Self-help Therapy and Recovery Trial: evaluation of a recovery guide for psychosis
| ISRCTN | ISRCTN50487713 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50487713 |
| Protocol serial number | 8246 |
| Sponsor | University of Manchester (UK) |
| Funder | National Institute for Health Research - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1086) |
- 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
Scientific
School of Psychological Sciences
Zochonis Building
Oxford Road
Manchester
M13 9PL
United Kingdom
| gillian.haddock@manchester.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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(s) |
Process of Recovery Questionnaire (QPR), measured at baseline, 9 months and 15 months |
| Key secondary outcome measure(s) |
Subjective Experiences of Psychotic Symptoms Scale (SEPS), measured at baseline, 9 months and 15 months |
| Completion date | 01/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
School of Psychological Sciences
Manchester
M13 9PL
United Kingdom
M13 9PL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/04/2017: Publication reference added.
