Prolonged Exposure Therapy for Post-Traumatic Stress Disorder

Overseen By Vladimir Ivkovic, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Psychotic disorders, Untreated bipolar, Severe TBI, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 10 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Prolonged Exposure therapy can help individuals with post-traumatic stress disorder (PTSD). The researchers aim to understand changes in the brain and body before, during, and after the therapy to assess its effectiveness. Suitable candidates for this trial include those diagnosed with PTSD who are interested in trying this specific therapy. As an unphased study, this trial provides a unique opportunity to contribute to groundbreaking research and potentially benefit from a novel therapeutic approach.

Will I have to stop taking my current medications?

If you are taking psychotropic medication, you can continue as long as your medication use has been stable for 2 months before joining the study and stays stable during the trial.

What prior data suggests that Prolonged Exposure Therapy is safe for treating PTSD?

Research has shown that Prolonged Exposure (PE) therapy is a well-known and safe treatment for PTSD. It effectively reduces symptoms for many, with studies indicating that 65% to 80% of patients respond positively. This means many individuals feel better after the treatment.

In terms of safety, most people find PE therapy manageable. Participants typically complete the sessions without major issues. The therapy involves discussing traumatic experiences in a controlled setting, which can be intense but is designed to help over time.

Overall, PE therapy has a strong record of safety and effectiveness in treating PTSD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Prolonged Exposure therapy is unique because it involves a structured approach to treating PTSD by helping patients confront their traumatic memories in a safe and controlled environment. Unlike many traditional treatments for PTSD, which may rely heavily on medication or less interactive therapy methods, Prolonged Exposure focuses on reducing fear through repeated, guided exposure to trauma-related thoughts, feelings, and situations. This therapy aims to decrease the power of traumatic memories and improve emotional processing, potentially offering a more lasting and empowering solution for individuals struggling with this condition. Researchers are excited about its potential to deliver significant improvements with a more personalized and direct approach to trauma recovery.

What evidence suggests that Prolonged Exposure therapy is effective for PTSD?

Research has shown that prolonged exposure therapy effectively treats PTSD. A review of several studies found it greatly reduces PTSD symptoms compared to no treatment, such as being on a waiting list. In one study with veterans, those who underwent prolonged exposure therapy experienced a significant drop in PTSD symptoms. Another study found long-lasting benefits, with participants reporting fewer PTSD and depression symptoms even two weeks after treatment. Overall, strong evidence supports the effectiveness of prolonged exposure therapy in helping people with PTSD. Participants in this trial will receive a full course of prolonged exposure therapy to further evaluate its effectiveness. ^{2 6 7 8 9}

Who Is on the Research Team?

Vladimir Ivkovic, Ph.D.

Principal Investigator

Massachusetts General Hospital

Amanda W Baker, Ph.D.

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have been diagnosed with PTSD according to DSM-5 criteria and are interested in starting Prolonged Exposure therapy. It's not specified who can't join, but typically those with conditions that might interfere with the treatment or assessment would be excluded.

Inclusion Criteria

I am 18 years old or older.

Meeting diagnostic criteria for PTSD as defined by DSM-5 assessed by the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and related Psychiatric Disorders (DIAMOND),

I am interested in starting PE.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-treatment Assessment

Multimodal assessment batteries are administered to measure baseline neural, psychophysiological, and subjective markers

1 week

1 visit (in-person)

Treatment

Participants receive 10 sessions of Prolonged Exposure therapy, with psychophysiological and neural measures recorded

10 weeks

10 visits (in-person)

Mid-treatment Assessment

Assessment of neural, psychophysiological, and subjective markers post session 5

1 week

1 visit (in-person)

Post-treatment Assessment

Assessment of neural, psychophysiological, and subjective markers post session 10

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Prolonged Exposure

Trial Overview The study tests how well Prolonged Exposure (PE) therapy works for PTSD by looking at changes in brain function, body responses, and personal feelings before, during, and after the therapy. Participants will undergo a standard 10-session PE treatment with assessments throughout.

How Is the Trial Designed?

Group I: Prolonged Exposure therapy for posttraumatic stress disorder Experimental Treatment 1 Intervention

15 participants who meet study inclusion/exclusion criteria will be individually administered a full course of PE during 10, 60 minute-sessions, with independent multimodal assessment batteries administered at pre-treatment, mid-treatment (post session 5), post-treatment, and a 1-month follow-up.

Prolonged Exposure is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Prolonged Exposure Therapy for:

• Post-traumatic Stress Disorder (PTSD)

Approved in European Union as Prolonged Exposure Therapy for:

• Post-traumatic Stress Disorder (PTSD)

Approved in Canada as Prolonged Exposure Therapy for:

• Post-traumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK79056/

A meta-analytic review of prolonged exposure for ... - NCBI - NIH Prolonged exposure therapy was highly effective in treating post-traumatic stress disorder and significantly more effective than inactive (waiting list) and ...

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

Prolonged Exposure for PTSD 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. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2808302

Written Exposure Therapy vs Prolonged ... Conclusions and Relevance In this study, WET was noninferior to PE in PTSD symptom change and was associated with significantly less attrition.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S002239562200334X

Long-term effectiveness of a prolonged exposure-based ... Participants (N = 376) demonstrated high retention (91%) and large effect size reductions in self-reported PTSD and depression symptoms after two weeks. Small ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00057629

Prolonged Exposure Therapy for Post Traumatic Stress ... Prolonged Exposure (PE) consists of 10 weekly 90-minute treatment sessions, which may be extended up to 20 sessions, depending on client response. Treatment ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9160482/

Enhancing Prolonged Exposure therapy for PTSD using ... Prolonged Exposure (PE) therapy is one of the most effective treatments for PTSD, with response rates ranging from 65 to 80% [[9], [10], [11]].

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2800086

Massed vs Intensive Outpatient Prolonged Exposure for ... These findings suggest that both massed and intensive outpatient forms of prolonged exposure therapy are fast and effective for combat-related PTSD.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272735817302271

Long-term efficacy of psychotherapy for posttraumatic ... This meta-analysis evaluated enduring effects of psychotherapy for PTSD in randomized controlled trials (RCTs) with long-term follow-ups (LTFUs) of at least six ...

9. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.focus.11.3.428

A Meta-Analytic Review of Prolonged Exposure for ... Thus, the average participant receiving prolonged exposure fared better than 79% of the control participants at posttreatment on secondary outcome measures.