Post-Traumatic Stress Disorder Focused Psychodynamic Psychotherapy (RCT of TFPP)

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.

Study Overview

• Status: Recruiting
• Conditions: PTSD
• Intervention / Treatment: Other: TFPP; Other: TAU

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cory K Chen, Ph.D.; Phone Number: 4002 (212) 686-7500; Email: Cory.Chen@va.gov
• Study Contact Backup: Name: Emily Villeveuve; Phone Number: 3003 (212) 686-7500; Email: Emily.Villeneuve@va.gov

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • Recruiting
      • VA New York Harbor Healthcare System - Manhattan Campus
      • Contact: Lauren Wash; Phone Number: 3003 212-686-7500; Email: Lauren.Wash@va.gov
      • Contact: Cory K Chen, Ph.D.; Phone Number: 4002 212-686-7500; Email: Cory.Chen@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TFPP; TFPP is a manualized 16-24 session psychodynamic psychotherapy targeted on trauma symptoms of PTSD	Other: TFPP; Trauma-Focused Psychodynamic Psychotherapy; Other Names: psychodynamic psychotherapy
Active Comparator: TAU; TAU in this study is treatment for PTSD as currently delivered at the VA	Other: TAU; treatment as usual at the VA for PTSD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline, 16 weeks (termination), 3 month follow-up
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.	baseline, 16 weeks (termination), 3 month follow-up
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)	baseline, 16 weeks (termination), 3 month follow-up
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.	baseline, 16 weeks (termination), 3 month follow-up
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.	baseline, 16 weeks (termination), 3 month follow-up
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	baseline, 16 weeks (termination), 3 month follow-up
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+	baseline
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.	baseline, 16 weeks (termination), 3 month follow-up
Assessment of life events on LEC.	Life Events Checklist (LEC). No composite score-tracks traumatic life events	baseline

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: National Center for Advancing Translational Sciences (NCATS); VA New York Harbor Healthcare System; Weill Medical College Clinical Science Translation Center; American Psychoanalytic Association (APsA); International Psychoanalytic Association (IPA)
• Investigators: Principal Investigator: Barbara Milrod, MD, Weill Medical College of Cornell University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2018
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: November 13, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: psychotherapy; psychodynamic psychotherapy
• Other Study ID Numbers: 2021-13720; 1UL1TR002384-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No