At a glance
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Naturalistic Study of Alpha-Stim in Patients With a Primary Working Diagnosis of Moderate-to-severe Generalised Anxiety Disorder Who Did Not Improve With Low Intensity Psychological Therapy Intervention
In Brief
A clinical study evaluating Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test, and 6 other interventions for Anxiety. Completed, enrolled 161 participants across 1 site.
Detailed Summary
This is a single-centre research study in patients seen within an NHS Improving Access to Psychological Interventions (IAPT) service with suspected generalised anxiety disorder (GAD). The study will involve 120 patients from the Leicestershire and Rutland area in England, United Kingdom. Participants will use the Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) medical device, which is approved for use and proven to be safe and work for the treatment for anxiety, depression and insomnia. Participants will use the Alpha-Stim AID for 60 minutes every day for 6 or 12 weeks, either whilst on the waiting list for standard care treatment from IAPT, or in conjunction with standard care treatment from IAPT. The study will involve 6 study visits - one face-to-face at visit 1, followed by 5 visits via telephone at week 4, 6, 8, 12 and 24. At each visit, participants will be asked to complete questionnaires to assess anxiety, depression, sleep difficulty, quality of life and work and social functioning. The purpose of the study is to gather evidence for the clinical benefits and cost effectiveness of the Alpha-Stim AID when used in an NHS setting - how well does it work, and does it's use result in cost savings for the NHS. The study may show that the Alpha-Stim AID should be available on the NHS for patients with suspected GAD.
Study Details
Timeline
Interventions
\- 60 minutes of cranial electrotherapy stimulation via Alpha Stim AID once per day, for a minimum of 6 and maximum of 12 weeks.
\- Pregnancy test x 1 (day 1)
\- GAD-7 questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
\- EQ-5D-5L questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
\- WASA questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
\- Athens questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
\- PHQ-9 questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
\- CSRI questionnaire x 3 (day 1, week 12 and week 24)