Approach-Avoidance Conflict-a Multi-level Predictor for Therapy Response

Summary

This project aims to identify brain and behavioral characteristics of individuals experiencing symptoms of generalized anxiety disorder that will predict the effectiveness of Exposure-based therapy versus Behavioral Activation Therapy. Brain imaging aspects of the study will use functional magnetic resonance imaging (fMRI) and electroencephalography (EEG). Behavioral assessments will include self-report questionnaires, computer-based and observational tasks, and interviews. Assessments will focus on how individuals process positive information (such as reward) and negative information (such as distressing images), as well as how people make decisions. These assessments will be conducted across 2-3 in-person sessions prior to beginning the treatment, and will be repeated across 2-3 in-person sessions after completing treatment. A blood draw will also be conducted pre- and post- treatment. Both the Exposure-based and Behavior Activation therapy will consist of 10, 90-minute weekly therapy sessions conducted in small groups.

Conditions

• Generalized Anxiety Disorder

Interventions

BEHAVIORAL

Exposure-based therapy

Exposure-based therapy

BEHAVIORAL

Behavioral Activation therapy

Behavioral Activation therapy

BEHAVIORAL

Computer-based behavioral assessment

Computer-based tasks during which participants respond to images on the screen, including abstract images, emotional faces, and pleasant and unpleasant images.

BEHAVIORAL

Surveys and Interviews

Surveys and interviews in which participants will be asked to answer questions related to their mental and physical health history and current symptoms.

DEVICE

Magnetic resonance imaging (MRI)

Magnetic resonance imaging (MRI) will be used to obtain information concerning the structure of the brain, as well as to assess changes associated with blood flow in the brain while participants are completing behavioral tasks (see description of computer-based behavioral assessment intervention).

DEVICE

Electroencephalography (EEG)

Electroencephalography (EEG) will be used to assess changes in the electrical activity of the brain while participants are completing behavioral tasks (see description of computer-based behavioral assessment intervention).

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Laureate Institute for Brain Research, Inc.

  lead OTHER

Principal Investigators

• Robin L Aupperle, Ph.D. · Laureate Institute for Brain Research

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2021-07-27

Completion

2022-03-04

Countries

• United States

Study Locations