Assessment of the effect of transcranial direct current stimulation (tDCS) on insomnia in primary care patients
Insomnia
Design The study has an open-label patient cohort design with no control group. Patients complete pre- and post-intervention self-report measures. In-depth interviews will be undertaken with patients and NHS GPs. Participants Approximately 100 primary care patients will use tDCS and complete outcome measures. Approximately 14 patients will complete in-depth interviews, purposely recruited to be representative in terms of gender and age. Approximately 8 GPs will also complete in-depth interviews. Setting Participants will be recruited through a primary healthcare general practice (GP). Flow will be self-administered at home by participants living in the community. Flow Neuroscience AB (manufacturer of the Flow device) provides GPs and other healthcare staff with training. Procedure Patients’ records will be reviewed/screened by NHS staff with permission to access to identify those meeting the inclusion criteria. Patients selected by their GP if they meet the inclusion/exclusion criteria will be provided with PIS. Participants can choose to stay on the same medication and continue any current psychological interventions they were undertaking (this will be recorded). Informed consent will be obtained before beginning treatment. Participants can withdraw consent or stop treatment at any point without the need to provide a reason. The research team will keep any data supplied before this, and this is noted on the PIS and consent forms. Following informed consent, a note will be made on the patient’s records, participants will collect the Flow device and instructions from the GP reception and complete the self-report measures. Participants are informed about Flow Neuroscience AB’s website, which provides information, training on use, and email-based support. Follow-up measures will be collected after treatment. For the professionals’ interviews, GPs will be given a PIS and consent form, and they will be provided with the opportunity to ask questions. If they agree to
1. Age 18 years and over 2. Patients reporting insomnia symptoms 3. Able to provide written informed consent 4. Have a smart mobile phone with internet access and a data download contract
1. Epilepsy (or having a history of seizures) 2. Having a defect in the neurocranium and/or a cranial implant 3. Having an active, implanted medical device (e.g., cardiac pacemaker, spinal cord stimulator, vagal nerve stimulator, auricular stimulator, deep-brain-stimulating electrodes, cochlear implant, implanted hearing aid or defibrillator) or other implanted, metallic, or electronic device 4. A neurological condition 5. A history of hypomanic/manic episodes 6. Do not have the capacity to consent 7. Open wound in the area of pad contact on the forehead 8. Pregnant