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

University of North Carolina (UNC)

Status: Completed

Conditions: Major Depressive Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05693922

22-2271

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Delta-beta tACS

Experimental group

Description:

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).

Treatment:

Behavioral: Single-session behavioral activation

Device: Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC

Active-sham tACS

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Single-session behavioral activation

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