NCT01809899

Enhanced Consent for Symptom Provocation Research

Risks and Outcomes of Enhanced Consent in Symptom-provocation Research

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The overall goal of the proposed study is to insure the protection and safety of human subjects who have been previously exposed to interpersonal traumatic events and who are participants in symptom provocation research. The investigators intend to examine trauma history, cognitive, interpersonal, and genetic predictors of participants' unfavorable reaction to participation in research involving trauma-related script-driven imagery (SDI). The design includes comparing participants in a consent as usual group to participants in an enhanced consent group to see which minimizes unfavorable effects of participating in a research provocation study. In addition, the two different consent groups will be assessed for their effects on psychobiological and neurobiological stress response. Furthermore, the investigators will examine the relationship between the psychobiological responses and neural mechanism during SDI, and unfavorable reactions to participation in symptom provocation research.

Detailed description

The overall goal of the proposed study is to insure the protection and safety of human subjects who have been previously exposed to interpersonal traumatic events and who are participants in symptom provocation research. The investigators intend to examine trauma history, cognitive, interpersonal, and genetic predictors of participants' unfavorable reaction to participation in research involving trauma-related script-driven imagery (SDI). The design includes comparing participants with and without Posttraumatic Stress Disorder (PTSD) in a consent as usual group to participants in an enhanced consent group to see which group minimizes unfavorable effects of participating in a research provocation study. In addition, the two different consent groups will be assessed for their effects on psychobiological and neurobiological stress response. Furthermore, the investigators will examine the relationship between the psychobiological responses and neural mechanism during SDI, and unfavorable reactions to participation in symptom provocation research.

Conditions

• Trauma

Interventions

Type	Name	Description
BEHAVIORAL	Enhanced consent procedure	Enhanced consent entails a more detailed consent procedure
BEHAVIORAL	Consent as Usual	Routine informed consent procedures

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-06-01
• Completion: 2014-08-01
• First posted: 2013-03-13
• Last updated: 2018-01-24
• Results posted: 2018-01-24