Brain Stimulation + Psychotherapy for Depression
(CARED Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to primarily assess the feasibility and secondarily assess the efficacy of a single session intervention (SSI) that combines non-invasive brain stimulation and psychotherapy for Major Depressive Disorder (MDD). investigators will recruit 30 people with MDD, with at least mild to moderate symptoms, who are resistant to typical treatments for Major Depressive Disorder. In this trial, participants will receive psychotherapy, Intermittent Theta Burst Stimulation Transcranial Magnetic Stimulation (iTBS), and either active or sham (placebo) Transcranial Alternating Current Stimulation (tACS).
Who Is on the Research Team?
Flavio Frohlich, PhD
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single Session Intervention
Participants receive psychotherapy, iTBS, and either active or sham tACS in a single session
Follow-up 1
Participants are monitored for symptom reduction and safety 2 weeks after the intervention
Follow-up 2
Participants are monitored for the longevity of intervention effectiveness 3 months after the intervention
What Are the Treatments Tested in This Trial?
Interventions
- Intermittent Theta Burst Stimulation (iTBS)
- Psychotherapy
- Sham (Placebo) Transcranial Alternating Current Stimulation (tACS)
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive psychotherapy, active iTBS, and active tACS in which alpha-theta tACS will be delivered with a 20 second ramp up and ramp down, at the beginning and end of stimulation followed by 2 mA between the stimulation sites. The stimulation amplitude delivered is standard for tACS studies conducted in the Frohlich Lab
Participants will receive psychotherapy, active iTBS, and sham tACS in which alpha-theta tACS is delivered for 40 seconds before ramping down to close to 0 mA of current. The sham is designed to mimic the sensation of receiving Alpha and Theta tACS without delivering a sufficient dose.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
Foundation of Hope, North Carolina
Collaborator
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