Major Depressive DisorderABBANCT05693922
Augmenting Single-session Behavioral Activation (BA) With Delta-beta Transcranial Alternating Current Stimulation (tACS) for the Treatment of Depression
A study testing Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC and Single-session behavioral activation in people with Major Depressive Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC and Single-session behavioral activation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2023to 22 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
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.
Read the 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
- Being tested
- Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC, Single-session behavioral activation, Active sham cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC
- Keywords
- transcranial alternating current stimulation, cross-frequency coupling, behavioral activation
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 activationBehavioural
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 MCDevice
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 group | Role | What they receive |
|---|---|---|
| Delta-beta tACS | Experimental | 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). Receives: Device: Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC; Behavioral: Single-session behavioral activation |
| Active-sham tACS | Sham comparator | 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. Receives: Behavioral: Single-session behavioral activation; Device: Active sham cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 weeks post treatment
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, 2 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start9 Feb 2023
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Responsible party
- Sponsor
- Investigators
- Flavio Frohlich, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693922
- Sponsor's protocol ID
- 22-2271
- Acronym
- ABBA
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2023
- Last updated
- 20 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Single-session Behavioral Activation (BA) With Delta-beta Transcranial Alternating Current Stimulation (tACS) for the Treatment of Depression
- ClinicalTrials.gov ID
- NCT05693922
- Acronym / sponsor ID
- ABBA / 22-2271
- Conditions
- Major Depressive Disorder
- Keywords
- transcranial alternating current stimulation, cross-frequency coupling, behavioral activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 23 Jan 2023 (actual)
- Results
- Posted 20 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Delta-beta tACS | Experimental | Device: Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC, Behavioral: Single-session behavioral activationParticipants 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). |
| Active-sham tACS | Sham comparator | Behavioral: Single-session behavioral activation, Device: Active sham cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MCParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MCDelta-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. | Device | Delta-beta tACS |
| Single-session behavioral activationParticipants 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 | Behavioural | Active-sham tACS, Delta-beta tACS |
| Active sham cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MCActive 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. | Device | Active-sham tACS |
Primary outcome
Clinician-rated Depressive Symptoms
Time frame: Baseline, 2 weeks post treatment
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.
2 secondary outcomes
Phase-amplitude Coupling (PAC) Between Delta-beta Oscillations During Task Performance of the Streamlined Expenditure of Effort for Reward Task (S-EEfRT)
Time frame: Baseline, 2 weeks post treatment
Proportion of Hard Trials Chosen During the S-EEfRT
Time frame: Baseline, 2 weeks post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flavio Frohlich, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC and Single-session behavioral activation in people with Major Depressive Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-rated Depressive Symptoms (time frame: Baseline, 2 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.