Trial Outcomes & Findings for Information Processing Modification in PTSD (Oct. 18) (NCT NCT00601952)
NCT ID: NCT00601952
Last Updated: 2014-02-04
Results Overview
The PCL-M is a 17-item questionnaire that assesses the severity of PTSD symptoms using a 5-point Likert scale ranging from "not at all" to "extremely," with a minimum score of 17 and a maximum score of 85 (Weathers, Litz, Herman, Huska, \& Keane, 1993). Participants are asked to rate to what extent they experienced PTSD symptoms over the previous month due to prior combat experiences. The military version of the PCL (PCL-M) refers specifically to a traumatic military related event (Weathers, Litz, Huska, \& Keane, 1994). Research suggests that the PCL-M has good test-retest reliability (r = .70) and internal consistency (alpha = .97; Weathers et al., 1993).
COMPLETED
NA
37 participants
Pre, Post, Followup
2014-02-04
Participant Flow
Participant milestones
| Measure |
1 Attention Bias Modification (ABM)
The ABM comprised a probe detection paradigm, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
|
2 Attention Control Condition (ACC)
The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
17
|
|
Overall Study
COMPLETED
|
12
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Information Processing Modification in PTSD (Oct. 18)
Baseline characteristics by cohort
| Measure |
1 Attention Bias Modification (ABM)
n=14 Participants
The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
|
2 Attention Control Condition (ACC)
n=17 Participants
The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=99 Participants
|
17 participants
n=107 Participants
|
31 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Pre, Post, FollowupThe PCL-M is a 17-item questionnaire that assesses the severity of PTSD symptoms using a 5-point Likert scale ranging from "not at all" to "extremely," with a minimum score of 17 and a maximum score of 85 (Weathers, Litz, Herman, Huska, \& Keane, 1993). Participants are asked to rate to what extent they experienced PTSD symptoms over the previous month due to prior combat experiences. The military version of the PCL (PCL-M) refers specifically to a traumatic military related event (Weathers, Litz, Huska, \& Keane, 1994). Research suggests that the PCL-M has good test-retest reliability (r = .70) and internal consistency (alpha = .97; Weathers et al., 1993).
Outcome measures
| Measure |
1 Attention Bias Modification (ABM)
n=12 Participants
The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
|
2 Attention Control Condition (ACC)
n=17 Participants
The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
|
|---|---|---|
|
Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M)
Pre-Treatment
|
57.14 units on a scale
Standard Deviation 12.48
|
61.33 units on a scale
Standard Deviation 11.09
|
|
Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M)
Post-Treatment
|
52.21 units on a scale
Standard Deviation 18.01
|
53.78 units on a scale
Standard Deviation 18.31
|
Adverse Events
1 Attention Bias Modification (ABM)
2 Attention Control Condition (ACC)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Nader Amir
San Diego State University/University of California Joint Doctoral Program in Clinical Psychology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place