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NCT04426461 · ClinicalTrials.gov registry record · NA

Approach-Avoidance, Computational Framework for Predicting Behavioral Therapy Outcome (AAC-BeT)

A NA study of Depression and Anxiety, sponsored by Laureate Institute for Brain Research.

Recruiting
Registry status
NA
Development phase
220
Enrollment target
1
Study location

NCT04426461: Recruiting NA study of Depression and Anxiety, sponsored by Laureate Institute for Brain Research.

NCT04426461 is a NA study of Depression and Anxiety that is actively recruiting participants, run by Laureate Institute for Brain Research. The registered enrollment target is 220 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04426461, a NA study of Depression and Anxiety, is actively recruiting participants, sponsored by Laureate Institute for Brain Research.

RECRUITING
Registry status
NA
Development phase
220 participants
Enrollment target
1
Study location

Study 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 sympto

Primary Outcome

Composite score (averaging of the standardized Z scores) from the Hamilton Anxiety Rating Scale (HAM-A) and Hamilton Rating Scale for Depression (HAM-D). These Z scores will range from -3.0 to +3.0, with greater scores indicating more severe anxiety and depression symptoms or worse outcome.

Conditions Studied

Interventions

  • BEHAVIORAL Behavioral Activation
  • BEHAVIORAL Exposure-based therapy
  • BEHAVIORAL Supportive therapy

Study Locations (1)

Oklahoma

  • Laureate Institute for Brain Research - Tulsa

Trial Details

FieldValue
Enrollment Target 220 participants
Start Date 2020-09-11
Est. Completion 2025-06-30
Phase NA

What NCT04426461 shows while recruiting

NCT04426461 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (72% lower).

The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 3 interventions - of which Behavioral Activation is the first listed.

NCT04426461 reports a single indexed study location in Oklahoma.

Frequently Asked Questions

What is clinical trial NCT04426461 about?

NCT04426461 is a clinical study titled "Approach-Avoidance, Computational Framework for Predicting Behavioral Therapy Outcome (AAC-BeT)". 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 be...

What is the current status of trial NCT04426461?

This trial is currently recruiting. It is a NA study. The enrollment target is 220 participants. The study started on 2020-09-11. Estimated completion is 2025-06-30.

What conditions does trial NCT04426461 study?

This clinical trial studies the following conditions: Depression, Anxiety.

What interventions are being tested in trial NCT04426461?

The interventions under investigation include: Behavioral Activation (BEHAVIORAL), Exposure-based therapy (BEHAVIORAL), Supportive therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT04426461?

This trial is sponsored by Laureate Institute for Brain Research, which has 45 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04426461 being conducted?

This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Depression

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04426461's enrollment target sits among peer trials

220 196th of 679 higher than 483 of 679 other Depression trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04426461, the US trial registry maintained by the National Library of Medicine. NCT04426461 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.