Attention Bias Modification for Transdiagnostic Anxiety

Anxiety Clinical Trial

Official title:

Neural Dimensions of Attention Bias Modification for Transdiagnostic Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02303691
• Other study ID #: 5K23MH100259
• Status: Completed
• Phase: N/A
• First received: November 25, 2014
• Last updated: March 6, 2018
• Start date: April 2013
• Est. completion date: January 2018

Study information

• Verified date: March 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Attention Bias Modification
Excessive attention to threat is theorized to be a critical contributor to chronic anxiety symptoms and related negative health consequences. Attention Bias Modification, which directly targets this mechanism, is a highly cost-effective intervention with growing empirical support for its potential efficacy in clinically anxious populations.
• Neutral Training
A control version of computerized attention training.

Locations

Country	Name	City	State
United States	University of Pittsburgh Department of Psychiatry	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional Magnetic Resonance Imaging	(collected post-treatment in subsample of active arm only)	1 month
Other	Pupillometry		1 month
Primary	CAPS--Hypervigilance item		1 month
Secondary	Mood and Anxiety Symptoms Questionnaire		1 month
Secondary	Mini International Neuropsychiatric Interview (MINI)		1 month
Secondary	Attentional bias towards threat (Performance-based assessment of attentional bias towards threat based on reaction times and eye tracking)	Performance-based assessment of attentional bias towards threat based on reaction times and eye tracking	immediate
Secondary	Penn State Worry Questionnaire		1 month
Secondary	Liebowitz Social Anxiety Scale		1 month
Secondary	World Health Organization Disability Assessment Scale (WHODAS)		1 month
Secondary	Speilberger State-Trait Anxiety Inventory		1 month
Secondary	Beck Anxiety Inventory		1 month

External Links

•   NIH reporter page for NIMH K23 award