What side effects are associated with this type of intervention?

Common treatments for PTSD, such as Trauma-Focused Psychodynamic Psychotherapy (TFPP), can cause emotional distress as patients confront traumatic memories. Cognitive Behavioral Therapy (CBT) and exposure therapy may also lead to increased anxiety during sessions. Pharmacological treatments, including SSRIs like sertraline, can cause nausea, insomnia, sexual dysfunction, and increased anxiety. Mood stabilizers and antipsychotics, used for affective dysregulation, may result in weight gain, metabolic changes, and sedation.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Post-Traumatic Stress Disorder (PTSD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications help alleviate symptoms by addressing the underlying neurochemical imbalances associated with PTSD. Additionally, serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine have shown efficacy in treating PTSD symptoms. While second-generation antipsychotics (SGAs) and prazosin are used off-label to manage specific symptoms like psychosis and sleep disturbances, they are not FDA-approved for PTSD. These pharmacological treatments are often used in combination with psychotherapies, such as Trauma-Focused Psychodynamic Psychotherapy, to address the underlying psychological conflicts and trauma.

What other types of research exist?

Promising novel alternatives to Trauma-Focused Psychodynamic Psychotherapy for PTSD patients include: 1) Accelerated Resolution Therapy (ART), which is effective in treating acute stress reactions and preventing PTSD progression in military settings. 2) Psilocybin-assisted psychotherapy, which has shown efficacy in treatment-resistant depression and psychiatric distress. 3) Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), particularly effective in children and adolescents, and adaptable for telehealth delivery. 4) Eye Movement Desensitization and Reprocessing (EMDR), which incorporates saccadic eye movements and has shown mixed but promising results in children. 5) MDMA-assisted psychotherapy, which is under expanded access by the FDA for PTSD treatment.

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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

Must not have

Organic mental syndromes, delirium, or unstable medical conditions that would interfere with trial demands

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 16 weeks (termination), 3 month follow-up

Awards & highlights

Summary

This trial tests a new talk therapy called TFPP for veterans with PTSD who haven't been helped by current treatments. TFPP helps veterans understand and process their trauma through structured conversations, aiming to improve their overall mental health.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have moderate PTSD with a CAPS score over 40.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any mental or unstable health conditions that would affect my participation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 16 weeks (termination), 3 month follow-up

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in PTSD symptoms as per DSM-5 as measured by CAPS-5

Secondary study objectives

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

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Post-Traumatic Stress Disorder (PTSD) include Trauma-Focused Psychodynamic Psychotherapy (TFPP), trauma-focused cognitive-behavioral therapy (TF-CBT), and exposure therapy. TFPP works by addressing underlying psychological conflicts and trauma, helping patients process and integrate traumatic experiences. TF-CBT combines cognitive restructuring with exposure techniques to help patients confront and reframe traumatic memories, reducing their emotional impact. Exposure therapy involves repeated, controlled exposure to trauma-related cues to desensitize patients and reduce avoidance behaviors. These treatments are crucial for PTSD patients as they target the root causes of symptoms, promote emotional processing, and improve coping mechanisms, leading to significant symptom reduction and improved quality of life.

The Effectiveness of Trauma-Focused Psychodrama in the Treatment of PTSD in Inpatient Substance Abuse Treatment.