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

Feasibility Studies Clinical Trial

— TechCare  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02439619
• Other study ID #: TechCare-LCFT
• Status: Recruiting
• Phase: N/A
• First received: May 5, 2015
• Last updated: May 6, 2015
• Start date: October 2014
• Est. completion date: September 2017

Study information

• Verified date: May 2015
• Source: Lancashire Care NHS Foundation Trust
• Contact: Charlotte Bee, PhD
• Phone: 01772 773498
• Email: charlotte.bee[@]lancashirecare.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Feasibility Studies

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Lancashire Care NHS Foundation Trust	Preston	Lancashire

Sponsors (2)

Lead Sponsor	Collaborator
Lancashire Care NHS Foundation Trust	University of Central Lancashire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Psychopathology on The Psychotic Symptom Rating Scales (PSYRATS)	The PSYRATS is a semi-structured interview measuring dimensions of delusions and hallucinations.	24 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No