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| Name | Class |
|---|---|
| University of Nottingham | OTHER |
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The study will be a multi-centre parallel group, double blind, non-commercial, randomised controlled superiority trial. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active CES Therapy | Active Comparator | Participants will be asked to use Alpha-Stim 60 minutes daily for 8 weeks. Active devices are programmed to emit a current intensity of 100 uA at 0.5 Hz and will be programmed to run for 60 minutes. Participants will not be able to adjust the settings on the devices. |
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| Sham CES Therapy | Sham Comparator | Participants will be asked to use Alpha-Stim 60 minutes daily for 8 weeks. Sham devices are programmed to display a current intensity of 100 uA at 0.5 Hz and will be programmed to run for 60 minutes, but no current will be emitted from the device. Participants will not be able to adjust the settings on the devices. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Alpha-Stim CES | Device | Active Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in depression | Determine if there is a significant difference from baseline to 16 weeks on the Grid version of the Hamilton Depression Scale. The GRID-HAMD is a 17 item scale with scores ranging from 0-54. Higher scores indicate increased severity of depression. Scores of 0-7 is generally accepted to be within the normal range (clinical remission) and a score of 20 or above indicates moderate severity. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cost effectiveness | This will be analysed through the measurement of costs from personal, health and social care perspectives using Client Service Receipt inventory at 4, 8 and 16 weeks. The CSRI is a measure of the full health and social care cost and patient cost of treatment. | 16 weeks |
| Change in anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard Morriss, MD | Contact | 0115 8230427 | richard.morriss@nottignham.ac.uk | |
| Shireen Patel | Contact | shireen.patel@nottingham.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Richard Morriss, MD | University of Nottingham Research and Innovation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nottingham | Recruiting | Nottingham | United Kingdom |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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The study is a multi-centre parallel group, double blind, non-commercial, randomised controlled trial (RCT).
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Devices are programmed by the manufacturer prior to shipping to investigator. Active devices are programmed at 100 uA for 60 minutes, which is subsensory. Sham devices will display 100 uA and count down from 60 minutes, but will not emit a current. Neither the investigators nor the participants will know which devices are active and which are sham.
| Sham Alpha-Stim CES | Device | Sham Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks. |
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Determine if there is a significant difference from baseline to 16 weeks on the Generalized Anxiety Disorder Scale. The GAD-7 is a 7-item self-rated measure of the severity of Generalized Anxiety Disorder. Scores range from 0-21. Scores of 5, 10, 15 and 20 represent cut off points for mild, moderate, moderately severe and severe anxiety. |
| 16 weeks |
| Change in quality of life - work and social functioning | Determine if there is a significant difference in quality of life related to work and social functioning from baseline to 16 weeks, as measured by the Work and Social Adjustment Scale. The WASA is a 5-item self-rated measure of work and social function. The maximum score of the WSAS is 40, lower scores indicate less impairment in functioning. | 16 weeks |
| Change in quality of life - health related | Determine if there is a significant difference in quality of life related to overall health using a standardized measure developed by the Euroqual group. EQ5D-5L is 5 item standardized instrument for measuring generic health status. It is used by NICE to generate quality adjusted life years for cost effectiveness assessments. | 16 weeks |
| D001519 |
| Behavior |