N/A N=132 Randomized Single-blind Treatment

Novel Neural Circuit Biomarkers of Major Depression Response to CCBT

Depression · Major Depressive Disorder · Depressive Disorder · Depression, Unipolar

Bottom Line

View on ClinicalTrials.gov: NCT03096886 ↗

Enrolled (actual)

132

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Resting State Functional Connectivity: MDD vs Controls — .51; .65; .54 Z normalized correlation

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Computer-Augmented Cognitive Behavioral Therapy (Behavioral)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Oct 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Resting State Functional Connectivity: MDD vs Controls	.51; .65; .54	—
SECONDARY Resting State Functional Connectivity: Immediate CCBT vs Waitlist Followed by CCBT	.46; .57	—

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 the end of the waitlist and 8-week course of CCBT, respectively, will allow within-subject comparison of CCBT vs Waitlist treatment effects. This clinical trial has two IRB protocol numbers: 826910 and 832295. The data collected through both protocol numbers will be analyzed together to accomplish the target of 100 subjects for this clinical trial.

Eligibility Criteria

Inclusion Criteria

Adults 18 - 60 years old, gender inclusive
Willing to not take psychotropic medications for the duration of the study
Fluent in English (both verbally and written)
Able and willing to provide consent
Has reliable access to a private computer or electronic tablet
Owns a smart phone (iPhone or Android) with ability to download apps

Experimental group 1) Diagnosis of MDD, experiencing current episode as determined by SCID-5 2) Current major depressive episode of moderate severity, as determined by MADRS score of 20 or higher

Control group 1) No history of MDD in lifetime 2) No indication of current, significant depressive symptoms, as determined by MADRS score of 8 or lower

Exclusion Criteria

Diagnosis of severe or poorly controlled concurrent medical disorders that may cause depression or require medication that could cause depressive symptoms
Unwilling to provide informed consent
Diagnosis of concurrent DSM-5 (SCID) psychiatric disorders: any psychotic or organic mental disorder, bipolar disorder, active alcohol or drug dependence, primary anxiety disorder or primary eating disorders (primary refers to the diagnosis associated with the most functional impairment)
Diagnosed (DSM-5 criteria) by the clinical coordinator with attention deficit hyperactivity disorder, learning disorder, borderline personality disorder, antisocial personality disorder, or paranoid personality disorder
Cannot complete questionnaires written in English
Have not completed at least a 10th grade education or a general education degree (GED)
Represent an active suicide risk
Centrally acting antiadrenergic agents
Have MRI contraindications (e.g., foreign metallic implants, pacemaker, severe claustrophobia)
Currently demonstrating a response to antidepressant/psychotropic medication (besides SSRIs, which are acceptable if use has been stable over at least a 2 month period)

Experimental group 1) Score less than 20 on the MADRS at either initial interview or 18 at second interview 2) Have previously failed to respond to a trial of at least 8 weeks of CBT conducted by a certified therapist) 3) Are currently demonstration a response to antidepressant/psychotropic medication besides SSRIs, which are acceptable if use has been stable over at least a 2 month period (individuals taking a psychotropic medication may stop taking it for the purpose of the study ONLY if they are not receiving clinical benefits from taking it and after meeting with one of the study doctors to discuss the risks/benefits of discontinuing the medication and other treatment options)

Control group 1) Must have no lifetime history of a major depressive episode 2) Must score below 8 on the MADRS

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03096886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.