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DoD PTSD November 13 - Information Processing Modification in the Treatment of PTSD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nader Amir, San Diego State University
ClinicalTrials.gov Identifier:
NCT00604045
First received: January 16, 2008
Last updated: February 11, 2014
Last verified: January 2008
Results First Received: December 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Stress Disorders, Post-Traumatic
Interventions: Behavioral: Attention Bias Modification (ABM)
Behavioral: Attention Control Condition (ACC)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    1 Attention Bias Modification (ABM)   2 Attention Control Condition (ACC)
STARTED   15   10 
COMPLETED   14   9 
NOT COMPLETED   1   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   1 Attention Bias Modification (ABM)   2 Attention Control Condition (ACC)   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   10   25 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   15   10   25 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   1   1   2 
Male   14   9   23 
Region of Enrollment 
[Units: Participants]
     
United States   15   10   25 


  Outcome Measures

1.  Primary:   Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M)   [ Time Frame: Pre-Treatment, Post-Treatment (after 4 weeks of treatment) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Nader Amir
Organization: San Diego State University/University of California Joint Doctoral Program in Clinical Psychology
phone: 6192293740
e-mail: namir@mail.sdsu.edu



Responsible Party: Nader Amir, San Diego State University
ClinicalTrials.gov Identifier: NCT00604045     History of Changes
Other Study ID Numbers: PT075321
PT075321 ( Other Identifier: Department of Defense )
Study First Received: January 16, 2008
Results First Received: December 13, 2013
Last Updated: February 11, 2014