Feasibility StudiesTechCareNCT02439619
TechCare: Mobile-AssessmenT and ThErapy for PsyCHosis: An Intervention for Clients Within the EArly InteRvention SErvice
A study testing TechCare in people with Feasibility Studies, run by Lancashire Care NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of the project is to conduct a feasibility study of the mobile phone application "TechCare" for individuals with psychosis in the North West of England. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Feasibility Studies
- What is being tested?
- TechCare
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Each client must be accepted into the Psychosis Group of the Lancashire Early Intervention Service.
- Ages 18 - 35 years
- Medication stable for previous two months
- Clients must be currently stable-The Lancashire Early Intervention Team uses a traffic light system to indicate current symptomatology and risks of each client. For this study we will use only clients with a Green Light, signifying that they are currently stable.
- A score of 3 or more on positive symptoms on the PANSS
- Minimum score of 1 on the Calgary depression scale.
Who cannot join
- Drug induced psychosis
- An acquired brain injury or learning disability
- Clients who are undergoing assessment, not formally diagnosed and accepted into the service.
- Lacking capacity for informed consent.
- Ultra High Risk of Developing Psychosis Group (i.e. Prodromal, not first episode)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Lancashire Care NHS Foundation Trust
Preston, Lancashire, PR2 8DW
Charlotte Bee, PhD, 01772 773498, charlotte.bee@lancashirecare.nhs.uk
Nadeem Gire, BSc MSc, 07507847569, nadeem.gire@lancashirecare.nhs.uk
About this study
The aim of the project is to conduct a feasibility study of the mobile phone application "TechCare" for individuals with psychosis in the North West of England.
Read the detailed description
This feasibility study will follow the NIHR guidance on feasibility study design (NIHR, 2014) and will consist of both qualitative and quantitative components. The study will run across three strands as follows 1) Qualitative work \& Systematic review 2) Test run and Intervention refinement 3) Feasibility trial.
- Conditions
- Feasibility Studies
- Being tested
- TechCare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TechCareOther
The TechCare software is being developed specifically for use on a touch screen mobile phone. The mobile application will alert participants through notifications and ask a number of questions. Based on participant responses the app will provide a CBT based response to individuals or the service users preferred multimedia such as music, images and videos.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility Trial | Experimental | Not described Receives: Other: TechCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Acceptability
We will measure feasibility and acceptability by exploring whether appropriate individuals can be identified and recruited to an open trial of TechCare; whether TechCare is an acceptable intervention for individuals with psychosis and what measures will be important for assessing the impact of TechCare on delusions and low mood in psychosis.
Measured: 36 months
Secondary outcomes (8)
Psychopathology on The Positive and Negative Syndrome Scale (PANSS)
The 30- item PANSS, is a clinician administered 30 item semi structured interview which provides balanced representation of positive symptoms and negative symptoms and gauges their relationship to one another and to global/general psychopathology
Measured: 24 months
Psychopathology on The Psychotic Symptom Rating Scales (PSYRATS)
The PSYRATS is a semi-structured interview measuring dimensions of delusions and hallucinations.
Measured: 24 months
Satisfaction with CBT therapy on the CHoice of Outcome In Cbt for psychosEs
This is an outcome measure which reflects the aims of cognitive behavioural therapy for psychosis and the priorities of service users.
Measured: 24 months
Mental wellbeing on the Warwick-Edinburgh Mental Well Being Scale (WEMWBS)
The WEMWBS is a measure of mental wellbeing which focuses entirely on positive aspects of mental health.
Measured: 24 months
Measure of core beliefs regarding self and others on the Brief Core Schema Scale
This is a 24 item measure of core beliefs regarding self and others. It is a nine item scale which allows for the quantitative and subjective dimension of depression in schizophrenia.
Measured: 24 months
Depression on the Calgary depression scale
The CDS was developed to measure the level of depression in schizophrenia. It is a nine item scale which allows for the quantitative and subjective dimension of depression in schizophrenia.
Measured: 24 months
Work and social functioning on The Work and Social Adjustment Scale
This is a five item measure of perceived impairment in five areas: work, home management, social life, private leisure and relationships
Measured: 24 months
Quality of life on the EuroQoL-5 Dimensions EQ5-D
the measure is standardised instrument looking at quality of life across five health domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startOct 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feasibility StudiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lancashire Care NHS Foundation Trust
- Sponsor type
- Research network
- Collaborators
- University of Central Lancashire
- Responsible party
- Sponsor
- Investigators
- Imran B Chaudhry, MBBS MD, Principal investigator, Lead Consultant Psychiatrist, Lancashire Care Early Intervention Service & Hon Clinical Professor Adult Psychiatry University of ManchesterNusrat Husain, MBBS MD, Principal investigator, Reader in Psychiatry University of Manchester, Director Research Global Health Manchester Academic Health Sciences Centre & Consultant Psychiatrist Lancashire Care Early Intervention ServiceJames Kelly, DClinPsych, Principal investigator, Lancashire Care NHS Foundation Trust Early Intervention Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439619
- Sponsor's protocol ID
- TechCare-LCFT
- Acronym
- TechCare
- Status last verified
- May 2015
- First submitted
- 5 May 2015
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gire N, Caton N, McKeown M, Mohmed N, Duxbury J, Kelly J, Riley M, J Taylor P, Taylor CDJ, Naeem F, Chaudhry IB, Husain N. 'Care co-ordinator in my pocket': a feasibility study of mobile assessment and therapy for psychosis (TechCare). BMJ Open. 2021 Nov 16;11(11):e046755. doi: 10.1136/bmjopen-2020-046755.
PubMed 34785541
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TechCare: Mobile-AssessmenT and ThErapy for PsyCHosis: An Intervention for Clients Within the EArly InteRvention SErvice
- ClinicalTrials.gov ID
- NCT02439619
- Acronym / sponsor ID
- TechCare / TechCare-LCFT
- Conditions
- Feasibility Studies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Lancashire Care NHS Foundation TrustResearch network
- Collaborators
- University of Central Lancashire
- Study start
- Oct 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the project is to conduct a feasibility study of the mobile phone application "TechCare" for individuals with psychosis in the North West of England.
Detailed description
This feasibility study will follow the NIHR guidance on feasibility study design (NIHR, 2014) and will consist of both qualitative and quantitative components. The study will run across three strands as follows 1) Qualitative work \& Systematic review 2) Test run and Intervention refinement 3) Feasibility trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility Trial | Experimental | Other: TechCare |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Each client must be accepted into the Psychosis Group of the Lancashire Early Intervention Service.
- Ages 18 - 35 years
- Medication stable for previous two months
- Clients must be currently stable-The Lancashire Early Intervention Team uses a traffic light system to indicate current symptomatology and risks of each client. For this study we will use only clients with a Green Light, signifying that they are currently stable.
- A score of 3 or more on positive symptoms on the PANSS
Key exclusion criteria (5 listed)
- Drug induced psychosis
- An acquired brain injury or learning disability
- Clients who are undergoing assessment, not formally diagnosed and accepted into the service.
- Lacking capacity for informed consent.
- Ultra High Risk of Developing Psychosis Group (i.e. Prodromal, not first episode)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TechCareThe TechCare software is being developed specifically for use on a touch screen mobile phone. The mobile application will alert participants through notifications and ask a number of questions. Based on participant responses the app will provide a CBT based response to individuals or the service users preferred multimedia such as music, images and videos. | Other | Feasibility Trial |
Primary outcome
Feasibility and Acceptability
Time frame: 36 months
We will measure feasibility and acceptability by exploring whether appropriate individuals can be identified and recruited to an open trial of TechCare; whether TechCare is an acceptable intervention for individuals with psychosis and what measures will be important for assessing the impact of TechCare on delusions and low mood in psychosis.
8 secondary outcomes
Psychopathology on The Positive and Negative Syndrome Scale (PANSS)
Time frame: 24 months
Psychopathology on The Psychotic Symptom Rating Scales (PSYRATS)
Time frame: 24 months
Satisfaction with CBT therapy on the CHoice of Outcome In Cbt for psychosEs
Time frame: 24 months
Mental wellbeing on the Warwick-Edinburgh Mental Well Being Scale (WEMWBS)
Time frame: 24 months
Measure of core beliefs regarding self and others on the Brief Core Schema Scale
Time frame: 24 months
Depression on the Calgary depression scale
Time frame: 24 months
Work and social functioning on The Work and Social Adjustment Scale
Time frame: 24 months
Quality of life on the EuroQoL-5 Dimensions EQ5-D
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Derived from this study: PubMed 34785541Gire N, Caton N, McKeown M, Mohmed N, Duxbury J, Kelly J, Riley M, J Taylor P, Taylor CDJ, Naeem F, Chaudhry IB, Husain N. 'Care co-ordinator in my pocket': a feasibility study of mobile assessment and therapy for psychosis (TechCare). BMJ Open. 2021 Nov 16;11(11):e046755. doi: 10.1136/bmjopen-2020-046755.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imran B Chaudhry, MBBS MD principal investigator
Lead Consultant Psychiatrist, Lancashire Care Early Intervention Service & Hon Clinical Professor Adult Psychiatry University of Manchester
Nusrat Husain, MBBS MD principal investigator
Reader in Psychiatry University of Manchester, Director Research Global Health Manchester Academic Health Sciences Centre & Consultant Psychiatrist Lancashire Care Early Intervention Service
James Kelly, DClinPsych principal investigator
Lancashire Care NHS Foundation Trust Early Intervention Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TechCare in people with Feasibility Studies, run by Lancashire Care NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Bee, PhD (01772 773498, charlotte.bee@lancashirecare.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Acceptability (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02439619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.