Actively Recruiting
Causal Role of Delta-beta Coupling for Goal-directed Behavior in Anhedonic Depression
Led by Florida State University · Updated on 2026-03-11
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Florida State University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying major depressive disorder with a focus on anhedonia, which is the inability to seek out or feel pleasure and is linked to treatment resistance and reduced goal-directed behavior. This study evaluates how five consecutive days of brain stimulation affect neural activity and behavior in people experiencing a unipolar major depressive episode with significant anhedonia. The goal is to understand changes in brain connectivity related to goal-directed actions. Participants undergo eight sessions in total. The first session includes clinical assessments to confirm eligibility. The second session involves an MRI scan while completing reward-based tasks. Then, participants are randomly assigned to receive one of three types of non-invasive brain stimulation over five days: delta-beta frequency stimulation, theta-gamma frequency stimulation, or a sham (placebo) stimulation designed to mimic sensations without active treatment. During stimulation sessions, participants complete goal-setting and action planning activities. Throughout the study, participants complete self-report assessments and EEG recordings during reward-based tasks to track changes in brain activity and symptoms. Sessions vary in length from about one to three hours. A follow-up visit occurs approximately two weeks after stimulation ends to evaluate lasting effects. The primary outcome is change in brain coupling strength one week after stimulation, with symptom changes assessed at four weeks. Safety and adherence are monitored throughout the study period.
CONDITIONS
Brief Title
Causal Role of Delta-beta Coupling for Goal-directed Behavior in Anhedonic Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between the ages of 18 and 65
- Able to provide informed consent
- Have normal to corrected vision
- Willing to comply with all study procedures and be available for the duration of the study
- Speak and understand English
- Mild suicide risk as determined by specific rating scales
- Patient Health Questionnaire (PHQ-8) score of 8 or higher prior to the first session
- Snaith Hamilton Pleasure Scale (SHAPS) score greater than 33 at the first session
- Diagnosis of major depressive disorder confirmed by a structured interview
You will not qualify if you...
- Currently treated for ADHD
- Neurological disorders such as epilepsy, seizures (except childhood febrile seizures), dementia, stroke, Parkinson's disease, multiple sclerosis, brain tumors, or cerebral aneurysm
- Medical or neurological illnesses that could interfere with participation, including unstable cardiac disease, HIV/AIDS, malignancy, liver or kidney impairment
- Prior brain surgery
- Any implanted brain or electronic device like cochlear implants or pacemakers
- History of current traumatic brain injury
- Pregnancy (for females)
- Severe substance use disorder currently or in the past year, or psychotic disorder in the last 12 months
- Claustrophobia
- Metal in the body that is ferrous or other MRI contraindications such as tattoos on face or neck, metal jewelry, or metal in clothing or gear
- Any condition deemed by investigators to increase risk or prevent study completion
- Moderate or severe substance or alcohol use disorder currently or past severe disorder according to DSM-V criteria
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for clinical assessments
Duration - 1 day
Participants complete a functional MRI session with reward-based decision-making tasks to assess brain function.
1 visit (in-person) involving MRI and tasks
Duration - 5 days
Participants receive five consecutive days of cross-frequency transcranial alternating current stimulation (CF-tACS) while completing goal-setting and action planning worksheets.
5 daily visits; 3 hours for the 1st and 5th visits, approximately 1 hour for visits 2 to 4
Duration - Concurrent with Implementation
Participants complete brief self-report clinical assessments and EEG recordings during reward-based tasks before and after stimulation on specific days.
Assessments on the 1st and 5th days of stimulation visits
Duration - 1 day
Approximately two weeks after the stimulation sessions, participants return for an in-person session with clinical assessments and EEG during reward-based decision-making tasks.
1 visit (in-person) approximately 2 weeks post-stimulation
Trial Site Locations
Total: 1 location
1
Florida State University
Tallahassee, Florida, United States, 32306
Actively Recruiting
Research Team
J
Justin M Riddle, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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