Clinical trial NCT03755401: Post-Traumatic Stress Disorder Focused Psychodynamic Psychotherapy
Official title: A Pilot Randomized Controlled Trial of Trauma-Focused Psychodynamic Psychotherapy (TFPP) at the VA in Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Keywords: psychotherapy
psychodynamic psychotherapy
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: VA New York Harbor Healthcare System
name: Weill Medical College Clinical Science Translation Center
name: American Psychoanalytic Association (APsA)
name: International Psychoanalytic Association (IPA)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2018-11-28
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial of psychosocial interventions
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Change in PTSD symptoms as per DSM-5 as measured by CAPS-5
timeFrame: baseline, 16 weeks (termination), 3 month follow-up
Secondary outcomes:
measure: Change in anxiety symptoms as measured by HARS.
timeFrame: baseline, 16 weeks (termination), 3 month follow-up
measure: Change in reflective capacity as measured by RF score.
timeFrame: baseline, 16 weeks (termination), 3 month follow-up
measure: Change in depression symptoms as measured by HDRS.
timeFrame: baseline, 16 weeks (termination), 3 month follow-up
measure: Change in mental and physical symptoms as measured by VR-12.
timeFrame: baseline, 16 weeks (termination), 3 month follow-up
measure: Change in work and social adjustment as measured by WSAS.
timeFrame: baseline, 16 weeks (termination), 3 month follow-up
measure: Change in degree of limitation in ability to work as measured by WLQ
timeFrame: baseline, 16 weeks (termination), 3 month follow-up
measure: Childhood abuse history and trauma with CTQ
timeFrame: baseline
measure: Change in adult separation anxiety symptoms as measured by the SCI-SAS
timeFrame: baseline, 16 weeks (termination), 3 month follow-up
measure: Assessment of life events on LEC.
timeFrame: baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: VA New York Harbor Healthcare System - Manhattan Campus
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Barbara Milrod, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.