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Completed

NCT Number: NCT01888653

Attention-Bias Modification Treatment for PTSD

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.

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Key information

Conditions

Posttraumatic Stress Disorder (PTSD) Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York State Psychiatric INstitute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Attention Bias Modification (ABM)

Behavioral

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.

Other names: ABMT

Attention control training (ACT)

Behavioral

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.

Other names: ABMT Placebo

Primary outcomes

  1. Primary Outcome: Clinician Administered PTSD Scale (CAPS)

    Time frame: 4 weeks

    Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).

Secondary outcomes

  1. Secondary Outcome: PTSD Check List-Civilian (PCL-C)

    Time frame: 4 weeks

    Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).

Sponsors and collaborators

Lead sponsor

Research Foundation for Mental Hygiene, Inc.

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jun 28, 2013
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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