Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000100099
Ethics application status
Approved
Date submitted
21/12/2009
Date registered
1/02/2010
Date last updated
16/11/2023
Date data sharing statement initially provided
15/10/2023
Date results provided
15/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of three forms of psychosocial early intervention for borderline personality disorder in youth.
Scientific title
MOBY: A randomised controlled trial of specialised early intervention with individual Cognitive Analytic Therapy, specialised early intervention without individual psychotherapy, and standard youth mental health care for first-presentation borderline personality disorder in youth.
Secondary ID [1] 1353 0
None
Universal Trial Number (UTN)
Trial acronym
Monitoring Outcomes of Borderline personality disorder in Youth (MOBY).
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline personality disorder 256433 0
Youth mental health 256434 0
Condition category
Condition code
Mental Health 256604 256604 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 service model for borderline personality disorder. It uses a shared psychosocial model of borderline personality disorder and a common language for communication with patients, families and carers, team members and the wider service system. HYPE+CAT includes: i) rigorous diagnosis of BPD and other personality pathology; ii) up to 16 x 50-minute individual Cognitive Analytic Therapy (CAT) sessions delivered over approximately 26 weeks; iii) assertive case management integrated with the delivery of psychotherapy; iv) developing a collaborative model of the individual patient’s difficulties that is shared with the patient, HYPE team, family and relevant others and is used for intra- and extra-service liaison; v) active engagement of families or carers, with psychoeducation and up to four sessions of family intervention; vi) general psychiatric care, with specific assessment and treatment of co-occurring psychiatric syndromes (‘comorbidity’), including the use of pharmacotherapy (where indicated), while minimising polypharmacy; vii) access to the shared elements of Orygen Youth Health – crisis team, inpatient care, activity group program; viii) with a clear model of brief and goal-directed crisis and inpatient care; ix) individual and group supervision of staff; and x) a quality assurance program.

HYPE+Bef will comprise all of the elements of HYPE+CAT except that ‘individual Cognitive Analytic Therapy’ will be substituted with up to 16 x 50-minute individual sessions of ‘Befriending’ delivered over approximately 26 weeks. Befriending is a manualised intervention that consists of talking about neutral topics that interest the participant (e.g. music, sport, books). If the participant finds verbal interaction difficult, activities such as board games, walking, or playing sport, can be used with a view to using the activity as a tool to engage the participant in further neutral conversation during and after the activity. The therapist’s primary goals are to keep the participant engaged for the full duration of therapy and to keep the conversation or activity as close to a neutral ‘pleasant chat’ as possible.
Intervention code [1] 255730 0
Treatment: Other
Comparator / control treatment
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 accessed from the state-based mental health system, as needed. In addition, participants in this group will receive up to 16 x 50-minute individual sessions of ‘Befriending’ delivered over approximately 26 weeks.
Control group
Active

Outcomes
Primary outcome [1] 257495 0
Interpersonal problems measured by the Inventory of Interpersonal Problems Circumplex Version (IIP-C)
Timepoint [1] 257495 0
Baseline, 3 months, 6 months, 12 months and 18 months.
Primary outcome [2] 257496 0
Social Adjustment measured by the Social Adjustment Scale Self Report (SAS-SR)
Timepoint [2] 257496 0
Baseline, 3 months, 6 months, 12 months and 18 months.
Secondary outcome [1] 262695 0
Client satisfaction measured by the Client Satisfaction Questionnaire (CSQ-8)
Timepoint [1] 262695 0
Baseline, 3 months, 6 months, 12 months and 18 months.
Secondary outcome [2] 262696 0
Suicidal Ideation as measured by the self-report Beck Suicidal Ideation Scale (BSS) and Mobiletype, a mobile phone program that asks open and closed questions about affect, suicidal ideation and parasuicidal behaviour.
Timepoint [2] 262696 0
The BSS will be completed at the Baseline, 3 month, 6 month, 12 month and 18 month assessments. Mobiletype will be completed 6 times per day for 6 days after each assessment at Baseline, 3 months, 6 months, 12 months and 18 months.
Secondary outcome [3] 262697 0
Parasuicidal Acts as measured by the Suicide Attempt and Self-Injury Interview (SASII) and Mobiletype, a mobile phone program that asks open and closed questions about affect, suicide ideation and parasuicidal behaviour.
Timepoint [3] 262697 0
Baseline, 3 months, 6 months, 12 months and 18 months.
Secondary outcome [4] 262698 0
Affective Instability as measured by the 10-item self-report Short PANAS (Positive and Negative Affect Schedule), administered with Mobiletype.
Timepoint [4] 262698 0
Mobiletype is administered six times per day for six days following the Baseline, 3-month, 6-month, 12-month and 18-month assessments.
Secondary outcome [5] 273484 0
Borderline Personality Disorder Symptoms as measured by the Borderline Personality Disorder Severity Index (BPDSI-IV).
Timepoint [5] 273484 0
Baseline, 3-month, 6-month, 12-month and 18-month assessments.
Secondary outcome [6] 273485 0
Depression as measured by the self-report Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) and the semi-structured interview and rating scale of the Montgomery-Asberg Depression Rating Scale (SIGMA).
Timepoint [6] 273485 0
Baseline, 3-month, 6-month, 12-month and 18-month assessments.
Secondary outcome [7] 273486 0
Substance Use as measured by the self-report Alcohol Use Disorders Identification Test (AUDIT) and the interview measure, the Opiate Treatment Index (OTI - Section II).
Timepoint [7] 273486 0
Baseline, 3-month, 6-month, 12-month and 18-month assessment.
Secondary outcome [8] 273487 0
Therapeutic Alliance as measured by the Working Alliance Inventory (WAI).
Timepoint [8] 273487 0
In the HYPE+CAT arm, after the first, sixth and final CAT sessions. In the HYPE+Bef and YMH+Bef arm, after the first, sixth and final befriending sessions and after the first case work/case management session, after two months of case work/case management, and after the final case work/case management session.
Secondary outcome [9] 273488 0
Quality of Life as measured by the Assessment of Quality of Life (AQoL-8D).
Timepoint [9] 273488 0
Baseline, 3-month, 6-month, 12-month and 18-month assessment.
Secondary outcome [10] 273489 0
Social and Occupational Functioning as measured by the Social and Occupational Assessment of Functioning Scale (SOFAS).
Timepoint [10] 273489 0
Baseline, 3-month, 6-month, 12-month and 18-month assessment.
Secondary outcome [11] 273490 0
Emotion Regulation as measured by the Difficulties in Emotion Regulation Scale (DERS).
Timepoint [11] 273490 0
Baseline, 3-month, 6-month, 12-month and 18-month assessment.

Eligibility
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.
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be identified through the Orygen Youth Health triage system and the headspace Sunshine intake systems using the 15 BPD items from the SCID-II PQ or the SCID-II BPD module. Written informed consent will be obtained from all participants and for minors, from a parent or guardian. Following baseline assessment, participants will be assigned randomly and consecutively in a ratio of 1:1:1 to one of the three interventions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence will be computer-generated by an independent statistician. Treatment allocation will use randomised permuted blocking and participants will be stratified by age (<18 years old/= 18 years old), sex and CESD-R score (cut point=37).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
No
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The main analysis will be based on the intent-to-treat principle. To determine whether there are group differences on the primary and secondary outcome measures at 6, 12 and 18 months a series of mixed effects model repeated measures analysis of variances models (MMRM) will be employed. The within groups factor will be time and group will serve as the between subjects factor. MMRM is a preferred method for analysing clinical trial data in psychiatry, compared with more traditional repeated measures analysis of variance (ANOVA) and analysis of covariance (ANCOVA models). The advantages of MMRM over these traditional models include: 1) all existing data are included in the model; 2) there is no imputation or substitution of missing data; and 3) dispersion and correlation of data at all occasions can be modelled. Planned comparisons and sensitivity analysis can also be successfully conducted with this technique.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/03/2011
Actual
17/03/2011
Date of last participant enrolment
Anticipated
31/12/2015
Actual
30/09/2015
Date of last data collection
Anticipated
30/06/2017
Actual
7/07/2017
Sample size
Target
135
Accrual to date
Final
139
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 6966 0
3052 - Parkville
Recruitment postcode(s) [2] 6967 0
3011 - Footscray
Recruitment postcode(s) [3] 6968 0
3020 - Sunshine

Funding & Sponsors
Funding source category [1] 256204 0
Government body
Name [1] 256204 0
National Health and Medical Research
Country [1] 256204 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council
Address
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 251546 0
None
Name [1] 251546 0
Address [1] 251546 0
Country [1] 251546 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258306 0
Melbourne Health Research and Ethics Committee
Ethics committee address [1] 258306 0
Ethics committee country [1] 258306 0
Australia
Date submitted for ethics approval [1] 258306 0
01/02/2010
Approval date [1] 258306 0
03/06/2010
Ethics approval number [1] 258306 0
2010.055
Ethics committee name [2] 258503 0
Melbourne Helath Human Research and Ethics Committee
Ethics committee address [2] 258503 0
Ethics committee country [2] 258503 0
Australia
Date submitted for ethics approval [2] 258503 0
26/02/2010
Approval date [2] 258503 0
Ethics approval number [2] 258503 0
2010.055

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30638 0
Prof Andrew Chanen
Address 30638 0
Orygen, (Locked Bag 10), Parkville, VIC, 3052
Country 30638 0
Australia
Phone 30638 0
+61 03 9966 9100
Fax 30638 0
+61393873003
Email 30638 0
[email protected]
Contact person for public queries
Name 13885 0
Andrew Chanen
Address 13885 0
Locked Bag 10
Parkville VIC 3052
Country 13885 0
Australia
Phone 13885 0
+61 03 9966 9100
Fax 13885 0
Email 13885 0
[email protected]
Contact person for scientific queries
Name 4813 0
Andrew Chanen
Address 4813 0
Locked Bag 10
Parkville VIC 3052
Country 4813 0
Australia
Phone 4813 0
+61 3 9342 2800
Fax 4813 0
Email 4813 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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 (start and end dates)?
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.
How or where can data be obtained?
Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health). Search for the ACTRN number in the catalogue to find datasets associated with this trial.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20651Study protocolTrials, 16, 476 (2015). [email protected]
20652Statistical analysis planThe analysis plan is detailed in our published protocol, Trials, 16, 476 (2015).  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseComparing three forms of early intervention for youth with borderline personality disorder (the MOBY study): Study protocol for a randomised controlled trial.2015https://dx.doi.org/10.1186/s13063-015-1001-x
EmbasePredictors of substance use in youth with borderline personality disorder.2018https://dx.doi.org/10.1037/per0000257
EmbaseSubstance Use in Youth With Borderline Personality Disorder.2018https://dx.doi.org/10.1521/pedi_2017_31_315
EmbaseA Comparison of Adolescent versus Young Adult Outpatients with First-Presentation Borderline Personality Disorder: Findings from the MOBY Randomized Controlled Trial.2022https://dx.doi.org/10.1177/0706743721992677
EmbaseCOMPARING THREE FORMS OF EARLY INTERVENTION FOR YOUTH WITH BORDERLINE PERSONALITY DISORDER (THE MOBY TRIAL): MAIN OUTCOMES.2022https://dx.doi.org/10.1177/00048674221088686
EmbaseEffect of 3 Forms of Early Intervention for Young People with Borderline Personality Disorder: The MOBY Randomized Clinical Trial.2022https://dx.doi.org/10.1001/jamapsychiatry.2021.3637
N.B. These documents automatically identified may not have been verified by the study sponsor.