Trial Outcomes & Findings for Enhanced Consent for Symptom Provocation Research (NCT NCT01809899)
NCT ID: NCT01809899
Last Updated: 2018-01-24
Results Overview
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.
TERMINATED
NA
12 participants
Baseline
2018-01-24
Participant Flow
12 participants were recruited, but we were unsuccessful in recruiting sufficient number of non-PTSD, but trauma exposed patients.
Participant milestones
| Measure |
Enhanced Consent Procedure
Enhanced consent includes use of teach back methods, video clips illustrating various study methods, and repeated confirmation of consent.
|
Consent as Usual
Consent as Usual, with no Enhanced Consent features
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
4
|
|
Overall Study
COMPLETED
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhanced Consent for Symptom Provocation Research
Baseline characteristics by cohort
| Measure |
Enhanced Consent Procedure
n=8 Participants
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.
|
Consent as Usual Procedure
n=4 Participants
Participants in this group will receive a normal consent procedure to the study
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Enhanced Consent Procedure
Consent as Usual Procedure
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place