N/A
N=30
Augmenting Single-session Behavioral Activation (BA) With Delta-beta Transcranial Alternating Current Stimulation (tACS) for the Treatment of Depression
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05693922 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Clinician-rated Depressive Symptoms — 19.33; 19.93; 11.33; 13.93 score on a scale — p=0.34
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC (Device); Single-session behavioral activation (Behavioral); Active sham cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician-rated Depressive Symptoms |
19.33; 19.93; 11.33; 13.93 | 0.34 |
| SECONDARY Phase-amplitude Coupling (PAC) Between Delta-beta Oscillations During Task Performance of the Streamlined Expenditure of Effort for Reward Task (S-EEfRT) |
0.286; 0.290; 0.286; 0.044 | 0.54 |
| SECONDARY Proportion of Hard Trials Chosen During the S-EEfRT |
0.562; 0.521; 0.504; 0.454 | 0.865 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05693922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.