Group schema therapy for borderline personality disorder
| ISRCTN | ISRCTN76381242 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76381242 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/01/2018
- Registration date
- 22/01/2018
- Last edited
- 27/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
PO Box 22
Helsinki
00014
Finland
 ORCID ID |
0000-0001-5956-2399 |
|---|
Study information
| Study design | Randomized intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Group schema therapy for borderline personality disorder: a randomized study |
| Study acronym | GST-BPD |
| Study objectives | Group schema therapy plus usual psychiatric treatment result in greater decline in borderline personality disorder symptoms than usual psychiatric treatment alone. |
| Ethics approval(s) | Helsinki and Uusimaa Hospital District (HUS) Ethics Committee, 16/11/2017; research permit within the HUS Department of Psychiatry 08/01/2018 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 15/09/2017 |
| Completion date | 31/05/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 64 |
| Total final enrolment | 42 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/01/2017 |
| Date of final enrolment | 31/08/2018 |
Locations
Countries of recruitment
- Finland
Study participating centre
Mood Disorder Division
Helsinki
00029
Finland
Sponsor information
Hospital/treatment centre
HUH Psychiatry Center
Välskärinkatu 12
Helsinki
00029 HUS
Finland
"ROR" |
https://ror.org/020cpqb94 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Intended to be published in a psychiatric journal in 2019-20. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2021 | 27/10/2020 | Yes | No |
Editorial Notes
27/10/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
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
