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
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
Scientific
Noordeinde 27A
Delft
2611 KG
Netherlands
 ORCID ID |
0000-0002-7043-6761 |
|---|---|
| Phone | +31 (0)158200240 |
| mf.vanvreeswijk@g-kracht.com |
Study information
| 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 |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Predicting efficacy of time-limited schema group therapy |
| Study acronym | PETLSGT |
| Study objectives | Patient 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) studied | 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 |
| 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 study start date | 01/06/2019 |
| Completion date | 01/03/2021 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 90 |
| Total final enrolment | 85 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 26/06/2020 |
| Date of final enrolment | 01/03/2021 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Delft
2611 KG
Netherlands
Sponsor information
Hospital/treatment centre
Noordeinde 27A
Delft
2611 KG
Netherlands
| Phone | +31 (0)158200240 |
|---|---|
| mf.vanvreeswijk@g-kracht.com | |
| Website | http://www.g-kracht.com |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
Results and Publications
| Intention to publish date | 01/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed international journal |
| IPD sharing plan | 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. |
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.
