Condition category
Mental and Behavioural Disorders
Date applied
15/01/2018
Date assigned
22/01/2018
Last edited
04/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Helsinki and Uusimaa Hospital District

Sponsor details

HUH Psychiatry Center
Välskärinkatu 12
Helsinki
00029 HUS
Finland

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes

04/10/2018: The following changes have been made to the trial record: 1. The overall trial end date has been changed from 28/02/2019 to 31/05/2020 2. The plain English summary has been updated 3. The intention to publish date has been changed from 31/12/2019 to 01/06/2020