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PTSDRCT of TFPPNCT03755401

Post-Traumatic Stress Disorder Focused Psychodynamic Psychotherapy

A study testing TFPP and TAU in people with PTSD, run by Montefiore Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
PTSD
What is being tested?
TFPP and TAU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteUnited States
Study dates
2 Nov 2018to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emily Villeveuve contact

(212) 686-7500 ext. 3003

Emily.Villeneuve@va.gov

Cory K Chen, Ph.D. contact

(212) 686-7500 ext. 4002

Cory.Chen@va.gov

United States1 site, 1 recruiting

  • VA New York Harbor Healthcare System - Manhattan Campus

    New York, New York, 10010

    Lauren Wash, 212-686-7500 ext. 3003, Lauren.Wash@va.gov

    Cory K Chen, Ph.D., 212-686-7500 ext. 4002, Cory.Chen@va.gov

    Recruiting

Other trials in United States

About this study

Official title: A Pilot Randomized Controlled Trial of Trauma-Focused Psychodynamic Psychotherapy (TFPP) at the VA in Veterans With PTSD

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.

Read the detailed description

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
PTSD
Being tested
TFPP, TAU
Keywords
psychotherapy, psychodynamic psychotherapy
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TFPPOther

    Also called psychodynamic psychotherapy

    Trauma-Focused Psychodynamic Psychotherapy

  • TAUOther

    treatment as usual at the VA for PTSD

Study groups in NCT03755401
Study groupRoleWhat they receive
TFPPExperimentalTFPP is a manualized 16-24 session psychodynamic psychotherapy targeted on trauma symptoms of PTSD
Receives: Other: TFPP
TAUActive comparatorTAU in this study is treatment for PTSD as currently delivered at the VA
Receives: Other: TAU

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (9)

  1. Change in anxiety symptoms as measured by HARS.

    Hamilton Anxiety Rating Scale (HARS). Low score indicates fewer state anxiety symptoms, high score indicates greater state anxiety symptoms

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

  2. Change in reflective capacity as measured by RF score.

    Reflective Function Scale (RF). Low score indicates poor ability to reflect on relationships and self, high score, indicates better capacity to reflect on others and self.

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

  3. Change in depression symptoms as measured by HDRS.

    Hamilton Depression Rating Scale (HDRS). Low score indicates few depressive symptoms, high score indicates high level of depressive burden (depression)

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

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

    Veterans RAND 12-Item Health Survey (VR-12). The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Therefore, each increment of 10 points above or below 50 corresponds to one standard deviation away from the population average.

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

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

    Work and Social Adjustment Scale (WSAS). Low score indicates good social and work adjustment, high score indicates impairment socially and at work.

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

  6. Change in degree of limitation in ability to work as measured by WLQ

    Work Limitations Questionnaire (WLQ). Low score indicates few limitations at work, high score indicates many limitations at work

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

  7. Childhood abuse history and trauma with CTQ

    Childhood Trauma Questionnaire (CTQ). Several different domains: Emotional Abuse: None=5-8; Low=9-12; Moderate=13-15; Severe=16+ Physical Abuse: None=5-7; Low=8-9; Moderate=10-12; Severe=13+ Sexual Abuse: None=5; Low=6-7; Moderate=8-12; Severe=13+ Emotional Neglect: None=5-9; Low=10-14; Moderate=15-17; Severe=18+ Physical Neglect: None=5-7; Low=8-9; Moderate=10-12; Severe=13+

    Measured: baseline

  8. Change in adult separation anxiety symptoms as measured by the SCI-SAS

    Separation anxiety-child and adult measure rating scale (SCI-SAS). Separate scores generated for childhood separation anxiety and adult separation anxiety. Low scores indicate few separation anxiety symptoms, high scores indicate large separation anxiety burden.

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

  9. Assessment of life events on LEC.

    Life Events Checklist (LEC). No composite score-tracks traumatic life events

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2018
  2. Study start2 Nov 2018
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial of psychosocial interventions
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03755401
Sponsor's protocol ID
2021-13720
Other IDs
1UL1TR002384-02, 1UL1TR002384
Acronym
RCT of TFPP
Status last verified
Nov 2025
First submitted
13 Nov 2018
Last updated
6 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29739526

  • 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.

    PubMed 39277802

Questions about this trial

What is this clinical trial studying?

A study testing TFPP and TAU in people with PTSD, run by Montefiore Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emily Villeveuve ((212) 686-7500 ext. 3003, Emily.Villeneuve@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03755401, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.

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