College Clinical Science Translation Center

UNKNOWN

Sponsor Role collaborator

American Psychoanalytic Association (APsA)

UNKNOWN

Sponsor Role collaborator

International Psychoanalytic Association (IPA)

UNKNOWN

Sponsor Role collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara Milrod, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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VA New York Harbor Healthcare System - Manhattan Campus

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emily Villeveuve

Role: CONTACT

(212) 686-7500 ext. 3003

Cory K Chen, Ph.D.

Role: CONTACT

(212) 686-7500 ext. 4002

Facility Contacts

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Lauren Wash

Role: primary

212-686-7500 ext. 3003

Cory K Chen, Ph.D.

Role: backup

212-686-7500 ext. 4002

References

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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)

Kehn M, Milrod B, Chen CK. Clinical Case of Trauma-Focused Psychodynamic Psychotherapy for a Veteran With PTSD and Race-Based Trauma. Am J Psychother. 2024 Sep 1;77(3):146-150. doi: 10.1176/appi.psychotherapy.20230040. No abstract available.

Reference Type RESULT
PMID: 39277802 (View on PubMed)

Other Identifiers

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1UL1TR002384-02

Identifier Type: NIH

Identifier Source: secondary_id

1UL1TR002384

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2021-13720

Identifier Type: -

Identifier Source: org_study_id

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