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Augmenting Single-session Behavioral Activation (BA) With Delta-beta Transcranial Alternating Current Stimulation (tACS) for the Treatment of Depression

Not Applicable
Completed
Conditions
Major Depressive Disorder
Registration Number
NCT05693922
Lead Sponsor
University of North Carolina, Chapel Hill
Brief Summary

Investigating whether delta-beta cross-frequency transcranial alternating current stimulation can augment the effects of a single session of behavioral activation in participants with major depressive disorder.

Detailed Description

The purpose of this study is to examine whether concurrent transcranial alternating current stimulation (tACS) augments the effects of a single session behavioral activation (BA) treatment of depression. Following a series of clinical assessments, participants will perform a reward-based decision-making task while electroencephalography (EEG) is collected.

Then, all participants will take part in a single-session 90-minute BA intervention; half of the participants will receive delta-beta tACS during the final 30 minutes of the session and half will receive an active sham stimulation. Participants will return two weeks later for another task-based EEG. Four weeks after the intervention session, they will receive self-report questionnaires via email to complete online.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria
  • 18 years old or order
  • Able to provide informed consent
  • Willing to comply with all study procedures and be available for the duration of the study
  • Speak and understand English
  • DSM-5 diagnosis of major depressive disorder (MDD) as assessed by the MINI
Exclusion Criteria
  • Participants must not have active suicide intent as determined by the Columbia Suicide Severity Rating Scale (C-SSRS). Active suicide intent will be captured in responses to items 4 and/or 5 on the C-SSRS.
  • Participants must not meet criteria for current severe substance use disorder, anorexia nervosa, or active psychosis as captured by the MINI.
  • Participants may not currently be in psychotherapy and have not received any other psychotherapy and/or stimulation (ECT, TMS) within the last 4 weeks.
  • Any participants taking psychotropic medication must be on a stable dose for at least 4 weeks with no planned dose changes within the next 4 weeks.
  • (for female participants) Participants must not be pregnant or breastfeeding.
  • Participants may not have any medical or neurological illness for which symptom presentation or treatment could interfere with study participation
  • Participants may not have undergone prior brain surgery
  • Participants may not have any brain devices/implants, including cochlear implants and aneurysm clips
  • Participants may not have had brain injury or concussion within the last three months
  • Participants may not have a history of brain injury requiring current treatment

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Clinician-rated Depressive SymptomsBaseline, 2 weeks post treatment

Treatment response will be reported for clinician-rated depression symptom scores using the Hamilton Depression Rating Scale (HDRS). Items are scaled either from 0-2 to 0-4, and each item is summed for a total score ranging from 0 to 53 with higher scores indicating greater depression symptoms. Benchmarks suggested at: 0-7 normal; 8-13 mild depression; 14-18 moderate depression; 19-22 severe depression; \>=23 very severe depression.

Secondary Outcome Measures
NameTimeMethod
Phase-amplitude Coupling (PAC) Between Delta-beta Oscillations During Task Performance of the Streamlined Expenditure of Effort for Reward Task (S-EEfRT)Baseline, 2 weeks post treatment

Participants choose to complete a "hard" task or "easy" task. Coupling during the hard/easy decision is calculated between delta oscillations phase (2-3Hz) in prefrontal electrodes (FCz and surrounding electrodes) and the beta oscillations amplitude (15-25Hz) in left motor electrodes (C3 and surrounding electrodes). Instantaneous phase \& amplitude of oscillations is calculated by averaging the signal in the two regions, band-filtering the signal to the specified range, and performing the Hilbert transform. PAC is normalized by creating a null distribution randomly shifting the beta time series by at least 10% of the number of time points. PAC is calculated between the delta-phase time series and each randomly shifted beta-amplitude time series. PAC is z-transformed relative to the null distribution. Values range from -3 to 3 and a score \>=0.4 means the coupling is present. A higher value represents greater coupling strength which has been linked with greater cognitive processing.

Proportion of Hard Trials Chosen During the S-EEfRTBaseline, 2 weeks post treatment

In the Streamlined Expenditure of Effort for Reward Task (S-EEfRT), participants choose to complete a "hard" task requiring many button presses or an "easy" task with fewer button presses for variable monetary incentives. Number of button presses is individualized for each participant. Goal-directed behavior will be calculated as the proportion of "hard" tasks chosen across trials.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill

🇺🇸

Chapel Hill, North Carolina, United States

University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States

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