Behavioral Therapies for Anxiety and Depression
(AAC-BeT Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those who regularly use benzodiazepines (a type of medication often used for anxiety). It's best to discuss your specific medications with the trial coordinators.
What data supports the effectiveness of the treatment Behavioral Activation for anxiety and depression?
Behavioral Activation (BA) is a well-supported treatment for depression, shown to be as effective as traditional cognitive-behavioral therapy (CBT). It focuses on increasing positive activities to improve mood and has been successfully used for various mental health conditions, suggesting its potential effectiveness for anxiety and depression.12345
Is behavioral activation therapy safe for humans?
How is the treatment Behavioral Activation different from other treatments for anxiety and depression?
Behavioral Activation (BA) is unique because it focuses on increasing engagement in positive activities to improve mood and reduce avoidance behaviors, which is different from other therapies that might focus more on changing thought patterns. It is often used as part of a broader cognitive-behavioral therapy approach and can be effective for both depression and anxiety.12468
Research Team
Robin L Aupperle, PhD
Principal Investigator
Laureate Institute for Brain Research
Eligibility Criteria
This trial is for individuals who experience both anxiety and depression, scoring above 55 on the PROMIS scales for these conditions. They must be able to give informed consent, speak English well enough for the study's procedures, and consider their symptoms a clinical concern. People with severe mental health issues like bipolar or psychotic disorders, recent substance abuse, neurological disorders, MRI contraindications (like metal implants), or regular benzodiazepine use cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to one of three therapy interventions: behavioral activation, exposure-based therapy, or supportive therapy. Clinical, self-report, behavioral, and fMRI assessments are conducted before and after therapy.
Follow-up
Participants are monitored for changes in mental health symptoms and brain responses after therapy completion.
Treatment Details
Interventions
- Behavioral Activation
- Exposure-based therapy
- Supportive therapy
Behavioral Activation is already approved in United States, China, European Union for the following indications:
- Depression
- Anxiety in older adults undergoing cardiac procedures
- Loneliness in older adults
- Depression
- Depression
- Anxiety
Find a Clinic Near You
Who Is Running the Clinical Trial?
Laureate Institute for Brain Research, Inc.
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator