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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 weeks after the baseline assessments.

Awards & highlights

AAC-BeT Trial 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.Check my eligibility

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.See study design

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.

AAC-BeT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 weeks after the baseline assessments.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite score from Hamilton Anxiety Rating Scale (HAM-A) and Hamilton Rating Scale for Depression (HAM-D)

Quinolinic Acid

Secondary outcome measures

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 outcome measures

Amygdala reactivity to negative outcomes

Approach behavior during approach-avoidance conflict decision making

Bilateral amygdala volume

+6 more

AAC-BeT 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

~2980

Exposure-based therapy

2016

N/A

~130

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Laureate Institute for Brain Research, Inc.Lead Sponsor

50 Previous Clinical Trials

5,125 Total Patients Enrolled

17 Trials studying Depression

2,437 Patients Enrolled for Depression

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,479 Total Patients Enrolled

666 Trials studying Depression

251,364 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently being observed in this medical experiment?

"Correct. Per the clinicaltrials.gov record, this research endeavor is still recruiting participants since its inception on September 11th 2020 and most recent update on October 18th 2021. A total of 220 volunteers are sought from a single location for inclusion in the trial."

Answered by AI

What is the desired outcome of this research endeavor?

"The primary metric of efficacy over the 18 week period is peripheral serum concentration of Quinolinic Acid. Additionally, secondary metrics such as Ratio of Kynurenic Acid to Tryptophan and Sheehan Disability Scale (which ranges from 0-30 with higher scores indicating increased disability or poorer outcome) will also be tracked."

Answered by AI

Does this medical trial allow persons over the age of 75 to participate?

"In order to be considered for participation in this study, individuals need to be between 18-65 years old. There are 219 separate trials open specifically to those below the age of consent and 989 that cater exclusively to people over 65."

Answered by AI

Are there any remaining opportunities for patients to partake in this clinical endeavor?

"According to the information accessible through clinicaltrials.gov, this medical trial is currently in search of volunteers. It was initiated on September 11th 2020 and most recently revised on October 18th 2021."

Answered by AI

Who meets the criteria to take part in this research experiment?

"This medical trial seeks 220 people aged 18 to 65 with depression, who self-report anxiety and depressive symptoms as clinically significant, score of 55+ on the PROMIS Anxiety/Depression scales, and a 5 or higher on any one item of the SDS."

Answered by AI

Who else is applying?

What state do they live in?

Kansas

Oklahoma

How old are they?

18 - 65

What site did they apply to?

Laureate Institute for Brain Research

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I’d like to try to work on my avoidance behavior. i have mentalillness and would like to help the study and need the money.

PatientReceived 1 prior treatment

Very interested in finding help as well as helping the science behind it. I never know if my meds are helping.ery interested in finding help as well as helping the science behind i.

PatientReceived 2+ prior treatments