Which schemas and modes predict outcome of schematherapy?

ISRCTN ISRCTN17131709
DOI https://doi.org/10.1186/ISRCTN17131709
Secondary identifying numbers OpenlabelST2020
Submission date
04/08/2020
Registration date
07/09/2020
Last edited
19/01/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Schema therapy is a therapy for patients with longstanding mental health problems (e.g. depression, anxiety disorders and personality problems). It has been shown to be an effective treatment both as individual treatment and as group treatment. Little is known about what variables predict outcome of time-limited schema group therapy. This study aims to get a better understanding of what works for whom in time-limited schema group therapy.

Who can participate?
Patients aged 18-75 with a clinical syndrome or personality disorder according to the DSM-V

What does the study involve?
This study is based on analyzing (ROM) data of patients files of patients, who have given their consent and who have been in treatment at G-kracht mental health care institute in Delft in the Netherlands between 2016 and 2020. Patient records will be collected between June 2020 and March 2021.

What are the possible benefits and risks of participating?
The benefit for participants was that their progress will be systematically followed and used in evaluating their therapy process. By allowing their files to be opened for research, they will contribute to the accumulation of knowledge to predict what treatment works for whom.

Where is the study run from?
G-kracht Mental Health Care Institute (Netherlands)

When is the study starting and how long is it expected to run for?
June 2019 to March 2021

Who is funding the study?
Investigator initiated and funded with support from PsyQ (Netherlands)

Who is the main contact?
Michiel van Vreeswijk
mf.vanvreeswijk@g-kracht.com

Contact information

Mr Michiel Van Vreeswijk
Scientific

Noordeinde 27A
Delft
2611 KG
Netherlands

ORCiD logoORCID ID 0000-0002-7043-6761
Phone +31 (0)158200240
Email mf.vanvreeswijk@g-kracht.com

Study information

Study designOpen-label trial (patients files between the end of 2016 - June 2020) in a single-centre naturalistic clinical setting with a within-subject design with three measurement moments as part of ROM
Primary study designObservational
Secondary study designEcological study
Study setting(s)Other
Study typeTreatment
Participant information sheet No participant information sheet available
Scientific titlePredicting efficacy of time-limited schema group therapy
Study acronymPETLSGT
Study objectivesPatient characteristics (SES, clinical variables and schemas and modes) predict treatment outcome as measured with the BSI.
Ethics approval(s)This study does not require ethics approval as the study is based on data in patient files which already have been treated and for whom certain self-reports were part of treatment as in Routine Outcome Monitoring (ROM). Patients were not subjected to any extra intervention which was not part of their regular treatment process.
Health condition(s) or problem(s) studiedMental health care: patients with longstanding clinical syndromes and/or personality disorders
InterventionThis is an observational study using historical data. Patient data will be collected from patient files of patients who had ST-group therapy between 2016 and the first half of 2020. These participants received time-limited schema group therapy of 18 group therapy sessions with either the focus on experiential schema therapy techniques, cognitive behavioural schema therapy techniques of a combination of the above.
Intervention typeBehavioural
Primary outcome measureTreatment outcome measured using the Brief symptom inventory (BSI) at baseline (start-of-treatment), 9 weeks (mid-treatment), and 18 weeks (end-of-treatment)
Secondary outcome measuresPatient characteristics measured using the Young schema questionnaire (YSQ) and the Schema mode inventory (SMI) at the baseline, 9, and 18 weeks
Overall study start date01/06/2019
Completion date01/03/2021

Eligibility

Participant type(s)Other
Age groupAdult
Lower age limit18 Years
Upper age limit75 Years
SexBoth
Target number of participants90
Total final enrolment85
Key inclusion criteria1. Age 18-75 years
2. Having a clinical syndrome or personality disorder according to the DSM-5
3. Being fluent in writing/speaking Dutch
Key exclusion criteria1. Having a psychosis
2. Having a diagnosis of schizophrenia
3. Being in a crisis which needs admission to a mental health care hospital
4. Having very severe hearing problems which results in that working in a group therapy is not possible
5. Having very severe stuttering problems which results in that working in a group therapy is not possible
Date of first enrolment26/06/2020
Date of final enrolment01/03/2021

Locations

Countries of recruitment

  • Netherlands

Study participating centre

G-kracht Mental Health Care Institute
Noordeinde 27A
Delft
2611 KG
Netherlands

Sponsor information

G-kracht Mental Health Care Institute
Hospital/treatment centre

Noordeinde 27A
Delft
2611 KG
Netherlands

Phone +31 (0)158200240
Email mf.vanvreeswijk@g-kracht.com
Website http://www.g-kracht.com

Funders

Funder type

Hospital/treatment centre

Investigator initiated and funded

No information available

PsyQ

No information available

Results and Publications

Intention to publish date01/01/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed international journal
IPD sharing planRequests for part of the data can be e-mailed to mf.vanvreeswijk@g-kracht.com. The data is collected from the files and put in an SPSS file. The data (outcome of self-report questionnaires YSQ, SMI, BSI and SES and clinical variables) will undergo an anonymization as is regular practice in research. The data will become available after publication of an article in an international scientific journal. The data will be available for 10 years after publication of the article. It will be accessible for other clinical psychology researchers having at least an academic title of PhD. It will be accessible for those who want to check the integrity of the outcome as is published and for those who want to use the data for a review of meta-analysis under the condition that the data set will be destroyed immediately after use and ownership will remain with us as a research group. It is preferred that only the minimum of data is shared which is really needed and not automatically the whole data set, because even though the data will have been anonymized the privacy laws are very strict on this.

Editorial Notes

19/01/2024: The intention to publish date was changed from 01/01/2024 to 01/01/2026.
24/03/2021: The total final enrolment number has been added.
11/08/2020: Trial’s existence confirmed by G-kracht Mental Health Care Institute.