TechCare: Mobile-AssessmenT and ThErapy for PsyCHosis: An Intervention for Clients Within the EArly InteRvention SErvice

Study Overview
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Brief Summary
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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
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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.

Official Title
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TechCare: Mobile-AssessmenT and ThErapy for PsyCHosis: An Intervention for Clients Within the EArly InteRvention SErvice

Conditions
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Feasibility Studies

Intervention / Treatment
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* Other: TechCare


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feasibility Trial<br> | Other: TechCare<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 months | 
| Psychopathology on The Psychotic Symptom Rating Scales (PSYRATS) | The PSYRATS is a semi-structured interview measuring dimensions of delusions and hallucinations. | 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. | 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. | 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. | 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. | 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 | 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). | 24 months |