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Information Processing Modification in PTSD (Oct. 18)

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ClinicalTrials.gov Identifier: NCT00601952
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : February 4, 2014
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
Nader Amir, San Diego State University

Brief Summary:
The purpose of this study is to determine whether a computerized intervention designed to change the nature of attention biases will be effective in reducing the symptoms of post traumatic stress disorder (PTSD) in American combat veterans returning from the wars in Afghanistan and Iraq.

Condition or disease Intervention/treatment
Stress Disorders, Post-traumatic Behavioral: Attention Bias Modification (ABM) Behavioral: Attention Control Condition (ACC)

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Information Processing Modification in PTSD
Study Start Date : July 2012
Primary Completion Date : July 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.
Placebo Comparator: 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.
Behavioral: 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.



Primary Outcome Measures :
  1. Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M) [ Time Frame: Pre, Post, Followup ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary DSM-IV-TR Axis I diagnosis of post-traumatic stress disorder
  • Combat veteran from Iraq and/or Afghanistan

Exclusion Criteria:

  • No change in medication type or dose during the twelve weeks prior to treatment
  • No current psychotherapy
  • No evidence of suicidal intent
  • No evidence of current substance dependence in the past 6 months
  • No evidence of current or past schizophrenia, bipolar disorder, or organic mental disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601952


Locations
United States, California
Center for Understanding and Treating Anxiety
San Diego, California, United States, 92120
Sponsors and Collaborators
San Diego State University
Investigators
Principal Investigator: Nader Amir, PhD San Diego State University

Responsible Party: Nader Amir, Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT00601952     History of Changes
Other Study ID Numbers: PT074970
PT074970 ( Other Identifier: Department of Defense )
First Posted: January 28, 2008    Key Record Dates
Results First Posted: February 4, 2014
Last Update Posted: February 4, 2014
Last Verified: July 2009

Keywords provided by Nader Amir, San Diego State University:
post traumatic stress disorder
cognitive bias
attention
combat

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders