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Behavioral Therapies for Anxiety and Depression (AAC-BeT Trial)

N/A
Recruiting
Led By Robin L Aupperle, PhD
Research Sponsored by Laureate Institute for Brain Research, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Diagnosis of neurologic disorders
Uncorrected vision/hearing problems
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 weeks after the baseline assessments.
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether behavioral activation, exposure-based therapy, or supportive therapy are more effective for treating comorbid anxiety and depression by looking at changes in brain and behavior responses during approach-avoidance decision-making.

Who is the study for?
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.
What is being tested?
The AAC-BeT trial tests how different therapies—behavioral activation (enhancing engagement in meaningful activities), exposure-based therapy (reducing avoidance of negative expectations), and supportive therapy—affect decision-making in those with anxiety and depression. Participants will undergo brain imaging (fMRI) and behavioral assessments before and after treatment to see which approach works best.
What are the potential side effects?
As this is a psychotherapy trial involving behavioral activation, exposure-based therapy, and supportive therapy rather than medication or invasive procedures; it does not have typical 'side effects.' However participants may experience emotional discomfort when discussing personal issues during sessions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a neurological disorder.
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I have vision or hearing problems that haven't been corrected.
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I do not have any severe or unstable health conditions needing immediate care.
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I regularly use benzodiazepines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 weeks after the baseline assessments.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 weeks after the baseline assessments. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite score from Hamilton Anxiety Rating Scale (HAM-A) and Hamilton Rating Scale for Depression (HAM-D)
Quinolinic Acid
Secondary study objectives
Kynurenic acid
National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Anxiety Scale
National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Depression Scale
+3 more
Other study objectives
Amygdala reactivity to negative outcomes
Approach behavior during approach-avoidance conflict decision making
Bilateral amygdala volume
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Exposure-based therapyExperimental Treatment1 Intervention
Group II: Behavioral activationExperimental Treatment1 Intervention
Group III: Supportive therapyActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Activation
2013
Completed Phase 3
~2900
Exposure-based therapy
2016
N/A
~130

Find a Location

Who is running the clinical trial?

Laureate Institute for Brain Research, Inc.Lead Sponsor
52 Previous Clinical Trials
5,220 Total Patients Enrolled
17 Trials studying Depression
2,437 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,936 Previous Clinical Trials
2,741,822 Total Patients Enrolled
706 Trials studying Depression
260,838 Patients Enrolled for Depression
Robin L Aupperle, PhDPrincipal InvestigatorLaureate Institute for Brain Research
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Depression
100 Patients Enrolled for Depression

Media Library

Depression Clinical Trial 2023: Behavioral Activation Highlights & Side Effects. Trial Name: NCT04426461 — N/A
Depression Patient Testimony for trial: Trial Name: NCT04426461 — N/A
~23 spots leftby Jun 2025
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