Trial results for a study investigating augmentation of behavioral activation with delta-beta transcranial alternating current stimulation (tACS) for Depression were posted on ClinicalTrials.gov on 2025-05-20. The study, involving 30 participants, found that clinician-rated depressive symptoms in the delta-beta tACS group were similar to those in the active-sham tACS group after intervention.

Background

Major Depressive Disorder (MDD) is a common and serious mood disorder that negatively affects how one feels, thinks, and acts. It can lead to a variety of emotional and physical problems and can decrease a person's ability to function at work and at home. Current treatments for depression include psychotherapy, pharmacotherapy, and neuromodulation techniques. Behavioral activation (BA) is a psychotherapy approach that focuses on increasing engagement in activities that are pleasurable or provide a sense of accomplishment. Transcranial alternating current stimulation (tACS) is a non-invasive brain stimulation technique that delivers weak electrical currents to the scalp to modulate brain oscillations. Investigating whether tACS can augment the effects of behavioral activation represents an effort to enhance treatment efficacy for individuals with MDD.

Trial design

This completed study enrolled 30 participants with Major Depressive Disorder. The trial aimed to investigate whether delta-beta cross-frequency transcranial alternating current stimulation could augment the effects of a single session of behavioral activation. The study was not assigned a specific phase (Phase NA). Participants were randomized to receive either delta-beta tACS or active-sham tACS alongside a single session of behavioral activation.

Key results

The trial results included several key measurements related to depressive symptoms, neural activity, and behavioral engagement. Measurements were taken at what appears to be a baseline and a post-intervention time point for both groups:

Further analyses using ANOVA for unspecified outcomes yielded p-values of 0.34, 0.54, and 0.865.

What this means

The posted results suggest that while both groups showed a reduction in clinician-rated depressive symptoms, the augmentation of behavioral activation with delta-beta tACS did not demonstrate a statistically significant difference compared to active-sham tACS, based on the provided p-values for unspecified outcomes. The mean post-intervention depressive symptom score for the delta-beta tACS group was 11.33, which was numerically lower than the 13.93 observed in the active-sham tACS group. However, without specific p-values tied to this outcome, it is not possible to conclude statistical significance. Similarly, measurements of phase-amplitude coupling and the proportion of hard trials chosen during a reward task also showed numerical differences between groups, but the overall ANOVA results (p-values of 0.34, 0.54, 0.865) indicate a lack of statistical significance across the analyzed outcomes. These findings imply that further research may be needed to determine the efficacy of delta-beta tACS as an augmentation strategy for behavioral activation in depression.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05693922, titled "Augmenting Single-session Behavioral Activation (BA) With Delta-beta Transcranial Alternating Current Stimulation (tACS) for the Treatment of Depression", were posted on 2025-05-20 on clinicaltrials.gov.