ISRCTN ISRCTN69299093
DOI https://doi.org/10.1186/ISRCTN69299093
Secondary identifying numbers 5671
Submission date
29/04/2010
Registration date
29/04/2010
Last edited
03/06/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Fiona Lobban
Scientific

Associate Director of Spectrum Centre
School of Health and Medicine
Lancaster University
Lancaster
LA1 4YQ
United Kingdom

Study information

Study designRandomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAn evaluation of the feasibility and effectiveness of a supported self management package for relatives of people with recent onset psychosis
Study acronymREACT
Study objectivesThe main aims are as follows:
Phase 1: To finalise a cognitive behavioural therapy (CBT) orientated self management intervention for relatives of people with recent onset psychosis
Phase 2: To determine the acceptability, feasibility and effectiveness of offering this intervention in an NHS Early Intervention Service for psychosis (EIS). To identify service user preferences for mode of delivery and method of use.
Phase 3: To modify the intervention in light of service user feedback and develop guidelines to disseminate and implement the intervention throughout the NHS
Ethics approval(s)Sefton Research Ethics Committee, 21/08/2008, ref: 08/H1001/147
Health condition(s) or problem(s) studiedTopic: Mental Health Research Network; Subtopic: Psychosis; Disease: Psychosis
InterventionRelatives randomised to the intervention arm will then meet with the relative support worker. This meeting will introduce them to the self management materials and discuss the format of support they will receive. Relatives will be given a choice of support including email, telephone and skype. These are all easy to set up and operate and are likely to increase the accessibility of the intervention. The package will be based on existing evidence based interventions.

Follow up length: 6 months.
Intervention typeOther
Primary outcome measureSelf management intervention, measured with the General Health Questionnaire at baseline and at 6 months follow-up.
Secondary outcome measures1. Carer Wellbeing and Support Scale
2. Experience of Caregiving Inventory
3. Relatives needs assessment
4. Service satisfaction
5. Relationship quality, measured using the Lobell Scale
6. Herth Hope Index

All measures are completed at baseline and at 6 months follow-up.
Overall study start date01/09/2009
Completion date01/06/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 95; UK Sample Size: 95
Key inclusion criteria1. Aged 18 years or older, either sex
2. Relative of individuals receiving input from Early Intervention Services for psychosis in participating trusts
Key exclusion criteria1. Aged less than 18 years
2. Difficulty understanding written and spoken English
Date of first enrolment01/09/2009
Date of final enrolment01/06/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Associate Director of Spectrum Centre
Lancaster
LA1 4YQ
United Kingdom

Sponsor information

Lancashire Care NHS Trust (UK)
Hospital/treatment centre

Sceptre Way
Bamber Bridge
Preston
PR5 6AW
England
United Kingdom

Website http://www.lancashirecare.nhs.uk/
ROR logo "ROR" https://ror.org/03zefc030

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 16/06/2011 Yes No
Results article results 01/11/2013 Yes No