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

Major Depressive Disorder Clinical Trial

— ABBA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05693922
• Other study ID #: 22-2271
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2023
• Est. completion date: March 2024

Study information

• Verified date: January 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Erin Bondy, MA
• Phone: 919-843-7694
• Email: erin_bondy[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• 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.

Behavioral:
• 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

Device:
• 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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Foundation of Hope, North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Change in clinician-rated depressive symptoms	Treatment response will be calculated as the change in 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. Benchmarks suggested at: 0-7 normal; 8 - 13 mild depression; 14-18 moderate depression; 19-22 severe depression; >=23 very severe depression.	Baseline up to follow-up 2 weeks post treatment
Secondary	Change in phase-amplitude coupling between delta-beta oscillations during task performance of the Streamlined Expenditure of Effort for Reward Task (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.; Delta-beta coupling during the HARD/EASY decision will be calculated between the phase of delta oscillations (2-3Hz) in prefrontal electrodes (FCz and surrounding electrodes) and the amplitude of beta oscillations (15-25Hz) in left motor electrodes (C3 and surrounding electrodes). The instantaneous phase and amplitude of these oscillations will be calculated by averaging the signal in these two regions, band-filtering the signal to the specified range, and then performing the Hilbert transform on the signal. Phase-amplitude coupling (PAC) is calculated by creating a hybrid signal using the beta oscillation amplitude in left motor electrodes and the delta oscillation phase in prefrontal electrodes.	Baseline up to follow-up 2 weeks post treatment
Secondary	Change in percentage 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 average decision to perform the HARD task across trials.	Baseline up to follow-up 2 weeks post treatment