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

Primary Purpose

Feasibility Studies

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
TechCare
Sponsored by
Lancashire Care NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Feasibility Studies

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Lancashire Care NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Feasibility Trial

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Psychopathology on The Psychotic Symptom Rating Scales (PSYRATS)
The PSYRATS is a semi-structured interview measuring dimensions of delusions and hallucinations.
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.
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.
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.
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.
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
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).

Full Information

First Posted
May 5, 2015
Last Updated
May 6, 2015
Sponsor
Lancashire Care NHS Foundation Trust
Collaborators
University of Central Lancashire
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1. Study Identification

Unique Protocol Identification Number
NCT02439619
Brief Title
TechCare: Mobile-AssessmenT and ThErapy for PsyCHosis: An Intervention for Clients Within the EArly InteRvention SErvice
Acronym
TechCare
Official Title
TechCare: Mobile-AssessmenT and ThErapy for PsyCHosis: An Intervention for Clients Within the EArly InteRvention SErvice
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lancashire Care NHS Foundation Trust
Collaborators
University of Central Lancashire

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feasibility Studies

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Feasibility Trial
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
TechCare
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility and Acceptability
Description
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.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Psychopathology on The Positive and Negative Syndrome Scale (PANSS)
Description
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
Time Frame
24 months
Title
Psychopathology on The Psychotic Symptom Rating Scales (PSYRATS)
Description
The PSYRATS is a semi-structured interview measuring dimensions of delusions and hallucinations.
Time Frame
24 months
Title
Satisfaction with CBT therapy on the CHoice of Outcome In Cbt for psychosEs
Description
This is an outcome measure which reflects the aims of cognitive behavioural therapy for psychosis and the priorities of service users.
Time Frame
24 months
Title
Mental wellbeing on the Warwick-Edinburgh Mental Well Being Scale (WEMWBS)
Description
The WEMWBS is a measure of mental wellbeing which focuses entirely on positive aspects of mental health.
Time Frame
24 months
Title
Measure of core beliefs regarding self and others on the Brief Core Schema Scale
Description
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.
Time Frame
24 months
Title
Depression on the Calgary depression scale
Description
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.
Time Frame
24 months
Title
Work and social functioning on The Work and Social Adjustment Scale
Description
This is a five item measure of perceived impairment in five areas: work, home management, social life, private leisure and relationships
Time Frame
24 months
Title
Quality of life on the EuroQoL-5 Dimensions EQ5-D
Description
the measure is standardised instrument looking at quality of life across five health domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Bee, PhD
Phone
01772 773498
Email
charlotte.bee@lancashirecare.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Nadeem Gire, BSc MSc
Phone
07507847569
Email
nadeem.gire@lancashirecare.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imran B Chaudhry, MBBS MD
Organizational Affiliation
Lead Consultant Psychiatrist, Lancashire Care Early Intervention Service & Hon Clinical Professor Adult Psychiatry University of Manchester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nusrat Husain, MBBS MD
Organizational Affiliation
Reader in Psychiatry University of Manchester, Director Research Global Health Manchester Academic Health Sciences Centre & Consultant Psychiatrist Lancashire Care Early Intervention Service
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Kelly, DClinPsych
Organizational Affiliation
Lancashire Care NHS Foundation Trust Early Intervention Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lancashire Care NHS Foundation Trust
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR2 8DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Bee, PhD
Phone
01772 773498
Email
charlotte.bee@lancashirecare.nhs.uk
First Name & Middle Initial & Last Name & Degree
Nadeem Gire, BSc MSc
Phone
07507847569
Email
nadeem.gire@lancashirecare.nhs.uk
First Name & Middle Initial & Last Name & Degree
Imran B Chaudhry, MBBS MD
First Name & Middle Initial & Last Name & Degree
Nusrat Husain, MBBS MD
First Name & Middle Initial & Last Name & Degree
James Kelly, DClinPsych

12. IPD Sharing Statement

Citations:
PubMed Identifier
34785541
Citation
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.
Results Reference
derived

Learn more about this trial

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

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