Clinical and Cost Effectiveness of Alpha-Stim AID CES

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

Interventions

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)

Sponsors & Collaborators

• Electromedical Products International, Inc.

  lead INDUSTRY

Principal Investigators

• Richard Morris, Professor · University of Nottingham

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-11

Primary Completion

2017-10-31

Completion

2017-12-31

Countries

• United Kingdom

Study Locations