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Attention-Bias Modification Treatment for PTSD

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ClinicalTrials.gov Identifier: NCT01888653
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Yuval Y Neria, Research Foundation for Mental Hygiene, Inc.

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder (PTSD) Behavioral: Attention Bias Modification (ABM) Behavioral: Attention control training (ACT) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Attention-Bias Modification Treatment for PTSD
Study Start Date : May 2013
Actual Primary Completion Date : April 2, 2018
Actual Study Completion Date : April 2, 2018

Arm Intervention/treatment
Placebo Comparator: 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
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.
Other Name: ABMT Placebo

Active Comparator: 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.
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.
Other Name: ABMT




Primary Outcome Measures :
  1. PTSD symptoms [ Time Frame: 4 weeks ]
    PTSD symptoms will be assessed by an independent evaluator using the Clinician-Administered PTSD Scale (CAPS), before and after a 4-week (8-sessions) course of either Attention Bias Modification treatment (ABMT) or an inactive placebo treatment


Secondary Outcome Measures :
  1. Attention Bias: the Dot-Probe Task [ Time Frame: 4 weeks ]
    The dot-probe task will be used for the assessment of attention bias at baseline and post-treatment follow up



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888653


Locations
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United States, New York
New York State Psychiatric INstitute
New York, New York, United States, 10032
Sponsors and Collaborators
Research Foundation for Mental Hygiene, Inc.
Investigators
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Principal Investigator: Yuval Neria, PhD Columbia University and the New York State Psychiatric Institute
Additional Information:
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Responsible Party: Yuval Y Neria, Professor of Medical Psychology and Director of Trauma and PTSD, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier: NCT01888653    
Other Study ID Numbers: IRB# 6688
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yuval Y Neria, Research Foundation for Mental Hygiene, Inc.:
PTSD
Attention Bias to threat
Attention Bias Modification Treatment
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders