The emergence of personality disorder traits in adolescents who deliberately self harm and the potential for using a mentalisation based treatment approach as an early intervention for such individuals: a randomised controlled trial

ISRCTN ISRCTN95266816
DOI https://doi.org/10.1186/ISRCTN95266816
Secondary identifying numbers N/A
Submission date
29/10/2007
Registration date
13/12/2007
Last edited
09/01/2014
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 Trudie Rossouw
Scientific

Brookside
107a Barley Lane
Ilford
IG3 8XQ
United Kingdom

trudie.rossouw@googlemail.com

Study information

Study designBlinded randomised controlled trial with two treatment groups: mentalisation based treatment versus treatment as usual. Pretest-post test design.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesThe proposed sample group will be adolescents who harm themselves either through cutting or self poisoning and our hypotheses, which we aim to test in this study, is that the sample group will have a higher incidence of deficit in their capacity to mentalise (the ability to observe and understand invisible mental states of the self and the others, such as intentions, thoughts, desires, expectations, memories). Our hypothesis further is that the self harm group is likely to have a higher incidence of personality dysfunction, in particular of the borderline kind.

Secondly, we aim to compare Mentalisation Based Treatment (MBT) for the clinical sample group against Treatment As Usual (TAU) to test whether MBT will lead to a reduction in self harm behaviour; a reduction in sense of hopelessness and improved interpersonal relationships in comparison to TAU.

Lastly we hope to examine the mentalisation capacity and personality profiles in the parents of the clinical and the non-clinical groups, with the hypothesis being that the clinical group will present with a higher incidence of mentalisation deficit in the parents. We also hope to measure whether mentalisation based family therapy (Short Term Mentalisation and Relational Therapy [SMART]) improves the mentalisation capacity in the parents and in family functioning.
Ethics approval(s)Ethics approval received from the Redbridge and Waltham Forest Ethics Committee in February 2006.
Health condition(s) or problem(s) studiedSelf harm/borderline personality traits
InterventionTwo treatments: mentalisation based treatment measured against treatment as usual.

MBT Treatment programme:
The treatment will take three forms:
1. Individual once weekly psychotherapy sessions using the MBT approach
2. Family therapy using the SMART technique, fortnightly moving to once monthly after 4 sessions
3. Group therapy fortnightly beginning 6 months into treatment when sufficient participants have been recruited to comprise the groups

Treatment is planned to continue for an 18-month period. At the end of this period, further treatment/monitoring shall be offered to those individuals who still display severe psychopathology and/or risk to themselves or others where it is judged by the clinicians involved that further support may be beneficial. If this applies to a number of individuals this continued treatment may take to form of a group.

Qualified professionals in mental health who have additional training in MBT and in SMART treatment will provide treatment. The clinicians in the study will receive weekly supervision on their clinical work. Some of the individual and family sessions will be randomly selected to be recorded or observed in order that they can be independently rated. This will ensure that the therapy is consistent with the model and that the measure of the therapies’ effect is valid.

Risk will be managed by a detailed risk assessment at the outset of the study, as well as an ongoing monitoring of risk by the clinicians. Dr T Rossouw will provide psychiatric input. Emergencies after hours will be managed via the routine emergency procedures in North East London Mental Health Trust (NELMHT), which is that the young people are seen in Accident and Emergency (A & E) where they are medically examined and managed by the A & E staff and then seen for a mental state examination and risk assessment by the on call psychiatrist, who will liaise telephonically with Dr Rossouw.

Treatment as Usual:
This treatment will be provided by the tier 3 clinicians as they routinely do. Tier 3 clinicians are trained professionals working in child and adolescent psychiatry. For this group we shall be recording the number of times they were seen, the professions of the clinicians they saw and the clinician’s definition of the sessions’ format and purpose, i.e. assessment or intervention, type of assessment and type of intervention.
Intervention typeOther
Primary outcome measureThe assessment battery will consist of the following assessments for the identified adolescent:
1. Mood and Feelings Questionnaire
2. Millon Adolescent Clinical Inventory (MACI)
3. Childhood Inventory of Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) Borderline Personality Disorder (CI-BPD)
4. The Reading the Mind in the Eyes Test
5. Trust game and questionnaire
7. Intelligence Quotient (IQ)
8. Self Harming Inventory

Every 3 months the self harm inventory and the mood and feelings questionnaire will be re-adminstered.

Outcome/Post-treatment measures:
1. Mood and Feelings Questionnaire
2. Millon Adolescent Clinical Inventory (MACI)
3. Childhood Inventory of DSM-IV Borderline Personality Disorder (CI-BPD)
4. The Reading the Mind in the Eyes Test
5. Social Functioning
6. Self-harming Inventory
Secondary outcome measuresIn addition the following assessments will be given to the adolescents’ parent or guardian:
1. Millon Clinical Multiaxial Inventory-III (MCMI-III)
2. Family assessment tool (Systemic Inventory of Change [STIC])
3. The Reading the mind in the Eyes Test

At the end of the study the following measures will be given to the parents. In addition the following assessments will be given to the adolescents’ parent or guardian:
1. MCMI-III
2. Family assessment tool
3. The Reading the mind in the Eyes Test
Overall study start date14/01/2008
Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit13 Years
Upper age limit18 Years
SexAll
Target number of participants60 for the RCT
Key inclusion criteria1. Young people between the ages of 13 - 18 years with a history of self harm
2. Self harm will be defined as any act performed with the intention to harm themselves, e.g. cutting, burning, overdose
3. Eating disorders will only be included if accompanied by another form of self harm as well
Key exclusion criteria1. Learning disability
2. Autism and Asperger's
3. Psychosis
Date of first enrolment14/01/2008
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Brookside
Ilford
IG3 8XQ
United Kingdom

Sponsor information

Funders

Funder type

Government

North East London Mental Health Trust (NELMHT) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2012 Yes No
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