Clinical trial NCT02303691: Attention Bias Modification for Transdiagnostic Anxiety
Official title: Neural Dimensions of Attention Bias Modification for Transdiagnostic Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Anxiety Disorders
Keywords: anxiety
attention bias modification
computer
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-12-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Completer analyses focused on prediction of active ABM outcomes using neural measures. Control arm used for effect size comparisons.
Primary purpose: TREATMENT

Brief summary: This project seeks to identify neural mechanisms underlying the tendency for anxious individuals to pay more attention to threatening information than to other types of information. A computerized treatment designed to train individuals to reduce their attention towards threat will be tested, with a focus on understanding the aspects of brain function that predict response to the treatment. This work could ultimately lead to the ability to treat anxiety more effectively by directly targeting the aspects of brain function that are altered in a given patient.


Eligibility criteria: Inclusion Criteria:

* Participants will:

  1. be between the ages of 18 and 55 years,
  2. score \>45 on the Spielberger State-Trait Anxiety Inventory-trait form.
  3. score \>=75th percentile on the World Health Organization Disability Assessment Schedule 2.0

Exclusion Criteria:

1. Current medication or Cognitive-Behavioral Therapy for anxiety or depression;
2. Failure to meet standard Magnetic Resonance Imaging (MRI) inclusion criteria: those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, Intrauterine Devices, metal braces, or other metal objects in their body, especially in the eye. If the subject has any metal or implants in the body they must be deemed safe by the MRI Research Center's safety screening procedure prior to enrollment. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. Pregnancy, determined by pregnancy tests on females.
3. currently suicidal or at risk for harm to self or others,
4. visual disturbance (\<20/40 as per the Snellen test, corrective lenses allowed)
5. \<6th grade reading level as per the Wide Range Achievement Test
6. presence of bipolar, psychotic, autism spectrum, substance dependence, or primary depressive disorder
7. positive urine drug test

Primary outcomes:
measure: CAPS--Hypervigilance item
timeFrame: 1 month
Secondary outcomes:
measure: Mood and Anxiety Symptoms Questionnaire
timeFrame: 1 month
measure: Mini International Neuropsychiatric Interview (MINI)
timeFrame: 1 month
measure: Attentional bias towards threat (Performance-based assessment of attentional bias towards threat based on reaction times and eye tracking)
timeFrame: immediate
measure: Penn State Worry Questionnaire
timeFrame: 1 month
measure: Liebowitz Social Anxiety Scale
timeFrame: 1 month
measure: World Health Organization Disability Assessment Scale (WHODAS)
timeFrame: 1 month
measure: Speilberger State-Trait Anxiety Inventory
timeFrame: 1 month
measure: Beck Anxiety Inventory
timeFrame: 1 month
Other outcomes:
measure: Functional Magnetic Resonance Imaging
timeFrame: 1 month
measure: Pupillometry
timeFrame: 1 month
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Department of Psychiatry
state: Pennsylvania
Study officials:
References:
citation: Price RB, Cummings L, Gilchrist D, Graur S, Banihashemi L, Kuo SS, Siegle GJ. Towards personalized, brain-based behavioral intervention for transdiagnostic anxiety: Transient neural responses to negative images predict outcomes following a targeted computer-based intervention. J Consult Clin Psychol. 2018 Dec;86(12):1031-1045. doi: 10.1037/ccp0000309.
citation: Price RB, Brown V, Siegle GJ. Computational Modeling Applied to the Dot-Probe Task Yields Improved Reliability and Mechanistic Insights. Biol Psychiatry. 2019 Apr 1;85(7):606-612. doi: 10.1016/j.biopsych.2018.09.022. Epub 2018 Oct 5.