Post-Traumatic Stress Disorder Focused Psychodynamic Psychotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TFPP, TAU.
- Who it may be relevant to
- Registry conditions: PTSD. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Randomized Controlled Trial of Trauma-Focused Psychodynamic Psychotherapy (TFPP) at the VA in Veterans With PTSD
Overview
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.
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.
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]
Secondary outcome measures (9)
- Change in anxiety symptoms as measured by HARS. [Time frame: baseline, 16 weeks (termination), 3 month follow-up]
- Change in reflective capacity as measured by RF score. [Time frame: baseline, 16 weeks (termination), 3 month follow-up]
- Change in depression symptoms as measured by HDRS. [Time frame: baseline, 16 weeks (termination), 3 month follow-up]
- Change in mental and physical symptoms as measured by VR-12. [Time frame: baseline, 16 weeks (termination), 3 month follow-up]
- Change in work and social adjustment as measured by WSAS. [Time frame: baseline, 16 weeks (termination), 3 month follow-up]
- Change in degree of limitation in ability to work as measured by WLQ [Time frame: baseline, 16 weeks (termination), 3 month follow-up]
- Childhood abuse history and trauma with CTQ [Time frame: baseline]
- Change in adult separation anxiety symptoms as measured by the SCI-SAS [Time frame: baseline, 16 weeks (termination), 3 month follow-up]
- Assessment of life events on LEC. [Time frame: baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- VA New York Harbor Healthcare System - Manhattan Campus — New York
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. PMID 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. PMID 39277802
Identifiers
NCT: NCT03755401 · 2021-13720 · 1UL1TR002384-02 · 1UL1TR002384