Enhanced Consent for Symptom Provocation Research

Georgetown University

Status: Terminated

Conditions: Trauma

Treatments: Behavioral: Consent as Usual; Behavioral: Enhanced consent procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT01809899

4295-033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Enhanced Consent Procedure

Experimental group

Description:

Participants in this group will receive an enhanced consent that will be an hour longer than usual.

Treatment:

Behavioral: Enhanced consent procedure

Consent as Usual Procedure

Active Comparator group

Description:

Participants in this group will receive a normal consent procedure to the study

Treatment:

Behavioral: Consent as Usual