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Clinical and Cost Effectiveness of Alpha-Stim AID CES

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ClinicalTrials.gov Identifier: NCT02901080
Recruitment Status : Unknown
Verified September 2016 by Electromedical Products International, Inc..
Recruitment status was:  Recruiting
First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Electromedical Products International, Inc.

Brief 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.


Condition or disease Intervention/treatment Phase
Anxiety 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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Cranial electrotherapy stimulation
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
Device: 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.

Behavioral: Pregnancy test
- Pregnancy test x 1 (day 1)

Other: Anxiety questionnaire
- GAD-7 questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)

Other: Quality of life questionnaire
- EQ-5D-5L questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)

Other: Work and social questionnaire
- WASA questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)

Other: Sleep questionnaire
- Athens questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)

Other: Depression questionnaire
- PHQ-9 questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)

Other: Quality of life and financial questionnaire
- CSRI questionnaire x 3 (day 1, week 12 and week 24)




Primary Outcome Measures :
  1. Clinical effectiveness in generalised anxiety disorder [ 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, clinically significant improvement, and recovery, from baseline to week 24, following previous treatment with low intensity psychological therapy intervention.


Secondary Outcome Measures :
  1. Cost effectiveness in generalised anxiety disorder [ Time Frame: 24 weeks ]
    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).

  2. Clinical effectiveness in depression [ Time Frame: 24 weeks ]
    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, clinically significant improvement, and recovery, from baseline to week 24, following previous treatment with low intensity psychological therapy intervention.

  3. Clinical effectiveness in insomnia [ Time Frame: 24 weeks ]
    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, clinically significant improvement, and recovery, from baseline to week 24, following previous treatment with low intensity psychological therapy intervention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901080


Contacts
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Contact: Jeff Marksberry 9403280788 jeff@epii.com

Locations
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United Kingdom
Leicestershire and Rutland Improving Access to Psychological Therapies (IAPT) Service Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG3 6AA
Contact: Peter Caunt    0115876174    peter.caunt@nottshc.nhs.uk   
Sponsors and Collaborators
Electromedical Products International, Inc.
Investigators
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Principal Investigator: Richard Morris, Professor University of Nottingham

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Responsible Party: Electromedical Products International, Inc.
ClinicalTrials.gov Identifier: NCT02901080     History of Changes
Other Study ID Numbers: 206555
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data will form part of the final study report which will be used for submission to the UK National Institute for Clinical Excellence.
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders