Brief talking therapies on wards
| ISRCTN | ISRCTN37625384 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37625384 |
| Protocol serial number | 19490 |
| Sponsor | King's College London |
| Funder | National Institute for Health Research |
- Submission date
- 19/08/2015
- Registration date
- 19/08/2015
- Last edited
- 25/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Public
King's College London
Institute Of Psychiatry
16 De Crespigny Park
London
SE5 8AF
United Kingdom
 ORCID ID |
0000-0001-8847-7775 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Mindfulness-based crisis interventions (MBCI) for psychosis within acute inpatient psychiatric settings: a feasibility randomised controlled trial |
| Study acronym | amBITION |
| Study objectives | 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(s) | London - Camberwell St Giles Research Ethics Committee, 15/LO/1338 |
| Health condition(s) or problem(s) studied | Topic: Mental Health; Subtopic: Psychosis; Disease: Psychosis |
| Intervention | 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 | Other |
| Primary outcome measure(s) |
Feasibility/acceptability; Timepoint(s): At trial end (incl. recruitment rate/retention) |
| Key secondary outcome measure(s) |
1. Pilot clinical/symptom measures; Timepoint(s): Baseline, Post-therapy, 3 month follow-up, 6 month follow-up |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2015 |
| Date of final enrolment | 01/01/2017 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
16 De Crespigny Park
London
SE5 8AF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 29/04/2020 | 25/11/2020 | Yes | No |
| Protocol article | protocol | 01/12/2016 | Yes | No | |
| Basic results | 06/09/2018 | 07/09/2018 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN37625384_BasicResults_06Sep2018.pdf
- Uploaded 07/09/2018
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.
