Contact information
Type
Scientific
Primary contact
Prof Gillian Haddock
ORCID ID
Contact details
School of Psychological Sciences
Zochonis Building
Oxford Road
Manchester
M13 9PL
United Kingdom
-
gillian.haddock@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8246
Study 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
Acronym
STAR-T
Study hypothesis
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
North West 10 REC - Greater Manchester North, 09/02/2010, ref: 09/H1011/81
Study design
Single centre 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 contact Samantha Hartley (Trial Manager) on +44 (0)161 275 8497 or samantha.hartley@manchester.ac.uk to request a copy or more information
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
10/03/2010
Overall trial end date
01/09/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 120; UK sample size: 120
Participant exclusion criteria
1. Do not speak/read English
2. Experiencing an acute exacerbation of symptoms requiring inpatient or other changes to treatment
Recruitment start date
10/03/2010
Recruitment end date
01/09/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Psychological Sciences
Manchester
M13 9PL
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
Oxford Road
Manchester
M13 9PL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1086)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25257960