ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02439619
Recruitment Status : Unknown
Verified May 2015 by Lancashire Care NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Sponsor:
Collaborator:
University of Central Lancashire
Information provided by (Responsible Party):
Lancashire Care NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Feasibility Studies Other: TechCare Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: TechCare: Mobile-AssessmenT and ThErapy for PsyCHosis: An Intervention for Clients Within the EArly InteRvention SErvice
Study Start Date : October 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Feasibility Trial 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.




Primary Outcome Measures :
  1. Feasibility and Acceptability [ Time Frame: 36 months ]
    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 :
  1. Psychopathology on The Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 24 months ]
    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

  2. Psychopathology on The Psychotic Symptom Rating Scales (PSYRATS) [ Time Frame: 24 months ]
    The PSYRATS is a semi-structured interview measuring dimensions of delusions and hallucinations.

  3. Satisfaction with CBT therapy on the CHoice of Outcome In Cbt for psychosEs [ Time Frame: 24 months ]
    This is an outcome measure which reflects the aims of cognitive behavioural therapy for psychosis and the priorities of service users.

  4. Mental wellbeing on the Warwick-Edinburgh Mental Well Being Scale (WEMWBS) [ Time Frame: 24 months ]
    The WEMWBS is a measure of mental wellbeing which focuses entirely on positive aspects of mental health.

  5. Measure of core beliefs regarding self and others on the Brief Core Schema Scale [ Time Frame: 24 months ]
    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.

  6. Depression on the Calgary depression scale [ Time Frame: 24 months ]
    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.

  7. Work and social functioning on The Work and Social Adjustment Scale [ Time Frame: 24 months ]
    This is a five item measure of perceived impairment in five areas: work, home management, social life, private leisure and relationships

  8. Quality of life on the EuroQoL-5 Dimensions EQ5-D [ Time Frame: 24 months ]
    the measure is standardised instrument looking at quality of life across five health domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439619


Contacts
Contact: Charlotte Bee, PhD 01772 773498 charlotte.bee@lancashirecare.nhs.uk
Contact: Nadeem Gire, BSc MSc 07507847569 nadeem.gire@lancashirecare.nhs.uk

Locations
United Kingdom
Lancashire Care NHS Foundation Trust Recruiting
Preston, Lancashire, United Kingdom, PR2 8DW
Contact: Charlotte Bee, PhD    01772 773498    charlotte.bee@lancashirecare.nhs.uk   
Contact: Nadeem Gire, BSc MSc    07507847569    nadeem.gire@lancashirecare.nhs.uk   
Principal Investigator: Imran B Chaudhry, MBBS MD         
Principal Investigator: Nusrat Husain, MBBS MD         
Principal Investigator: James Kelly, DClinPsych         
Sponsors and Collaborators
Lancashire Care NHS Foundation Trust
University of Central Lancashire
Investigators
Principal Investigator: 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

Responsible Party: Lancashire Care NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02439619     History of Changes
Other Study ID Numbers: TechCare-LCFT
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015