Trial Outcomes & Findings for Augmenting Single-session Behavioral Activation (BA) With Delta-beta Transcranial Alternating Current Stimulation (tACS) for the Treatment of Depression (NCT NCT05693922)

Last Updated: 2025-05-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Baseline, 2 weeks post treatment

Results posted on

2025-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	Delta-beta tACS Participants will receive a 90- minute single session intervention of behavioral activation (BA) psychotherapy. Stimulation will be delivered during the final 30 minutes 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). 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.	Active-sham tACS Participants will receive a 90-minute single session intervention of behavioral activation (BA) psychotherapy. The active sham condition includes brief stimulation beginning in the final 30 minutes, mimicking the skin sensations associated with tACS, assisting with blinding the participant's assignment. 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.
Overall Study STARTED	15	15
Overall Study Completed Week 2 Follow-Up	15	12
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Delta-beta tACS n=15 Participants Participants will receive a 90- minute single session intervention of behavioral activation (BA) psychotherapy. Stimulation will be delivered during the final 30 minutes 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 n=15 Participants Participants will receive a 90-minute single session intervention of behavioral activation (BA) psychotherapy. The active sham condition includes brief stimulation beginning in the final 30 minutes, mimicking the skin sensations associated with tACS, assisting with blinding the participant's assignment.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	36.8 years STANDARD_DEVIATION 17.78 • n=5 Participants	35.6 years STANDARD_DEVIATION 13.56 • n=7 Participants	36.2 years STANDARD_DEVIATION 15.56 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 2 weeks post treatment

Population: Three participants randomized to the sham condition did not complete the follow-up visit. Missing data for these participants was handled using the intent-to-treat last value carried forward method.

Outcome measures

Outcome measures
Measure	Delta-beta tACS n=15 Participants Participants will receive a 90- minute single session intervention of behavioral activation (BA) psychotherapy. Stimulation will be delivered during the final 30 minutes 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 n=15 Participants Participants will receive a 90-minute single session intervention of behavioral activation (BA) psychotherapy. The active sham condition includes brief stimulation beginning in the final 30 minutes, mimicking the skin sensations associated with tACS, assisting with blinding the participant's assignment.
Clinician-rated Depressive Symptoms Baseline	19.33 score on a scale Standard Deviation 4.59	19.93 score on a scale Standard Deviation 4.71
Clinician-rated Depressive Symptoms 2 weeks post treatment	11.33 score on a scale Standard Deviation 5.15	13.93 score on a scale Standard Deviation 6.23

SECONDARY outcome

Timeframe: Baseline, 2 weeks post treatment

Population: Data were not properly collected for some participants due to technical difficulties.

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.

Outcome measures

Outcome measures
Measure	Delta-beta tACS n=11 Participants Participants will receive a 90- minute single session intervention of behavioral activation (BA) psychotherapy. Stimulation will be delivered during the final 30 minutes 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 n=11 Participants Participants will receive a 90-minute single session intervention of behavioral activation (BA) psychotherapy. The active sham condition includes brief stimulation beginning in the final 30 minutes, mimicking the skin sensations associated with tACS, assisting with blinding the participant's assignment.
Phase-amplitude Coupling (PAC) Between Delta-beta Oscillations During Task Performance of the Streamlined Expenditure of Effort for Reward Task (S-EEfRT) Baseline	0.286 Z-score Standard Deviation 0.606	0.290 Z-score Standard Deviation 0.516
Phase-amplitude Coupling (PAC) Between Delta-beta Oscillations During Task Performance of the Streamlined Expenditure of Effort for Reward Task (S-EEfRT) 2 weeks post treatment	0.286 Z-score Standard Deviation 0.786	0.044 Z-score Standard Deviation 0.655

SECONDARY outcome

Timeframe: Baseline, 2 weeks post treatment

Population: Data were not properly collected for some participants due to technical difficulties.

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.

Outcome measures

Outcome measures
Measure	Delta-beta tACS n=14 Participants Participants will receive a 90- minute single session intervention of behavioral activation (BA) psychotherapy. Stimulation will be delivered during the final 30 minutes 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 n=15 Participants Participants will receive a 90-minute single session intervention of behavioral activation (BA) psychotherapy. The active sham condition includes brief stimulation beginning in the final 30 minutes, mimicking the skin sensations associated with tACS, assisting with blinding the participant's assignment.
Proportion of Hard Trials Chosen During the S-EEfRT Baseline	0.562 proportion of trials Standard Deviation 0.158	0.521 proportion of trials Standard Deviation 0.205
Proportion of Hard Trials Chosen During the S-EEfRT 2 weeks post treatment	0.504 proportion of trials Standard Deviation 0.188	0.454 proportion of trials Standard Deviation 0.103

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to follow-up 2 weeks post treatment

The Snaith-Hamilton Pleasure Scale-Clinician (SHAPS-C) is a clinician administered tool to assess symptoms of anhedonia. The SHAPS-C items use a Likert scale of 1-4, with higher scores reflecting greater pathology.

Outcome measures

Outcome data not reported

Adverse Events

Delta-beta tACS

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Active-sham tACS

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Delta-beta tACS n=15 participants at risk Participants will receive a 90- minute single session intervention of behavioral activation (BA) psychotherapy. Stimulation will be delivered during the final 30 minutes 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 n=15 participants at risk Participants will receive a 90-minute single session intervention of behavioral activation (BA) psychotherapy. The active sham condition includes brief stimulation beginning in the final 30 minutes, mimicking the skin sensations associated with tACS, assisting with blinding the participant's assignment.
Psychiatric disorders Suicidal Ideation	6.7% 1/15 • Number of events 1 • From the time of signing informed consent through intervention visit (1 week later) and study follow-up visit (2 weeks after intervention), approximately 3 weeks total.	6.7% 1/15 • Number of events 1 • From the time of signing informed consent through intervention visit (1 week later) and study follow-up visit (2 weeks after intervention), approximately 3 weeks total.
Skin and subcutaneous tissue disorders Tingling	0.00% 0/15 • From the time of signing informed consent through intervention visit (1 week later) and study follow-up visit (2 weeks after intervention), approximately 3 weeks total.	13.3% 2/15 • Number of events 2 • From the time of signing informed consent through intervention visit (1 week later) and study follow-up visit (2 weeks after intervention), approximately 3 weeks total.
Skin and subcutaneous tissue disorders Warm Skin Sensation	6.7% 1/15 • Number of events 1 • From the time of signing informed consent through intervention visit (1 week later) and study follow-up visit (2 weeks after intervention), approximately 3 weeks total.	20.0% 3/15 • Number of events 3 • From the time of signing informed consent through intervention visit (1 week later) and study follow-up visit (2 weeks after intervention), approximately 3 weeks total.
Eye disorders Flickering Lights	20.0% 3/15 • Number of events 3 • From the time of signing informed consent through intervention visit (1 week later) and study follow-up visit (2 weeks after intervention), approximately 3 weeks total.	20.0% 3/15 • Number of events 3 • From the time of signing informed consent through intervention visit (1 week later) and study follow-up visit (2 weeks after intervention), approximately 3 weeks total.

Additional Information

Erin Bondy, PhD

University of North Carolina at Chapel Hill

Phone: 919-843-7694

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place