Self-help Therapy and Recovery Trial: evaluation of a recovery guide for psychosis

ISRCTN	ISRCTN50487713
DOI	https://doi.org/10.1186/ISRCTN50487713
Secondary identifying numbers	8246

Submission date: 21/05/2010
Registration date: 21/05/2010
Last edited: 11/04/2017

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

Prof Gillian Haddock
Scientific

School of Psychological Sciences
Zochonis Building
Oxford Road
Manchester
M13 9PL
United Kingdom

Email	gillian.haddock@manchester.ac.uk

Study information

Study design	Single centre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please contact Samantha Hartley (Trial Manager) on +44 (0)161 275 8497 or samantha.hartley@manchester.ac.uk to request a copy or more information
Scientific title	An evaluation of different levels of support in using a recovery guide for people with psychosis and the impact of choice on outcomes
Study acronym	STAR-T
Study objectives	This study is a partially randomised patient preference trial. The aims of the study are to: 1. Evaluate the feasibility and acceptability of a recovery guide for psychosis when provided with either low or high support 2. To assess the relative impact of the guide in relation to low and high support and no treatment on psychotic symptoms, affect, well-being and functioning Participants will be able to choose their preferred treatment option (treatment as usual [TAU], low support or high support) or elect to be randomised to a treatment option.
Ethics approval(s)	North West 10 REC - Greater Manchester North, 09/02/2010, ref: 09/H1011/81
Health condition(s) or problem(s) studied	Topic: Mental Health Research Network; Subtopic: Psychosis; Disease: Psychosis
Intervention	Therapy will consist of (in addition to TAU) either: 1. Low support: this therapy will be delivered over 9 months and will consist of the following: 1.1. Receive a copy of the Self Help Recovery Guide 1.2. Weekly CBT telephone sessions 1.3. Up to 5 telephone peer support sessions 2. High support: this will consist of all the components of low support. In addition, participants will receive group sessions. Follow up length: 15 months Study entry: registration only
Intervention type	Other
Primary outcome measure	Process of Recovery Questionnaire (QPR), measured at baseline, 9 months and 15 months
Secondary outcome measures	Subjective Experiences of Psychotic Symptoms Scale (SEPS), measured at baseline, 9 months and 15 months
Overall study start date	10/03/2010
Completion date	01/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 120; UK sample size: 120
Key inclusion criteria	1. Aged 18 - 65 years, either sex 2. In contact with mental health services 3. Meeting International Classification of Diseases, version 10 (ICD-10) criteria for non-affective psychosis (schizophrenia, schizophreniform disorder, schizo-affective disorder, delusional disorder) 4. At least one month of stabilisation if the person has experienced a symptom exacerbation in the last 6 months 5. Able to provide written informed consent 6. Able to read the Recovery Guide 7. Able to complete the assessments in English 8. Able to use the telephone
Key exclusion criteria	1. Do not speak/read English 2. Experiencing an acute exacerbation of symptoms requiring inpatient or other changes to treatment
Date of first enrolment	10/03/2010
Date of final enrolment	01/09/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Psychological Sciences

Manchester
M13 9PL
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

Oxford Road
Manchester
M13 9PL
England
United Kingdom

Website	http://www.manchester.ac.uk/
"ROR"	https://ror.org/027m9bs27

Funders

Funder type

Government

National Institute for Health Research - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1086)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2015		Yes	No

Editorial Notes

11/04/2017: Publication reference added.