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Attention Bias Modification for Transdiagnostic Anxiety

Primary Purpose

Anxiety, Anxiety Disorders

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Attention Bias Modification

Neutral Training

About this trial

This is an interventional treatment trial for Anxiety focused on measuring anxiety, attention bias modification, computer

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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:

Current medication or Cognitive-Behavioral Therapy for anxiety or depression;
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.
currently suicidal or at risk for harm to self or others,
visual disturbance (<20/40 as per the Snellen test, corrective lenses allowed)
<6th grade reading level as per the Wide Range Achievement Test
presence of bipolar, psychotic, autism spectrum, substance dependence, or primary depressive disorder
positive urine drug test

Sites / Locations

University of Pittsburgh Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Computerized Attention Bias Modification

Computerized Neutral Training

Arm Description

Outcomes

Primary Outcome Measures

CAPS--Hypervigilance item

Secondary Outcome Measures

Mood and Anxiety Symptoms Questionnaire

Mini International Neuropsychiatric Interview (MINI)

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

Penn State Worry Questionnaire

Liebowitz Social Anxiety Scale

World Health Organization Disability Assessment Scale (WHODAS)

Speilberger State-Trait Anxiety Inventory

Beck Anxiety Inventory

Full Information

NCT ID

NCT02303691

First Posted

November 25, 2014

Last Updated

March 6, 2018

Sponsor

University of Pittsburgh

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT02303691

Brief Title

Attention Bias Modification for Transdiagnostic Anxiety

Official Title

Neural Dimensions of Attention Bias Modification for Transdiagnostic Anxiety

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Anxiety Disorders

Keywords

anxiety, attention bias modification, computer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Completer analyses focused on prediction of active ABM outcomes using neural measures. Control arm used for effect size comparisons.

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Computerized Attention Bias Modification

Arm Type

Experimental

Arm Title

Computerized Neutral Training

Arm Type

Sham Comparator

Intervention Type

Behavioral

Intervention Name(s)

Attention Bias Modification

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Neutral Training

Intervention Description

A control version of computerized attention training.

Primary Outcome Measure Information:

Title

CAPS--Hypervigilance item

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Mood and Anxiety Symptoms Questionnaire

Time Frame

1 month

Title

Mini International Neuropsychiatric Interview (MINI)

Time Frame

1 month

Title

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

Description

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

Time Frame

immediate

Title

Penn State Worry Questionnaire

Time Frame

1 month

Title

Liebowitz Social Anxiety Scale

Time Frame

1 month

Title

World Health Organization Disability Assessment Scale (WHODAS)

Time Frame

1 month

Title

Speilberger State-Trait Anxiety Inventory

Time Frame

1 month

Title

Beck Anxiety Inventory

Time Frame

1 month

Other Pre-specified Outcome Measures:

Title

Functional Magnetic Resonance Imaging

Description

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

Time Frame

1 month

Title

Pupillometry

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants will: be between the ages of 18 and 55 years, score >45 on the Spielberger State-Trait Anxiety Inventory-trait form. score >=75th percentile on the World Health Organization Disability Assessment Schedule 2.0 Exclusion Criteria: Current medication or Cognitive-Behavioral Therapy for anxiety or depression; 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. currently suicidal or at risk for harm to self or others, visual disturbance (<20/40 as per the Snellen test, corrective lenses allowed) <6th grade reading level as per the Wide Range Achievement Test presence of bipolar, psychotic, autism spectrum, substance dependence, or primary depressive disorder positive urine drug test

Facility Information:

Facility Name

University of Pittsburgh Department of Psychiatry

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30507228

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.

Results Reference

derived

PubMed Identifier

30449531

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.

Results Reference

derived

Links:

URL

https://projectreporter.nih.gov/project_info_description.cfm?aid=9198058&icde=33613833&ddparam=&ddvalue=&ddsub=&cr=1&csb=default&cs=ASC&pball=

Description

NIH reporter page for NIMH K23 award

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Attention Bias Modification for Transdiagnostic Anxiety

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