N/A
Completed N=161
Clinical and Cost Effectiveness of Alpha-Stim AID CES
Source: ClinicalTrials.gov NCT02901080 ↗Enrolled (actual)
161
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Clinical Effectiveness in Generalised Anxiety Disorder Measured by at Least a 5 Point Reduction in Scores on the GAD-7 — 102 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Effectiveness in Generalised Anxiety Disorder Measured by at Least a 5 Point Reduction in Scores on the GAD-7 |
102 | — |
| SECONDARY Cost Effectiveness in Generalised Anxiety Disorder Compared to Current Treatment Approaches |
540 | — |
| SECONDARY Clinical Effectiveness in Depression as Measured by Reduction of at Least 6 Points in Scores on the Personal Health Questionnaire (PHQ-9) |
80 | — |
| SECONDARY Clinical Effectiveness in Insomnia as Measured by at Least a 50% Reduction in Score on the Athens Insomnia Scale (AIS) |
48 | — |
Eligibility Criteria
Inclusion Criteria
- Primary working diagnosis of moderate-to-severe GAD indicated via a GAD-7 score of 10 or more at baseline visit
- Previous treatment within an IAPT service with step two low intensity psychological therapy intervention
- Indicated for step three high intensity psychological therapy intervention and on the waiting list
- Capable of giving informed consent
- Female participants of child-bearing potential must have a negative urine human chorionic gonadotropin dipstick pregnancy test
- Female participants of child-bearing potential must be practising a highly effective method of contraception (failure rate of less than 1% per year when used consistently and correctly and agree to remain on a highly effective method throughout the 6 or 12 week treatment period. Examples of highly effective contraceptives include: barrier condoms, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), vasectomised partner, sexual abstinence (refraining from heterosexual intercourse), and oestrogen and progestogen containing hormonal contraception associated with ovulation.
- 18 years of age or above at baseline visit
- Able to understand written and verbal English
Exclusion Criteria
- Primary working diagnosis of a mental disorder other than moderate-to-severe GAD (but other mental and anxiety disorders as secondary comorbidities is not an exclusion criteria)
- No previous treatment within an IAPT service with step two low intensity psychological therapy intervention
- Not indicated for step three high intensity psychological therapy intervention and not on the waiting list
- Requiring urgent clinical care
- Female participants of child-bearing potential with a positive urine human chorionic gonadotropin dipstick pregnancy test
- Female participants of child-bearing potential not willing to practice a highly effective method of contraception during the treatment period
- Implantation with a pace maker
- Implantation with an implantable cardioverter defibrillator (ICD)
- Incapable of giving informed consent
- 17 years of age or less at baseline visit
- Unable to understand written and verbal English
Data sourced from ClinicalTrials.gov (NCT02901080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.