Protocol Overview

November 21, 2014

This section will be completed when reviewed by an Expert Review Panel.

The Baseline and Trauma Challenge Psychophysiological Recordings protocol consists of a Baseline phase and a Trauma Challenge (trauma interview and trauma imagery) phase. During the baseline phase, skin conductance and heart rate are monitored continuously for 5 minutes while the participant rests quietly without talking. During the first part of the Trauma Challenge, heart rate and skin conductance are continuously measured while the participant is administered a 21-question, open-ended trauma interview. After the interview, skin conductance and heart rate are monitored continuously for 60 seconds while the participant is asked to think about and imagine the traumatic event.

Derived scores include average skin conductance and heart rate calculated for baseline, trauma interview, and trauma imagery as well as the difference in heart rate and skin conductance between (1) trauma interview and baseline, (2) trauma imagery and baseline, and (3-5) the first and last minutes within each measurement period (baseline, trauma interview, and trauma imagery).

This protocol combines the Standardized Trauma Interview (STI) developed by Foa & Rothbaum (1998) with the procedure for recording skin conductance and heart rate during trauma script imagery developed by Pitman et al. (1987). The procedure included in Pitman et al. (1987) utilizes participant-specific scripts that were developed during a prior interview and then read during the trauma challenge. This process for developing the trauma-script is not standardized and does not meet the PhenX criteria for low burden protocols. Both of these issues are resolved by instead using the STI for trauma script imagery.

BASELINE AND TRAUMA CHALLENGE PSYCHOPHYSIOLOGICAL RECORDINGS PROTOCOL

Have the individual sit comfortably in a chair.

Skin conductance (SC): Any device that records continuously at a rate of 5 samples per second or higher. Add isotonic paste to metal part of electrodes and attach them to fingers.

Heart rate (HR): Any device that records continuously at a rate of 20 samples per second or higher. Attach to finger (devices such as pulse oximeters) or wrist (for watch devices).

Once device is attached, verify that data is being recorded (either by visual or numerical representation of the data).

BASELINE

Ask individual to rest quietly without talking for 5 minutes. Record SC and HR continuously for 5 minutes. Mark the end of the 5-minute period or stop and save the data as "Baseline."

TRAUMA INTERVIEW (Adapted from Standardized Trauma Interview, Foa & Rothbaum, 1998)

Start recording data and ask the following questions:

1. Please briefly describe the event that happened to you

2. What time of day did it happen?

3. Where did it happen?

4. How long did this event last? That is, how long was it from the moment you first felt like you were in danger until you felt safe again?

5. How long ago did it happen?

6. How much have you slept since it happened?

7. What is your relationship with the perpetrator (if applicable)?

8. Was anyone under the influence of drugs or alcohol when it happened?

9. Was anyone else with you?

10. Did you have any injuries? What were they?

11. Do you anticipate long-term physical problems as a result of this event?

12. Was anyone else injured?

13. Was anyone killed?

14. Did you see other people’s injury or death?

15. At the time of the incident, did you think you would be seriously injured or killed?

16. During the event, how helpless did you feel?

17. During the event, how horrified or shocked did you feel?

18. During the event, how terrified or afraid did you feel?

19. During the event, how much control did you feel?

20. Have you ever experienced a similar event before?

21. How many times?

Mark the end of the interview of stop and save the data as "Trauma interview"

TRAUMA IMAGERY

Start recording data and ask the participant to think about and imagine the traumatic event. Record SC and HR continuously for 60 seconds. Mark the end of the 1-minute period or stop and save the data as "Trauma imagery."

DATA SCORING:

Calculate average SC for 5-minute Baseline, Trauma interview, and Trauma imagery. Calculate the difference between Trauma interview and Baseline, and Trauma imagery and Baseline. Calculate average SC for first minute and last minute of each phase. Note duration of Trauma interview. Calculate change score from first to last minute within each phase (correct Trauma interview by duration). Repeat with HR data.

There will be a total of 9 variables for each measure:

1. Baseline average

2. Trauma interview average

3. Trauma imagery average

4. Difference between Baseline and Trauma interview averages

5. Difference between Baseline and Trauma imagery averages

6. Change from first to last minute of Baseline

7. Change from first to last minute of Trauma interview

8. Change from first to last minute of Trauma imagery

Change from first to last minute of Trauma interview divided by interview duration

Export Variables

Variable Name	Variable ID	Variable Description	Version	Mapping
PX630901_Average_SkinConductance_Baseline	PX630901010000	Average Skin Conductance for 5-minute Baseline	4	N/A
PX630901_Average_SkinConductance_TraumaInterview	PX630901020000	Average Skin Conductance for Trauma interview	4	N/A
PX630901_Average_SkinConductance_TraumaImagery	PX630901030000	average Skin Conductance for Trauma imagery	4	N/A
PX630901_Difference_SkinConductance_Baseline_TraumaInterview	PX630901040000	Difference of Skin Conductance between Baseline and Trauma interview averages	4	N/A
PX630901_Difference_SkinConductance_Baseline_TraumaImagery	PX630901050000	Difference of Skin Conductance between Baseline and Trauma imagery averages	4	N/A
PX630901_Change_SkinConductance_Baseline_FirstToLast_Minute	PX630901060000	Change of Skin Conductance from first to last minute of Baseline	4	N/A
PX630901_Change_SkinConductance_TraumaInterview_FirstToLast_Minute	PX630901070000	Change of Skin Conductance from first to last minute of Trauma interview	4	N/A
PX630901_Change_SkinConductance_TraumaImagery_FirstToLast_Minute	PX630901080000	Change of Skin Conductance from first to last minute of Trauma imagery	4	N/A
PX630901_Change_SkinConductance_TraumaInterview_Over_Duration	PX630901090000	Change of Skin Conductance from first to last minute of Trauma interview divided by interview duration	4	N/A
PX630901_Average_HeartRate_Baseline	PX630901100000	Average Heart Rate for 5-minute Baseline	4	N/A
PX630901_Average_HeartRate_TraumaInterview	PX630901110000	Average Heart Rate for Trauma interview	4	N/A
PX630901_Average_HeartRate_TraumaImagery	PX630901120000	average Heart Rate for Trauma imagery	4	N/A
PX630901_Difference_HeartRate_Baseline_TraumaInterview	PX630901130000	Difference of Heart Rate between Baseline and Trauma interview averages	4	N/A
PX630901_Difference_HeartRate_Baseline_TraumaImagery	PX630901140000	Difference of Heart Rate between Baseline and Trauma imagery averages	4	N/A
PX630901_Change_HeartRate_Baseline_FirstToLast_Minute	PX630901150000	Change of Heart Rate from first to last minute of Baseline	4	N/A
PX630901_Change_HeartRate_TraumaInterview_FirstToLast_Minute	PX630901160000	Change of Heart Rate from first to last minute of Trauma interview	4	N/A
PX630901_Change_HeartRate_TraumaImagery_FirstToLast_Minute	PX630901170000	Change of Heart Rate from first to last minute of Trauma imagery	4	N/A
PX630901_Change_HeartRate_TraumaInterview_Over_Duration	PX630901180000	Change of Heart Rate from first to last minute of Trauma interview divided by interview duration	4	N/A

The Baseline and Trauma Challenge Psychophysiological Recordings protocol is a widely used, valid, and reliable objective measure of emotion-related biological arousal.

Foa, E. B., & Rothbaum, B. O. (1998). Treating the trauma of rape: Cognitive-behavioral therapy for PTSD. New York: Guilford Press.

Pitman, R. K., Orr, S. P., Forgue, D. F., de Jong, J. B., & Claiborn, J. M. (1987). Psychophysiologic assessment of posttraumatic stress disorder imagery in Vietnam combat veterans. Archives of General Psychiatry, 44(11), 970-975.

Adult

English

Adults, ages 18 and older

The interviewer must be trained to conduct personal interviews with individuals from the general population and to respond appropriately to emotional distress that can be elicited by trauma interviews. The interviewer should be trained to prompt respondents further if a "don’t know" response is provided.

Research technicians must be trained in the proper administration and placement of the skin conductance and heart-rate monitors.

Skin conductance (SC): Any device that records continuously at a rate of 5 samples per second or higher that can export data for analysis. Add isotonic paste to metal part of electrodes, and attach them to fingers.

Heart rate (HR): Any device that records continuously at a rate of 20 samples per second or higher that can export data for analysis. Attach to finger (devices such as pulse oximeters) or wrist (for watch devices).

Standard	Name	ID	Source
Common Data Elements (CDE)	Trauma interview psychophysiological test Score	4588716	CDE Browser

Blechert, J., Michael, T., Grossman, P., Lajtman, M., & Wilhelm, F. H. (2007). Autonomic and respiratory characteristics of posttraumatic stress disorder and panic disorder. Psychosomatic Medicine, 69(9), 935-943.

Bryant, R. A. (2006). Longitudinal psychophysiological studies of heart rate: Mediating effects and implications for treatment. Annals of the New York Academy of Sciences, 1071, 19-26.

Buckley, T. C., & Kaloupek, D. G. (2001). A meta-analytic examination of basal cardiovascular activity in posttraumatic stress disorder. Psychosomatic Medicine, 63(4), 585-594.

Keane, T. M., Kolb, L. C., Kaloupek, D. G., Orr, S. P., Blanchard, E. B., Thomas, R. G., Hsieh, F. Y., & Lavori, P. W. (1998). Utility of psychophysiological measurement in the diagnosis of posttraumatic stress disorder: Results from a Department of Veterans Affairs Cooperative Study. Journal of Consulting and Clinical Psychology 66(6), 914-923.

Jovanovic, T., Norrholm, S. D., Sakoman, A. J., Esterajher, S., & Kozarić-Kovacić, D. (2009). Altered resting psychophysiology and startle response in Croatian combat veterans with PTSD. International Journal of Psychophysiology, 71(3), 264-268.

McTeague, L. M., Lang, P. J., Laplante, M. C., Cuthbert, B. N., Shumen, J. R., & Bradley, M. M. (2010). Aversive imagery in posttraumatic stress disorder: Trauma recurrence, comorbidity, and physiological reactivity. Biological Psychiatry, 67(4), 346-356.

Orr, S. P., Meyerhoff, J. L., Edwards, J. V., & Pitman, R. K. (1998). Heart rate and blood pressure resting levels and responses to generic stressors in Vietnam veterans with posttraumatic stress disorder. Journal of Traumatic Stress, 11(1), 155-164.

Pineles, S. L., Mostoufi, S. M., Ready, C. B., Street, A. E., Griffin, M. G., & Resick, P. A. (2011). Trauma reactivity, avoidant coping, and PTSD symptoms: A moderating relationship? Journal of Abnormal Psychology, 120(1), 240-246.

Pineles, S. L., Suvak, M. K., Liverant, G. I., Gregor, K., Wisco, B. E., Pitman, R. K., & Orr, S. P. (2013). Psychophysiologic reactivity, subjective distress, and their associations with PTSD diagnosis. Journal of Abnormal Psychiatry, 122(3), 635-644.

Pole, N., Neylan, T. C., Otte, C., Metzler, T. J., Best, S. R., Henn-Haase, C., & Marmar, C. R. (2007). Associations between childhood trauma and emotion-modulated psychophysiological responses to startling sounds: A study of police cadets. Journal of Abnormal Psychology, 116(2), 352-361.

Shalev, A. Y., Peri, T., Brandes, D., Freedman, S., Orr, S. P., & Pitman, R. K. (2000). Auditory startle response in trauma survivors with posttraumatic stress disorder: A prospective study. American Journal of Psychiatry, 157(2), 255261.

Zatzick, D. F., Grossman, D. C., Russo, J., Pynoos, R., Berliner, L., Jurkovich, G., Sabin, J. A., Katon, W., Ghesquiere, A., McCauley, E., & Rivara, F. P. (2006). Predicting posttraumatic stress symptoms longitudinally in a representative sample of hospitalized injured adolescents. Journal of the American Academy of Child and Adolescent Psychiatry, 45(10), 1188-1195.

Physical Measurement

None

Requirement Category	Required
Average time of greater than 15 minutes in an unaffected individual	No
Major equipment	No
Specialized requirements for biospecimen collection	No
Specialized training	No

This section will be completed when reviewed by an Expert Review Panel.