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Information Processing Modification in PTSD (Oct. 18)

Primary Purpose

Stress Disorders, Post-traumatic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attention Bias Modification (ABM)
Attention Control Condition (ACC)
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-traumatic focused on measuring post traumatic stress disorder, cognitive bias, attention, combat

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Understanding and Treating Anxiety

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1 Attention Bias Modification (ABM)

2 Attention Control Condition (ACC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M)
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).

Secondary Outcome Measures

Full Information

First Posted
January 15, 2008
Last Updated
December 13, 2013
Sponsor
San Diego State University
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1. Study Identification

Unique Protocol Identification Number
NCT00601952
Brief Title
Information Processing Modification in PTSD (Oct. 18)
Official Title
Information Processing Modification in PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) in Afghanistan are the largest sustained ground operations since the Vietnam War, and the psychological effects of combat on military personnel can be devastating. Approximately thirty percent of returning veterans present with mental health problems. Posttraumatic stress disorder (PTSD) is 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%). Of those veterans screened positive for mental health problems 70% have not received any mental health services. Therefore, even for individuals identified as having psychological problems the majority are not receiving any help. Prevention and treatment of this disorder represents one of the greatest challenges facing government officials and health care professionals working with combat veteran populations. PTSD often manifests after the experience of a trauma in which individuals undergo threat of injury or death to themselves or others. The experience includes intense feelings of fear, helplessness, and/or horror. Symptoms of this disorder are often chronic lasting for years. 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. Moreover, they tend to report less life satisfaction, experience poorer physical health, earn less money, and change jobs frequently. Although effective treatments do exist for PTSD, as many as 44% of individuals 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 inforamtion. This knowledge; however, has not been translated into more effective treatments for this disorder. This three-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 a very similar training procedure to successfully establish a pattern of enhanced attention disengagement to threat words in our pilot studies. We present the results from 2 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=32) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-traumatic
Keywords
post traumatic stress disorder, cognitive bias, attention, combat

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Attention Bias Modification (ABM)
Arm Type
Experimental
Arm Description
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.
Arm Title
2 Attention Control Condition (ACC)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attention Bias Modification (ABM)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attention Control Condition (ACC)
Intervention Description
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 Measure Information:
Title
Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M)
Description
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).
Time Frame
Pre, Post, Followup

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nader Amir, PhD
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Understanding and Treating Anxiety
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States

12. IPD Sharing Statement

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Information Processing Modification in PTSD (Oct. 18)

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