CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 121 enrolled
Drug / intervention
Exposure-based therapy +5 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02807480
NCT02807480N/ACompleted

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

Laureate Institute for Brain Research, Inc.·interventional·Posted Jun 21, 2016·Updated Mar 26, 2024

In Brief

A clinical study evaluating Exposure-based therapy, Behavioral Activation therapy, and 4 other interventions for Generalized Anxiety Disorder. Completed, enrolled 121 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 21, 2016
Enrollment StartJun 1, 2016
Primary CompletionJul 27, 2021
Study CompletionMar 4, 2022
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 10.0 years ago

Interventions

Exposure-based therapybehavioral

Exposure-based therapy

Behavioral Activation therapybehavioral

Behavioral Activation therapy

Computer-based behavioral assessmentbehavioral

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

Surveys and Interviewsbehavioral

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

Magnetic resonance imaging (MRI)device

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).

Electroencephalography (EEG)device

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).