Condition category
Mental and Behavioural Disorders
Date applied
16/01/2012
Date assigned
16/01/2012
Last edited
09/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Clara Strauss

ORCID ID

Contact details

University of Surrey
Psychology Department
Guildford
GU2 7XH
United Kingdom
-
C.Strauss@surrey.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11045

Study information

Scientific title

Mindfulness-based therapy groups for people distressed by hearing Voices: a pragmatic randomised controlled trial

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

NRES Committee South East Coast - Brighton and Sussex, First MREC approval date 08/09/2011, ref: 11/LO/1330

Study design

Randomised; Interventional; Design type: Treatment

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 use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

15/11/2011

Overall trial end date

09/11/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 144; UK Sample Size: 144

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

United Kingdom

Trial participating centre

University of Surrey
Guildford
GU2 7XH
United Kingdom

Sponsor information

Organisation

Sussex NHS Research Consortium (UK)

Sponsor details

Research & Development Department
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
-
Helen.Evans@wsht.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit Programme (RfPB)

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

Publication citations

Additional files

Editorial Notes