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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT05693922
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC — DEVICE
    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 activation — BEHAVIORAL
    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 — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Feb 9, 2023
Status verified
Jan 2024
Primary completion
May 22, 2024
Completion
May 22, 2024

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Delta-beta tACS
    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).
  • Sham Comparator: Active-sham tACS
    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 Measure

Clinician-rated Depressive Symptoms [ Time Frame: Baseline, 2 weeks post treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-

Find similar trials in Chapel Hill, NC

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of North Carolina at Chapel Hill· Chapel Hill, NC

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