Active Versus Sham Transcranial Pulsed Electromagnetic Field Headband Treatment for Major Depression: a Study Protocol for a Double-blinded Randomized Trial
An 8-week, two-armed, randomized-controlled trial that examines the antidepressant effect of treatment with transcranial pulsed electromagnetic fields (T-PEMF) in patients diagnosed with moderate to severe depression using using a new device, the MoodHeadBand (MHB). The participants will use an active or placebo MHB for 30 minutes daily for 8 weeks. Additionally, the following research questions will be answered: 1\. If there is a positive effect on the patients' emotional and non-emotional cognition after 8 weeks of active treatment compared to the sham group and if possible early changes in the emotional cognition can predict the treatment response after 8 weeks of treatment. 1\. If the T-PEMF treatment provides improvement in restorative sleep after 8 weeks of treatment
• Meeting the diagnostic criteria for moderate to severe depressive episode without psychotic symptoms according to the International Classification of Diseases and Related Health Problems 10th Revision (ICD-10)(The ICD-10 Classification of Mental and Behavioural Disorders: Diagnostic Criteria for Research 1993).
• Female participants: Females in the fertile age must deliver a negative pregnancy test, or previously have been sterilized.
• Female fertile participants: They must use safe contraceptive methods to be included in the study, and during the whole study.
• Has given written, informed consent to the trial.