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

Montefiore Medicine Academic Health System

Status: Enrolling

Conditions: PTSD

Treatments: Other: TAU; Other: TFPP

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT03755401

2021-13720

1UL1TR002384-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

75 participants in 2 patient groups

TFPP

Experimental group

Description:

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

Treatment:

Other: TFPP

TAU

Active Comparator group

Description:

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

Treatment:

Other: TAU