Enhanced Consent for Symptom Provocation Research
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|ClinicalTrials.gov Identifier: NCT01809899|
Recruitment Status : Terminated (Time and funding ran out prior to full recruitment)
First Posted : March 13, 2013
Results First Posted : January 24, 2018
Last Update Posted : January 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Trauma||Behavioral: Enhanced consent procedure Behavioral: Consent as Usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Risks and Outcomes of Enhanced Consent in Symptom-provocation Research|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||August 2014|
Experimental: Enhanced Consent Procedure
Participants in this group will receive an enhanced consent that will be an hour longer than usual.
Behavioral: Enhanced consent procedure
Enhanced consent entails a more detailed consent procedure
Active Comparator: Consent as Usual Procedure
Participants in this group will receive a normal consent procedure to the study
Behavioral: Consent as Usual
Routine informed consent procedures
- Blood Oxygen-Level Dependent (BOLD) Signal [ Time Frame: Baseline ]Functional Magnetic Resonance Imaging (fMRI). We were examining differences in Blood Oxygen-Level Dependent (BOLD) signal indicating reaction to a stress-provocation paradigm between the Enhanced Consent and Consent as Usual conditions.
- Heart Rate [ Time Frame: Baseline ]Heart rate was measured while in the scanner as a secondary psychobiological outcome to be considered in tandem with the BOLD signals from the scanner.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809899
|Principal Investigator:||Mary Ann Dutton, PhD||Georgetown University|