Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Inpatient psychiatric care is a scarce resource, yet large numbers of patients are being re-admitted to hospital care. This study will investigate the possibility of running a trial of a brief talking therapy for people with distressing psychotic symptoms receiving inpatient care following a mental health crisis.

Who can participate?
Adults (aged at least 18) that are inpatients in a psychiatric ward.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 (intervention) receive the talking (mindfulness-based crisis interventions) therapy. Those in group 2 (control) receive a control therapy (social activity therapy). Information is gathered on how many people are re-admitted to hospital 6 months later.Participants also fill out some questionnaires asking about their symptoms, emotions and recovery. Questionnaire data is collected at the beginning and end of therapy, and 3 and 6 months after people are discharged from hospital. Participants and staff involved in the study are also invited to give feedback on the study in an interview or focus group. This may help plan a larger future study to find out whether this simple intervention can help people with psychosis stay out of hospital for longer following a crisis.

What are the possible benefits and risks of participating?
Both therapies are likely to have some benefit. However, this will vary from person to person. 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 trial therapist is very experienced in keeping this to a level which is manageable. Participants can always stop a therapy session or indeed to stop therapy altogether if they do not wish to carry on.

Where is the study run from?
King’s College London, Institute Of Psychiatry (UK)

When is the study starting and how long is it expected to run for?
October 2015 to July 2017

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

Who is the main contact?
Dr Pamela Jacobsen

Trial website

Contact information



Primary contact

Dr Pamela Jacobsen


Contact details

King's College London
Institute Of Psychiatry
16 De Crespigny Park
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Mindfulness-based crisis interventions (MBCI) for psychosis within acute inpatient psychiatric settings: a feasibility randomised controlled trial



Study hypothesis

This study aims to investigate the feasibility of conducting a trial of a brief talking therapy for people with distressing psychotic symptoms receiving inpatient care following a mental health crisis.

Ethics approval

London - Camberwell St Giles Research Ethics Committee, 15/LO/1338

Study design

Randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet


Topic: Mental Health; Subtopic: Psychosis; Disease: Psychosis


1. Control therapy - SAT, Social Activity Therapy (SAT) is a brief intervention (1-5 sessions) which involves helping the client to identify activities they enjoy, and carrying these out with the therapist on the ward.;
2. Talking therapy - MBCI, Mindfulness-Based Crisis Interventions (MBCI) is a brief therapy (1-5 sessions) focussing on developing a shared understanding of what has brought the person into crisis, and introducing other ways of coping with future distressing experiences using mindfulness-based techniques.; Follow Up Length: 6 month(s); Study Entry : Single Randomisation only

Intervention type



Drug names

Primary outcome measure

Feasibility/acceptability; Timepoint(s): At trial end (incl. recruitment rate/retention)

Secondary outcome measures

1. Pilot clinical/symptom measures; Timepoint(s): Baseline, Post-therapy, 3 month follow-up, 6 month follow-up
2. Pilot outcome data on re-admission rates; Timepoint(s): 3 and 6 month follow-up
3. Self-ratings of Psychotic Symptoms
4. Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ)
5. Depression, anxiety and stress scales (DASS-21)
6. Southampton Mindfulness Questionnaire (SMQ)
7. Questionnaire about the Process of Recovery (QPR)

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Aged 18 or above
2. Current psychiatric inpatient on a working-age adult ward
3. Diagnosis of schizophrenia-spectrum disorder or psychotic symptoms in the context of an affective disorder (International Statistical Classification of Diseases and Related Health Problems, Tenth edition [ICD-10], F2039)
4. Reports at least one current distressing positive psychotic symptom
5. Able to give informed consent to participate in trial, as assessed by consultant psychiatrist/responsible clinician
6. Willing and able to engage in psychological therapy

Participant type


Age group




Target number of participants

Planned Sample Size: 60; UK Sample Size: 60; Description: This is a feasibility randomised controlled trial (RCT) with 2 arms (experimental and control therapy). 60 patients will be recruited to the trial, 30 in each arm.

Total final enrolment


Participant exclusion criteria

1. Established diagnosis of learning disability, or major cognitive impairment arising from any underlying medical condition (e.g. head injury, neurological disorder) resulting in significant functional impairment
2. Unable to engage in a talking therapy in English, or to complete simple written questionnaires in English
3. Primary diagnosis of substance misuse
4. Does not report any current distressing psychotic symptoms
5. Lacks capacity to consent to participation in research trial
6. Unable to take part in individual therapy due to risk of aggression/violence
7. Mental state precludes possibility of engaging in a talking therapy, e.g. significant thought disorder

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

King's College London
Institute Of Psychiatry 16 De Crespigny Park
United Kingdom

Sponsor information


King's College London

Sponsor details

Room 1.8
Hodgkin Building
Guy's Campus
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


United Kingdom

Results and Publications

Publication and dissemination plan

1. Submission of trial protocol to BMC Psychiatry (peer reviewed open access journal)
2. Poster presentation of trial protocol at World Congress of Behavioural and Cognitive Therapies (June 2016)
3. Paper presentation of trial outcomes at British Association for Behavioural and Cognitive Psychotherapies
4. Paper submission of quantitative/qualitative outcomes to clinical psychology/psychiatry peer-reviewed journal
5. Dissemination at a local level to NHS services and via service user and charity networks

Updated 07/09/2018:
The main trial paper is currently being prepared for submission to a peer-reviewed journal, with publication expected by July 2019.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from the Chief Investigator Dr Pamela Jacobsen. Anonymised data will be shared in accordance with participant consent and ethical approval for the study.

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

See additional file ISRCTN37625384_BasicResults_06Sep2018.pdf

Publication list

2016 protocol in
2020 results in (added 25/11/2020)

Publication citations

Additional files

Editorial Notes

25/11/2020: Publication reference and total final enrolment. 29/01/2020: The public contact has been changed. 07/09/2018: Publication and dissemination plan updated and IPD sharing statement added. The basic results of this trial have been uploaded as an additional file. 22/08/2016: Publication reference added.