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

University of North Carolina, Chapel Hill30 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Major Depressive Disorder

Interventions

Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MCDEVICE

Delta-beta stimulation will be delivered via the NeuroConn DC-STIMULATOR MC, an investigational electrical non-invasive brain stimulation device that is being used for foundational neuroscience and translational research.

Single-session behavioral activationBEHAVIORAL

Participants will take part in a single-session behavioral activation (BA) intervention. This intervention was adapted from standard BA protocols for the treatment of depression to be completed in a single, 90-minute session. This intervention will have 4 main components based on prior protocols: * Treatment overview and rationale * Tracking of daily activities * Exploration of values * Planning/scheduling activities

Active sham cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Clinician-rated Depressive Symptoms

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.

Time frame: Baseline, 2 weeks post treatment

Secondary Outcomes

Phase-amplitude Coupling (PAC) Between Delta-beta Oscillations During Task Performance of the Streamlined Expenditure of Effort for Reward Task (S-EEfRT)

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.

Time frame: Baseline, 2 weeks post treatment

Proportion of Hard Trials Chosen During the S-EEfRT

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.

Data from ClinicalTrials.gov

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