NCT03755401

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress88%
Nov 2018May 2027

Study Start

First participant enrolled

November 2, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

November 6, 2025

Status Verified

November 1, 2025

Enrollment Period

8.5 years

First QC Date

November 13, 2018

Last Update Submit

November 5, 2025

Conditions

PTSD

Keywords

psychotherapypsychodynamic psychotherapy

Outcome Measures

Primary Outcomes (1)

  • Change in PTSD symptoms as per DSM-5 as measured by CAPS-5

    Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Low score indicates fewer PTSD symptoms, high score indicates more PTSD symptoms.

    baseline, 16 weeks (termination), 3 month follow-up

Secondary Outcomes (9)

  • Change in anxiety symptoms as measured by HARS.

    baseline, 16 weeks (termination), 3 month follow-up

  • Change in reflective capacity as measured by RF score.

    baseline, 16 weeks (termination), 3 month follow-up

  • Change in depression symptoms as measured by HDRS.

    baseline, 16 weeks (termination), 3 month follow-up

  • Change in mental and physical symptoms as measured by VR-12.

    baseline, 16 weeks (termination), 3 month follow-up

  • Change in work and social adjustment as measured by WSAS.

    baseline, 16 weeks (termination), 3 month follow-up

  • +4 more secondary outcomes

Study Arms (2)

TFPP

EXPERIMENTAL

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

Other: TFPP

TAU

ACTIVE COMPARATOR

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

Other: TAU

Interventions

TFPPOTHER

Trauma-Focused Psychodynamic Psychotherapy

Also known as: psychodynamic psychotherapy
TFPP
TAUOTHER

treatment as usual at the VA for PTSD

TAU

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA New York Harbor Healthcare System - Manhattan Campus

New York, New York, 10010, United States

RECRUITING

Related Publications (2)

  • 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

  • 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.

    PMID: 39277802RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

2,2,3,3-tetrafluoroputrescinePsychotherapy, Psychodynamic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Barbara Milrod, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Villeveuve

CONTACT

(212) 686-7500Emily.Villeneuve@va.gov

Cory K Chen, Ph.D.

CONTACT

(212) 686-7500Cory.Chen@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All assessments will be performed by blinded clinical assessors; randomization accomplished by computer algorhythm
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial of psychosocial interventions
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2018

First Posted

November 28, 2018

Study Start

November 2, 2018

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

November 6, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)