Information Processing Modification in PTSD (Oct. 18) - Full Text View

Sponsored by:	San Diego State University
Information provided by:	San Diego State University
ClinicalTrials.gov Identifier:	NCT00601952

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 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:	72
Study Start Date:	November 2008
Estimated Primary Completion Date:	November 2011 (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.

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.

Show Detailed Description

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: NCT00601952

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

No publications provided

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

Keywords provided by San Diego State University:

post traumatic stress disorder
cognitive bias
attention
combat

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on May 06, 2009