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 |
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| 分期 | 不适用 |
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| 申办方 | University of Illinois at Chicago |
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| 状态 | 已完成 |
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| 受试者人数 | 203 人 |
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| 干预(药物) | CBT, ST |
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| 开始日期 | 2017年7月5日 |
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| 完成日期 | 2022年3月1日 |
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| 结果公布日 | 2026年6月23日 |
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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 |
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| Cognitive Behavioral Therapy | 0.884 ± 0.254 units on a scale |
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| Supportive Therapy | 0.869 ± 0.261 units on a scale |
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| Control | .04 ± .05 units on a scale |
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| Cognitive Behavioral Therapy | 0.482 ± 0.299 units on a scale |
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| Supportive Therapy | 0.601 ± 0.321 units on a scale |
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| 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 |
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| Cognitive Behavioral Therapy | .60 ± .69 arbitrary units |
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| Supportive Therapy | .39 ± .54 arbitrary units |
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| Control | .31 ± .98 arbitrary units |
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| Cognitive Behavioral Therapy | .52 ± .74 arbitrary units |
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| Supportive Therapy | .38 ± .57 arbitrary units |
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| 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 |
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| Cognitive Behavioral Therapy | .61 ± .63 arbitrary units |
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| Supportive Therapy | .36 ± .49 arbitrary units |
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| Control | .23 ± .64 arbitrary units |
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| Cognitive Behavioral Therapy | .47 ± .60 arbitrary units |
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| Supportive Therapy | .44 ± .51 arbitrary units |
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| p-value | >.05 |
| Mean Difference (Final Values) | .33 |
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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。