Table 3. Full List of 25 Reported Adverse Events According to Treatment Arm.
| Type of adverse event | No. | Group 0: CBT alone | Group 1: CBT + tDCS | Group 2: CBT + sham-tDCS |
|---|---|---|---|---|
| Influenza infection | 9 | 2 | 5 | 2 |
| Gastroenteritis | 4 | 0 | 1 | 3 |
| Functional diarrhea | 2 | 2 | 0 | 0 |
| Headache | 2 | 2 | 0 | 0 |
| Discomfort | 1 | 0 | 0 | 1 |
| Sleep problems | 1 | 0 | 1 | 0 |
| Local pain at stimulation sitea | 4 | 0 | 3 | 1 |
| Dizzinessa | 1 | 0 | 0 | 1 |
| Skin reddeningb | 0 | 0 | 0 | 0 |
| Fracture of wrist due to a bike accident | 1 | 0 | 0 | 1 |
Abbreviations: CBT, cognitive behavioral therapy; tDCS, transcranial direct current stimulation.
a
Five events were classified related or potentially related to the intervention because of a temporal correlation to the intervention; all others were classified as unrelated.
b
Skin reddening was assessed when devices were removed by members of the study team, which took place after the CBT session (ie, 60 minutes after tDCS ended). This process was done to prevent unblinding by different levels of skin reddening after active vs sham stimulation. Therefore, no cases of skin reddening could be observed.