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NCT04328103 · ClinicalTrials.gov registry record
Mechanisms of Emotion Regulation Underlying Successful CBT in Depression
A clinical trial of Major Depressive Disorder, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- 41
- Enrollment target
- 1
- Study location
NCT04328103: Completed study of Major Depressive Disorder, sponsored by New York State Psychiatric Institute.
NCT04328103 is a study of Major Depressive Disorder that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 41 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04328103, a study of Major Depressive Disorder, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
This research aims to elucidate mechanisms through which change occurs during cognitive behavior therapy (CBT) for depression. Assessing meta-cognitive processes of self-knowledge (top-down), electrophysiological and behavioral correlates of emotion processing (bottom-up), and their relation to treatment outcome will provide new insights into the mechanisms of emotion regulation deficits in depression. It will also contribute toward the clinical goal of identifying patients who may benefit most from CBT for unipolar depression.
Primary Outcome
17-item Hamilton Rating Scale for Depression (HRSD); standard clinical instrument (Hamilton, 1960) to assess symptom severity in major depressive disorder (MDD); interpretation: \< 7 = absence or remission of depression; 7-17 = mild depression; 18-24 = moderate depression; \> 25 = severe depression; HRSD rate of symptom change over time (slope); to obtain a continuous measure of treatment outcome, we will employ a mixed-effects model for all HRSD ratings to compute estimates of each patient's r
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Behavior Therapy (CBT)
- BEHAVIORAL Nonspecific Supportive Therapy (PBO)
Study Locations (1)
New York
- New York State Psychiatric Institute - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2020-11-25 |
| Est. Completion | 2023-06-02 |
What the finished NCT04328103 record still lists
NCT04328103 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Cognitive Behavior Therapy (CBT) is the first listed.
NCT04328103 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04328103 about?
NCT04328103 is a clinical study titled "Mechanisms of Emotion Regulation Underlying Successful CBT in Depression". This research aims to elucidate mechanisms through which change occurs during cognitive behavior therapy (CBT) for depression. Assessing meta-cognitive processes of self-knowledge (top-down), electrophysiological and behavioral correlates of emotion processing (bottom-up), and their relation to trea...
What is the current status of trial NCT04328103?
This trial is currently completed. The enrollment target is 41 participants. The study started on 2020-11-25. Estimated completion is 2023-06-02.
What conditions does trial NCT04328103 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT04328103?
The interventions under investigation include: Cognitive Behavior Therapy (CBT) (BEHAVIORAL), Nonspecific Supportive Therapy (PBO) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04328103?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04328103 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04328103's enrollment target sits among peer trials
41 195th of 282 higher than 88 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder 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.
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