Condition category
Mental and Behavioural Disorders
Date applied
13/01/2020
Date assigned
22/01/2020
Last edited
21/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

Background and study aims
Depression and anxiety are common problems and a major cause of disability in the UK.
Most people with these conditions are managed in primary care and will be offered a variety of options depending on the severity of symptoms, local service availability and personal preference.
This study will evaluate the effectiveness of a new treatment pathway designed to optimise the patient experience without increasing the cost burden. It uses new technologies to help patients identify and engage with support, manage symptoms and monitor response.

Who can participate?
Patients aged 18 years or older who attend the nurse-led mental health clinic at the trial centre.

What does the study involve?
Participants who are eligible and agree to take part will have their details registered on the I-spero system which will assist the clinician in identifying the most appropriate management option for their condition. Treatment will continue as usual for eight weeks, at which time participants will be asked to complete a satisfaction questionnaire.

What are the possible benefits and risks of participating?
Benefits include the chance to use new technology before widely available. No risks.

Where is the study run from?
The University of Nottingham Health Service, UK

When is the study starting and how long is it expected to run for?
January 2020 to June 2020

Who is funding the study?
1. The Microcurrent Site Limited, UK
2. P1vital Products Limited, UK
3. National Institute for Health Research (NIHR), UK

Who is the main contact?
Dr Simon Royal
ncccg.research@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Simon Royal

ORCID ID

http://orcid.org/0000-0002-4560-6036

Contact details

Cripps Health Centre
University Park
Nottingham
NG7 2QW
United Kingdom
+44 (0)1158468888
ncccg.research@nhs.net

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 44191, IRAS 271778

Study information

Scientific title

Optimising the effectiveness of the management of mental health problems in primary care using new technologies

Acronym

Study hypothesis

The optimised pathway improves the management of mental health problems in primary care

Ethics approval

Approved 10/12/2019, NHS Wales REC 6, (Health and Care Research Wales Support and Delivery Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB; +44 (0)1874 615949; Wales.REC6@wales.nhs.uk), ref: 19/WA/0344

Study design

Interventional non-randomized study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mood [affective] disorders, Neurotic, stress-related and somatoform disorders

Intervention

Entry into the study will be offered to attendees at a nurse-led clinic for people who have mental health problems which will be set up in Nottingham, UK. The clinic will run at the student health centre on the University of Nottingham main campus. All attendees will be assessed by a trained mental health nurse on presentation to the service. Those eligible to participate must be registered with the practice, must be aged 18 or over, must have capacity to understand the patient information sheet and give consent to participation and must not require immediate referral to secondary care because of symptom severity. Patients not meeting these criteria will be offered usual care according to the standard operating procedures of the service. Patients who are eligible to join the study will be given an information sheet and time to consider participation. Those who do not give consent will be offered usual care according to the standard operating procedures of the service. Those who consent will be entered into the trial.

The first study procedure will be registration with the ispero system (CE-marked but not currently part of standard management) and completion of the baseline assessments it contains. The results of this will be available immediately and will assist the clinician in identifying the most appropriate management option. This could be one or more of the following:
- self help
- support agencies including NHS, University and voluntary sector
- psychological therapy with one of the three NHS provider organisations in Nottingham
- Alpha-Stim treatment for those with generalized anxiety (CE-marked but not currently standard management)
- referral to a GP to discuss medication

The participants' response to these options will be monitored by ispero and used at future contacts to guide further management.

There will be no planned study visits but participants will be seen by the appropriate clinician at intervals agreed at the end of each contact.

Eight weeks after recruitment an investigator will contact the participant and ask permission to inspect their I-spero data and collect outcome measures. They will be offered an opportunity to withdraw consent for participation at this point. They will also be offered a personal appointment with a study clinician so that data can be reviewed in a consultation environment. They will also be asked to complete a short satisfaction survey.

A control group of patients attending their GP practice with mental health problems that would have been eligible for inclusion in the study will be identified at the end of the study and a retrospective notes review will be performed by the investigator as part of routine service evaluation. It will be possible to compare some of the baseline and eight week outcome measures as this information is collected as part of standard practice.

Any data extracted for comparison will be fully anonymised and no patient identifiable data will be seen by any person who is not an employee of the study practice.

The null hypothesis will be that the new pathway is no more effective or acceptable than standard treatment. This design has been chosen as it aligns with current NHS priorities and causes minimal disruption to participants and local services. We considered a randomised controlled design but felt that this would cause ethical and logistical problems that would not outweigh the benefits in outcome data quality and comparability.

Intervention type

Device

Phase

Not Applicable

Drug names

Alpha-Stim

Primary outcome measure

Improvements from baseline to 8-weeks in I-spero data (I-spero uses a number of validated tests and an AI algorithm to monitor response to treatment)

Secondary outcome measures

Satisfaction as measured by questionnaire at 8 weeks

Overall trial start date

01/08/2019

Overall trial end date

01/02/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Attendance at nurse-led mental health clinic
2. Registered with participating general practice (this is necessary to ensure that clinical alerts generated by the ispero system can be acted upon in a timely manner)
3. Capacity to understand information sheet and provide informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 100

Participant exclusion criteria

1. Patients not suitable for the nurse-led mental health clinic. These would include those who appear distressed or at acute risk of harm to themselves or others or who appear to be intoxicated. The reception staff at the practice are already skilled in identifying these patients. The nurse-led clinic would also not be suitable for those with mental health problems related to a terminal or acute physical illness.
2. Those unable to communicate effectively in English

Recruitment start date

01/02/2020

Recruitment end date

30/06/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The University of Nottingham Health Service
Cripps Health Centre University Park
Nottingham
NG7 2QW
United Kingdom

Sponsor information

Organisation

University of Nottingham

Sponsor details

Cripps Health Centre
Nottingham
NG7 2QW
United Kingdom
+44 (0)1158468888
ncccg.research@nhs.net

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Organisation

P1vital Products Ltd

Sponsor details

Manor House
Howbery Business Park
Wallingford
Oxford
OX10 8BA
United Kingdom
+44 (0)1865 522030
info@p1vital.com

Sponsor type

Industry

Website

Organisation

The MicroCurrent Site

Sponsor details

Unit 3
Brookside
Sawtry
Huntingdon
PE28 5SB
United Kingdom
+44 (0)1487 208041
info@themicrocurrentsite.co.uk

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

The Microcurrent Site Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Funder name

P1 Vital Products Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

31/03/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

21/04/2020: Due to current public health guidance, recruitment for this study has been paused. 13/01/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR)