ISRCTN ISRCTN69299093
DOI https://doi.org/10.1186/ISRCTN69299093
Protocol serial number 5671
Sponsor Lancashire Care NHS Trust (UK)
Funder National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
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

Primary study designInterventional
Study designRandomised interventional treatment trial
Secondary study designRandomised controlled trial
Study type Participant 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 measure(s)

Self management intervention, measured with the General Health Questionnaire at baseline and at 6 months follow-up.

Key secondary outcome measure(s)

1. 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.

Completion date01/06/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration95
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

  • United Kingdom
  • England

Study participating centre

Associate Director of Spectrum Centre
Lancaster
LA1 4YQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes