Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
161 participants
INTERVENTIONAL
2016-08-11
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Anxiety Management in Breathlessness.
NCT06066658
Cranial Electrotherapy Stimulation in Burned Patients
NCT00723008
Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits
NCT04961112
Cranial Electrotherapy for Military Beneficiaries With Restless Legs Syndrome
NCT02419014
Alpha tACS for Disorders of Consciousness : a Single Case Experimental Design
NCT07213869
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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.
Pregnancy test
\- Pregnancy test x 1 (day 1)
Anxiety questionnaire
\- GAD-7 questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Quality of life questionnaire
\- EQ-5D-5L questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Work and social questionnaire
\- WASA questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Sleep questionnaire
\- Athens questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Depression questionnaire
\- PHQ-9 questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Quality of life and financial questionnaire
\- CSRI questionnaire x 3 (day 1, week 12 and week 24)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Pregnancy test
\- Pregnancy test x 1 (day 1)
Anxiety questionnaire
\- GAD-7 questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Quality of life questionnaire
\- EQ-5D-5L questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Work and social questionnaire
\- WASA questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Sleep questionnaire
\- Athens questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Depression questionnaire
\- PHQ-9 questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
Quality of life and financial questionnaire
\- CSRI questionnaire x 3 (day 1, week 12 and week 24)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Electromedical Products International, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Richard Morris, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Leicestershire and Rutland Improving Access to Psychological Therapies (IAPT) Service
Nottingham, Nottinghamshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
206555
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.