Enhanced Consent for Symptom Provocation Research

Trauma Clinical Trial

Official title:

Risks and Outcomes of Enhanced Consent in Symptom-provocation Research

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01809899
• Other study ID #: 4295-033
• Status: Terminated
• Phase: N/A
• First received: August 27, 2009
• Last updated: June 20, 2017
• Start date: April 2009
• Est. completion date: August 2014

Study information

• Verified date: June 2017
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 2014
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• nonsmoker

• female

• between 18-55

• experienced trauma

• willing to have a brain scan

• provide consent

Exclusion Criteria:

• alcohol abuse or dependence

• bipolar disorder

• suicidal intent

• metal in the body or anything else that would interfere with an MRI

• claustrophobia or inability to lie still for 45 minutes

• receiving current counseling

• on certain antidepressants, benzodiazepines, or other psychotropic medication

• pregnant or nursing

Related Conditions & MeSH terms

• Trauma

Intervention

Behavioral:
• Enhanced consent procedure
Enhanced consent entails a more detailed consent procedure
• Consent as Usual
Routine informed consent procedures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Oxygen-Level Dependent (BOLD) Signal	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.	Baseline
Secondary	Heart Rate	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.	Baseline