Reduction of depressive symptoms for patients in primary care Mental and Behavioural Disorders Major depressive episode
Conditions
Interventions
Study participants will be referred from Primary Care GP practices via their GP and randomised into active Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) or sham Alpha-Stim AID CES. The stud
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged =16 years 2. Diagnosis of current Major Depressive Episode (MDE) 3. A Score of =10 or 9-item self-rated Personal Health Questionnaire (PHQ-9) 4. Have either been offered the option of anti-depressant medication or prescribed antidepressant medication for a minimum of 6 weeks in the last 3 months 5. Capable of giving oral and written informed consent to the study, and this consent is confirmed by the researcher at eligibility screening and baseline assessment 6. Agrees to return Alpha-Stim equipment at the end of the study and not to purchase this equipment privately during the study
Exclusion criteria
Exclusion criteria: 1. A score of =20 on the PHQ-9 2) Neurological conditions e.g. brain neoplasm, cerebrovascular events, epilepsy, neurodegenerative disorders, and prior brain surgery 3. Requiring urgent clinical care such as having persistent suicidal ideation, self-harm or suicidal intent. 4. Known to be pregnant 5. Implantation with a pacemaker or an implantable cardioverter device (ICD) 6. Major unstable medical illness requiring further investigation or treatment 7. A diagnosis of current substance use disorder or dependence, dementia, eating disorder, bipolar disorder or nonaffective psychosis because the use of CES treatment would otherwise require additional supervision or is associated with additional risk e.g. of mania in bipolar disorder 8. Completed and benefitted from/responded to psychological treatment for depression in the last 3 months or planning to commence psychological treatment in the next 6 months 9. Involved with any other clinical trial at the time of consent or 6 months prior
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Impact of Alpha-Stim AID CES on depressive symptoms measured by the change in the 17-item observer-rated face-to-face, video-conferencing or telephone rated grid version of the Hamilton Depression Rating Scale (GRID-HAMD) score at baseline and 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Depressive symptoms measured by the change in the 17-item observer-rated face-to-face, video-conferencing or telephone rated grid version of the Hamilton Depression Rating Scale (GRID-HAMD) score at 4 and 8 weeks Secondary outcome measures will be collected at baseline, 4, 8 and 16 weeks and will be the following. 2. Depression severity measured using the Patient Health Questionnaire-9 (PHQ-9) at 4, 8 and 16 weeks 3. Self-rated anxiety measured using the Generalised Anxiety Disorder Assessment (GAD-7) at 4, 8 and 16 weeks 4. Self-rated measure of function measured using the Work and Social Adjustment Scale (WSAS) at 4,8 and 16 weeks 5. Quality of life measured using the EuroQol Group 5 level, 5 dimension quality of life questionnaire (EQ-5D-5L) at 4, 8 and 16 weeks 6. Costs from personal, health and social care perspectives measured using Client Service Receipt inventory at 4, 8 and 16 weeks | — |
Countries
England, United Kingdom
Contacts
Public ContactShireen Patel
Outcome results
None listed