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NCT Number: NCT03755401

Post-Traumatic Stress Disorder Focused Psychodynamic Psychotherapy

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.

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TFPP

Other

Trauma-Focused Psychodynamic Psychotherapy

Other names: psychodynamic psychotherapy

TAU

Other

treatment as usual at the VA for PTSD

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in anxiety symptoms as measured by HARS.

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

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

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

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

    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.

  3. Change in depression symptoms as measured by HDRS.

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

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

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

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

    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.

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

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

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

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

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

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

  7. Childhood abuse history and trauma with CTQ

    Time frame: baseline

    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+

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

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

    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.

  9. Assessment of life events on LEC.

    Time frame: baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Cory K Chen, Ph.D.

CONTACT

[email protected]

(212) 686-7500 ext. 4002

Emily Villeveuve

CONTACT

[email protected]

(212) 686-7500 ext. 3003

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • American Psychoanalytic Association (APsA)
  • International Psychoanalytic Association (IPA)
  • National Center for Advancing Translational Sciences (NCATS)
  • VA New York Harbor Healthcare System
  • Weill Medical College Clinical Science Translation Center

Registry information

Official study title

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

Acronym: RCT of TFPP

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Nov 28, 2018
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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