Condition category
Mental and Behavioural Disorders
Date applied
08/03/2018
Date assigned
03/05/2018
Last edited
01/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients with long-lasting psychological problems quite often have pitfalls/ life traps which they find hard to change and which interfere with their daily functioning. For example patients have the idea that they are worthless and avoid certain tasks or people as they have the idea that they will fail or that people are not interested in them. Schematherapy is a psychotherapy which helps people break through these negative life patterns and enables them to respond in a more healthy way. This study looked into patient files to explore whether patients who followed an intensive schematherapy programme experienced a reduction in their pitfalls and psychological problems.

Who can participate?
Adult patients with personality problems and/ or long-lasting Axis-I disorders, who have followed an inday schematherapy program at the mental health care hospital GGZ Delfland in Delft in the period of 2006-2008

What does the study involve?
Patients’ files are studied to find out to what extent patients who had followed this program had a reduced psychological symptom level at the end of the 9-month treatment program.

What are the possible benefits and risks of participating?
Since only patient files were studied and no additional interventions were done, there were no additional benefits or risks for patients.

Where is the study run from?
GGZ Delfland (Netherlands)

When is the study starting and how long is it expected to run for?
July 2006 to July 2008

Who is funding the study?
GGZ Delfland (Netherlands)

Who is the main contact?
J. Broersen

Trial website

Contact information

Type

Public

Primary contact

Miss J. Broersen

ORCID ID

Contact details

Keizersgracht 188-G
Amsterdam
1016 DW
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

indayST

Study information

Scientific title

An open label trial of an inday schematherapy for patients with personality problems

Acronym

Study hypothesis

Patients in treatment of the inday schematherapy will show improvements on psychological symptoms and maladaptive schemas and modes.

Ethics approval

Since this study involved going through patients files of patients who have been treated with an inday schematherapy and patients did not have to do anything extra for this study under the Dutch law no ethical approval from an ethical committee has to be asked for

Study design

Observational longitudinal case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Personality problems

Intervention

In this study the patient files were studied of 38 adult male/female patients with personality problems and/or long-lasting Axis-I disorders, who have followed an inday schematherapy program at the mental health care hospital GGZ Delfland in Delft in the period of 2006-2008. It was looked for to what extent patients who had followed this program had a reduced psychological symptom level at the end of this treatment program which had a duration of 9 months.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Severity of psychological problems, measured using Brief Symptom inventory (BSI) before the start of the inday treatment, after 3 months during treatment and 7 months after the second measurement

Secondary outcome measures

Measured before the start of the inday treatment, after 3 months during treatment and 7 months after the second measurement:
1. Severity of personality problems, measured using the Personality Disorder Questionnaire (PDQ)
2. Young Schema Questionnaire (YSQ) measures 16 schemas as defined by Jeffrey Young
3. Schema Mode Inventory (SMI) measures 14 modes as defined by Jeffrey Young

Overall trial start date

01/07/2006

Overall trial end date

31/07/2008

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Personality problems or long-lasting Axis-I disorders
2. Being able to speak and read the Dutch language
3. Willing to participate in a group psychotherapy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

Having schizophrenia or being in such a crisis that submission to a psychiatric hospital was the first choice of intervention

Recruitment start date

03/07/2006

Recruitment end date

01/10/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

GGZ Delfland
2612 GA

Sponsor information

Organisation

GGZ Delfland

Sponsor details

Sint Jorisweg 2
Delft
2612 GA
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

GGZ Delfland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

It is the intention to publish an article in an English scientific psychology journal

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from J. Broersen. For privacy reasons only the outcomes of the questionnaires (BSI, PDQ, YSQ, SMI) will be shared and no other information. It will only be shared with researchers with a PhD and only after they have clearly and plainly stated for what reasons they want to have access to the data, how they will use the data and only when they state that they inform the contact person at any time about the process of the use of the data and allow the contact person to block further use of the data in any form at any time.

Intention to publish date

01/10/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes