Your session is about to expire
← Back to Search
Prolonged Exposure Therapy for PTSD
N/A
Recruiting
Led By Suzanne L Pineles, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 63 pcl-5 score at pe therapy session 10
Awards & highlights
Study Summary
This trial will study the effect of time of day on treating PTSD with Prolonged Exposure Therapy via telemedicine. Outcomes measured include psychophysiological & clinical changes. Participants will be randomized to morning or late afternoon sessions with daily imaginal-exposure homework.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves psychological therapy rather than medication, side effects may include temporary increases in distress, anxiety, or emotional discomfort related to recalling traumatic events during treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 63 pcl-5 score at pe therapy session 10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 63 pcl-5 score at pe therapy session 10
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CAPS-5: Primary Clinical Outcome
Clinician-Administered PTSD scale for Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition (CAPS-5): Primary Clinical Outcome
Psychophysiological reactivity to script-driven imagery (SDI-PR): Primary Mechanistic Outcome
+1 moreSecondary outcome measures
Mental disorders
PCL-5: Secondary Clinical Outcome
SUDS: Secondary Mechanistic Outcome
+1 moreOther outcome measures
Hydrocortisone
Trial Design
2Treatment groups
Experimental Treatment
Group I: Late afternoon PEExperimental Treatment1 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 PEExperimental Treatment1 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.
Find a Location
Who is running the clinical trial?
VA Boston Healthcare SystemFED
69 Previous Clinical Trials
970,440 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,941 Previous Clinical Trials
13,200,616 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,794 Previous Clinical Trials
2,693,838 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have completed 8 or more sessions of PE therapy.My mental health medication has been the same for the last 3 months.I do not have any serious liver, kidney, or unstable health conditions.I have a significant brain injury or disorder.I am interested in starting PE treatment.I am between 25 and 45 years old.I am interested in starting PE therapy.I have been diagnosed with PTSD and my condition is considered moderate to severe.I have been diagnosed with Cushing's or Addison's disease, or I'm taking medication that affects my cortisol levels.I can attend early morning or late afternoon appointments.I use benzodiazepines daily or when needed.I am currently in a specific therapy for trauma.I am on methadone or suboxone for past opioid addiction.I have a history of bipolar I, schizophrenia, or another psychotic disorder.You scored in the middle range (42-58) on the Morningness-Eveningness Questionnaire (MEQ), which measures if you are a morning or evening person.
Research Study Groups:
This trial has the following groups:- Group 1: Early morning PE
- Group 2: Late afternoon PE
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor extending its recruitment efforts to those over eighty-five years old?
"This clinical trial is trying to find participants aged between 25 and 45."
Answered by AI
Are opportunities still present to join the experiment?
"According to the clinicaltrials.gov website, this medical trial is currently in its recruitment phase and has been since it was first posted on July 1st 2022. The last update occurred February 25th 2023."
Answered by AI
Who is qualified to join this experiment?
"This medical trial requires participants to have a diagnosis of post traumatic stress disorder and be aged 25-45. 52 individuals are required for the study's completion."
Answered by AI
What are the chief aims of this clinical research endeavor?
"This trial's primary aim is to evaluate the psychophysiological reactivity of participants in response to script-driven imagery over a period of 64-71 days post-treatment. Secondary objectives include measuring symptoms of PTSD using PCL-5 and Subjective Units of Distress (SUDS) scales, which range from 0 (no distress) to 100 (extreme distress)."
Answered by AI
How many individuals have been chosen to participate in this experiment?
"That is correct. Clinicaltrials.gov data affirms that this research, which was originally posted on July 1st 2022, is actively pursuing patients. Approximately 52 participants must be recruited from a single site."
Answered by AI
Who else is applying?
What state do they live in?
Quebec
What site did they apply to?
VA Boston Healthcare System
What portion of applicants met pre-screening criteria?
Did not meet criteria
How responsive is this trial?
Typically responds via
Phone Call
Average response time
- < 2 Days
Most responsive sites:
- VA Boston Healthcare System: < 48 hours
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger