Psychodynamic Psychotherapy for PTSD

(RCT of TFPP Trial)

Overseen By Emily Villeveuve

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Must be taking: Psychiatric medications

Disqualifiers: Psychotic disorder, Bipolar, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 16 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called Trauma-Focused Psychodynamic Psychotherapy (TFPP) for veterans with PTSD who haven't improved with standard treatments at the VA. TFPP is a specialized talk therapy that addresses trauma symptoms. The trial compares TFPP to regular care at the VA to determine which is more effective. Veterans with moderate PTSD symptoms, despite trying other treatments like Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE), might be suitable candidates for this trial. As an unphased trial, it offers veterans a unique opportunity to explore a new therapy option that could potentially improve their PTSD symptoms.

Will I have to stop taking my current medications?

The trial requires participants to be stable on their psychiatric medications for at least 2 months before joining, so you should not stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Trauma-Focused Psychodynamic Psychotherapy (TFPP) is generally well-received by patients. One study found that 86% of participants completed the therapy, indicating its manageability for most people. This therapy addresses current PTSD symptoms rather than revisiting past traumatic events, which may make it easier for some compared to treatments that directly explore past trauma. Although TFPP has not been studied as extensively as treatments like Prolonged Exposure or Cognitive Processing Therapy, early results are promising regarding safety and patient tolerance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Trauma-Focused Psychodynamic Psychotherapy (TFPP) for PTSD because it offers a distinct approach compared to the standard cognitive-behavioral therapies. TFPP specifically targets trauma symptoms through a psychodynamic method, which delves into the underlying emotional conflicts and past experiences contributing to PTSD. This approach can be particularly beneficial for individuals who haven't fully responded to more conventional treatments like Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE). By focusing on the emotional and psychological roots of trauma, TFPP has the potential to offer deeper, more sustained healing for people with PTSD.

What evidence suggests that Trauma-Focused Psychodynamic Psychotherapy might be an effective treatment for PTSD?

This trial will compare Trauma-Focused Psychodynamic Psychotherapy (TFPP) with Treatment as Usual (TAU) for PTSD. Research has shown that TFPP can help reduce PTSD symptoms. One study found that TFPP significantly improved symptoms of PTSD, anxiety, and depression. Another study demonstrated that long-term psychodynamic therapy positively affected PTSD symptoms. Overall, TFPP appears promising for individuals who haven't found relief with other treatments. ^{2 6 7 8 9}

Who Is on the Research Team?

Barbara L Milrod, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have moderate PTSD with a CAPS score over 40.

I have been stable on my psychiatric medication for at least 2 months.

I have tried or was deemed unsuitable for CPT/PE therapy but still have symptoms.

Exclusion Criteria

You have very strong suicidal thoughts that need immediate attention and help.

I am able to participate in all required trial activities.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Trauma-Focused Psychodynamic Psychotherapy (TFPP) or Treatment as Usual (TAU) for PTSD

16 weeks

16-24 sessions (in-person)

Follow-up

Participants are monitored for changes in PTSD symptoms and other psychological measures

3 months

What Are the Treatments Tested in This Trial?

Interventions

• TAU
• Trauma-Focused Psychodynamic Psychotherapy (TFPP)

Trial Overview 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.

How Is the Trial Designed?

Group I: TFPP Experimental Treatment 1 Intervention

TFPP is a manualized 16-24 session psychodynamic psychotherapy targeted on trauma symptoms of PTSD

Group II: TAU Active Control 1 Intervention

TAU in this study is treatment for PTSD as currently delivered at the VA

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

International Psychoanalytic Association (IPA)

Collaborator

Trials

1

Recruited

80+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Weill Medical College Clinical Science Translation Center

Collaborator

Trials

1

Recruited

80+

American Psychoanalytic Association (APsA)

Collaborator

Trials

1

Recruited

80+

International Psychoanalytic Association

Collaborator

Trials

1

Recruited

80+

VA New York Harbor Healthcare System

Collaborator

Trials

25

Recruited

14,400+

CTSC

Collaborator

Trials

1

Recruited

80+

American Psychoanalytic Association Fund for Psychoanalytic Research

Collaborator

Trials

1

Recruited

80+

Published Research Related to This Trial

Trauma-focused cognitive behavioral therapy (Tf-CBT) is an effective treatment for children and adolescents aged 3-17 with posttraumatic stress disorder (PTSD), supported by 13 randomized controlled trials and recognized as a first-line treatment in international guidelines.

Tf-CBT includes eight key components that help children process trauma and develop coping skills, making it a comprehensive approach that involves both the child and a supportive caregiver in the therapeutic process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Trauma-focused Cognitive-behavioral Therapy with children and adolescents: Practice, evidence base, and future directions]. Sachser, C., Rassenhofer, M., Goldbeck, L.[2018]

Trauma-focused psychodynamic psychotherapy (TFPP) was effectively used to treat a 33-year-old U.S. Army veteran with PTSD, involving 16 sessions over 5.5 months, leading to significant improvements in PTSD and panic disorder symptoms.

Three months after therapy ended, the patient maintained much of the improvement, suggesting that TFPP could be a promising treatment option for veterans with PTSD in VA settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-Focused Psychodynamic Psychotherapy of a Patient With PTSD in a Veterans Affairs Setting. Busch, FN., Nehrig, N., Milrod, B.[2019]

Trauma-focused psychodynamic psychotherapy (TFPP) was well tolerated by LGBTQ patients with PTSD, with 86% of the 14 participants completing the 24-session treatment, and significant improvements in PTSD symptoms were observed, including a mean decrease of 21.8 points on the CAPS-5 scale.

The treatment led to a 71% clinical response rate and 50% diagnostic remission, with additional improvements in complex PTSD symptoms, anxiety, depression, and psychosocial functioning, indicating TFPP's effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open Trial of Trauma-Focused Psychodynamic Psychotherapy for Posttraumatic Stress Disorder Among LGBTQ Individuals. Keefe, JR., Louka, C., Moreno, A., et al.[2023]

Transference-focused psychotherapy (TFP) is an effective treatment for severe personality disorders that can be applied in various clinical settings, even by residents without extensive psychodynamic training.

Residents report that TFP provides a useful framework for understanding and treating personality pathology, making it enjoyable and easy to implement in both long-term and acute care situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transference-focused psychotherapy in the general psychiatry residency: a useful and applicable model for residents in acute clinical settings. Zerbo, E., Cohen, S., Bielska, W., et al.[2019]

Psychodynamic psychotherapy can be effectively integrated with other treatment approaches for PTSD, as demonstrated through the author's work with a patient who experienced multiple terrorist attacks.

The author utilized an assimilative integration model, which combines different therapeutic interventions, to enhance the effectiveness of psychodynamic therapy, highlighting its specific contributions in treating PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The place of psychodynamic psychotherapy in the integrated treatment of posttraumatic stress disorder and trauma recovery. Moss, E.[2011]

Trauma-focused psychotherapy (TF-P) significantly reduced PTSD symptoms, depressive symptoms, and functional impairment in patients with complex post-traumatic stress disorder (CPTSD) compared to those who only received stabilization and waiting, based on a study of 59 patients over a 3-year period.

The study found no significant differences in outcomes between the specific types of TF-P treatments (like TF-CBT or EMDR), indicating that the overall approach of TF-P is effective regardless of the specific method used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of trauma-focused psychotherapy for complex post-traumatic stress disorder: A retrospective study. Melegkovits, E., Blumberg, J., Dixon, E., et al.[2023]

Trauma-focused psychodynamic psychotherapy effectively addresses PTSD by exploring the psychological meanings behind symptoms and their connections to traumatic events, helping patients regain narrative coherence.

The therapy utilizes the therapeutic relationship to work through feelings of mistrust, authority issues, and intense emotions, providing a structured approach to understanding and managing PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-Focused Psychodynamic Psychotherapy. Busch, FN., Milrod, BL.[2019]

Transference-focused psychotherapy (TFP) is a structured psychodynamic therapy specifically designed for patients with personality disorders, combining empirical research with psychoanalytic techniques.

The training and supervision of TFP emphasize a systematic approach, allowing therapists to effectively apply its principles while maintaining the depth of psychoanalytic exploration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of Transference-Focused Psychotherapy and Its Model of Supervision. Yeomans, F., Caligor, E., Diamond, D.[2023]

In a study of 1,861 children with PTSD, those who received trauma-focused cognitive-behavioral therapy (TF-CBT) showed significantly greater improvements in problem severity and functioning compared to those receiving other usual care treatments, with an effect size of 0.21-0.24.

Approximately one-third of the children received TF-CBT, and factors such as experiencing sexual victimization and being non-Hispanic White were associated with a higher likelihood of receiving this specific treatment, highlighting the importance of targeted interventions for different demographics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing trauma-focused cognitive-behavioral therapy to commonly used treatments in usual care for children with posttraumatic stress disorder. Lee, P., Lang, JM.[2023]

A mobile phone-delivered serious game designed to enhance trauma-focused cognitive behavioral therapy (TF-CBT) for PTSD was found to be acceptable to both patients and clinicians, indicating potential for improved treatment engagement.

Both service users and clinicians suggested that the game should be therapist-guided and acknowledged that it may not be suitable for all patients, emphasizing the need for careful prescription by clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a Plasticity-Focused Serious Game Intervention for Posttraumatic Stress Disorder: User Requirements Analysis. Jones, M., Denisova, A., Mitchell, S., et al.[2020]

Citations

1. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.psychotherapy.20230043

A Meta-Analysis of Interpersonal and Psychodynamic ... Established trauma-focused cognitive-behavioral therapies for posttraumatic stress disorder (PTSD) have remission rates of approximately ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6099301/

First‐line therapy for post‐traumatic stress disorder Britvić et al. (2006) found long‐term group PDT had significant positive effects on reducing symptoms of PTSD, while Kellett and Beail (1997) reported that ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04532996

Trauma-focused Psychodynamic Psychotherapy for LGBT ... The purpose of this study is: (a) to preliminarily characterize PTSD within an LGBT sample; and (b) to test out the preliminary effects and acceptability of a ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8311818/

Long-term outcomes of psychological treatment for ... Trauma-focused treatment (TFT) and non-TFT showed large improvements from pretest to follow-up, and effect sizes did not significantly differ from each other.

5. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.psychotherapy.20220037

Open Trial of Trauma-Focused Psychodynamic ... Patients generally experienced significant, concomitant improvements in complex PTSD symptoms, general anxiety, depression, and psychosocial ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29739526/

Trauma-Focused Psychodynamic Psychotherapy - PubMed The authors describe a psychodynamic psychotherapeutic approach to posttraumatic stress disorder (PTSD), trauma-focused psychodynamic psychotherapy.

7. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.psychotherapy.20230040

Clinical Case of Trauma-Focused Psychodynamic ... TFPP offers an alternative to exposure-based treatments by focusing on exploring a patient's current PTSD symptoms, in contrast to focusing on traumatic events.

8. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/overview_therapy.asp

Overview of Psychotherapy for PTSD Overall, PE, CPT and EMDR are the most highly recommended treatments for PTSD and have strong evidence bases.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37203147/

Open Trial of Trauma-Focused Psychodynamic ... Results: TFPP was well tolerated by patients, with 12 (86%) completing the intervention. CAPS-5-measured PTSD symptoms, including dissociation, ...