NCT02439619

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

1.9 years

First QC Date

May 5, 2015

Last Update Submit

May 6, 2015

Conditions

Feasibility Studies

Outcome Measures

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.

    36 months

Secondary Outcomes (8)

  • Psychopathology on The Positive and Negative Syndrome Scale (PANSS)

    24 months

  • Psychopathology on The Psychotic Symptom Rating Scales (PSYRATS)

    24 months

  • Satisfaction with CBT therapy on the CHoice of Outcome In Cbt for psychosEs

    24 months

  • Mental wellbeing on the Warwick-Edinburgh Mental Well Being Scale (WEMWBS)

    24 months

  • Measure of core beliefs regarding self and others on the Brief Core Schema Scale

    24 months

  • +3 more secondary outcomes

Study Arms (1)

Feasibility Trial

EXPERIMENTAL
Other: TechCare

Interventions

TechCareOTHER

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.

Feasibility Trial

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lancashire Care NHS Foundation Trust

Preston, Lancashire, PR2 8DW, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34785541DERIVED

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Bee, PhD

CONTACT

01772 773498charlotte.bee@lancashirecare.nhs.uk

Nadeem Gire, BSc MSc

CONTACT

07507847569nadeem.gire@lancashirecare.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2015

First Posted

May 12, 2015

Study Start

October 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2017

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations

GB(1)