JOSHUA: a pilot randomised controlled trial of joint crisis plans for people who self harm
| ISRCTN | ISRCTN12440268 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12440268 |
| Secondary identifying numbers | G0701752 |
- Submission date
- 17/09/2009
- Registration date
- 05/10/2009
- Last edited
- 07/05/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Paul Moran
Scientific
Scientific
Sir David Goldberg Building
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
| Phone | +44 (0)20 7848 0568 |
|---|---|
| paul.moran@iop.kcl.ac.uk |
Study information
| Study design | Single-centre pilot randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | JOSHUA |
| Study objectives | At this stage, it is premature to formulate a clear primary hypothesis. Nevertheless, the JOSHUA trial will provide an opportunity to examine the following exploratory hypotheses: 1. Use of a joint crisis plans (JCP) will lead to a significant increase in the length of time to first act of self harm during the follow-up period, compared with the control condition 2. Use of a JCP will result in a significant reduction in the number of acts of self-harm during the follow-up period, compared with the control condition 3. Regarding the most recent act of self-harm at follow-up, compared with the control condition, use of JCP will lead to a significant increase in the length of time from contemplation of self-harm to self-harm act 4. Regarding the most recent act of self-harm at follow-up, compared with the control condition, use of JCP will lead to a significant increase in help-seeking behaviour 5. Use of a JCP will result in a significant improvement in engagement with mental health services, compared with the control condition 6. Use of a JCP will lead to a significant improvement in therapeutic alliance, compared with the control condition 7. Use of a JCP will lead to a significant improvement in satisfaction with care, compared with the control condition 8. Use of a JCP will lead to a significant improvement in quality of life, compared with the control condition 9. Use of a JCP will lead to a significant reduction in total costs of care, compared with the control condition, or that the additional costs will be worthwhile in terms of improvements in outcomes |
| Ethics approval(s) | This study will be discussed at the Wandsworth Ethics Committee meeting on the 23rd September 2009. |
| Health condition(s) or problem(s) studied | Borderline personality disorder |
| Intervention | This is a single-centre pilot randomised controlled trial of JCPs compared with a treatment as usual control condition for people with BPD. The total duration of the study will be two years. Experimental Intervention At each site, a clinically experienced facilitator will organise a meeting with each service user randomised to receive a JCP. The facilitator will introduce the JCP 'menu' (a list of topics to be considered for inclusion in the JCP) to each service user. He/she will then organise a meeting between the service user and the Care Co-ordinator, when the JCP contents will be finalised. The service user is encouraged to bring a carer or friend to act as an advocate. The JCP contains information for the service user, information for health professionals and details of practical help which the service user might require when in a future crisis. The Facilitator produces a typed version of the JCP, computer-generated to allow replacement and updating (the feasibility of updating the plan will be examined during the course of the trial). Copies will be sent to all those whom the service user specifies and a copy will also be attached to each service user's electronic patient record (attached in the 'correspondence' section with an alert on the front page of the record, notifying staff of its existence). Control intervention After careful consideration, we have chosen to use a treatment as usual (TAU) control condition, as this provides a fair comparison with routine clinical practice and will answer the question of whether JCP use is superior to current standard care. TAU includes, as a part of the Care Programme Approach (CPA), the need for service users to receive written copies of their care plan, including a 'crisis contingency plan'. We expect that the CPA arrangements will be applied equally by routine services to intervention and control groups. |
| Intervention type | Other |
| Primary outcome measure | Self-harm history, assessed by a questionnaire at baseline and 6 months (trial end). Previous research indicates that JCPs for psychotic patients give them a greater sense of control over their health management and that one of the perpetuating factors for repeat self-harm is a sense of loss of control. We therefore think that in people with BPD (whose contact with mental health services is frequently characterised by the experience of disempowerment), self-harm is a reasonable choice for a primary outcome variable in a randomised controlled trial. Self-harm is also a major clinical problem in this patient population and is of great relevance from a public health perspective, given that it is a risk factor for suicide. Therefore, if JCPs could be shown to lead to an improvement in some aspect of self-harm behaviour, or the management of self-harm, this would be of great clinical relevance However, at this stage, we have no firm empirical evidence to show whether this is the case, or indeed which aspect of this behaviour might be affected by a JCP. There is no gold standard for measure of self-harm and possible candidates include: incidence, frequency, severity, help-seeking behaviour prior to and after a self-harm event. |
| Secondary outcome measures | 1. Client's experience of the treatment that he or she received at a particular service, assessed by the Treatment Experience Scale assessed at baseline and 6 months 2. Service Engagement Scale at baseline, 6 months (trial end) and trial drop-out 3. The Work and Social Adjustment Scale (WSAS) at baseline and 6 months (trial end) 4. Euroqol EQ-5D at baseline and 6 months (trial end) 5. Client Satisfaction Questionnaire at baseline and 6 months (trial end) 6. Working Alliance Inventory - short version (WAI-S) (client version) at baseline and 6 months (trial end). This is a measure of how well a client and a clinician work together. 7. WAI-S (staff version) at baseline, 6 months (trial end) and trial drop-out 8. Adult Service Use Schedule (ADSUS) to assess which services clients have accessed in the preceding 6 months, for health economics purposes, carried out at baseline and 6 months (trial end) 9. Alcohol Use Disorders Identification Test (AUDIT) at baseline 10. Hospital Anxiety and Depression scale (HADS) at baseline |
| Overall study start date | 01/10/2009 |
| Completion date | 01/11/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Service users (both males and females) aged 18 years or older 2. Current contact with a local Community Mental Health Team (CMHT) (will include assessment and brief treatment, continuing care, home treatment and out-patient clinics attached to these teams) 3. A primary clinical diagnosis of emotionally unstable personality disorder (International Statistical Classification of Diseases and Related Health Problems, 10th Revision [ICD-10] code F60.3) 4. An episode of self-harm in the previous year |
| Key exclusion criteria | 1. Service users aged under 18 years of age 2. Those unable to give informed consent 3. Those unable to speak English. Fluency in English is necessary to complete the assessment instruments (many of which have not been validated in non-English languages) and to fully participate in the development of the Joint Crisis Plans. 4. Primary diagnosis of psychosis 5. Current in-patients will not be recruited to avoid any perceived potential coercion to participate, nor any patient subject to a compulsory community treatment order No other exclusions will be made, to maximise the external validity of the trial. |
| Date of first enrolment | 01/10/2009 |
| Date of final enrolment | 01/11/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Sir David Goldberg Building
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
PO05, Institute of Psychiatry
De Crespigny Park
Denmark Hill
London
SE5 8AF
England
United Kingdom
| Website | http://www.kcl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
Medical Research Council (UK) (ref: G0701752; grant ID: 85397)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- 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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/02/2010 | Yes | No | |
| Results article | results | 01/05/2013 | Yes | No |
