Clinical trial NCT01888653: Attention-Bias Modification Treatment for PTSD
Official title: Attention-Bias Modification Treatment for PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD)
Keywords: PTSD
Attention Bias to threat
Attention Bias Modification Treatment
Lead sponsor: Research Foundation for Mental Hygiene, Inc.
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Primary Outcome: Clinician Administered PTSD Scale (CAPS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Secondary Outcome: PTSD Check List-Civilian (PCL-C)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric INstitute
state: New York
Study officials:
affiliation: Columbia University and the New York State Psychiatric Institute
name: Yuval Neria, PhD
role: PRINCIPAL_INVESTIGATOR
References: