Trauma-focused Psychotherapy for PTSD and HIV

(TFPP-PLWH Trial)

Recruiting at 1 trial location

Overseen By Barbara L Milrod, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Must be taking: Psychotropic medications

Disqualifiers: Psychosis, Bipolar I, Substance use, others

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

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy for individuals with both HIV and PTSD, a condition where past trauma affects daily life. The researchers aim to determine if trauma-focused psychodynamic psychotherapy, a type of talk therapy that emphasizes emotions and relationships, can improve PTSD symptoms and related health issues in people with HIV. Participants will attend therapy sessions twice a week, totaling 24 sessions. This trial may suit those diagnosed with both HIV and PTSD who have been on stable mental health medication for at least two months. As an unphased trial, it offers a unique opportunity to explore innovative therapy options that could enhance mental health and overall well-being.

Will I have to stop taking my current medications?

The trial requires that you stay on your current psychiatric or psychotropic medications if they have been stable for at least 2 months.

What prior data suggests that this psychotherapy is safe for people living with HIV and PTSD?

Research has shown that trauma-focused psychodynamic psychotherapy (TFPP) effectively treats PTSD in various groups, such as veterans and LGBTQ individuals. Studies indicate that people generally tolerate this therapy well. While all therapies can have side effects, TFPP tends to cause fewer negative reactions compared to some other PTSD treatments, meaning people usually handle it without many problems.

Although detailed information on specific side effects for TFPP is limited, its use across different groups suggests safety. As a therapy rather than a medication, it avoids typical drug side effects. The focus on talking through trauma has shown positive results with minimal risk.

For those considering joining a trial for this therapy, research suggests it is a safe option. However, discussing any concerns with the study team before participating is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for PTSD and HIV, which often involve medication or cognitive-behavioral therapy, trauma-focused psychodynamic psychotherapy delves into the deep-rooted emotional conflicts stemming from past trauma. This twice-weekly therapy over 24 sessions aims to address the unconscious processes influencing a person's behavior and emotions. Researchers are excited about this treatment because it offers a potentially transformative approach by helping patients understand and resolve the underlying emotional issues linked to their trauma, which could lead to more enduring relief from PTSD symptoms.

What evidence suggests that trauma-focused psychodynamic psychotherapy might be an effective treatment for PTSD in people living with HIV?

Research has shown that trauma-focused psychodynamic psychotherapy (TFPP), which participants in this trial will receive, can help treat PTSD. For instance, one case study showed a 33-year-old veteran improved significantly after 16 sessions of TFPP. Reviews of multiple studies also suggest that trauma-focused therapies, like TFPP, lead to similar positive results for adults with PTSD. Traditional PTSD treatments might not always be easy for everyone to handle, but TFPP focuses on understanding emotions and relationships affected by trauma. This approach could be especially helpful for people living with both HIV and PTSD, as it addresses their unique challenges. ^{1 2 3 4 6}

Who Is on the Research Team?

Barbara Milrod, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for people living with HIV who also have PTSD. Participants must have a confirmed diagnosis of PTSD with a certain severity score and be on stable psychiatric medication for at least two months, which will continue during the study.

Inclusion Criteria

I have been diagnosed with HIV.

My mental health medication has been stable for 2 months and will continue.

I have been diagnosed with PTSD and my severity score is 25 or higher.

Exclusion Criteria

Acute suicidality

Current substance use disorder

Organic mental syndrome or intellectual disability

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 twice-weekly for 24 sessions

12 weeks

24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Trauma-focused psychodynamic psychotherapy

Trial Overview The trial is testing trauma-focused psychodynamic psychotherapy, a type of therapy that helps patients reflect on emotions and relationships affected by trauma without directly exposing them to traumatic memories.

How Is the Trial Designed?

Group I: Trauma-focused psychodynamic psychotherapy Experimental Treatment 1 Intervention

Twice-weekly psychotherapy for 24 sessions

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

American Psychoanalytic Association

Collaborator

Trials

1

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

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]

Trauma-focused treatments (TFTs), particularly Eye Movement Desensitization and Reprocessing (EMDR), have shown a large effect size (d = 1.17) in reducing depressive symptoms in individuals whose primary concern is depression, based on a systematic review of 11 randomized controlled trials involving 567 participants.

EMDR was found to be more effective than non-trauma-focused cognitive behavioral therapy (CBT) and demonstrated sustained benefits at follow-up, indicating its potential as a strong treatment option for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused treatments for depression. A systematic review and meta-analysis. Dominguez, SK., Matthijssen, SJMA., Lee, CW.[2021]

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]

Trauma-focused cognitive behavioral therapy (Tf-CBT) significantly reduced posttraumatic stress symptoms in children and adolescents compared to a waiting list control, as shown by a decrease in CAPS-CA scores over 4 months in a study involving 159 participants.

Younger patients and those with fewer comorbid disorders responded better to Tf-CBT, indicating that age and the presence of other mental health issues are important factors in treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Trauma-Focused Cognitive Behavioral Therapy for Children and Adolescents: A Randomized Controlled Trial in Eight German Mental Health Clinics. Goldbeck, L., Muche, R., Sachser, C., et al.[2022]

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 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]

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]

The review identified two effective cognitive-behavioral therapy-based interventions specifically for treating PTSD symptoms in HIV-infected adults, highlighting a significant gap in available treatments for this population.

The authors propose that future research should adapt successful PTSD interventions from the general population to better meet the needs of HIV-infected individuals, aiming to expand the range of effective therapies available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Future directions for interventions targeting PTSD in HIV-infected adults. Applebaum, AJ., Bedoya, CA., Hendriksen, ES., et al.[2018]

Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) is a highly effective treatment for reducing posttraumatic stress symptoms in children, supported by high-level evidence from ten randomized controlled trials (RCTs).

While TF-CBT shows promise in addressing trauma-related symptoms, its effectiveness in reducing behavioral problems and depression symptoms remains less certain, highlighting the need for further research to optimize its application across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused cognitive-behavioral therapy for children and adolescents: assessing the evidence. de Arellano, MA., Lyman, DR., Jobe-Shields, L., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-stress-disorders-traumatic-7-2023-519ea

Trauma-focused Psychotherapy for PTSD and HIV 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05929911?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(PTSD%20OR%20post%20traumatic%20stress%20disorder%20OR%20post%20traumatic%20neuroses%20OR%20traumatic%20stress%20disorders%20OR%20combat%20disorders%20OR%20combat%20fatigue%20OR%20disaster%20survivor%20OR%20emotional%20trauma%20OR%20psychological%20shock)%20AND%20AREA%5BOverallStatus%5D(RECRUITING%20OR%20NOT_YET_RECRUITING%20OR%20AVAILABLE)%20AND%20AREA%5BFunderTypeSearch%5D(NIH)))&rank=8

Open Trial of Trauma -focused Psychodynamic ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

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

A Meta-Analysis of Interpersonal and Psychodynamic ... Currently validated psychotherapies for posttraumatic stress disorder (PTSD) have partial efficacy and, sometimes, poor tolerability (1). In the ...

4. 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.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/acps.13366

Trauma‐focused psychotherapies for post‐traumatic stress ... Meta-analytic reviews suggest similar outcomes across trauma-focused psychotherapies for adults with post-traumatic stress disorder (PTSD).

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03755401

Post-Traumatic Stress Disorder Focused Psychodynamic ... 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 ...