Psychotherapy for PTSD Due to Military Sexual Trauma

Overseen By Olivia Baryluk, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Must be taking: Psychotropic

Disqualifiers: Schizophrenia, Bipolar, Substance dependence, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 11-15 weeks

208 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether two therapies, exposure therapy and interpersonal psychotherapy, are equally effective for treating PTSD caused by military sexual trauma. Exposure therapy involves confronting fears in a safe environment, while interpersonal psychotherapy addresses how trauma impacts relationships. This trial suits individuals with PTSD from military sexual trauma who can attend regular therapy sessions. Participants must be English-speaking and stable on any medication for at least 60 days. As an unphased trial, this study provides a unique opportunity to explore effective therapies for PTSD without the constraints of traditional clinical trial phases.

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.

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

Research has shown that exposure therapy is a well-known treatment for PTSD (posttraumatic stress disorder) and is generally well-tolerated by patients. Studies have found it particularly effective for individuals with complex PTSD, including those with other mental health issues. Although some may feel uncomfortable during sessions, serious side effects are rare.

Interpersonal Psychotherapy (IPT) has also been studied for PTSD, including cases related to military sexual trauma. Early findings suggest that it is safe and can help reduce PTSD symptoms. Some studies have compared IPT to other treatments like medication, and IPT has demonstrated potential benefits without major safety concerns.

Both therapies have been used in various settings with good safety records, making them promising options for treating PTSD due to military sexual trauma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for PTSD due to military sexual trauma because they offer unique approaches to tackling the condition. Unlike many standard treatments like Cognitive Behavioral Therapy (CBT), which primarily focuses on changing thought patterns, Exposure Therapy specifically helps individuals face and process traumatic memories in a controlled environment, potentially leading to reduced PTSD symptoms. Interpersonal Psychotherapy, on the other hand, emphasizes improving interpersonal relationships and tackling the social aftereffects of trauma, which can be crucial for recovery. By addressing both the emotional and social impacts of trauma, these therapies provide a comprehensive approach that could enhance healing outcomes.

What evidence suggests that this trial's treatments could be effective for PTSD due to Military Sexual Trauma?

Research has shown that both Exposure Therapy (ET) and Interpersonal Psychotherapy (IPT) effectively treat PTSD, including cases from military sexual trauma. In this trial, participants will receive one of these therapies. Studies have found that Exposure Therapy greatly reduces PTSD symptoms in military groups, with many veterans experiencing long-term benefits. Interpersonal Psychotherapy has also proven effective, especially for those who have experienced sexual trauma. Some research suggests that IPT might be more beneficial for these individuals compared to other treatments. Overall, both therapies have a strong history of helping people manage PTSD symptoms. ^{2 3 5 6 7}

Who Is on the Research Team?

JoAnn Difede, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Exposure Therapy
• Interpersonal Psychotherapy

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.

How Is the Trial Designed?

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.

Exposure Therapy is already approved in United States for the following indications:

Approved in United States as Prolonged Exposure Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

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]

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]

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]

Veterans with a service-connected disability for a mental health condition experienced smaller treatment gains from prolonged exposure therapy (PE) compared to those without such a connection, indicating that this factor may hinder treatment effectiveness.

Veterans treated by certified PE therapists showed significantly larger treatment gains than those treated by noncertified therapists, highlighting the importance of therapist qualifications in improving PTSD treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of service-connected disability and therapist experience on outcomes from prolonged exposure therapy with veterans. Goodson, JT., Helstrom, AW., Marino, EJ., et al.[2018]

Intensive prolonged exposure (iPE) therapy significantly reduced PTSD symptoms in chronic patients, with a large effect size and 71% of participants showing a positive response after treatment, which persisted for at least six months.

The treatment was safe, with no dropouts during the intensive phase and only 5% during the booster phase, indicating high tolerability, and adverse events were minimal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive prolonged exposure therapy for chronic PTSD patients following multiple trauma and multiple treatment attempts. Hendriks, L., de Kleine, RA., Broekman, TG., et al.[2020]

In a study of 6735 veterans, those receiving individual cognitive processing therapy (CPT) showed a statistically greater reduction in PTSD symptoms at discharge compared to those in group CPT, although the difference was less than the clinically important threshold.

By the 4-month follow-up, there were no significant differences in PTSD symptom severity between the group and individual therapy participants, suggesting that both treatment formats may ultimately lead to similar long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of group v. individual trauma-focused treatment for posttraumatic stress disorder in veterans. Spiller, TR., Duek, O., Buta, E., 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3427616/

Prolonged Exposure Therapy for Combat-Related ... The current study compared treatment outcomes across 112 veterans of the Vietnam War, the first Persian Gulf War, and the wars in Afghanistan and Iraq.

2. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/prolonged_exposure_pro.asp

Prolonged Exposure for PTSD - PTSD: National Center for ... Results revealed significant reductions in PTSD symptom severity in both PE plus placebo and PE plus sertraline. In an RCT of 916 veterans randomized to PE or ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0887618522000809

Exposure therapy for PTSD in military populations Results of this study provide evidence that exposure therapy is effective for treating PTSD in military populations, with benefits that, on average, exceed ...

4. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2808302

Written Exposure Therapy vs Prolonged ... This randomized clinical trial compares treatment outcomes for written exposure therapy and prolonged exposure therapy among veterans ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8101418/

Emotion Dysregulation Predicts Dropout from Prolonged ... Emotion Dysregulation Predicts Dropout from Prolonged Exposure Treatment among Female Veterans with Military Sexual Trauma-Related Posttraumatic Stress Disorder.

6. rainn.org rainn.org/help-and-healing/hotline/

RAINN's National Sexual Assault Hotline What To Expect When You Contact RAINN. Since 1994, RAINN's victim service programs have helped over 5 million survivors of sexual violence and their loved ones ...

7. researchgate.net researchgate.net/profile/Carmen-Mclean-2/publication/380033370_State_of_the_Science_Prolonged_exposure_therapy_for_the_treatment_of_posttraumatic_stress_disorder/links/6639471b06ea3d0b742ca985/State-of-the-Science-Prolonged-exposure-therapy-for-the-treatment-of-posttraumatic-stress-disorder.pdf

State of the Science: Prolonged exposure therapy for the ... Prolonged exposure therapy (PE) is a well-established first-line treatment for posttraumatic stress disorder (PTSD) that is based on emotional ...