Condition category
Mental and Behavioural Disorders
Date applied
07/09/2017
Date assigned
20/09/2017
Last edited
18/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients with personality disorders or long lasting Axis-I disorders (e.g. anxiety disorders, depression) often do have specific ways of perceiving themselves and others. Events (in the past), temperament, biological make up, environment of upbringing makes people who they are and how they respond. People develop pitfalls and in most cases patients with personality problems and long lasting Axis-I disorders suffer more than healthy people from their pitfalls. Most often these patients have had several treatments already, but still experience problems where they seek treatment for. Schema therapy is an evidence based psychotherapy which specifically aims at changing/ reducing the pitfalls. In this therapy, patients become more aware of their pitfalls and how these interfere with their psychological wellbeing and functioning in daily life with other people. They learn to make more healthy choices and to understand more and act upon their healthy needs. As this therapy is given in a group format, patients learn from others and can practice with each other what they learn in the safety of a group setting with two schema therapists as group therapists guiding the group processes. The aim of this study is to investigate if Schema therapy can improve psychological symptoms in patients with personality problems.

Who can participate?
Adults aged 18-65 who have personality problems and are treatable in an outdoor mental health care institute.

What does the study involve?
This study reviews files of patients who have been participating in schema group therapy. Patients who participate in schema group therapy are indicated for this therapy because of longstanding psychological problems, mostly personality problems. In this therapy, patients become more aware of their pitfalls and how these interfere with their psychological wellbeing and functioning in daily life with other people. The researchers collect data about patients using their patient files to measure their duration of treatment, the amount of therapy time, whether they got more than five therapy sessions and the amount of patients who participating in the therapy who longer are in the therapy.

What are the possible benefits and risks of participating?
There are no benefits or risks with participating.

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?
January 2015 to December 2019

Who is funding the study?
1. Investigator initiated and funded (Netherlands)
2. G-kracht Mental Health Care Institute (Netherlands)

Who is the main contact?
Mr M.F. van Vreeswijk

Trial website

Contact information

Type

Scientific

Primary contact

Mr M. F. van Vreeswijk

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

-

Study information

Scientific title

Predictors, mediators and moderators of outcome of time-limited schema group therapy for outdoor patients with personality disorders: An open trial

Acronym

Study hypothesis

1. Schema's and modes as measured at pre-treatment predict therapy outcome in time-limited schema group therapy
2. Changes in schema's and modes co-occur with changes in psychological problems

Ethics approval

As this is an open label trial in which only the files where checked of 137 patients who have had schema group therapy and who did not have to do any additional work for the study (so no additional questionnaires or interviews had to be filled in by the patients) according to the Medical Ethical Committee no formal request had to be made. Everything is according to the Helsinki agreement/ WHO which allow research based on patients files solely. A request to the ethics board has not been done based on the Dutch law (WMO) with regard to retrospective patient files studies. The WMO incorporates WHO and Helsinki regulations and can be found via http://www.ccmo.nl/en/your-research-does-it-fall-under-the-wmo.

Study design

This study is a case-file study of patients with personality problems who have been treated with time-limited schema group therapy between 2007-2017 in an outdoor mental health care institute.

Primary study design

Observational

Secondary study design

Case series

Trial setting

Other

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Patients with personality problems being treated in an outdoor mental health care institute

Intervention

Patients who are in treatment at G-kracht Mental Health Care Institute and who are taking part of Schema group therapy (ST-g) for their personality problems as a part of their standard treatment package do have to fill in the BSI, YSQ, SMI as a standard evaluation measure at the beginning of the ST-g, in the middle of the ST-g and before the final ST-g session (the last follow up session). The outcome of this Routine Outcome Monitoring (ROM) is used in individual evaluation sessions with the patients as discussion material on the amount of change and whether or not more therapy is necessary. The ROM data is part of the Electronic Patient File (EPF) as it is standard part of the treatment. ST-g’s take around 10 months including the follow ups.

A research assistant collects all the data (SES, duration of treatment before ST-g, the amount of therapy time before ST-g, during ST-g and whether or not a patient got more than 5 therapy sessions after ST-g, BSI, YSQ, SMI; which were collected based on a preset of data which had to be included in the study) of the patients who had participated in ST-g during 2007-2017 and who are no longer in ST-g. The data collected was anonymized before it was entered in SPSS.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Psychological symptoms are measured using the Brief Symptom Inventory (BSI) at baseline, in the middle of ST-g and two months after the last therapy session but before the last follow up session.
2. Schema’s are measured using the Young Schema Questionnaire (YSQ) at baseline, in the middle of ST-g and two months after the last therapy session but before the last follow up session.
3. Modes are measured using the Schema Mode Inventory (SMI) at baseline, in the middle of ST-g and two months after the last therapy session but before the last follow up session.

NOTE: as some ST-g as there was a differentiation in amount of sessions of the ST-g’s the wording “in the middle” is used instead of 10, 12 weeks.

Secondary outcome measures

1. Socio Economic Status is measured using the records in the patient files at baseline
2. Total amount of treatment before and after the time-limited ST-g is measured using the records in the patient files at the end of this study

Overall trial start date

01/01/2015

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male/ female
2. Aged between 18-65
3. Personality problems
4. Treatable in an outdoor mental health care institute

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150 patients

Participant exclusion criteria

1. Patients whom's Axis-I diagnosis has not been treated yet by the more appropriate therapy forms for the particular Axis-I disorder
2. Patients who need constantly to be in a crisis unit
3. Patients with severe drug abuse
4. Patients whom's psychological problems will interfere with group therapy processes (e.g. moderate-severe narcissism, moderate-severe autism, moderate-severe anti-social personality problems)

Recruitment start date

03/02/2015

Recruitment end date

30/07/2017

Locations

Countries of recruitment

Netherlands

Trial participating centre

G-kracht Mental Health Care Institute
2611 KG

Sponsor information

Organisation

G-kracht Mental Health Care Institute

Sponsor details

Noordeinde 27A
Delft
2611 KG
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

G-kracht Mental Health Care Institute

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 journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from M. F. van Vreeswijk (mf.vanvreeswijk@g-kracht.com)

Intention to publish date

30/11/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes