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

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.

Study Overview

• Status: Unknown
• Conditions: Feasibility Studies
• Intervention / Treatment: Other: TechCare

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 Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charlotte Bee, PhD; Phone Number: 01772 773498; Email: charlotte.bee@lancashirecare.nhs.uk
• Study Contact Backup: Name: Nadeem Gire, BSc MSc; Phone Number: 07507847569; Email: nadeem.gire@lancashirecare.nhs.uk

Study Locations

• United Kingdom
  • Lancashire
    • Preston, Lancashire, United Kingdom, PR2 8DW
      • Recruiting
      • Lancashire Care NHS Foundation Trust
      • Contact: Charlotte Bee, PhD; Phone Number: 01772 773498; Email: charlotte.bee@lancashirecare.nhs.uk
      • Contact: Nadeem Gire, BSc MSc; Phone Number: 07507847569; Email: nadeem.gire@lancashirecare.nhs.uk
      • Principal Investigator: Imran B Chaudhry, MBBS MD
      • Principal Investigator: Nusrat Husain, MBBS MD
      • Principal Investigator: James Kelly, DClinPsych

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Feasibility Trial	Other: TechCare; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lancashire Care NHS Foundation Trust
• Collaborators: University of Central Lancashire
• Investigators: Principal Investigator: Imran B Chaudhry, MBBS MD, Lead Consultant Psychiatrist, Lancashire Care Early Intervention Service & Hon Clinical Professor Adult Psychiatry University of Manchester; Principal Investigator: Nusrat Husain, MBBS MD, Reader in Psychiatry University of Manchester, Director Research Global Health Manchester Academic Health Sciences Centre & Consultant Psychiatrist Lancashire Care Early Intervention Service; Principal Investigator: James Kelly, DClinPsych, Lancashire Care NHS Foundation Trust Early Intervention Service

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: May 5, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Estimate): May 12, 2015
• Last Update Submitted That Met QC Criteria: May 6, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders
• Other Study ID Numbers: TechCare-LCFT