The purpose of this study is to determine if taking a pill of estradiol (a form of estrogen) together with prolonged exposure (PE) therapy can improve this treatment outcome in women with Post-Traumatic Stress Disorder (PTSD). Prolonged Exposure (PE) therapy is a validated, evidence-based talk therapy that focuses on helping individuals with PTSD process memories of the trauma. Based on previous findings that the hormone estrogen facilitates people learning not to fear things they had feared before, we want to supplement prolonged exposure therapy with an estradiol pill given before each therapy session. Participants will be randomly assigned to either take estrogen or a placebo (which looks just like the estrogen pill but contains no medicine). Participants will not know which pill they are taking. As part of this study, participants will be asked to go through two separate fMRI scans, one before prolonged exposure therapy treatment and one after. This machine is routinely used by scientists to study the brain and does not use any radiation (x-rays).
The study involves 12 visits to our lab, which is located in midtown east Manhattan, over the course of a 6-9-week period. These visits can be broken down into 2 experimental days, 6 prolonged exposure therapy sessions, and 2 more experimental days. Participation in this study requires 12 visits over six weeks. Six of these visits will be therapy sessions. The other 6 days include assessment visits and going through an emotional learning and memory task before and after therapy. Participants will undergo a fear conditioning procedure that involves receiving an annoying but not painful, half-second electric current applied to the fingers. This procedure will be conducted during two consecutive days. The second day will be conducted in an fMRI scanner. Participants will be paid for their time. Blood samples will be gathered at different time points of the study. There will also be follow-up visits at 3 months and 6 months.
Eligibility criteria: Females between the ages of 18-45 who are taking an oral contraceptive (i.e., birth control)
Is the study therapeutic? Yes – participants will receive free Prolonged Exposure therapy no matter which study arm they are assigned to (i.e., placebo vs estradiol pill).
Is the study funded? Yes, this study is funded by the National Institute of Mental Health (NIMH)
Who will be conducting the study? The study is being conducted at two different sites: Dr. Mohammed Milad is conducting the study within the Department of Psychiatry at NYU Langone Health, and Dr. Edna Foa is conducting the study within the Department of Psychiatry at the University of Pennsylvania Perelman School of Medicine.
Will subjects be paid? Yes – The total compensation for all completed parts will be 480 dollars. Participants will receive 10 dollars for each study visit from visits 1-11 to help defray costs of travel and time. Participants will then receive 270 dollars upon completion of visit 12.
Participants will receive 50 dollars at each remaining follow-up visit. Participants who drop out of the study will be paid for the visits they attended.
Contact information: For more information regarding the study, you can call 1-888-44-WORRY or email Behavioralneuroscience@nyulangone.org. You can also complete the online pre-screening by following this link: https://is.gd/NYU_PTSD_STUDY and a research coordinator will reach out to you with further information about the study.
Post Expiration: The study will be recruiting until June 2023