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Time and funding ran out prior to full recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Consent Procedure | Experimental | Participants in this group will receive an enhanced consent that will be an hour longer than usual. |
|
| Consent as Usual Procedure | Active Comparator | Participants in this group will receive a normal consent procedure to the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced consent procedure | Behavioral | Enhanced consent entails a more detailed consent procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Ann Dutton, PhD | Georgetown University | Principal Investigator |
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Data was not valid due to error in data collection technology
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12 participants were recruited, but we were unsuccessful in recruiting sufficient number of non-PTSD, but trauma exposed patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Consent Procedure | Enhanced consent includes use of teach back methods, video clips illustrating various study methods, and repeated confirmation of consent. |
| FG001 | Consent as Usual | Consent as Usual, with no Enhanced Consent features |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Consent as Usual Procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Ann Dutton | Georgetown University Medical Center | 2026871997 | mad27@georgetown.edu |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D032962 | Consent Forms |
| ID | Term |
|---|---|
| D007258 | Informed Consent |
| D007603 | Jurisprudence |
| D012926 | Social Control, Formal |
| D004472 | Health Care Economics and Organizations |
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| Consent as Usual | Behavioral | Routine informed consent procedures |
|
Participants in this group will receive a normal consent procedure to the study |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Consent as Usual, involving no Enhanced Consent features
|
| 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. | 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. | Posted | Baseline |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Consent as Usual Procedure | Participants in this group will receive a normal consent procedure to the study Consent procedure: Enhanced consent entails a more detailed consent procedure | 0 | 4 | 0 | 4 |
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| D011996 | Records |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D003625 | Data Collection |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |