Prolonged Exposure Therapy for PTSD

Overseen By Edward F Pace-Schott, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Benzodiazepines, Methadone, Suboxone, Cortisol-targeting

Disqualifiers: Bipolar, Schizophrenia, Substance use, others

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

Compensation: Varies

Number of Visits: 11

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Prolonged Exposure Therapy to determine if the time of day influences its effectiveness in reducing trauma-related fears in individuals with PTSD (Posttraumatic Stress Disorder). Participants will attend therapy sessions either in the early morning or late afternoon and will complete related exercises at home during these times. The trial aims to discover whether morning or afternoon sessions more effectively reduce PTSD symptoms. It suits individuals with PTSD who are interested in this therapy and can attend sessions at the designated times. As an unphased trial, it provides a unique opportunity to explore personalized therapy timing for PTSD relief.

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

You don't have to stop taking your current medications, but any non-exclusionary psychotropic medications must be stable for at least 3 weeks before starting the trial and should remain stable throughout your participation.

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

Research has shown that Prolonged Exposure Therapy (PE) is a well-accepted treatment for PTSD. Studies have found that it not only reduces PTSD symptoms but is also generally safe for participants. For example, a large study with 916 veterans demonstrated significant improvements in PTSD symptoms, highlighting both its effectiveness and safety.

PE therapy involves revisiting trauma-related memories in a controlled setting to gradually lessen distress. This method has been tested in many studies, and most participants manage it well. While some people might experience temporary discomfort during sessions, these feelings are usually mild and manageable.

Overall, the consistent use of PE in various studies and its recognition as an effective PTSD treatment suggest that it is a safe option for most people seeking help for PTSD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Prolonged Exposure (PE) Therapy for PTSD because it explores the impact of session timing on treatment effectiveness. Unlike traditional therapy sessions that don’t typically consider the time of day, this trial is testing whether participating in therapy during early mornings or late afternoons can influence outcomes. By understanding how timing affects therapy benefits, this study could lead to more personalized, effective treatment schedules for individuals with PTSD.

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

Research has shown that Prolonged Exposure Therapy (PE) effectively treats PTSD. A small initial study found that PE significantly reduced PTSD symptoms, with improvements lasting at least six months. Another study discovered that both 60-minute and 90-minute PE sessions effectively reduced PTSD symptoms. Additionally, PE has proven effective for various groups, including adults who have experienced trauma from events like sexual assault. In this trial, participants will be randomized to receive PE sessions either in the early morning or late afternoon. Studies have shown that PE, regardless of the time of day, significantly decreases the severity of PTSD symptoms. Overall, PE has a strong history of helping people with PTSD feel better. ^{5 6 7 8 9}

Who Is on the Research Team?

Edward F Pace-Schott, PhD

Principal Investigator

Massachusetts General Hospital

Suzanne L Pineles, PhD

Principal Investigator

VA Boston Health System, Boston University

Are You a Good Fit for This Trial?

This trial is for veterans aged 25-45 with PTSD, who have a minimum severity score and are interested in Prolonged Exposure Therapy. They must be available for morning or late afternoon sessions and not be extreme morning or evening types as per the Morningness-Eveningness Questionnaire.

Inclusion Criteria

I am between 25 and 45 years old.

Veteran

Intermediate ('neither type') score of 42-58 on the Morningness-Eveningness Questionnaire (MEQ)

Exclusion Criteria

Pregnancy

I have completed 8 or more sessions of PE therapy.

My mental health medication has been the same for the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Pre-study Sleep Monitoring

Participants undergo a 7-day pre-study sleep-monitoring period with wrist actigraphy, sleep diaries, and salivary cortisol level assessment

1 week

Treatment

Participants receive 10 weekly Prolonged Exposure Therapy (PE) sessions with daily at-home imaginal-exposure homework

10 weeks

10 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post-treatment assessments of CAPS-5 and SDI-PR

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Prolonged Exposure Therapy for Posttraumatic Stress Disorder

Trial Overview The study tests how the time of day affects fear extinction during Prolonged Exposure Therapy via telemedicine. Participants will undergo therapy either shortly after waking up or later in the afternoon, with assessments at different stages to measure changes in stress reactions and PTSD symptoms.

How Is the Trial Designed?

Group I: Late afternoon PE Experimental Treatment 1 Intervention

26 participants randomized to 10 weekly PE sessions in late afternoon (16:00 or later) with homework exposures occurring occur at this same time of day.

Group II: Early morning PE Experimental Treatment 1 Intervention

26 participants randomized to 10 weekly PE sessions in early morning (between 07:00-10:00) with homework exposures occurring occur at this same time of day.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

VA Boston Healthcare System

Collaborator

Trials

73

Recruited

971,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10721715/

Treatment of Posttraumatic Stress Disorder with Prolonged ... In a pilot study, PE-PC showed significant and large reductions in PTSD from pre- to post-treatment that were maintained at six-month follow-up (Cigrang et al., ...

2. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id1595676.pdf

The Efficacy of 90-Min Versus 60-Min Sessions of ... The 60- and 90-min sessions of PE had comparable efficacy and efficiency in reducing PTSD symptoms. The implementation of shorter sessions of PE may increase ...

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. 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 ... In this review, we summarize the evidence base supporting the efficacy of. PE across populations, including adults with sexual assault–related ...

6. 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 ...

7. 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 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2451865422000576

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]]. A key component ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT00057629

Prolonged Exposure Therapy for Post Traumatic Stress ... This study will evaluate the effectiveness of a brief cognitive behavioral therapy, administered by community agencies, for the treatment of patients with Post ...