Condition category
Mental and Behavioural Disorders
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
03/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Fiona Lobban

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5671

Study information

Scientific title

An evaluation of the feasibility and effectiveness of a supported self management package for relatives of people with recent onset psychosis

Acronym

REACT

Study hypothesis

The 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

Sefton Research Ethics Committee, 21/08/2008, ref: 08/H1001/147

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Mental Health Research Network; Subtopic: Psychosis; Disease: Psychosis

Intervention

Relatives 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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.

Overall trial start date

01/09/2009

Overall trial end date

01/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or older, either sex
2. Relative of individuals receiving input from Early Intervention Services for psychosis in participating trusts

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 95; UK Sample Size: 95

Participant exclusion criteria

1. Aged less than 18 years
2. Difficulty understanding written and spoken English

Recruitment start date

01/09/2009

Recruitment end date

01/06/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Associate Director of Spectrum Centre
Lancaster
LA1 4YQ
United Kingdom

Sponsor information

Organisation

Lancashire Care NHS Trust (UK)

Sponsor details

Sceptre Way
Bamber Bridge
Preston
PR5 6AW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.lancashirecare.nhs.uk/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21679463
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24072754

Publication citations

  1. Results

    Lobban F, Glentworth D, Wainwright L, Pinfold V, Chapman L, Larkin W, Dunn G, Postlethwaite A, Haddock G, Relatives Education And Coping Toolkit--REACT. Study protocol of a randomised controlled trial to assess the feasibility and effectiveness of a supported self management package for relatives of people with recent onset psychosis., BMC Psychiatry, 2011, 11, 100, doi: 10.1186/1471-244X-11-100.

  2. Results

    Lobban F, Glentworth D, Chapman L, Wainwright L, Postlethwaite A, Dunn G, Pinfold V, Larkin W, Haddock G, Feasibility of a supported self-management intervention for relatives of people with recent-onset psychosis: REACT study., Br J Psychiatry, 2013, 203, 5, 366-372, doi: 10.1192/bjp.bp.112.113613.

Additional files

Editorial Notes