Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000158965
Ethics application status
Approved
Date submitted
23/12/2010
Date registered
9/02/2011
Date last updated
24/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Group Schema Therapy for Borderline Personality Disorder.
Scientific title
International multi-site RCT of two versions of Group Schema Therapy compared to treatment as usual for Borderline Personality Disorder in reducing symptom severity and improving quality of life
Secondary ID [1] 253331 0
NL28016.068.09
Secondary ID [2] 253332 0
MEC 09-3-044
Secondary ID [3] 253534 0
NTR2392
Universal Trial Number (UTN)
Trial acronym
STTURT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 258871 0
Condition category
Condition code
Mental Health 259008 259008 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental A: 118 group Schema Therapy sessions over 2 years with max. 17 individual sessions. Experimental B: 64 group Schema Therapy over 2 years with max. 61 individual sessions. Control: Treatment as usual - the standard treatment given for that patient at the treatment center. individual sessions last 50 minutes and group sessions 90 minutes
Intervention code [1] 257784 0
Treatment: Other
Comparator / control treatment
Treatment as usual - the standard treatment given for that patient at the treatment center.
Control group
Active

Outcomes
Primary outcome [1] 259865 0
Borderline Personality Disorder Severity Index, structured interview for severity of BPD symptoms
Timepoint [1] 259865 0
baseline, 6,12,18,24 months
Secondary outcome [1] 268743 0
BPD-checklist: self report measure of BPD symptoms
Timepoint [1] 268743 0
baseline, 3, 6,12,18,24 months
Secondary outcome [2] 268974 0
Brief Symptom Inventory: measure of general psychiatric symtoms
Timepoint [2] 268974 0
baseline, 3, 6,12,18,24 months
Secondary outcome [3] 268975 0
Global Assessment and Functioning Scale: measure of level of impact of psychiatric symptoms on functioning
Timepoint [3] 268975 0
baseline, 3, 6,12,18,24 months
Secondary outcome [4] 268976 0
Social Adjustment Scale
Timepoint [4] 268976 0
baseline, 3, 6,12,18,24 months
Secondary outcome [5] 268977 0
Social Occupational Functioning Assessment Scale
Timepoint [5] 268977 0
baseline, 3, 6,12,18,24 months
Secondary outcome [6] 268978 0
WHOQOL: WHO measure of quality of life
Timepoint [6] 268978 0
baseline, 6,12,24 months
Secondary outcome [7] 268979 0
Happiness Rating
Timepoint [7] 268979 0
baseline, 3, 6,12,18,24 months
Secondary outcome [8] 268980 0
Schema Questionnaire: measure severity of core early maladaptive schemas
Timepoint [8] 268980 0
baseline, 3, 6,12,18,24 months
Secondary outcome [9] 268981 0
Schema Mode Inventory: measures severity of mode
Timepoint [9] 268981 0
baseline, 3, 6,12,18,24 months

Eligibility
Key inclusion criteria
1. Age 18-65 years
2. Primary DSM-IV diagnosis of BPD (assessed with the SCID-II interview)
3. BPD severity above 20 on the BPDSI interview
4. Willingness to participate in the study (informed consent procedure)
5. Ability to participate in (group) treatment and research for 2 years (e.g., no plans to move to another city).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Lifetime psychotic disorder (short stress-related episodes are allowed, as described in DSM-IV BPD criterion 9)
2. IQ < 80 (in case of suspicion of low IQ, to be assessed with full intelligence test)
3. Unable to read, speak, or write the language used at the site (in case of suspicion an official language test is to be used)
4. Bipolar disorder type 1 (SCID-1)
5. Dissociative Identity Disorder (confirmed by senior investigators)
6. Full or sub-threshold (defined as one less than the number of criteria to qualify for the diagnosis) narcissistic or antisocial personality disorder (SCID-2)

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)
After the second baseline BPDSI assessment, patients will be randomized over three conditions: Schema Therapy (individual focus: weekly individual and group sessions) or schema therapy with a group focus in which the partcipants receive group treatment twice a week(GST) in blocks of by the central research assistant (at the main Netherlands site) using a computerized randomization program. The order in which the formats of GST will be delivered is randomized over sites, so that order of group format type is balanced over sites, controlling for therapist learning and time effects.

It will be explained to patients why the main assessor needs to be blind and they will be asked not to talk about the type of treatment they receive. After each assessment, blindness will be assessed by asking the assessor to guess the patient’s condition. The assessment of healthcare costs is done by a second unblinded assessor due to the information needed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
see above
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
DNA will also be collected to determine the possibility of genetic subtypes.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3528 0
6162
Recruitment outside Australia
Country [1] 3109 0
Netherlands
State/province [1] 3109 0
Country [2] 3110 0
United States of America
State/province [2] 3110 0
Country [3] 3111 0
Germany
State/province [3] 3111 0
Country [4] 3112 0
United Kingdom
State/province [4] 3112 0

Funding & Sponsors
Funding source category [1] 258255 0
Charities/Societies/Foundations
Name [1] 258255 0
Rotary
Country [1] 258255 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
South St
Murdoch
WA 6150
Country
Australia
Secondary sponsor category [1] 257420 0
Government body
Name [1] 257420 0
South Metropolitan Mental Health Sevice WA
Address [1] 257420 0
18 Dalgety St
East Fremantle
WA 6004
Country [1] 257420 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260230 0
Murdoch University
Ethics committee address [1] 260230 0
90 South St
Murdoch WA 6150
Ethics committee country [1] 260230 0
Australia
Date submitted for ethics approval [1] 260230 0
10/11/2010
Approval date [1] 260230 0
18/01/2011
Ethics approval number [1] 260230 0
2010/217

Summary
Brief summary
In the last five years, a treatment specifically developed for borderline personality disorder namely Schema Therapy has been found to be more effective than existing usual treatments and a specialized form of psychodynamic therapy. When compared to other specialized treatments, Schema Therapy has very low drop-out rate and is very effective, not only in reducing symptoms, but in improving quality of life. Schema Therapy can lead to full recovery from BPD and normal functioning. However, this schema therapy is yet to be tested outside of the centres that developed the programme.

A large scale international study to investigate the efficacy of the treatment programme across six countries in several different languages is planned for 2011. The research will compare two different delivery modes of Schema Therapy with existing treatments to see if there is some benefit of this new therapy. The study will enable us to determine not only if the therapy is beneficial in other parts of the world, but by including an Australian site, we can make specific recommendations in an Australian context.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32042 0
Address 32042 0
Country 32042 0
Phone 32042 0
Fax 32042 0
Email 32042 0
Contact person for public queries
Name 15289 0
Dr Christopher Lee
Address 15289 0
Clinical Psychology Programme Chair
Murdoch University
90 South St
Murdoch
WA 6150
Country 15289 0
Australia
Phone 15289 0
61 8 93606028
Fax 15289 0
Email 15289 0
[email protected]
Contact person for scientific queries
Name 6217 0
Dr Christopher Lee
Address 6217 0
Clinical Psychology Programme Chair
Murdoch University
90 South St
Murdoch
WA 6150
Country 6217 0
Australia
Phone 6217 0
+ 61 8 93606028
Fax 6217 0
Email 6217 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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