Mindfulness-based therapy groups for people distressed by hearing Voices
| ISRCTN | ISRCTN74054823 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74054823 |
| Secondary identifying numbers | 11045 |
- Submission date
- 16/01/2012
- Registration date
- 16/01/2012
- Last edited
- 19/12/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
This study aims to investigate the effectiveness of a psychological treatment that uses mindfulness meditation within group-based therapy to help people diagnosed with schizophrenia who hear voices. People diagnosed with schizophrenia often hear voices. Although for some hearing voices is comforting, for others it causes distress, low self-esteem and social isolation. Mindfulness mediation has been adapted by Professor Paul Chadwick’s research team for people who hear voices and focuses on helping people to learn new ways of managing and living with their voices. The treatment incorporates elements of cognitive behavioural therapy (CBT) but emphasises the principles and practices of mindfulness meditation. In a previous study mindfulness-based therapy (MBT) groups were found to be beneficial as voice hearers reported less distress, improved personal control and improved psychological health.
Who can participate?
Service users aged 18 or over who have been diagnosed with schizophrenia or schizoaffective disorder and are distressed by hearing voices.
What does the study involve?
Participants are randomly allocated to one of two groups. One group receives mindfulness-based therapy (MBT) offered in a group format over a 12-session period (each group will contain a maximum of 12 service users). The other group receives the treatment they usually receive from their mental health teams. Participants’ psychological health, distress and personal control are assessed at the start of the study, after treatment and at six months follow-up.
What are the possible benefits and risks of participating?
If mindfulness therapy is found to be effective then support will be offered to mental health teams to provide group therapy to people.
Where is the study run from?
University of Surrey (UK).
When is the study starting and how long is it expected to run for?
November 2011 to November 2012.
Who is funding the study?
National Institute of Health Research (NIHR) (UK).
Who is the main contact?
Leanne Bogen-Johnston
Leanne.Bogen-Johnston@sussexpartnership.nhs.uk
Contact information
Scientific
University of Surrey
Psychology Department
Guildford
GU2 7XH
United Kingdom
| C.Strauss@surrey.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| 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 use the contact details below to request a patient information sheet |
| Scientific title | Mindfulness-based therapy groups for people distressed by hearing Voices: a pragmatic randomised controlled trial |
| Study acronym | M4V |
| Study hypothesis | The study aims to evaluate the therapy using a more robust, randomised controlled design. It aims to recruit 144 mental health service users who are distressed by hearing voices. More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=11045 |
| Ethics approval(s) | NRES Committee South East Coast - Brighton and Sussex, First MREC approval date 08/09/2011, ref: 11/LO/1330 |
| Condition | Topic: Mental Health Research Network; Subtopic: Psychosis; Disease: Psychosis |
| Intervention | Participants will be allocated at random to either attending a 12 session mindfulness for voices group or to continuing with their usual mental health care. Follow Up Length: 6 month(s); Study Entry : Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure | 1. Psychological wellbeing (CORE) 2. Mindfulness skills (Southampton Mindfulness Questionnaire) 3. Anxiety and depression [Hospital Anxiety and Depression Scale (HADS)] 4. Self-esteem (Rosenberg Self-esteem Scale) 5. Recovery from psychosis (CHOICE) Timepoint(s): At 6 months |
| Secondary outcome measures | Fewer Voices, voice hearing experiences (Psychotic Symptom Rating Scales (PSYRATS); Timepoint(s): At 6 months |
| Overall study start date | 15/11/2011 |
| Overall study end date | 09/11/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 144; UK Sample Size: 144 |
| Participant inclusion criteria | 1. Is aged 18 years or over 2. Has been experiencing distressing voices for the preceding one year period 3. Has a current International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD 10) diagnosis of schizophrenia or schizo-affective disorder Target Gender: Male & Female; Upper Age Limit 75 years ; Lower Age Limit 18 years |
| Participant exclusion criteria | 1. Organic illness 2. Primary diagnosis of substance misuse |
| Recruitment start date | 15/11/2011 |
| Recruitment end date | 09/11/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
GU2 7XH
United Kingdom
Sponsor information
Government
Research & Development Department
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
| Helen.Evans@wsht.nhs.uk |
Funders
Funder type
Government
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 | 01/08/2016 | Yes | No |
Editorial Notes
19/12/2017: Publication reference added.
