MOBY: A randomised controlled trial of three forms of psychosocial early intervention for borderline personality disorder in youth.
OrygenDataset description
Dataset from a randomized controlled trial aimed at evaluating the effectiveness of early intervention methods for young individuals (aged 15-25) diagnosed with Borderline Personality Disorder (BPD) who are seeking treatment for the first time. The study compares three distinct interventions: two specialized forms of the "Helping Young People Early" (HYPE) intervention—one with and one without 16 sessions of individual Cognitive Analytic Therapy (CAT)—and a control group receiving general youth mental health care of equivalent duration. The primary outcomes assessed are improvements in interpersonal problems and social adjustment at 12 and 18 months post-enrolment. The dataset is designed to identify which intervention most effectively aids in the early stages of BPD management, with the hypothesis that HYPE combined with CAT will yield superior outcomes.Subjects
FOR: Mental Health |Identifiers
Source Study
Trial name (public)
A randomised controlled trial of three forms of psychosocial early intervention for borderline personality disorder in youth.Trial acronym
Monitoring Outcomes of Borderline personality disorder in Youth (MOBY).
Trial ID
ACTRN12610000100099
Purpose
Treatment
Phase
Not Applicable
Funding
Government body,National Health and Medical Research
Scientific enquiries
Prof Andrew Chanen
Brief Summary
Borderline Personality Disorder (BPD) is a severe mental disorder that arises during adolescence and young adulthood. This study investigates the most effective form of early intervention for young people (15-25 years old) presenting for treatment of BPD for the first time. It is a randomised controlled trial comparing three interventions: two forms of the specialised HYPE early intervention (one with and one without 16 sessions of individual Cognitive Analytic Therapy), along with an interventi .... Read more
Key Inclusion Criteria
Broad inclusion criteria to capture the "real world" clincial environment. These are: (1) Age 15-25 inclusive, (2) Ability to give informed consent and comply with study procedures, (3) Fluency in English, (4) Structured Clinical Interview for DSM-IV axis II disorders BPD.
Key Exclusion Criteria
(1) First episode psychosis within the 12 months prior to entering the study, (2) Structured Clinical Interview for DSM-IV Axis 1 Bipolar I or II Disorder, (3) Psychiatric condition due to a medical condition, (4) Severe disturbance, such that the person is unable to comply with the requirements of informed consent or the protocol, (5) A Schizophrenia Spectrum Disorder, (6) prior evidence-based BPD treatment, (7) does not meet the clinical services' eligibility criteria (e.g. catchment area).
Can healthy volunteers participate?
No
Population
Sample Size 139
Min. age 15 Years
Max. age 25 Years
Sex Both males and females
Condition category Borderline personality disorder , Youth mental health
Condition code Mental Health
Intervention
Intervention code Treatment: Other
Three interventions will be compared. Two of the interventions are two forms of the Helping Young People Early (HYPE) specialised early intervention for borderline personality disorder. The third intervention is youth mental health care. The three study arms will be: i) HYPE + individual Cognitive Analytic Therapy (HYPE+CAT); ii) HYPE + ‘Befriending’ (HYPE+Bef); iii) Youth mental health care + Befriending (YMH+Bef). HYPE+CAT is an integrated, multidisciplinary team-based early intervention servi .... Read more
Comparison
Control group Active
YMH+Bef includes individual practice by specialist youth mental health clinicians within a government-funded multidisciplinary group practice setting. Clinicians carry a diagnostically mixed patient load. They diagnose mental disorders, develop a management plan, offer psychoeducation, conduct assertive case management and offer general psychiatric care. General practitioner and/or psychiatric referrals and pharmacotherapy are initiated as clinically indicated. Crisis and inpatient services are .... Read more
Outcomes
Outcome: Interpersonal problems measured by the Inventory of Interpersonal Problems Circumplex Version (IIP-C)Timepoint: Baseline, 3 months, 6 months, 12 months and 18 months.
Outcome: Social Adjustment measured by the Social Adjustment Scale Self Report (SAS-SR)Timepoint: Baseline, 3 months, 6 months, 12 months and 18 months.
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
All of the individual trial-related participant data collected during the trial, after de-identification.
When will data be available?
Immediately following publication and for an indefinite time.
Available to whom?
Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data sharing policy.
Available for what types of analyses?
Any type of analyses. Assessed on a case-by-case basis.