AnxietyNCT02901080
Clinical and Cost Effectiveness of Alpha-Stim AID CES
A study testing Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test and Anxiety questionnaire in people with Anxiety, run by Electromedical Products International, Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test and Anxiety questionnaire
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Aug 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leicestershire and Rutland Improving Access to Psychological Therapies (IAPT) Service
Nottingham, Nottinghamshire, NG3 6AA
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
Participants will have a baseline visit (day 1, visit 1) following identification as potentially eligible. The baseline visit will be face-to-face with a member of the research team, held at routine facilities used by the IAPT service. At the baseline visit, the participant will be consented for participation, have a urine pregnancy test first (if a female of child bearing potential) and the research team will administer the GAD-7 secondly, followed by EQ-5D-5L, WASA, PHQ-9, Athens, and CSRI surveys. Participants will then be instructed on how to use the Alpha-Stim AID device, and will have their first 60 minute, self-directed treatment session at home.
All further visits will be facilitated via telephone, scheduled between the research team and participant, within a 5 calendar day window of each time point.
At visit 2 (week 4), visit 3 (week 6), visit 4 (week 8), visit 5 (week 12) and visit 6 (week 24), the research team will administer the GAD-7, EQ-5D-5L, WASA, PHQ-9 and Athens. The CSRI will be repeated only at visit 5 and 6. Compliance with the 60 minute daily treatment session will also be assessed during the 6 or 12 week treatment window, in addition to any adverse events.
The 60-minute self-directed Alpha-Stim AID treatment sessions are undertaken at participant's home, on a daily basis for 6 weeks for all participants. During this 6-week period, participants will be on the waiting list for high intensity psychological therapy interventions.
Following 6 weeks of Alpha-Stim AID CES treatment, participants have the option to receive a further 6 weeks of treatment, which is likely to coincide with start of high intensity psychological therapy interventions as clinically indicated.
Following a maximum of 12 weeks' treatment with Alpha-Stim AID CES, all participants will cease to receive treatment on study.
All participants will continue to receive standard care assessment, as undertaken by the NHS IAPT service, standard care high intensity psychological therapy interventions as clinically indicated and provided by the NHS IAPT service, and standard care pharmacological treatments as prescribed by the participant's GP. Participation in this study will not influence nor compromise standard care treatment - all study procedures are additional to standard care. Participation in the study will have no impact upon the duration of the waiting time for high intensity psychological therapy interventions.
- Conditions
- Anxiety
- Being tested
- Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test, Anxiety questionnaire, Quality of life questionnaire, Work and social questionnaire
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha Stim AID cranial electrotherapy stimulationDevice
- 60 minutes of cranial electrotherapy stimulation via Alpha Stim AID once per day, for a minimum of 6 and maximum of 12 weeks.
Pregnancy testBehavioural
- Pregnancy test x 1 (day 1)
Anxiety questionnaireOther
- GAD-7 questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Quality of life questionnaireOther
- EQ-5D-5L questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Work and social questionnaireOther
- WASA questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Sleep questionnaireOther
- Athens questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Depression questionnaireOther
- PHQ-9 questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Quality of life and financial questionnaireOther
- CSRI questionnaire x 3 (day 1, week 12 and week 24)
| Study group | Role | What they receive |
|---|---|---|
| Cranial electrotherapy stimulation | Experimental | Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test, Anxiety questionnaire, Quality of life questionnaire, Work and social questionnaire, Sleep questionnaire, Depression questionnaire, Quality of life and financial questionnaire Receives: Device: Alpha Stim AID cranial electrotherapy stimulation; Behavioral: Pregnancy test; Other: Anxiety questionnaire; Other: Quality of life questionnaire; Other: Work and social questionnaire; Other: Sleep questionnaire; Other: Depression questionnaire; Other: Quality of life and financial questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Effectiveness in Generalised Anxiety Disorder Measured by at Least a 5 Point Reduction in Scores on the GAD-7
The primary objective of this study is to evaluate the clinical effectiveness of treatment with Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) for participants with a primary working diagnosis of generalised anxiety disorder (GAD), as defined by the NHS IAPT service in terms of reliable improvement (at least a 5 point improvement on the GAD-7),or recovery (total score of less than 7 and at least a 5 point improvement on the GAD-7), from baseline to week 24, following previous treatment with low intensity psychological therapy intervention.
Measured: 24 weeks
Secondary outcomes (3)
Cost Effectiveness in Generalised Anxiety Disorder Compared to Current Treatment Approaches
The secondary objective of this study is to evaluate the cost effectiveness of treatment with Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) for participants with a primary working diagnosis of generalised anxiety disorder (GAD), in terms of health and social care service cost, and patient cost, from baseline to week 24, following previous treatment with low intensity psychological therapy intervention. The health and social care service cost and patient cost will be aggregated to determine the QALY (quality adjusted life year) value of the intervention. QALYs are used by the National Institute for Clinical Excellence (NICE) in the United Kingdom to determine the cost effectiveness of a treatment, and to determine whether it should be made available free at point of use in the National Health Service (NHS).
Measured: 24 weeks
Clinical Effectiveness in Depression as Measured by Reduction of at Least 6 Points in Scores on the Personal Health Questionnaire (PHQ-9)
The third objective of this study is to evaluate the clinical effectiveness of treatment with Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) for depression in participants with a primary working diagnosis of generalised anxiety disorder (GAD), in terms of reliable improvement (a 6 point reduction in scores on the PHQ-9) or recovery (a score of 9 or less and at least a 6 point drop on the PHQ-9), from baseline to week 24, following previous treatment with low intensity psychological therapy intervention.
Measured: 24 weeks
Clinical Effectiveness in Insomnia as Measured by at Least a 50% Reduction in Score on the Athens Insomnia Scale (AIS)
The fourth objective of the tertiary objective of this study is to evaluate the clinical effectiveness of treatment with Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) for insomnia in participants with a primary working diagnosis of generalised anxiety disorder (GAD), in terms of reliable improvement (at least a 50% reduction in scores on the AIS), and recovery (a score of less than 4 and a reduction of at least 50% in AIS score), from baseline to week 24, following previous treatment with low intensity psychological therapy intervention.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study start11 Aug 2016
- Primary completionOct 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Electromedical Products International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Morris, Professor, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901080
- Sponsor's protocol ID
- 206555
- Status last verified
- Jul 2021
- First submitted
- 1 Sep 2016
- Last updated
- 22 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Anonymised data will form part of the final study report which will be used for submission to the UK National Institute for Clinical Excellence.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02901080
- Acronym / sponsor ID
- 206555
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Electromedical Products International, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Posted 25 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will have a baseline visit (day 1, visit 1) following identification as potentially eligible. The baseline visit will be face-to-face with a member of the research team, held at routine facilities used by the IAPT service. At the baseline visit, the participant will be consented for participation, have a urine pregnancy test first (if a female of child bearing potential) and the research team will administer the GAD-7 secondly, followed by EQ-5D-5L, WASA, PHQ-9, Athens, and CSRI surveys. Participants will then be instructed on how to use the Alpha-Stim AID device, and will have their first 60 minute, self-directed treatment session at home.
All further visits will be facilitated via telephone, scheduled between the research team and participant, within a 5 calendar day window of each time point.
At visit 2 (week 4), visit 3 (week 6), visit 4 (week 8), visit 5 (week 12) and visit 6 (week 24), the research team will administer the GAD-7, EQ-5D-5L, WASA, PHQ-9 and Athens. The CSRI will be repeated only at visit 5 and 6. Compliance with the 60 minute daily treatment session will also be assessed during the 6 or 12 week treatment window, in addition to any adverse events.
The 60-minute self-directed Alpha-Stim AID treatment sessions are undertaken at participant's home, on a daily basis for 6 weeks for all participants. During this 6-week period, participants will be on the waiting list for high intensity psychological therapy interventions.
Following 6 weeks of Alpha-Stim AID CES treatment, participants have the option to receive a further 6 weeks of treatment, which is likely to coincide with start of high intensity psychological therapy interventions as clinically indicated.
Following a maximum of 12 weeks' treatment with Alpha-Stim AID CES, all participants will cease to receive treatment on study.
All participants will continue to receive standard care assessment, as undertaken by the NHS IAPT service, standard care high intensity psychological therapy interventions as clinically indicated and provided by the NHS IAPT service, and standard care pharmacological treatments as prescribed by the participant's GP. Participation in this study will not influence nor compromise standard care treatment - all study procedures are additional to standard care. Participation in the study will have no impact upon the duration of the waiting time for high intensity psychological therapy interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cranial electrotherapy stimulation | Experimental | Device: Alpha Stim AID cranial electrotherapy stimulation, Behavioral: Pregnancy test, Other: Anxiety questionnaire, Other: Quality of life questionnaire, Other: Work and social questionnaire, Other: Sleep questionnaire, Other: Depression questionnaire, Other: Quality of life and financial questionnaireAlpha Stim AID cranial electrotherapy stimulation, Pregnancy test, Anxiety questionnaire, Quality of life questionnaire, Work and social questionnaire, Sleep questionnaire, Depression questionnaire, Quality of life and financial questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha Stim AID cranial electrotherapy stimulation- 60 minutes of cranial electrotherapy stimulation via Alpha Stim AID once per day, for a minimum of 6 and maximum of 12 weeks. | Device | Cranial electrotherapy stimulation |
| Pregnancy test- Pregnancy test x 1 (day 1) | Behavioural | Cranial electrotherapy stimulation |
| Anxiety questionnaire- GAD-7 questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24) | Other | Cranial electrotherapy stimulation |
| Quality of life questionnaire- EQ-5D-5L questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24) | Other | Cranial electrotherapy stimulation |
| Work and social questionnaire- WASA questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24) | Other | Cranial electrotherapy stimulation |
| Sleep questionnaire- Athens questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24) | Other | Cranial electrotherapy stimulation |
| Depression questionnaire- PHQ-9 questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24) | Other | Cranial electrotherapy stimulation |
| Quality of life and financial questionnaire- CSRI questionnaire x 3 (day 1, week 12 and week 24) | Other | Cranial electrotherapy stimulation |
Primary outcome
Clinical Effectiveness in Generalised Anxiety Disorder Measured by at Least a 5 Point Reduction in Scores on the GAD-7
Time frame: 24 weeks
The primary objective of this study is to evaluate the clinical effectiveness of treatment with Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) for participants with a primary working diagnosis of generalised anxiety disorder (GAD), as defined by the NHS IAPT service in terms of reliable improvement (at least a 5 point improvement on the GAD-7),or recovery (total score of less than 7 and at least a 5 point improvement on the GAD-7), from baseline to week 24, following previous treatment with low intensity psychological therapy intervention.
3 secondary outcomes
Cost Effectiveness in Generalised Anxiety Disorder Compared to Current Treatment Approaches
Time frame: 24 weeks
Clinical Effectiveness in Depression as Measured by Reduction of at Least 6 Points in Scores on the Personal Health Questionnaire (PHQ-9)
Time frame: 24 weeks
Clinical Effectiveness in Insomnia as Measured by at Least a 50% Reduction in Score on the Athens Insomnia Scale (AIS)
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Anonymised data will form part of the final study report which will be used for submission to the UK National Institute for Clinical Excellence.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Morris, Professor principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha Stim AID cranial electrotherapy stimulation, Pregnancy test and Anxiety questionnaire in people with Anxiety, run by Electromedical Products International, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Effectiveness in Generalised Anxiety Disorder Measured by at Least a 5 Point Reduction in Scores on the GAD-7 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.