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DoD PTSD November 13 - Information Processing Modification in the Treatment of PTSD
This study is not yet open for participant recruitment.
Verified by San Diego State University, January 2008
Sponsored by: San Diego State University
Information provided by: San Diego State University
ClinicalTrials.gov Identifier: NCT00604045
  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 Modification Program

MedlinePlus related topics: Post-Traumatic Stress Disorder
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment
Official Title: Information Processing Modification in the Treatment of PTSD

Further study details as provided by San Diego State University:

Primary Outcome Measures:
  • Clinician-Administered PTSD Scale for DSM-IV [ Time Frame: Pre, Post, Followup ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mississippi Scale for Combat Related PTSD (M-PTSD) [ Time Frame: Pre, Post, Followup, Every Other Session ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: November 2008
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Behavioral: Attention Modification Program
The AMP protocol includes twelve 30-min sessions delivered over a 6-week period. During each session, participants will see 240 trials consisting of the various combinations of probe type (E or F), probe position (top or bottom), and word type (Neutral or Trauma). Of the 240 trials, 48 include only neutral words: 2 (probe type) X 2 (probe position) X 12 (word pairs). The remaining 192 trials include one neutral word and one trauma word: 2 (probe type) X 2 (probe position) X 2 (repetitions) X 24 (word pairs). On trials where participants see one neutral word and one trauma word (i.e., 80% of the trials), the probe always follows the neutral word.
2: Placebo Comparator Behavioral: Attention Modification Program
The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat word is present, the probe will appear with equal frequency in the position of threat and neutral words. Thus, neither threat nor neutral words have signal value with regard to the position of the probe.

Detailed Description:

Thirty percent of returning veterans present with mental health problems with Posttraumatic stress disorder (PTSD) as the most common problem in this group (52% of overall diagnoses). This translates into PTSD prevalence rates of 12% in Afghani veterans and 19% for Iraqi veterans, rates that are two to three times higher than the overall lifetime prevalence rate in the general population (8%). Moreover, 70% have not received any mental health services. Thus the majority are not receiving any help. Those with PTSD are likely to experience problems across several life domains including higher rates of divorce, problems raising children, and engaging in domestic violence. They are also more likely to suffer from other mental health problems including depression, substance abuse, and generalized anxiety disorder. Forty four percent of individuals with PTSD do not respond to psychosocial and pharmacological treatments. Thus, there is a clear need to develop highly effective and efficient treatments for PTSD. Researchers have established a relationship between PTSD and difficulty disengaging attention from threat relevant information. This knowledge; however, has not been translated into more effective treatments for this disorder. This five-year proposal aims to test a computerized treatment for PTSD in a double-blind, placebo-controlled study that would bridge research on attention bias and treatment development. Those in the active condition will receive a computer-delivered attention modification program (AMP) designed to enhance attention disengagement from threatening stimuli. The AMP protocol includes six weeks of biweekly sessions in which participants see 240 trials consisting of the various combinations of probe type (E or F), probe position (top or bottom), and word type (Neutral or Trauma). Of the 240 trials, 48 include only neutral words: 2 (probe type) X 2 (probe position) X 12 (word pairs). The remaining 192 trials include one neutral word and one trauma word: 2 (probe type) X 2 (probe position) X 2 (repetitions) X 24 (word pairs). On trials where participants see one neutral word and one trauma word (i.e., 80% of the trials), the probe always follows the neutral word. Thus, although there is no specific instruction to direct attention away from threat word, on 80% of the trials the position of the threat word indicates the position of the probe (i.e., in the location opposite the threat word). The placebo condition (PC) will be identical to the AMP condition except that during the presentation of threat/neutral word pairs, the probe will appear with equal frequency in the position of threat and neutral words. Thus, neither threat nor neutral words have signal value. We have used this intervention to successfully establish a pattern of enhanced attention disengagement to threat words in 3 studies. We present the results from 3 clinical trials demonstrating the efficacy of attention modification programs (AMP) in ameliorating symptoms of anxiety. Specifically, we report results from studies of individuals with generalized social phobia (GSP; n=53) and generalized anxiety disorder (GAD; n=24) demonstrating the effectiveness of the procedures described in this proposal. In brief, our intervention was effective in: a) changing biased attention, b) reducing clinical symptoms of anxiety, c) maintaining its effects in up to one year follow-up. This efficient and efficacious technique for changing attention bias in anxiety can provide a low cost, easy to administer treatment that is grounded in basic cognitive science that may help reduce suffering in individuals with anxiety. The goal of the current proposal is to extend these findings to the highly related disorder of PTSD, and to examine the generalizability of the results to individuals with comorbid conditions. In the current proposal we will test two hypotheses: 1) Individuals with PTSD completing the AMP will show a larger reduction in their attention bias to threat compared to the placebo group, 2) Individuals with PTSD completing AMP will show a larger reduction in anxiety symptoms compared to the placebo group.

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604045

Contacts
Contact: Nader Amir, PhD 619 229-3740 namir@mail.sdsu.edu

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

Responsible Party: San Diego State University ( Nader Amir, PhD )
Study ID Numbers: PT075321, PT075321
Study First Received: January 16, 2008
Last Updated: January 28, 2008
ClinicalTrials.gov Identifier: NCT00604045  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on January 14, 2009