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

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ClinicalTrials.gov Identifier: NCT02807480
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Laureate Institute for Brain Research, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Behavioral: Exposure-based therapy Behavioral: Behavioral Activation therapy Behavioral: Computer-based behavioral assessment Behavioral: Surveys and Interviews Device: Magnetic resonance imaging (MRI) Device: Electroencephalography (EEG) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Approach-Avoidance Conflict-a Multi-level Predictor for Therapy Response
Study Start Date : June 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Exposure-based therapy
Participants will complete 10, 90-minute sessions of Exposure-based therapy, conducted using a group format. Each group will include 8-12 participants. Exposure-based therapy seeks to increase abilities to manage anxiety through repeated practice in facing the situations or thoughts that are the focus of worry or fear. All participants will complete computer-based behavioral assessments, surveys and interviews, functional magnetic resonance imaging (fMRI), and electroencephalography (EEG).
Behavioral: Exposure-based therapy
Exposure-based 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).

Experimental: Behavioral Activation therapy
Participants will complete 10, 90-minute sessions of Behavioral Activation therapy, conducted using a group format. Each group will include 8-12 participants. Behavioral Activation therapy seeks to target behaviors that might maintain or worsen negative mood. All participants will complete computer-based behavioral assessments, surveys and interviews, functional magnetic resonance imaging (fMRI), and electroencephalography (EEG).
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).




Primary Outcome Measures :
  1. For Aim1: Baseline generalized anxiety disorder symptoms as measured by the Generalized Anxiety Disorder - 7 item scale (GAD-7). [ Time Frame: Baseline assessment (one time point) ]
    Test the relationship between imaging and behavioral factors and the level of symptoms at baseline assessment.

  2. For Aims 2 and 3: Change in generalized anxiety disorder symptoms as measured by the Generalized Anxiety Disorder - 7 item scale (GAD-7). [ Time Frame: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment. ]
    Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment.


Secondary Outcome Measures :
  1. Change in anxiety symptoms as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale. [ Time Frame: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment ]
    Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment.

  2. Change in depressive symptoms as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale. [ Time Frame: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment ]
    Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment.

  3. Change in level of disability as measured by the Sheehan Disability Scale [ Time Frame: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment ]
    Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment.

  4. Change in depressive symptoms as measured by the Beck Depression Inventory - II. [ Time Frame: Change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment ]
    Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment.

  5. Change in worry symptoms as measured by the Penn State Worry Questionnaire. [ Time Frame: Change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment ]
    Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: 18-55
  2. All genders
  3. All races
  4. Eligibility as clinically significant anxiety will be determined by:

    • Scoring greater than 7 on the Overall Anxiety Severity and Impairment Scale (OASIS) or greater than 10 on the generalized anxiety disorder 7-item scale (GAD-7) and/or diagnosis of Generalized Anxiety Disorder.
    • Self-report that they are interested in obtaining treatment for anxiety.
    • Anxiety symptoms are the primary disorder of concern.
  5. Able to provide written, informed consent
  6. Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures

Exclusion Criteria:

  1. Has a history of unstable liver or renal insufficiency; glaucoma; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
  2. A history of drug or alcohol abuse in the past 6 months,
  3. Has any of the following diagnostic and statistical manual (DSM-5) disorders:

    • Schizophrenia Spectrum and Other Psychotic Disorders
    • Bipolar and Related Disorders
    • Obsessive-Compulsive and Related Disorders
    • Anorexia or Bulimia Nervosa
    • Substance use disorder within 6 months
  4. Moderate to severe traumatic brain injury (>30 min. loss of consciousness or >24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits, neurological disorders, or severe or unstable medical conditions that might be compromised by participation in the study.
  5. Active suicidal ideation with intent or plan
  6. Current use of a medication that could affect brain functioning (e.g., anxiolytics, antipsychotics, mood stabilizers). However, participants reporting current use of prescribed antidepressants (selective serotonin reuptake inhibitors [SSRIs]) will be included as long as the dose has been stable for 6 weeks prior to enrolling in the study.
  7. Prescription of a medication outside of the accepted range, as determined by the best clinical practices and current research
  8. Taking drugs that affect the fMRI hemodynamic response.
  9. MRI contraindications including: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a professional metal worker/welder, history of eye surgery/eyes washed out because of metal, vision problems uncorrectable with lenses, inability to lie still on one's back for 60-120 minutes; prior neurosurgery; tattoos or cosmetic makeup with metal dyes, unwillingness to remove body piercings, and pregnancy
  10. Unwillingness or inability to complete any of the major aspects of the study protocol, including magnetic resonance imaging (i.e., due to claustrophobia), blood draws, or behavioral assessment. However, failing to complete some individual aspects of these assessment sessions will be acceptable (i.e., being unwilling to answer individual items on some questionnaires or being unwilling to complete a behavioral task)
  11. Non-correctable vision or hearing problems
  12. Report of severe depressive symptoms, as indicated by a score greater than 17 on the Patient Health Questionnaire 9-item (PHQ-9).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807480


Contacts
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Contact: Robin Aupperle, PhD 918-502-5155 neurocatt@laureateinstitute.org
Contact: Robin L Aupperle, Ph.D. 918-502-5744 raupperle@laureateinstitute.org

Locations
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United States, Oklahoma
Laureate Institute for Brain Research Recruiting
Tulsa, Oklahoma, United States, 74008
Sponsors and Collaborators
Laureate Institute for Brain Research, Inc.
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Robin L Aupperle, Ph.D. Laureate Institute for Brain Research

Publications:
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Responsible Party: Laureate Institute for Brain Research, Inc.
ClinicalTrials.gov Identifier: NCT02807480     History of Changes
Other Study ID Numbers: 2015-006-02
1K23MH108707-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders