Trial Outcomes & Findings for DoD PTSD November 13 - Information Processing Modification in the Treatment of PTSD (NCT NCT00604045)
NCT ID: NCT00604045
Last Updated: 2014-03-28
Results Overview
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Scores range from 0 to 80, with higher scores indicating more severe symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Pre-Treatment, Post-Treatment (after 4 weeks of treatment)
Results posted on
2014-03-28
Participant Flow
Participant milestones
| Measure |
1 Attention Bias Modification (ABM)
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)
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
|
15
|
10
|
|
Overall Study
COMPLETED
|
14
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DoD PTSD November 13 - Information Processing Modification in the Treatment of PTSD
Baseline characteristics by cohort
| Measure |
1 Attention Bias Modification (ABM)
n=15 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=10 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=25 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
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
10 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-Treatment, Post-Treatment (after 4 weeks of treatment)The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Scores range from 0 to 80, with higher scores indicating more severe symptoms.
Outcome measures
| 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.
be.
|
2 Attention Control Condition (ACC)
n=9 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
|
63.08 units on a scale
Standard Deviation 9.13
|
61.71 units on a scale
Standard Deviation 9.04
|
|
Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M)
Post-Treatment (after 4 weeks of treatment)
|
42.83 units on a scale
Standard Deviation 12.04
|
51.65 units on a scale
Standard Deviation 14.72
|
Adverse Events
1 Attention Bias Modification (ABM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 Attention Control Condition (ACC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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
Phone: 6192293740
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place