Information Processing Modification in PTSD (Oct. 18)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nader Amir, San Diego State University
ClinicalTrials.gov Identifier:
NCT00601952
First received: January 15, 2008
Last updated: December 13, 2013
Last verified: July 2009
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Information Processing Modification in PTSD

Resource links provided by NLM:


Further study details as provided by San Diego State University:

Primary Outcome Measures:
  • Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M) [ Time Frame: Pre, Post, Followup ] [ Designated as safety issue: No ]
    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).


Enrollment: 37
Study Start Date: July 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Nader Amir, Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT00601952     History of Changes
Other Study ID Numbers: PT074970, PT074970
Study First Received: January 15, 2008
Results First Received: December 13, 2013
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 21, 2014