Trauma-focused Psychotherapy for PTSD and HIV

(TFPP-PLWH Trial)

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

Trial Summary

What is the purpose of this trial?

People living with HIV (PLWH) have a higher rate of post-traumatic stress disorder (PTSD) diagnosis than the general population. Comorbid PTSD is also associated with negative HIV-related health outcomes. Unfortunately, little outcome research has examined the usefulness of PTSD treatments for PTSD. This pilot study adapts for PLWH a non-exposure based psychotherapy for PTSD focused on reflecting on one's emotions and relationships and understanding and working through how trauma may have disrupted them. The study team is interested in better understanding the needs of PLWH with PTSD, learning whether PLWH with PTSD find this treatment acceptable and helpful, and beginning to understand the relationship between HIV-related health factors (e.g., inflammation and stress biology) and PTSD, and how these health factors may improve during treatment.

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 data supports the effectiveness of the treatment Trauma-focused psychodynamic psychotherapy (TFPP) for PTSD and HIV?

Research shows that Trauma-focused psychodynamic psychotherapy (TFPP) has been used effectively for PTSD in various populations, including veterans and LGBTQ individuals, by addressing emotional and psychological impacts of trauma. While specific studies on TFPP for PTSD and HIV are not available, its success in treating PTSD in other groups suggests potential benefits. ^{1 2 3 4 5}

Is trauma-focused psychodynamic psychotherapy (TFPP) safe for humans?

The available research on trauma-focused psychodynamic psychotherapy (TFPP) for PTSD, including studies with veterans and LGBTQ individuals, does not report any specific safety concerns, suggesting it is generally safe for humans. ^{1 2 6 7 8}

How is Trauma-focused Psychodynamic Psychotherapy (TFPP) different from other treatments for PTSD?

Trauma-focused Psychodynamic Psychotherapy (TFPP) is unique because it is a brief, manualized therapy that focuses on attachment and emotions, and it explicitly considers identity-related and societal factors, which can be particularly beneficial for individuals facing minority stress, such as LGBTQ patients. ^{1 2 5 7 9}

Research Team

Barbara Milrod, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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) 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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Trauma-Focused Psychodynamic Psychotherapy of a Patient With PTSD in a Veterans Affairs Setting. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Open Trial of Trauma-Focused Psychodynamic Psychotherapy for Posttraumatic Stress Disorder Among LGBTQ Individuals. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Trauma-Focused Psychodynamic Psychotherapy. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Trauma-focused Cognitive-behavioral Therapy with children and adolescents: Practice, evidence base, and future directions]. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Future directions for interventions targeting PTSD in HIV-infected adults. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Trauma-focused cognitive-behavioral therapy for children and adolescents: assessing the evidence. [2022]

8. Switzerland 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Trauma-focused treatments for depression. A systematic review and meta-analysis. [2021]