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Treatment Study for People Who Have Difficulties Calming Down - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if the combination of two successful interventions (noninvasive brain stimulation and cognitive therapy) will help adults calm down easier after they become emotionally distressed.
We are interested in the effects of this intervention on ability to manage emotions and general distress in the lab and in everyday life, both immediately after the intervention and a month later.

The noninvasive brain stimulation used in this study is known as repetitive magnetic stimulation (rTMS). 

What is the Condition Being Studied?

Emotional distress

Who Can Participate in the Study?

Adults age 18-65 who:
- Are NOT currently seeing a psychiatrist, psychologist, therapist, or other mental healthcare provider for psychotherapy services
- Have trouble managing their emotions.
- Are diagnosed or believe they should be diagnosed with a mental health disorder
- Have never done rTMS before

Please contact the study team for more information about who can be in the study.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Have 3-5 in-person visits over 1-2 months (each visit takes 1 - 4 hours) and includes medical and psychiatric history, questionnaires and interviews
- Be randomized (like the flip of a coin) to be in one of five repetitive transcranial magnetic stimulation treatment groups:
1) real left rTMS over the left side of your brain.
2) real right rTMS over the right side of your brain.
3) sham TMS: you will not receive active brain stimulation
4) real left rTMS with imaging: you will have extra brain imaging before and after the rTMS
5) sham rTMS with imaging: you will have extra brain imaging before and after sham rTMS

You will not know whether you had real or sham rTMS until the end of the study.
After the rTMS procedure visit, you will receive phone calls daily for one week then a series of online questionnaires.
1 month later you'll have a final interview and imaging visit

Study Details

Full Title
Neuromodulation Enhanced Cognitive Restructuring for Emotion Dysregulation: A Proof of Concept Study
Principal Investigator
Clinical Psychologist
Protocol Number
IRB:PRO00066383
NCT:NCT02573246
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698