Attention-Bias Modification Treatment for PTSD

NCT01888653 | Completed Results

• 1 other identifier: IRB# 6688
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

PTSD; Attention Bias to threat; Attention Bias Modification Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  4 weeks

Study Arms (2)

Comparison-Training-Program

PLACEBO COMPARATOR

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)

Attention Biased Modification

ACTIVE COMPARATOR

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)

Interventions

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.

Also known as: ABMT

Attention Biased Modification

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.

Also known as: ABMT Placebo

Comparison-Training-Program

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Foundation for Mental Hygiene, Inc.: lead

Study Sites (1)

New York State Psychiatric INstitute

New York, New York, 10032, United States

Location

Related Links

• PTSD Program, New York State Psychiatric Institute

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

While ACT is designed to train attention control in the context of attentional threat deployment, we did not directly assess attention control, and hence cannot conclusively determine that it was indeed enhanced in the ACT group.

Results Point of Contact

• Title: Yuval Neria
• Organization: Columbia University Medical Center/New York State Psychiatric Institute

yuval.neria@nyspi.columbia.edu

6467748092

Study Officials

• Yuval Neria, PhD

  Columbia University and the New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical Psychology and Director of Trauma and PTSD

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: June 28, 2013
• Study Start: May 1, 2013
• Primary Completion: April 2, 2018
• Study Completion: April 2, 2018
• Last Updated: April 13, 2022
• Results First Posted: April 13, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)