DoD PTSD November 13 - Information Processing Modification in the Treatment of PTSD
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 16, 2008 | ||||
| Last Updated Date | January 28, 2008 | ||||
| Start Date ICMJE | November 2008 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Clinician-Administered PTSD Scale for DSM-IV [ Time Frame: Pre, Post, Followup ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00604045 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Mississippi Scale for Combat Related PTSD (M-PTSD) [ Time Frame: Pre, Post, Followup, Every Other Session ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | DoD PTSD November 13 - Information Processing Modification in the Treatment of PTSD | ||||
| Official Title ICMJE | Information Processing Modification in the Treatment of PTSD | ||||
| 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. |
||||
| 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
||||
| Condition ICMJE | Stress Disorders, Post-Traumatic | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 96 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00604045 | ||||
| Other Study ID Numbers ICMJE | PT075321, PT075321 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Nader Amir, PhD, San Diego State University | ||||
| Study Sponsor ICMJE | San Diego State University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | San Diego State University | ||||
| Verification Date | January 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||