Attention Bias Modification Treatment for Warzone-Related Posttraumatic Stress Disorder (PTSD)

Posttraumatic Stress Disorder Clinical Trial

Official title:

Attention Bias Modification Treatment for Warzone-Related PTSD: A Randomized Clinical Trial Magnetoencephalography Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564667
• Other study ID #: 11-16311
• Status: Completed
• Phase: N/A
• First received: March 26, 2012
• Last updated: January 13, 2016
• Start date: April 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Veterans with Posttraumatic Stress Disorder (PTSD) will be randomly assigned to either Attention Bias Modification Treatment (ABMT) designed to reduce bias toward threat or a placebo control condition not designed to change attention patterns. Outcome measures will be PTSD, anxiety, depression, and alexithymia symptoms as measured by standard psychological interviews and questionnaires. Participants will also be invited to participate in physiological testing before and after receiving AMBT or placebo to serve as additional outcome measures and assess brain functioning, heart rate, and muscle tension.

The investigators expect to see significant PTSD symptom reduction in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group in which no symptomatic relief is expected. At the end of the study, if ABMT is shown to be effective, we will offer active ABMT to those participants randomly assigned to the placebo arm if they would like to receive the treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• Veterans with Posttraumatic Stress Disorder (PTSD) serving in United States Military after March 20, 2003.

Exclusion Criteria:

• Schizophrenia

• Bipolar Disorder

• Obsessive Compulsive Disorder

• Head Injury with Loss of Consciousness for more than 30 minutes

• Active Alcohol/Substance Dependence in past 6 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Attention Bias Modification Training Protocol
Attention Bias Modification computerized training sessions administered 2 times per week for 4 weeks making a total of 8 training sessions.

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	At Ease USA

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hakamata Y, Lissek S, Bar-Haim Y, Britton JC, Fox NA, Leibenluft E, Ernst M, Pine DS. Attention bias modification treatment: a meta-analysis toward the establishment of novel treatment for anxiety. Biol Psychiatry. 2010 Dec 1;68(11):982-90. doi: 10.1016/j.biopsych.2010.07.021. Erratum in: Biol Psychiatry. 2012 Sep 1;72(5):429. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Will Posttraumatic Stress Disorder and Symptom decrease with intervention	Using Clinician-Administered PTSD Scale (CAPS): The clinician-Administered PTSD Scale (CAPS) is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD (Blake, Weathers, Nagy, Kaloupek, Charney, & Keane, 1995) to assess symptoms of PTSD outcome.	8 weeks	No
Secondary	Other psychiatics symptoms (ie Depression, Anger, Anxiety)	To assess potential decrease in psychiatric symptoms associated with PTSD, by comparing pre intervention and post intervention scores on psychological measures of deprssion, anger and anxiety.	8 weeks	No