BENITIONSClinical Trial Intelligence

Transdiagnostic Brain-Behavior Profiling to Enhance Cognitive Behavioral Therapy Response

不适用 已完成 NCT03175068

适应症Major Depressive Disorder, Social Anxiety Disorder
分期不适用
申办方University of Illinois at Chicago
状态已完成
受试者人数203 人
干预(药物)CBT, ST
开始日期2017年7月5日
完成日期2022年3月1日
结果公布日2026年6月23日

摘要

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

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

同一适应症的其他试验

全部试验

本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。