Psychotherapy for PTSD Due to Military Sexual Trauma

Recruiting in Palo Alto (17 mi)

Overseen by JoAnn Difede, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Weill Medical College of Cornell University

Must be taking: Psychotropic

Disqualifiers: Schizophrenia, Bipolar, Substance dependence, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare two kinds of therapy for Posttraumatic Stress Disorder (PTSD): exposure therapy (ET) and Interpersonal Psychotherapy (IPT). The results of this study will allow us to see if IPT and ET are equally effective in treating PTSD due to Military Sexual Trauma, with the long-term goal of making PTSD treatment effective for as many people as possible.

Do I have to stop taking my current medications for the trial?

The trial requires that you have been stable on your psychotropic medication for the past 60 days, so you do not need to stop taking your current medications.

What data supports the effectiveness of the treatment for PTSD due to military sexual trauma?

Research shows that Prolonged Exposure Therapy (PE) is an effective treatment for PTSD in veterans, including those who have experienced military sexual trauma. PE helps patients by gradually exposing them to trauma-related memories and situations, reducing distress over time. ^{1 2 3 4 5}

Is Prolonged Exposure Therapy safe for treating PTSD?

Prolonged Exposure Therapy (PE) is generally considered safe for treating PTSD, with low rates of adverse events and symptom worsening. In a study of intensive PE, only a small number of participants experienced increased symptoms, and dropout rates were low, indicating good tolerability. ^{2 4 6 7 8}

How is the treatment of Exposure Therapy and Interpersonal Psychotherapy for PTSD due to Military Sexual Trauma different from other treatments?

This treatment is unique because it combines Prolonged Exposure Therapy (PE), which helps patients confront and process traumatic memories, with Interpersonal Psychotherapy (IPT), which focuses on improving social support and emotional awareness. While PE is well-established for PTSD, IPT's application to military-related PTSD is still being explored, offering a novel approach to addressing both trauma and interpersonal issues. ^{1 3 4 9 10}

Research Team

JoAnn Difede, PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for male and female military personnel who have PTSD due to Military Sexual Trauma (MST). Participants must speak English, be able to consent, have been stable on psychotropic medication for 60 days, and score over 40 on the CAPS assessment. They should not have unstable medical conditions or substance dependence in the last 90 days.

Inclusion Criteria

English-speaking

Diagnosed with PTSD consequent to MST, with a minimum CAPS score > 40

I have been on the same mental health medication for the last 60 days.

Exclusion Criteria

I have been in a trial or treated for PTSD or MST-related conditions recently.

Current or history of substance dependence in the past 90 days

I have been diagnosed with schizophrenia, bipolar disorder, or another psychotic disorder.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 14 weekly 50-minute Interpersonal Psychotherapy sessions or 10 90-minute exposure therapy sessions

11-15 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Exposure Therapy (Behavioral Intervention)
• Interpersonal Psychotherapy (Behavioral Intervention)

Trial Overview The study compares Exposure Therapy (ET) with Interpersonal Psychotherapy (IPT) to treat PTSD from MST. It aims to determine if both therapies are equally effective, potentially broadening treatment options for those affected by MST.

Participant Groups

Group I: Interpersonal Psychotherapy Active Control 1 Intervention

Participants receive 14 weekly 50-minute Interpersonal Psychotherapy sessions focused on the interpersonal sequelae of trauma in current daily life.

Group II: Exposure Therapy Active Control 1 Intervention

Participants receive 10 90-minute exposure therapy sessions for PTSD following the treatment procedures as outlined in the standard Prolonged Exposure therapy manual.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Dr. Robert Min

Weill Medical College of Cornell University

Chief Executive Officer since 2024

MD, MBA

Dr. Adam R. Stracher

Weill Medical College of Cornell University

Chief Medical Officer since 2024

MD

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Pete Hegseth

United States Department of Defense

Chief Executive Officer

Bachelor's degree in Political Science from Princeton University, JD from Harvard Law School

Lisa Hershman

United States Department of Defense

Chief Medical Officer since 2021

MD from Uniformed Services University of the Health Sciences

Findings from Research

In a study of 92 adults with chronic PTSD, both Prolonged Exposure (PE) and Interpersonal Psychotherapy (IPT) led to significant changes in patient distress and avoidance related to trauma reminders, with 51.9% of participants showing reliable change in distress and 48.1% in avoidance after 14 weeks of treatment.

Changes in distress and avoidance were linked to improvements in PTSD symptoms, depression, quality of life, and social functioning, with PE showing the strongest relationship, suggesting that addressing these factors is important in PTSD treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in avoidance and distress related to trauma reminders in PTSD psychotherapy. Wheaton, MG., Choo, TH., Markowitz, JC.[2023]

A training program for community providers on prolonged exposure (PE) and cognitive processing therapy (CPT) for PTSD was conducted with 170 participants over 8 months, significantly increasing their knowledge and comfort with these therapies.

Providers who received additional consultation after the initial training were more likely to implement PE and CPT with their patients, highlighting the importance of ongoing support in effectively delivering PTSD treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training community providers in evidence-based treatment for PTSD: Outcomes of a novel consultation program. Charney, ME., Chow, L., Jakubovic, RJ., et al.[2020]

Providers who received post-workshop consultation after a 4-day prolonged exposure therapy (PE) training reported significantly higher self-efficacy and used more components of PE, leading to better treatment delivery.

Patients treated by providers with post-workshop consultation experienced faster reductions in PTSD symptoms and lower severity at follow-up assessments, indicating that ongoing support for providers can enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial. Foa, EB., McLean, CP., Brown, LA., et al.[2022]

Prolonged exposure therapy (PE) is recognized as the most scientifically validated treatment for post-traumatic stress disorder (PTSD), outperforming various pharmacological and psychotherapeutic options.

The therapy includes both imaginal and in vivo exposure techniques, and the paper discusses its effectiveness and dissemination specifically in Japan, highlighting its importance in treating chronic PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prolonged Exposure Therapy for Post-traumatic Stress Disorder]. Asukai, N.[2018]

In a study of 31 combat veterans with PTSD undergoing prolonged exposure therapy, 9 out of 24 completers achieved complete remission from PTSD, indicating the therapy's potential efficacy.

The study found that successful remission from PTSD was associated with decreased activation in the left anterior insula during negative image anticipation and increased connectivity with other brain regions, suggesting that effective treatment may involve better regulation of anticipatory anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurosubstrates of remission following prolonged exposure therapy in veterans with posttraumatic stress disorder. Simmons, AN., Norman, SB., Spadoni, AD., et al.[2021]

In a trial involving 50 military service members, veterans, and family members, interpersonal psychotherapy (IPT) significantly reduced PTSD and depressive symptoms over 14 sessions, indicating its potential effectiveness for this population.

This study is the largest of its kind for IPT in military patients, showing that both service members and their families can benefit from this therapy, which has previously been under-researched in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interpersonal Psychotherapy of Posttraumatic Stress Disorder for Veterans and Family Members: An Open Trial. Pickover, A., Lowell, A., Lazarov, A., et al.[2023]

Prolonged exposure (PE) therapy significantly reduced PTSD symptoms in five patients with severe chronic combat-related PTSD, showing a mean decrease of 48% in PTSD Symptom Scale scores after 10-15 sessions.

Four out of five patients maintained or continued to improve their symptoms 6-18 months post-treatment, indicating the long-term efficacy of PE therapy for combat-related PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged exposure therapy for chronic combat-related PTSD: a case report of five veterans. Nacasch, N., Foa, EB., Fostick, L., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of group v. individual trauma-focused treatment for posttraumatic stress disorder in veterans. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Changes in avoidance and distress related to trauma reminders in PTSD psychotherapy. [2023]

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

Training community providers in evidence-based treatment for PTSD: Outcomes of a novel consultation program. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial. [2022]

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

The impact of service-connected disability and therapist experience on outcomes from prolonged exposure therapy with veterans. [2018]

6. Japan pubmed.ncbi.nlm.nih.gov

[Prolonged Exposure Therapy for Post-traumatic Stress Disorder]. [2018]

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

Intensive prolonged exposure therapy for chronic PTSD patients following multiple trauma and multiple treatment attempts. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Neurosubstrates of remission following prolonged exposure therapy in veterans with posttraumatic stress disorder. [2021]

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

Interpersonal Psychotherapy of Posttraumatic Stress Disorder for Veterans and Family Members: An Open Trial. [2023]

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

Prolonged exposure therapy for chronic combat-related PTSD: a case report of five veterans. [2019]