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

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ClinicalTrials.gov Identifier: NCT03755401
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Collaborator:
VA New York Harbor Healthcare System
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
PTSD Other: TFPP Other: TAU Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial of psychosocial interventions
Masking: Single (Outcomes Assessor)
Masking Description: All assessments will be performed by blinded clinical assessors; randomization accomplished by computer algorhythm
Primary Purpose: Treatment
Official Title: A Pilot Randomized Controlled Trial of Trauma-Focused Psychodynamic Psychotherapy (TFPP) at the VA in Veterans With PTSD
Actual Study Start Date : November 2, 2018
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2022

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 Name: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 based on diagnosis or Montreal Cognitive Assessment (MoCA)<22, delirium, or unstable medical conditions that would interfere with trial demands
  • Inability to meet trial demands.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755401


Contacts
Contact: Lauren Wash (212) 686-7500 ext 3003 Lauren.Wash@va.gov
Contact: Cory K Chen, Ph.D. (212) 686-7500 ext 4002 Cory.Chen@va.gov

Locations
United States, New York
VA New York Harbor Healthcare System - Manhattan Campus Recruiting
New York, New York, United States, 10010
Contact: Lauren Wash    212-686-7500 ext 3003    Lauren.Wash@va.gov   
Contact: Cory K Chen, Ph.D.    212-686-7500 ext 4002    Cory.Chen@va.gov   
Sponsors and Collaborators
Weill Medical College of Cornell University
VA New York Harbor Healthcare System
Investigators
Principal Investigator: Barbara Milrod, MD Weill Medical College of Cornell University

Publications:
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03755401     History of Changes
Other Study ID Numbers: 1UL1TR002384-02 ( U.S. NIH Grant/Contract )
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Weill Medical College of Cornell University:
psychotherapy
psychodynamic psychotherapy