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Attention-Bias Modification Treatment for PTSD

Primary Purpose

Posttraumatic Stress Disorder (PTSD)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attention Bias Modification (ABM)
Attention control training (ACT)
Sponsored by
Research Foundation for Mental Hygiene, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder (PTSD) focused on measuring PTSD, Attention Bias to threat, Attention Bias Modification Treatment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York State Psychiatric INstitute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Comparison-Training-Program

Attention Biased Modification

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Primary Outcome: Clinician Administered PTSD Scale (CAPS)
Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).

Secondary Outcome Measures

Secondary Outcome: PTSD Check List-Civilian (PCL-C)
Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).

Full Information

First Posted
June 25, 2013
Last Updated
February 15, 2022
Sponsor
Research Foundation for Mental Hygiene, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01888653
Brief Title
Attention-Bias Modification Treatment for PTSD
Official Title
Attention-Bias Modification Treatment for PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
April 2, 2018 (Actual)
Study Completion Date
April 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Foundation for Mental Hygiene, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder (PTSD)
Keywords
PTSD, Attention Bias to threat, Attention Bias Modification Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comparison-Training-Program
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Attention Biased Modification
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attention Bias Modification (ABM)
Other Intervention Name(s)
ABMT
Intervention Description
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
Intervention Name(s)
Attention control training (ACT)
Other Intervention Name(s)
ABMT Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Outcome: Clinician Administered PTSD Scale (CAPS)
Description
Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Secondary Outcome: PTSD Check List-Civilian (PCL-C)
Description
Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuval Neria, PhD
Organizational Affiliation
Columbia University and the New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric INstitute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://columbiapsychiatry.org/ptsd
Description
PTSD Program, New York State Psychiatric Institute

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Attention-Bias Modification Treatment for PTSD

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