Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Foundation of Hope, North Carolina | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinician-rated Anhedonia Symptoms Using SHAPS-C | 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. | Baseline up to follow-up 2 weeks post treatment |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Flavio Frohlich, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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.
beginning 9 and continuing for 36 months following publication
Deidentified individual data that supports the results will be shared provided the investigator who proposes to use the data has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2022 |
Not provided
Not provided
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.
Not provided
Not provided
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.
|
| 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:
|
|
| 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. |
|
| 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. | Baseline, 2 weeks post treatment |
| FG001 | 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. |
| Completed Week 2 Follow-Up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks post treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Data were not properly collected for some participants due to technical difficulties. | Posted | Mean | Standard Deviation | Z-score | Baseline, 2 weeks post treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Data were not properly collected for some participants due to technical difficulties. | Posted | Mean | Standard Deviation | proportion of trials | Baseline, 2 weeks post treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Clinician-rated Anhedonia Symptoms Using SHAPS-C | 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. | Not Posted | Baseline up to follow-up 2 weeks post treatment | Participants |
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.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 0 | 15 | 0 | 15 | 4 | 15 |
| EG001 | 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. | 0 | 15 | 0 | 15 | 6 | 15 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Tingling | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Warm Skin Sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Flickering Lights | Eye disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Bondy, PhD | University of North Carolina at Chapel Hill | 919-843-7694 | erin_bondy@med.unc.edu |
| Apr 3, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | 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. |
|
|
|
|
|
|