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
• Interventions: Device: Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC; Behavioral: Single-session behavioral activation; Device: Active sham cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC

• 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.

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-23
• Study Start: 2023-02-09
• Status Verified: 2024-01
• Primary Completion: 2024-05-22
• Study Completion: 2024-05-22
• Results First Submitted: 2025-04-09
• Results First Submitted QC: 2025-05-02
• Last Update Submitted: 2025-05-02
• Results First Posted: 2025-05-20
• Last Update Posted: 2025-05-20

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

Arm && Interventions

Group	Intervention	Description
Delta-beta tACS	Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC	Participants will receive a single session intervention of behavioral activation (BA) psychotherapy. Stimulation will be delivered via the NeuroConn DC-STIMULATOR MC at 1 milliampere (mA) zero-to-peak amplitude at the target electrodes and 2 mA zero to-peak amplitude at the return electrode. The tACS will be delivered using the cross-frequency stimulation waveform delta-beta (3-20Hz).
Delta-beta tACS	Single-session behavioral activation	Participants will receive a single session intervention of behavioral activation (BA) psychotherapy. Stimulation will be delivered via the NeuroConn DC-STIMULATOR MC at 1 milliampere (mA) zero-to-peak amplitude at the target electrodes and 2 mA zero to-peak amplitude at the return electrode. The tACS will be delivered using the cross-frequency stimulation waveform delta-beta (3-20Hz).
Active-sham tACS	Single-session behavioral activation	Participants will receive a single session intervention of behavioral activation (BA) psychotherapy. The active sham condition includes brief stimulation, mimicking the skin sensations associated with tACS, assisting with blinding the participant's assignment.
Active-sham tACS	Active sham cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC	Participants will receive a single session intervention of behavioral activation (BA) psychotherapy. The active sham condition includes brief stimulation, mimicking the skin sensations associated with tACS, assisting with blinding the participant's assignment.

Primary Outcome Measures

Name	Time	Method
Clinician-rated Depressive Symptoms	Baseline, 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

Name	Time	Method
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-EEfRT	Baseline, 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