Stop Worrying, Learn to Let Go Through a Combination of Neurostimulation and Psychotherapy

What this Trial Is About

Researchers are investigating whether combining transcranial Direct Current Stimulation (tDCS) with cognitive-behavioral therapy (CBT) improves treatment for repetitive negative thinking (RNT) in patients who experience high levels of rumination. This study includes patients with generalized anxiety disorder or depressive disorder and compares active tDCS combined with CBT to sham (inactive) tDCS combined with CBT to evaluate their therapeutic effects. The study has two stages. In the first stage, participants attend weekly CBT group sessions called "Drop It" for 7 weeks, each followed by either active or sham tDCS applied for 30 minutes. In the second stage, after these sessions, participants use the tDCS devices at home daily for 4 weeks, continuing with either active or sham stimulation, then return for a final CBT session. Neuroimaging scans (EEG and fNIRS) are done at the start and after 3 months of therapy to measure brain activity. During the study, participants complete questionnaires assessing worry, depression, anxiety, and quality of life at baseline, after the therapy course, and at 3-month follow-up. Psychiatrists also evaluate participants at these points. Questionnaires measuring rumination are completed after each session. The main outcomes are the therapeutic effect of the combination therapy and the lasting impact of tDCS on CBT benefits, with safety and brain activity monitored over up to 3 months. Participation lasts approximately 3 months.

Combination of Neurostimulation and Psychotherapy to Stop Worrying