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Status unknownNCT02439619TechCareUpdated May 12, 2015

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

An interventional study of TechCare in Feasibility Studies, sponsored by Lancashire Care NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2015-05-12.

Sponsored by Lancashire Care NHS Foundation Trust · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified May 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Feasibility Studies

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03

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Feasibility Trial

    Other: TechCare

Interventions

  • OtherTechCare

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 36 months

Secondary outcomes

  1. 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

    Time frame: 24 months

  2. Psychopathology on The Psychotic Symptom Rating Scales (PSYRATS)

    The PSYRATS is a semi-structured interview measuring dimensions of delusions and hallucinations.

    Time frame: 24 months

  3. 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.

    Time frame: 24 months

  4. 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.

    Time frame: 24 months

  5. 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.

    Time frame: 24 months

  6. 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.

    Time frame: 24 months

  7. 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

    Time frame: 24 months

  8. 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).

    Time frame: 24 months

06

Study locations

1 of 1 sites recruiting
  • Lancashire Care NHS Foundation Trust
    Preston, Lancashire PR2 8DW, United Kingdom
    Recruiting
07

References and documents

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. PubMed 34785541 ↗
08

Registry details

Key details

Study ID
NCT02439619
Lead sponsor
Lancashire Care NHS Foundation Trust
Collaborators
University of Central Lancashire
Responsible party
Sponsor
First posted
May 12, 2015
Start date
Oct 2014
Primary completion
Sep 2016 (estimated)
Completion
Sep 2017 (estimated)
Last update
May 12, 2015

Study contacts

Charlotte Bee, PhD
Contact
charlotte.bee@lancashirecare.nhs.uk
01772 773498
Nadeem Gire, BSc MSc
Contact
nadeem.gire@lancashirecare.nhs.uk
07507847569
Imran B Chaudhry, MBBS MD
principal investigator · Lead Consultant Psychiatrist, Lancashire Care Early Intervention Service & Hon Clinical Professor Adult Psychiatry University of Manchester
Nusrat Husain, MBBS MD
principal investigator · Reader in Psychiatry University of Manchester, Director Research Global Health Manchester Academic Health Sciences Centre & Consultant Psychiatrist Lancashire Care Early Intervention Service
James Kelly, DClinPsych
principal investigator · Lancashire Care NHS Foundation Trust Early Intervention Service

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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