Attention Bias Modification for Transdiagnostic Anxiety

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT02303691
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 57
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety; Anxiety Disorders	Behavioral: Attention Bias Modification; Behavioral: Neutral Training	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Completer analyses focused on prediction of active ABM outcomes using neural measures. Control arm used for effect size comparisons.Completer analyses focused on prediction of active ABM outcomes using neural measures. Control arm used for effect size comparisons.
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Neural Dimensions of Attention Bias Modification for Transdiagnostic Anxiety
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Computerized Attention Bias Modification	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.
Sham Comparator: Computerized Neutral Training	Behavioral: Neutral Training; A control version of computerized attention training.

Outcome Measures

Primary Outcome Measures

1. CAPS--Hypervigilance item [1 month]

Secondary Outcome Measures

1. Mood and Anxiety Symptoms Questionnaire [1 month]

2. Mini International Neuropsychiatric Interview (MINI) [1 month]

3. Attentional bias towards threat (Performance-based assessment of attentional bias towards threat based on reaction times and eye tracking) [immediate]

   Performance-based assessment of attentional bias towards threat based on reaction times and eye tracking

4. Penn State Worry Questionnaire [1 month]

5. Liebowitz Social Anxiety Scale [1 month]

6. World Health Organization Disability Assessment Scale (WHODAS) [1 month]

7. Speilberger State-Trait Anxiety Inventory [1 month]

8. Beck Anxiety Inventory [1 month]

Other Outcome Measures

1. Functional Magnetic Resonance Imaging [1 month]

   (collected post-treatment in subsample of active arm only)

2. Pupillometry [1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Department of Psychiatry	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh
• National Institute of Mental Health (NIMH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• NIH reporter page for NIMH K23 award

Publications

None provided.

• Responsible Party: Rebecca Price, PhD, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02303691
• Other Study ID Numbers: 5K23MH100259
• First Posted: Dec 1, 2014
• Last Update Posted: Mar 8, 2018
• Last Verified: Mar 1, 2018

• Keywords provided by Rebecca Price, PhD, University of Pittsburgh: anxiety; attention bias modification; computer
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Mar 8, 2018