NCT04426461 Approach-Avoidance, Computational Framework for Predicting Behavioral Therapy Outcome (AAC-BeT)
| NCT ID | NCT04426461 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laureate Institute for Brain Research, Inc. |
| Condition | Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2020-09-11 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2020-09-11 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Depression and anxiety disorders rank in the top ten causes of years lived with disability. Less than 50% of patients experiencing long-lasting improvements to current gold-standard treatments. Two gold-standard behavioral interventions include behavioral activation, focused on enhancing approach behavior towards meaningful activities, and exposure-based therapy, focused on decreasing avoidance and challenging negative expectations. While these interventions have divergent treatment targets, there is little knowledge to inform which strategies should be used in the frequent case of comorbid anxiety and depression. Approach-avoidance decision-making paradigms focus on assessing responses when faced with potential rewards and threats, tapping into processes important for both anxiety and depression as well as behavioral activation and exposure-based therapy. For this study, investigators will recruit individuals reporting both anxiety and depression symptoms and randomize them to one of three different interventions: (1) behavioral activation, (2) exposure-based therapy, and a non-specific therapy approach (3) supportive therapy. Participants will complete clinical, self-report, behavioral, and functional magnetic resonance imaging (fMRI) assessments before and after therapy. Investigators will use a computational approach to model factors that may influence one's behavior during approach-avoidance decision-making, including drives to avoid threat versus approach reward and confidence versus uncertainty in one's decisions. This project will accomplish the following aims (1) Determine how changes in brain and behavior responses during approach-avoidance conflict relate to changes in mental health symptoms with the different therapy approaches, (2) Determine the degree to which baseline brain and behavior responses during approach-avoidance conflict predict response to the different therapy approaches, above and beyond the influence of demographics and baseline symptom severity. In addition, by including peripheral blood draws and measures of grace matter volume, the project will also accomplish the following aims: (1) Determine whether kynrenine metabolites measures peripherally may be beneficial as a biomarker of treatment response and (2) determine whether there is an association between change in kynurenine metabolites and changes in gray matter volume with treatment. Results will enhance understanding of how different psychotherapy approaches (behavioral activation, exposure-based therapy) may impact brain responses and decisions when faces with potential reward versus threat and approach versus avoidance drives. In addition, results will have important implications concerning the potential for a more personalized approach to psychotherapy, enhancing knowledge of which types of therapy strategies may be most beneficial for which individuals.
Eligibility Criteria
Inclusion Criteria: * score \>55 on both the PROMIS Anxiety and PROMIS Depression scales * score \>5 on any one item of the SDS * able to provide informed consent * report of anxiety and depressive symptoms as areas of clinical concern * sufficient English proficiency to complete procedures. Exclusion Criteria: * significant or unstable physical or mental health conditions (e.g., immediate suicidal intent) requiring medical attention * history of bipolar, psychotic, cognitive, obsessive compulsive disorder, posttraumatic stress disorder (PTSD) * history of moderate to severe substance use disorder over the past year * diagnosis of neurologic disorders * MRI contra-indications (e.g., metal in body) * uncorrected vision/hearing problems * current, regular benzodiazepine use
Contact & Investigator
Robin L Aupperle, PhD
PRINCIPAL INVESTIGATOR
Laureate Institute for Brain Research
Frequently Asked Questions
Who can join the NCT04426461 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04426461 currently recruiting?
Yes, NCT04426461 is actively recruiting participants. Contact the research team at neurocatt@laureateinstitute.org for enrollment information.
Where is the NCT04426461 trial being conducted?
This trial is being conducted at Tulsa, United States.
Who is sponsoring the NCT04426461 clinical trial?
NCT04426461 is sponsored by Laureate Institute for Brain Research, Inc.. The principal investigator is Robin L Aupperle, PhD at Laureate Institute for Brain Research. The trial plans to enroll 220 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.