Condition category
Mental and Behavioural Disorders
Date applied
19/12/2016
Date assigned
03/01/2017
Last edited
13/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Schizophrenia is a long-term mental health condition that affects how a person thinks, feels and behaves. Many people with a diagnosis of Schizophrenia experience persecutory delusions, thinking that other people are intentionally trying to harm or kill them. Persecutory delusions are often associated with high levels of depression and distress. Treatments that use mindfulness, a type of mediation which helps people to become more aware of themselves and their surroundings, are being used to help people with mental health problems. Until recently, these treatments have rarely been made available to people with a diagnosis of schizophrenia, despite the significant level of need within this group. This study is looking at a mindfulness-based group therapy programme which has been developed for people who hear distressing voices. This small scale study aims to find out whether it would be possible to conduct a full scale study by looking at the effectiveness of the mindfulness treatment as well as how many patients can be recruited and take part in the entire study.

Who can participate?
Adults with a diagnosis of Schizophrenia, and be experiencing current distressing persecutory delusions

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in 12 sessions of group therapy which are run by two therapists. Each session lasts for an hour and a half and involves exploring what leads to paranoia and how to avoid it using established mindfulness techniques. Those in the second group continue to receive the usual treatment offered within their community mental health recovery services, and may involve medication and support and contact from a key worker. At the end of the study, the number of participants who took part and the number who stayed in the study all the way through are recorded. In addition, participants complete a number of questionnaires at the start of the study and after 12 weeks in order to assess their mental wellbeing.

What are the possible benefits and risks of participating?
The therapy group used in this study is a new type of therapy group and so it is not known whether or not it will be helpful. Talking therapies can sometimes involve talking about feelings, thoughts or experiences which may be upsetting at times. This is a completely normal part of therapy and the therapists are very experienced in keeping this to a level you can manage. For the research assessments, there are no right or wrong answers and participants do not have to answer any questions they do not want to. Participants are free to ask the interviewer to move on to another subject or to stop the session altogether if they find any of the questions upsetting. By taking part in the study participants will be helping the researchers to learn if this therapy is helpful for people with distressing paranoia and this will help mental health services when they are planning what therapies they offer.

Where is the study run from?
1. Community Mental Health Recovery Service: Woking (UK)
2. Community Mental Health Recovery Service: Runnymede (UK)
3. Community Mental Health Recovery Service: Guildford (UK)

When is the study starting and how long is it expected to run for?
December 2016 to November 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Ms Eryna Tarant
Eryna.Tarant@sabp.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Eryna Tarant

ORCID ID

Contact details

Abraham Cowley Unit
Holloway Hill
Chertsey
KT16 0AE
United Kingdom
+44 (0)1932 722247
Eryna.Tarant@sabp.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

31912

Study information

Scientific title

Group mindfulness-based therapy for distressing persecutory delusions: A pilot study for a randomised controlled trial

Acronym

Study hypothesis

The aim of this study is to test the feasibility of conducting a full scale randomised controlled trial comparing the effectiveness of group mindfulness-based therapy (MBT) plus treatment as usual for individuals distressed by persecutory delusions with treatment as usual (TAU) alone.

Ethics approval

South East Coast – Surrey Research Ethics Committee, 18/10/2016, ref: 16/LO/1685

Study design

Randomised; Both; Design type: Treatment, Education or Self-Management, Psychological & Behavioural, Complex Intervention, Qualitative

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 to request a patient information sheet

Condition

Specialty: Mental Health, Primary sub-specialty: Psychosis - schizophrenia; UKCRC code/ Disease: Mental Health/ Schizophrenia, schizotypal and delusional disorders

Intervention

After baseline assessments have been completed, participants will be randomly allocated to either one of two groups by the Clinical Trials Unit at King's College London using block randomisation.

Intervention group: Participants will receive the manualised mindfulness-based group intervention (MBT). This involves taking part in mindfulness-based group therapy, conducted over 12 1.5-hour-long group sessions. The sessions will explore, through participants’ experience, how rumination, interpersonal beliefs and avoidance help to maintain paranoia, and key mindfulness principles of acceptance, self-compassion and turning towards the difficult will be used to target these maintenance processes and to support behaviour change in relation to paranoia.

Control group: Participants will receive the usual treatment offered within their community mental health recovery services (CMHRS). This involves psychiatric consultation and medication, and regular support and contact with a key worker.

Follow up takes place at the participants CMHRS base and involves participants completing the post-group assessments, which are identical to the assessments completed prior to the Mindfulness Intervention or TAU. Participants who have completed the intervention will be invited to complete a qualitative interview which will include questions on the implementation and acceptability of the intervention.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Depression is measured using Beck Depression Inventory II (Beck et al, 1996) at baseline and 12 weeks
2. Recruitment rate is recorded as the number of participants consented to the study per research assistant days, measured at trial end
3. Retention rate is recorded as the number of participants contributing to all data collection points (providing full baseline and post-group data) at 12 weeks. The number of participants classified as completers (attended at least 6 mindfulness sessions) will also be reported.

Secondary outcome measures

1. Quality of Life is measured using the World Health Organisation Quality of Life-Bref (WHOQOL-BREF) at baseline and 12 weeks
2. Psychotic symptoms are measured using the Psychotic Symptoms Rating Scale (PSYRATS): Delusions subscale at baseline and 12 weeks
3. Progress towards recovery is measured by The Choice of outcome in CBT for Psychosis (CHOICE) at baseline and 12 weeks

Overall trial start date

01/12/2016

Overall trial end date

30/11/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of schizophrenia, and be experiencing current distressing persecutory delusions (assessed using the PSYRATS)
2. Stable on psychiatric medication for at least three months prior to the consent meeting
3. No plans for changes to psychiatric medication during the course of the study
4. Not received psychological therapy in the past three months or to have any plans for psychological therapy during the course of the study
5. Aged over 18 years of age
6. Able to provide informed consent to take part

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 40; UK Sample Size: 40

Participant exclusion criteria

1. Participants will not have an identified organic cause for their symptoms
2. Diagnosis of a learning disability.
3. Participants with a significant risk of violence to others.

Recruitment start date

19/12/2016

Recruitment end date

31/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Community Mental Health Recovery Service: Woking
Bridgewell House Claremont Avenue
Woking
GU22 7SF
United Kingdom

Trial participating centre

Community Mental Health Recovery Service: Runnymede
Lake House St Peter's Hospital Site Guildford Road
Chertsey
KT16 0QA
United Kingdom

Trial participating centre

Community Mental Health Recovery Service: Guildford
Redwood Centre Farnham Road Hospital Farnham Road
Guildford
GU2 7LX
United Kingdom

Sponsor information

Organisation

Surrey and Borders Partnership NHS Foundation Trust

Sponsor details

18 Mole Business Park
Randalls Road
Leatherhead
KT22 7AD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

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

1. The study findings will be disseminated to both local (e.g. Forum of Carers & People who use services, FoCUS, in SABP) and national (e.g. National Paranoia Network) service user and carer organisations to ensure the research outcomes are accessible to people with lived experience of paranoia. This will involve both written material and oral presentations. Results from the pilot study will be published in a high-impact peer reviewed academic journal, such as British Journal of Clinical Psychology, or Psychiatry Research. Results from the full trial will be submitted to the British Journal of Psychiatry. A paper from the pilot study will be submitted for presentation at the British Association of Behavioural and Cognitive Psychotherapy conference in 2018.
2. A written report will be produced in collaboration with Peter Jones for the National Paranoia Network, a service-user led organisation that aims to raise awareness of how disabling paranoia can be, for posting on their website. This will be cautious in tone given that definitive conclusions cannot be drawn from this pilot study.
3. Several seminars will be held in Surrey & Borders Partnership in order to present the findings of the pilot study and plans for the full trial. This will include presentations at the R&D department’s annual research day, to the FoCUS service user forums, and at the Mental Health Clinical Academic Group.
4. A summary of study findings will be written for distribution to all study participants. This will be written jointly between Paul Chadwick and Peter Jones

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

13/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting. 08/08/2017: The recruitment end date was changed from 31/03/2017 to 31/03/2018.