Plain English Summary
Background and study aims
Borderline personality disorder (BPD) is a severe mental disorder characterized by instability of self-image, instability of mood, tumultuous relationships, and recurrent episodes of self-harm. Patients with BPD are also prone to depression, anxiety and substance use disorders, and are commonly severely psychosocially disabled. There is a great need for effective psychosocial interventions for BPD. Schema therapy is a promising psychotherapeutic treatment for BPD. It has been investigated in traditional individual treatment format, but little research exists about a more cost-effective group format that has been recently developed. The aim of this study is to investigate the effectiveness of group schema therapy for the treatment of psychiatric outpatients with BPD.
Who can participate?
Psychiatric outpatients with BPD receiving treatment in the Mood Disorder Division of Department of Psychiatry, Helsinki University Hospital, in Finland
What does the study involve?
Participants are randomly allocated to either usual psychiatric treatment alone, or usual psychiatric treatment with group schema therapy. The usual psychiatric outpatients treatment received by both groups generally involves 1-2 appointments per month with a professional (commonly a psychiatric nurse or a psychologists), plus drug treatment prescribed by a psychiatrist (antidepressants, low-dose antipsychotics, or mood stabilizers). Group schema therapy involves 20 consecutive weekly two hour therapy sessions over a period of five months, with up to eight patients and two therapists per group. The therapists have been trained in the treatment format and are regularly supervised. Participants’ BPD symptoms are compared before and after the therapy.
What are the possible benefits and risks of participating?
The benefits of participation include receiving a promising psychotherapeutic treatment, and careful evaluation of symptoms and other factors related to treatment needs. The risks include the need to discuss psychologically distressing problems, which may occasionally be stressful.
Where is the study run from?
Helsinki University Hospital (Finland)
When is the study starting and how long is it expected to run for?
September 2017 to May 2020 (as of 04/10/2018)
Who is funding the study?
Helsinki and Uusimaa Hospital District (Finland)
Who is the main contact?
Prof. Erkki Isometsa
Trial website
Contact information
Type
Scientific
Primary contact
Prof Erkki Isometsä
ORCID ID
http://orcid.org/0000-0001-5956-2399
Contact details
PO Box 22
Helsinki
00014
Finland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Group schema therapy for borderline personality disorder: a randomized study
Acronym
GST-BPD
Study hypothesis
Group schema therapy plus usual psychiatric treatment result in greater decline in borderline personality disorder symptoms than usual psychiatric treatment alone.
Ethics approval
Helsinki and Uusimaa Hospital District (HUS) Ethics Committee, 16/11/2017; research permit within the HUS Department of Psychiatry 08/01/2018
Study design
Randomized intervention study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Borderline personality disorder
Intervention
Consenting BPD patients were randomized in blocks of three by using the Research Randomizer® in ratio 2:1 to group schema therapy plus usual psychiatric treatment vs. usual psychiatric treatment alone. Because blinding of psychotherapy is impossible, patients are aware of their allocation. All the outcomes are self-reported questionnaires (therefore, no blinding of assessment).
The usual psychiatric outpatients treatment received by both groups generally involves 1-2 appointments per month with a professional (commonly a psychiatric nurse or a psychologists), plus pharmacotherapy prescribed by a psychiatrist (antidepressants, low-dose antipsychotics, or mood stabilizers).
Group schema therapy involves 20 consecutive weekly two hour therapy sessions over a period of five months, with up to eight patients and two therapists per group. The therapists have been trained in the treatment format and will be regularly supervised.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Within-individual change in borderline personality symptoms, measured using the BSL-23 scale score before and after the intervention
Secondary outcome measures
Within-individual change before vs after intervention in:
1. Borderline personality criteria symptoms, measured using the MSI-BPD score
2. Depressive symptoms, measured using the PHQ-9 score
3. Anxiety symptoms, measured using the OASIS score
4. Alcohol use, measured using the AUDIT score
5. Disability, measured using the Sheehan Disability Score
6. Schema modes, measured using the Schema Mode Inventory
Overall trial start date
15/09/2017
Overall trial end date
31/05/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Psychiatric outpatients receiving treatment within the facilities of Helsinki University Hospital Department of Psychiatry, Mood Disorder Division, having a principal clinical diagnosis of borderline personality disorder
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
64
Participant exclusion criteria
1. Psychotic symptoms
2. Imminent risk of suicide
3. Principle diagnosis of or uncontrollable substance use disorder
4. Any illness or symptoms that would hamper participation in treatment
5. Other ongoing specific psychotherapy
Recruitment start date
15/01/2017
Recruitment end date
31/08/2018
Locations
Countries of recruitment
Finland
Trial participating centre
Helsinki University Hospital
Department of Psychiatry
Mood Disorder Division
Helsinki
00029
Finland
Funders
Funder type
Hospital/treatment centre
Funder name
Helsinki and Uusimaa Hospital District
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intended to be published in a psychiatric journal in 2019-20.
IPD sharing statement
The data will be held by the Helsinki and Uusimaa Hospital District, and it will not be available because of limitations caused by the Finnish data protection legislation, content of consent requested, and research permit.
Intention to publish date
01/06/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list