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View Clinical Trial (Medical Research Study)
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DoD PTSD November 13 - Information Processing Modification in the Treatment of PTSD - NCT00604045-92120 (Clinical Trial 200901)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy200901.aspx
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| City: |
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San Diego |
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State:
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CA |
| Zip Code: |
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92120 |
| Conditions: |
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Stress Disorders, Post-Traumatic |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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Center for Understanding and Treating Anxiety
San Diego, CA 92120
United States
Primary Contact:
Nader Amir, PhD
Email: namir@mail.sdsu.edu
Phone: 619 229-3740 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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