Novel Neural Circuit Biomarkers of Major Depression Response to CCBT

Summary

Participation Requirements

Description

This study is a randomized study. 80 subjects with MDD will be randomly assigned (1:1) to immediately receive 8 weeks of CCBT or delayed treatment, consisting of up to 4 weeks of waitlist, followed by 8 weeks of CCBT. 50 healthy controls of similar age/sex will be recruited to serve as a comparison ...

This study is a randomized study. 80 subjects with MDD will be randomly assigned (1:1) to immediately receive 8 weeks of CCBT or delayed treatment, consisting of up to 4 weeks of waitlist, followed by 8 weeks of CCBT. 50 healthy controls of similar age/sex will be recruited to serve as a comparison group for baseline magnetic resonance imaging (MRI) scanning. The study will enroll subjects for approximately 4 years (~2 subjects per month for 48 months). The length of subject participation will vary based on what group the participants are randomized to. Healthy controls will participate for approximately 8 weeks. Subjects with MDD who were randomized to Early CCBT will participate for approximately 8 weeks; subjects with MDD who were randomized to Late CCBT will participate for approximately 12 weeks. Variability in the study duration for each group depends on each subjects' personal availability for visits and the availability of the magnetic resonance scanner. Potential participants will complete a phone screen to determine eligibility. If the individual is eligible, the individual will be scheduled for an in-person screening visit. Information collected during the phone screening will not be used in the data analysis; phone screening information will be collected and retained in REDCap. Remote contact options are available as needed/possible. Screening Visit - all participants will have the study described to them in detail, including the risks and study procedures as outlined in the informed consent form and will sign the informed consent form (ICF) and HIPAA authorization, prior to any study procedures being completed. Participants will be screened for symptoms of psychological disorders and severity of major depressive symptoms by a trained research team member. If determined eligible, HEALTHY CONTROLS will be scheduled for return to complete an fMRI scan and baseline visit, in which self-report measures, including reports of mood, behavior, and thoughts will be collected, as well as neuropsychological testing. The HIPAA-compliant phone app Beiwe and actigraph setup will take place during the baseline visit. Participants will complete mood monitoring questions on the phone app and also have their activity levels monitored by the phone app and the actigraph for the duration of the study. If determined eligible at screening, MDD (EXPERIMENTAL GROUP) participants will be randomized (1:1) as follows: One half of the depressed participants will be randomized to receive 8 weeks of CCBT immediately after completing pretreatment assessments and the remainder will be randomized to a waitlist of up to 4 weeks followed by 8 weeks of CCBT. MDD, EARLY CCBT GROUP Early CCBT participants will be scheduled for return to complete an fMRI scan at the baseline visit, in which self-report measures, including reports of mood, behavior, and thoughts will be collected, as well as neuropsychological testing. The phone apps Beiwe and Ethica and actigraph setup will take place during the baseline visit. Participants will complete mood monitoring questions on the phone apps and also have their activity levels monitored by the phone app and the actigraph for the duration of the study. Participants will complete Good Days Ahead (GDA) computer training throughout the 8 weeks of CCBT, and having 6 encounters with a licensed psychologist/psychiatrist. Additionally, outcome measures will be assessed by an independent clinical evaluator (without knowledge of treatment assignment) every other week. As soon as can be arranged after Week 9 of CCBT treatment (last CCBT Clinical Contact), participants will return to complete an fMRI scan and end of study visit, in which self-report measures, including reports of mood, behavior, and thoughts will be collected, as well as neuropsychological testing. MDD, LATE CCBT GROUP Late CCBT participants will be scheduled for return to complete an fMRI scan and baseline visit, in which self-report measures, including reports of mood, behavior, and thoughts will be collected, as well as neuropsychological testing. The phone apps Beiwe and Ethica and actigraph setup will take place during the baseline visit. During the 2-4 week waitlist phase, participants will complete mood monitoring questions on the phone apps and also have their activity levels monitored by the phone app and the actigraph. At the conclusion of the waitlist of up to 4 weeks, participants will complete a second fMRI scan and complete self-report measures, including reports of mood, behavior, and thoughts will be collected, as well as neuropsychological testing. Participants will then enter the CCBT phase and will complete Good Days Ahead (GDA) computer training throughout the 8 weeks of CCBT. They will have 6 encounters with a licensed psychologist/psychiatrist at multiple time points during this period. Additionally, outcome measures will be assessed by an independent clinical evaluator (without knowledge of treatment assignment) every other week during this study phase. At Week 9 of CCBT treatment (last CCBT Clinical Contact), participants will complete a 1-hour fMRI scan and self-report measures, including reports of mood, behavior, and thoughts will be collected, as well as neuropsychological testing. 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 130 subjects for this clinical trial.

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