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Psychodynamic Psychotherapy

Psychodynamic Psychotherapy for PTSD (RCT of TFPP Trial)

N/A
Recruiting
Led By Barbara Milrod, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Reporting moderate PTSD, as defined by a CAPS score of >40
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 16 weeks (termination), 3 month follow-up
Awards & highlights

RCT of TFPP Trial Summary

This trial is testing a new type of therapy, Trauma-Focused Psychodynamic Psychotherapy (TFPP), to see if it helps Veterans with PTSD who have not responded to standard treatment.

Who is the study for?
This trial is for Veterans with moderate PTSD (CAPS score >40) who haven't improved after standard VA treatments. They must have stable psychiatric meds for 2 months and a history of not responding well to certain PTSD therapies. It's not for those with severe suicidality, psychosis, bipolar disorder, substance issues that affect participation, or unstable medical conditions.Check my eligibility
What is being tested?
The study tests Trauma-Focused Psychodynamic Psychotherapy (TFPP) against Treatment as Usual (TAU) at the VA in a randomized controlled setup. Of the 75 participants, two-thirds will receive TFPP and one-third TAU to see which helps more with PTSD symptoms.See study design
What are the potential side effects?
Since this trial involves psychotherapy rather than medication, side effects may include emotional discomfort due to discussing traumatic events but are generally considered low-risk compared to pharmacological interventions.

RCT of TFPP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have moderate PTSD with a CAPS score over 40.

RCT of TFPP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 16 weeks (termination), 3 month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 16 weeks (termination), 3 month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in PTSD symptoms as per DSM-5 as measured by CAPS-5
Secondary outcome measures
Assessment of life events on LEC.
Change in adult separation anxiety symptoms as measured by the SCI-SAS
Change in anxiety symptoms as measured by HARS.
+6 more

RCT of TFPP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TFPPExperimental Treatment1 Intervention
TFPP is a manualized 16-24 session psychodynamic psychotherapy targeted on trauma symptoms of PTSD
Group II: TAUActive Control1 Intervention
TAU in this study is treatment for PTSD as currently delivered at the VA

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,201 Total Patients Enrolled
International Psychoanalytic Association (IPA)UNKNOWN
National Center for Advancing Translational Sciences (NCATS)NIH
321 Previous Clinical Trials
401,674 Total Patients Enrolled

Media Library

Trauma-Focused Psychodynamic Psychotherapy (TFPP) (Psychodynamic Psychotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03755401 — N/A
Post-Traumatic Stress Disorder Research Study Groups: TAU, TFPP
Post-Traumatic Stress Disorder Clinical Trial 2023: Trauma-Focused Psychodynamic Psychotherapy (TFPP) Highlights & Side Effects. Trial Name: NCT03755401 — N/A
Trauma-Focused Psychodynamic Psychotherapy (TFPP) (Psychodynamic Psychotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03755401 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this trial open to geriatric individuals?

"The eligibility criteria for this trial requires that participants are no older than 70 and not younger than 18."

Answered by AI

How many participants are being included in this investigation?

"Affirmative. According to information posted on clinicaltrials.gov, recruitment for this trial is currently underway and began on November 2nd 2018 with an update occurring five years later in November of 2022. A total of 75 patients need to be enrolled from one location."

Answered by AI

Who meets the criteria to take part in this medical experiment?

"To take part in this trial, patients must be aged 18 to 70 and have a confirmed diagnosis of PTSD with a CAPS score over 40. Additionally, they must remain stable on their psychiatric medications for two months prior to enrolling as well as having previously declined or dropped out of treatment options."

Answered by AI

Is this medical experiment actively seeking volunteers?

"Affirmative. The information posted on clinicaltrials.gov suggests that this medical trial is open for recruitment, with its initial posting dated November 2nd 2018 and last update taking place on the 7th of November 2022. 75 individuals are needed from a single site to participate in the study."

Answered by AI

Who else is applying?

What site did they apply to?
VA New York Harbor Healthcare System - Manhattan Campus
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Just want some relief.
PatientReceived 2+ prior treatments
~8 spots leftby Jan 2025