Clinical and Cost Effectiveness of Alpha-Stim AID CES

NCT02901080 | Completed Results

• 1 other identifier: 206555
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Secondary Outcomes (3)

• Cost Effectiveness in Generalised Anxiety Disorder Compared to Current Treatment Approaches

  24 weeks

• Clinical Effectiveness in Depression as Measured by Reduction of at Least 6 Points in Scores on the Personal Health Questionnaire (PHQ-9)

  24 weeks

• Clinical Effectiveness in Insomnia as Measured by at Least a 50% Reduction in Score on the Athens Insomnia Scale (AIS)

  24 weeks

Study Arms (1)

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

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

Interventions

Alpha Stim AID cranial electrotherapy stimulation DEVICE

\- 60 minutes of cranial electrotherapy stimulation via Alpha Stim AID once per day, for a minimum of 6 and maximum of 12 weeks.

Cranial electrotherapy stimulation

Pregnancy test BEHAVIORAL

\- Pregnancy test x 1 (day 1)

Cranial electrotherapy stimulation

Anxiety questionnaire OTHER

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

Cranial electrotherapy stimulation

Quality of life questionnaire OTHER

\- EQ-5D-5L questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)

Cranial electrotherapy stimulation

Work and social questionnaire OTHER

\- WASA questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)

Cranial electrotherapy stimulation

Sleep questionnaire OTHER

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

Cranial electrotherapy stimulation

Depression questionnaire OTHER

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

Cranial electrotherapy stimulation

Quality of life and financial questionnaire OTHER

\- CSRI questionnaire x 3 (day 1, week 12 and week 24)

Cranial electrotherapy stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age or above at baseline visit
• Able to understand written and verbal English

You may not qualify if:

• 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
• years of age or less at baseline visit
• Unable to understand written and verbal English

Sponsors & Collaborators

• Electromedical Products International, Inc.: lead

Study Sites (1)

Leicestershire and Rutland Improving Access to Psychological Therapies (IAPT) Service

Nottingham, Nottinghamshire, NG3 6AA, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Pregnancy Tests; Patient Health Questionnaire; Quality of Life

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Investigative Techniques; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Health Status; Demography; Epidemiologic Measurements

Limitations and Caveats

Sample was not an RCT and did not have a placebo control group. Lack of ethnic diversity in the sample.

Results Point of Contact

• Title: Science and Education Director
• Organization: Electromedical Products International, Inc.

josh@epii.com

8174583295

Study Officials

• Richard Morris, Professor

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 15, 2016
• Study Start: August 11, 2016
• Primary Completion: October 1, 2017
• Study Completion: December 31, 2017
• Last Updated: July 22, 2021
• Results First Posted: June 25, 2020

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)