Trauma
Conditions
Keywords
Trauma, Abuse, Domestic Violence, Rape, Assault, MRI
Brief 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.
Interventions
BEHAVIORALEnhanced consent procedure
Enhanced consent entails a more detailed consent procedure
BEHAVIORALConsent as Usual
Routine informed consent procedures
Sponsors
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Oxygen-Level Dependent (BOLD) Signal | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | 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. |
Participant flow
Recruitment details
12 participants were recruited, but we were unsuccessful in recruiting sufficient number of non-PTSD, but trauma exposed patients.
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Consent Procedure Participants in this group will receive an enhanced consent that will be an hour longer than usual.
Consent procedure: Enhanced consent entails a more detailed consent procedure than is routine. | 8 |
| Consent as Usual Procedure Participants in this group will receive a normal consent procedure to the study | 4 |
| Total | 12 |
Baseline characteristics
| Characteristic | Enhanced Consent Procedure | Consent as Usual Procedure | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 4 Participants | 12 Participants |
| Region of Enrollment United States | 8 participants | 4 participants | 12 participants |
| Sex: Female, Male Female | 8 Participants | 4 Participants | 12 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 4 |
| serious Total, serious adverse events | 0 / 8 | 0 / 4 |
Outcome results
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.
Time frame: Baseline
Population: No analyses were conducted due to an error in the scanner that resulted in no usable neuroimaging or physiological data. This includes the BOLD signal as well as the heart rate data and all other data collected while in the scanner.
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.
Time frame: Baseline
Population: No analyses were conducted due to an error in the scanner that resulted in no usable neuroimaging or physiological data. This includes the BOLD signal as well as the heart rate data and all other data collected while in the scanner.