NCT05693922

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC	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.
BEHAVIORAL	Single-session behavioral activation	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
DEVICE	Active sham cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC	Active sham 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.

Timeline

• Start date: 2023-02-09
• Primary completion: 2024-05-22
• Completion: 2024-05-22
• First posted: 2023-01-23
• Last updated: 2025-05-20
• Results posted: 2025-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study