Clinical trial NCT02439619: TechCare: Mobile-AssessmenT and ThErapy for PsyCHosis: An Intervention for Clients Within the EArly InteRvention SErvice
Official title: TechCare: Mobile-AssessmenT and ThErapy for PsyCHosis: An Intervention for Clients Within the EArly InteRvention SErvice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Feasibility Studies
Lead sponsor: Lancashire Care NHS Foundation Trust
Sponsor class: NETWORK
Collaborators: name: University of Central Lancashire
First posted: 2015-05-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Feasibility and Acceptability
timeFrame: 36 months
Secondary outcomes:
measure: Psychopathology on The Positive and Negative Syndrome Scale (PANSS)
timeFrame: 24 months
measure: Psychopathology on The Psychotic Symptom Rating Scales (PSYRATS)
timeFrame: 24 months
measure: Satisfaction with CBT therapy on the CHoice of Outcome In Cbt for psychosEs
timeFrame: 24 months
measure: Mental wellbeing on the Warwick-Edinburgh Mental Well Being Scale (WEMWBS)
timeFrame: 24 months
measure: Measure of core beliefs regarding self and others on the Brief Core Schema Scale
timeFrame: 24 months
measure: Depression on the Calgary depression scale
timeFrame: 24 months
measure: Work and social functioning on The Work and Social Adjustment Scale
timeFrame: 24 months
measure: Quality of life on the EuroQoL-5 Dimensions EQ5-D
timeFrame: 24 months
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: Lancashire Care NHS Foundation Trust
state: Lancashire
Study officials:
affiliation: Lead Consultant Psychiatrist, Lancashire Care Early Intervention Service & Hon Clinical Professor Adult Psychiatry University of Manchester
name: Imran B Chaudhry, MBBS MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Reader in Psychiatry University of Manchester, Director Research Global Health Manchester Academic Health Sciences Centre & Consultant Psychiatrist Lancashire Care Early Intervention Service
name: Nusrat Husain, MBBS MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancashire Care NHS Foundation Trust Early Intervention Service
name: James Kelly, DClinPsych
role: PRINCIPAL_INVESTIGATOR
References:
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.