Condition category
Mental and Behavioural Disorders
Date applied
21/05/2010
Date assigned
21/05/2010
Last edited
27/08/2014
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

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

http://www.manchester.ac.uk/

Funders

Funder type

Government

Funder name

National Insititute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1086)

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

Publication citations

Additional files

Editorial Notes