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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-09

Study Completion Date

2024-05-22

Brief Summary

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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.

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Detailed Description

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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

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will take part in a single-session behavioral activation (BA) intervention. To examine the effects of neurostimulation on treatment response, participants will be randomized to receive either delta-beta cross-frequency transcranial alternating current stimulation (tACS) or an active sham.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

This study is designed to be double-blind. This means that the participant and the researchers are unaware of each participant's assignment until the completion of all data collection. This is accomplished using the randomization codes described above. Furthermore, this study utilizes an active sham stimulation. The active sham condition includes brief stimulation, mimicking the skin sensations associated with tACS. In our previously concluded trial, participants in the delta-beta tACS and active sham groups responded similarly to the blinding questionnaire, indicating that our active sham stimulation successfully blinded the participants.

Study Groups

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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).

Group Type EXPERIMENTAL

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

Intervention Type 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

Intervention Type 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 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.

Group Type SHAM_COMPARATOR

Single-session behavioral activation

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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

Intervention Type BEHAVIORAL

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No