Attention-Bias Modification Treatment for PTSD

NCT ID: NCT01888653

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2018-04-02

Brief 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.

Detailed 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.

Conditions

Posttraumatic Stress Disorder (PTSD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Comparison-Training-Program

Placebo-training program: attention control training (ACT), is identical to the ABM protocol except that during the presentation of the trials where a threat word is presented, the probe will appear with equal frequency in the position of the threat and neutral word. Thus, neither threat nor neutral words provide information regarding the position of the target probe, and there is no contingency between the position of either threat or neutral words, and the position of the probes

Group Type: PLACEBO_COMPARATOR

Attention control training (ACT)

Intervention Type: 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.

Attention Biased Modification

Attention-bias-modification treatment (ABM) is designed to implicitly modify patients' biased threat attendance via computerized training protocols. During each session, 240 trials (80 neutral-neutral pairs, 160 threat-neutral pairs) will be presented. On trials where participants see one neutral word and one threat word, the probe will always follow the neutral word location. Thus, although there is no specific instruction to direct attention away from threat words, on 66% of all trials (and 100% of the threat-neutral trials) the position of the neutral word will indicate the position of the target probe.

Group Type: ACTIVE_COMPARATOR

Attention Bias Modification (ABM)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

ABMT; ABMT Placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Foundation for Mental Hygiene, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Yuval Y Neria

Professor of Medical Psychology and Director of Trauma and PTSD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuval Neria, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University and the New York State Psychiatric Institute

Locations

New York State Psychiatric INstitute

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://columbiapsychiatry.org/ptsd

PTSD Program, New York State Psychiatric Institute

Other Identifiers

IRB# 6688

Identifier Type: -

Identifier Source: org_study_id