N/A
N=94
Approach-Avoidance Conflict-a Multi-level Predictor for Therapy Response
Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02807480 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: For Aim1: Baseline Generalized Anxiety Disorder Symptoms as Measured by the Generalized Anxiety Disorder - 7 Item Scale (GAD-7). — 12.85; 11.62 units on a scale — p=.088
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exposure-based therapy (Behavioral); Behavioral Activation therapy (Behavioral); Computer-based behavioral assessment (Behavioral); Surveys and Interviews (Behavioral); Magnetic resonance imaging (MRI) (Device); Electroencephalography (EEG) (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laureate Institute for Brain Research, Inc.
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY For Aim1: Baseline Generalized Anxiety Disorder Symptoms as Measured by the Generalized Anxiety Disorder - 7 Item Scale (GAD-7). |
12.85; 11.62 | .088 |
| PRIMARY For Aims 2 and 3: Change in Generalized Anxiety Disorder Symptoms as Measured by the Generalized Anxiety Disorder - 7 Item Scale (GAD-7). |
8.48; 5.90 | .007 sig |
| SECONDARY Change in Anxiety Symptoms as Measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale. |
60.68; 55.98 | 0.006 sig |
| SECONDARY Change in Depressive Symptoms as Measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale. |
53.70; 52.12 | 0.001 sig |
| SECONDARY Change in Level of Disability as Measured by the Sheehan Disability Scale |
8.93; 5.36 | 0.028 sig |
| SECONDARY Worry Symptoms as Measured by the Penn State Worry Questionnaire |
64.26; 56.29 | .276 |
| SECONDARY Depressive Symptoms as Measured by the Beck Depression Inventory - II. |
13.56; 9.68 | .357 |
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.
Eligibility Criteria
Inclusion Criteria
- Age: 18-55
- All genders
- All races
- 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.
- Able to provide written, informed consent
- Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures
Exclusion Criteria
- 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.
- A history of drug or alcohol abuse in the past 6 months,
- 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
- 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.
- Active suicidal ideation with intent or plan
- 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.
- Prescription of a medication outside of the accepted range, as determined by the best clinical practices and current research
- Taking drugs that affect the fMRI hemodynamic response.
- 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
- 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)
- Non-correctable vision or hearing problems
- Report of severe depressive symptoms, as indicated by a score greater than 17 on the Patient Health Questionnaire 9-item (PHQ-9).
Data sourced from ClinicalTrials.gov (NCT02807480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.