Condition category
Mental and Behavioural Disorders
Date applied
04/08/2020
Date assigned
07/09/2020
Last edited
07/09/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Michiel Van Vreeswijk

ORCID ID

http://orcid.org/0000-0002-7043-6761

Contact details

Noordeinde 27A
Delft
2611 KG
Netherlands
+31 (0)158200240
mf.vanvreeswijk@g-kracht.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

OpenlabelST2020

Study information

Scientific title

Predicting efficacy of time-limited schema group therapy

Acronym

PETLSGT

Study hypothesis

Patient characteristics (SES, clinical variables and schemas and modes) predict treatment outcome as measured with the BSI.

Ethics approval

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.

Study design

Open-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 design

Observational

Secondary study design

Ecological study

Trial setting

Other

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Mental health care: patients with longstanding clinical syndromes and/or personality disorders

Intervention

This 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 type

Behavioural

Phase

Drug names

Primary outcome measure

Treatment 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 measures

Patient characteristics measured using the Young schema questionnaire (YSQ) and the Schema mode inventory (SMI) at the baseline, 9, and 18 weeks

Overall trial start date

01/06/2019

Overall trial end date

01/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age 18-75 years
2. Having a clinical syndrome or personality disorder according to the DSM-5
3. Being fluent in writing/speaking Dutch

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. 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

Recruitment start date

26/06/2020

Recruitment end date

01/03/2021

Locations

Countries of recruitment

Netherlands

Trial participating centre

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

Sponsor information

Organisation

G-kracht Mental Health Care Institute

Sponsor details

Noordeinde 27A
Delft
2611 KG
Netherlands
+31 (0)158200240
mf.vanvreeswijk@g-kracht.com

Sponsor type

Hospital/treatment centre

Website

http://www.g-kracht.com

Funders

Funder type

Hospital/treatment centre

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

PsyQ

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed international journal

IPD sharing statement:
Requests 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.

Intention to publish date

01/01/2024

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/08/2020: Trial’s existence confirmed by G-kracht Mental Health Care Institute.