BENITIONSClinical Trial Intelligence

Transdiagnostic Brain-Behavior Profiling to Enhance Cognitive Behavioral Therapy Response

N/A Completed NCT03175068

ConditionMajor Depressive Disorder, Social Anxiety Disorder
PhaseN/A
SponsorUniversity of Illinois at Chicago
StatusCompleted
Enrollment203 participants
InterventionsCBT, ST
Start dateJul 5, 2017
Completion dateMar 1, 2022
Results postedJun 23, 2026

Summary

Many patients with Major Depressive Disorder (MDD) and generalized Social Anxiety Disorder (gSAD) are treated with cognitive behavioral therapy (CBT) but few have meaningful improvement. MDD and gSAD are diseases of brain dysfunction that manifest as impaired emotion regulation; CBT teaches emotion regulation strategies but how it works in the brain remains largely unknown. Individual differences in brain function related to emotion regulation may make some patients better suited for CBT and CBT may remedy the brain dysfunction that underlies these disorders. This project will compare CBT with a placebo psychotherapy (i.e., supportive therapy) in MDD and gSAD to test, validate, and refine brain-based markers and examine mechanisms of change to examine how CBT works and for whom.

Changes in Symptom Severity From Baseline to Week 12 Between Treatment Arms

baseline and week 12 · units on a scale

Control.05 ± .06 units on a scale
Cognitive Behavioral Therapy0.884 ± 0.254 units on a scale
Supportive Therapy0.869 ± 0.261 units on a scale
Control.04 ± .05 units on a scale
Cognitive Behavioral Therapy0.482 ± 0.299 units on a scale
Supportive Therapy0.601 ± 0.321 units on a scale
p-value<.05
Mean Difference (Final Values).01

Baseline Brain Activity During Emotion Regulation Differences Between Controls and Patients

baseline · arbitrary units

Control.33 ± .91 arbitrary units
Cognitive Behavioral Therapy.60 ± .69 arbitrary units
Supportive Therapy.39 ± .54 arbitrary units
Control.31 ± .98 arbitrary units
Cognitive Behavioral Therapy.52 ± .74 arbitrary units
Supportive Therapy.38 ± .57 arbitrary units
p-value>.05
Mean Difference (Final Values).04

Comparisons Between Emotion Regulation Task Brain Activity at Baseline and After Completing Therapy (12 Weeks).

baseline and 12 weeks · arbitrary units

Control.27 ± 1.10 arbitrary units
Cognitive Behavioral Therapy.61 ± .63 arbitrary units
Supportive Therapy.36 ± .49 arbitrary units
Control.23 ± .64 arbitrary units
Cognitive Behavioral Therapy.47 ± .60 arbitrary units
Supportive Therapy.44 ± .51 arbitrary units
p-value>.05
Mean Difference (Final Values).33

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