Recruiting

Psychodynamic Psychotherapy

Sponsor:

Montefiore Medical Center

Code:

NCT03755401

Conditions

PTSD

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

TFPP

TAU

Study Details

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.

Conditions

PTSD

Study ID

NCT03755401

Start date

Nov 2, 2018

Status verified date

Nov, 2025

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TFPP

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

active comparator: TAU

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

Interventions

TFPP

Trauma-Focused Psychodynamic Psychotherapy

TAU

treatment as usual at the VA for PTSD

Primary outcome measure

  • Change in PTSD symptoms as per DSM-5 as measured by CAPS-5 [ Time Frame: baseline, 16 weeks (termination), 3 month follow-up ]

Central Contacts and Locations

Central contacts

Emily Villeveuve

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

Cory K Chen, Ph.D.

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

Locations

VA New York Harbor Healthcare System - Manhattan Campus

Recruiting

New York, New York, United States, 10010

Contacts

Lauren Wash

212-686-7500Lauren.Wash@va.gov

Cory K Chen, Ph.D.

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

More Information

Sponsor

Montefiore Medical Center

Last update posted

Nov 6, 2025

Last verified

Nov, 2025

Keywords

  • psychotherapy
  • psychodynamic psychotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2025-11-06.