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NCT03096886 · ClinicalTrials.gov registry record · NA
Novel Neural Circuit Biomarkers of Major Depression Response to CCBT
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 132
- Enrollment target
NCT03096886: Completed NA study, sponsored by University of Pennsylvania.
NCT03096886 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 132 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03096886, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 132 participants
- Enrollment target
Study Summary
The purpose of the study is to learn more about computer-assisted cognitive behavioral therapy or "CCBT" and to examine connections in the brains of patients with depression. CCBT is approved by the FDA as a form of treatment for depression. It is done partly on the computer and partly with a therapist. This study will enroll participants with depression and participants without depression. The investigators will recruit a total of 100 participants: 80 with Major Depressive Disorder (MDD) and 50 matched comparison participants. Healthy control subjects will participate for approximately 8 weeks. All MDD participants will receive CCBT. Half of the MDD participants will all receive computer-augmented skills training with the Good Days Ahead (GDA) protocol immediately (Early CCBT). Early CCBT subjects will participate for approximately 8 weeks. The other half of the MDD participants initially will be randomized to a waitlist of up to 4 weeks and subsequently will receive CCBT treatment (Late CCBT). Late CCBT subjects will participate for approximately 12 weeks. All participants are asked to complete a screening, which includes a series of clinical interviews and self-report questionnaires about the individual's thoughts, moods, and behaviors. All participants are asked to wear an actigraph, which is a watch-like device that measures activity levels. Additionally, participants are asked to completed short questions and have their activity levels monitored through phone app(s). All participants (Healthy Control and MDD participants) will receive functional magnetic resonance imaging (fMRI) scanning at baseline. Early CCBT participants will receive fMRI scanning after 8 weeks of CCBT, and Late CCBT participants will receive fMRI scanning at the conclusion of the waitlist and after the 8-week course of CCBT. Brain activity will be compared between MDD and controls at baseline and between Early CCBT vs Late CCBT. The 2nd and 3rd brain scans of Late CCBT participants at
Interventions
- BEHAVIORAL Computer-Augmented Cognitive Behavioral Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2017-06-05 |
| Est. Completion | 2023-10-23 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03096886
The ClinicalTrials.gov registry entry for NCT03096886 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Computer-Augmented Cognitive Behavioral Therapy is the first listed.
NCT03096886 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03096886 about?
NCT03096886 is a clinical study titled "Novel Neural Circuit Biomarkers of Major Depression Response to CCBT". The purpose of the study is to learn more about computer-assisted cognitive behavioral therapy or "CCBT" and to examine connections in the brains of patients with depression. CCBT is approved by the FDA as a form of treatment for depression. It is done partly on the computer and partly with a therap...
What is the current status of trial NCT03096886?
This trial is currently completed. It is a NA study. The enrollment target is 132 participants. The study started on 2017-06-05. Estimated completion is 2023-10-23.
What interventions are being tested in trial NCT03096886?
The interventions under investigation include: Computer-Augmented Cognitive Behavioral Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT03096886?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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