Attention-Bias Modification Treatment for PTSD

Posttraumatic Stress Disorder (PTSD) Clinical Trial

Official title:

Attention-Bias Modification Treatment for PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01888653
• Other study ID #: IRB# 6688
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: April 2, 2018

Study information

• Verified date: February 2022
• Source: Research Foundation for Mental Hygiene, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Emerging research implicates biased attention to threat in the pathophysiology of anxiety disorders. Recent findings demonstrate significant associations between attention bias and stress vulnerability. This work has motivated the development of a novel therapy, attention-bias-modification (ABM) treatment . ABM is designed to implicitly modify patients' biased threat attendance via computerized training protocols. Emerging evidence indicates that ABM is effective in modifying threat-related attention biases and in ameliorating anxiety symptoms. However, it is unclear whether ABM is efficacious for posttraumatic stress disorder (PTSD). The present pilot study is a double blind trial that seeks to examine feasibility, acceptability, safety, efficacy, and risk/benefit ratio of ABM in individuals with PTSD. In addition this pilot study seeks to identify specific genes associated with anxiety disorders and to examine whether these can predict the success of the ABM.

Description:

ABM is designed to implicitly modify patients' biased threat attendance via computerized training protocols. Emerging evidence indicates that ABM is effective in modifying threat-related attention biases and in ameliorating anxiety symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2, 2018
• Est. primary completion date: April 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Males or females between the ages of 18 and 60;

• Current DSM-IV PTSD for the last 12 months or more;

• Fluent in English and willing and able to give informed written consent and participate responsibly in the protocol;

• Attention bias toward or away from threat assessed by Dot-probe attention bias task

Exclusion Criteria:

• Current DSM-IV Axis I disorder other than PTSD.

• Patients with comorbid (i.e., secondary diagnosis of) major depressive disorder (MDD) will be allowed for enrollment if their HAM-D score doesn't exceed 25;

• Prior or current diagnosis of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial, schizotypal, and schizoid personality disorders;

• Suicidal ideation or behavior that poses a significant danger to the subject. Unstable clinical condition such that participation in a controlled trial would pose a significant danger;

• Prior participation in attention bias modification treatment (ABMT);

• Current or past history of seizure disorder (except febrile seizure in childhood);

• Currently on psychotropic medication. (excluding the use of hypnotics);

• Currently participating in formal psychotherapy. This includes:

• psychodynamic,

• cognitive behavioral and interpersonal therapies

• Current unstable or untreated medical illness;

• Vision loss.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Attention Bias Modification (ABM)
The training protocol consisted of 160 trials per session with 120 angry-neutral and 40 neutral-neutral trials. Each participant was trained with an alternative set of faces to the one used in the assessment task (i.e. if measured with set A then trained with set B and vice-versa). In the ABM condition, training was contin- gent on the bias measured at pre-treatment. Specifically, for those showing a bias toward the threat, the target appeared at the neutral-face location in 100% of the threat-neutral trials, while for those showing a bias away from the threat, the target appeared at the threat-face location in 100% of the threat-neutral trials.
• Attention control training (ACT)
In the ACT condition, threat- face location, probe location, and probe type were fully counter- balanced with no contingency between face valence and probe location, thus resembling the assessment task.

Locations

Country	Name	City	State
United States	New York State Psychiatric INstitute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Research Foundation for Mental Hygiene, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome: Clinician Administered PTSD Scale (CAPS)	Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).	4 weeks
Secondary	Secondary Outcome: PTSD Check List-Civilian (PCL-C)	Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).	4 weeks

External Links

•   PTSD Program, New York State Psychiatric Institute