NCT03755401 · Montefiore Medical Center
Post-Traumatic Stress Disorder Focused Psychodynamic Psychotherapy
(RCT of TFPP)
What this study is about
This is a randomly assigned 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.
View original scientific description
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.
Interventions
OTHER
TFPP
Trauma-Focused Psychodynamic Psychotherapy
OTHER
TAU
treatment as usual at the VA for PTSD
Primary outcome measures
Change in PTSD symptoms as per DSM-5 as measured by CAPS-5
Time frame: baseline, 16 weeks (termination), 3 month follow-up
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Low score indicates fewer PTSD symptoms, high score indicates more PTSD symptoms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New York, New York
Collaborators
VA New York Harbor Healthcare System, Weill Medical College Clinical Science Translation Center, American Psychoanalytic Association (APsA), International Psychoanalytic Association (IPA), National Center for Advancing Translational Sciences (NCATS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 6, 2025 · Source of record for eligibility and locations