DoD PTSD November 13 - Information Processing Modification in the Treatment of PTSD

NCT00604045 | Completed Results DMC

• 1 other identifier: PT075321
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic

Keywords

post traumatic stress disorder; cognitive bias; attention; combat; neuroimaging

Outcome Measures

Primary Outcomes (1)

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

  The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Scores range from 0 to 80, with higher scores indicating more severe symptoms.

  Pre-Treatment, Post-Treatment (after 4 weeks of treatment)

Study Arms (2)

1 Attention Bias Modification (ABM)

EXPERIMENTAL

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.

Behavioral: Attention Bias Modification (ABM)

2 Attention Control Condition (ACC)

PLACEBO COMPARATOR

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.

Behavioral: Attention Control Condition (ACC)

Interventions

Attention Bias Modification (ABM) BEHAVIORAL

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.

1 Attention Bias Modification (ABM)

Attention Control Condition (ACC) BEHAVIORAL

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.

2 Attention Control Condition (ACC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary DSM-IV-TR Axis I diagnosis of post-traumatic stress disorder
• Combat veteran from Iraq and/or Afghanistan

You may not qualify if:

• 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

Sponsors & Collaborators

• San Diego State University: lead

Study Sites (1)

Center for Understanding and Treating Anxiety

San Diego, California, 92120, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Nader Amir
• Organization: San Diego State University/University of California Joint Doctoral Program in Clinical Psychology

namir@mail.sdsu.edu

6192293740

Study Officials

• Nader Amir, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2008
• First Posted: January 29, 2008
• Study Start: May 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 28, 2014
• Results First Posted: March 28, 2014

Record last verified: 2008-01

Locations

US (1)