Condition category
Mental and Behavioural Disorders
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
13/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.accare.nl

Contact information

Type

Scientific

Primary contact

Dr H.M. Schuppert

ORCID ID

Contact details

University Medical Center Groningen
Department of Psychiatry
P.O. Box 30001
Groningen
9700 AR
Netherlands
m.schuppert@accare.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1558; NTR356

Study information

Scientific title

Acronym

Study hypothesis

Adolescents with emotion regulation problems who followed the emotion regulation training will show improvement on the following items:
1. Symptoms of emotional dysregulation
2. Positive and negative coping behaviour
3. Stress symptoms in the adolescent
4. Stress symptoms in the parents (or care-takers)
5. Consumption of public health services
Compared to a waitlist control group

Ethics approval

Received from the local medical ethics committee

Study design

Multicentre randomised single-blind active-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Psychiatric, mental disorders/illness, borderline personality disorder

Intervention

The emotion regulation training (ERT) is a skills training (17 weekly sessions of 1.75 hours as well as one session for significant others) based on psycho-education, cognitive behavioural principles, and exercises for relaxation.

Care as usual generally includes individual sessions with the adolescent and medication checks, sometimes combined with family sessions, crisis intervention or parent training.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Borderline Personality Disorder Severity Index (BPDSI and BPDSI - parent version): a semi-structured interview based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) classification of psychopathology. Trained psychologists will conduct this semi-structured interview.
2. VERS-scale: to measure negative as well as positive behaviour in a certain period. This questionnaire is to be completed by the adolescent as well as the parents.

Secondary outcome measures

Questionnaires completed by the adolescents as well as the parents:
1. Frequency list of Emotion Regulation Problems (F-ERP)
2. Global Assessment of Functioning (GAF): present level of functioning (axis V of DSM-IV)
3. MALC-ERT: list of 18 items to draw up an inventory of cognitions on emotional dysregulation (locus of control)
4. Child Behaviour Checklist (CBCL): consists of 118 items describing a wide domain of behaviour problems of children

Questionnaire only to be completed by parents:
Nijmeegse Ouderlijke Stress Index (NOSI; Parental Stress Index): to measure stress in parents (124 items)

Questionnaire only to be completed by the adolescent:
Healthcare consumption: a short list to be completed weekly during the training, about different types of healthcare being used in the last week (e.g. primary healthcare, emergency rooms, crisis contact psychiatry department).

Overall trial start date

01/06/2005

Overall trial end date

01/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 14 - 18 years
2. Emotion regulation problems
3. Some self-awareness
4. Sufficient internal motivation
5. Willing to share his or her experiences in a group
6. Environment is rather stable
7. Capable to join a group-session without aggressive behaviour
8. No substance abuse and self-mutilating behaviour during the session

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48

Participant exclusion criteria

If the adolescent does not meet the inclusion criteria.

Recruitment start date

01/06/2005

Recruitment end date

01/09/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen
Groningen
9700 AR
Netherlands

Sponsor information

Organisation

University Medical Centre Groningen (UMCG) (Netherlands)

Sponsor details

Hanzeplein 1
Groningen
9713 GZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcg.nl/azg/nl/english/azg/

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19630069

Publication citations

  1. Results

    Schuppert HM, Giesen-Bloo J, van Gemert TG, Wiersema HM, Minderaa RB, Emmelkamp PM, Nauta MH, Effectiveness of an emotion regulation group training for adolescents--a randomized controlled pilot study., Clin Psychol Psychother, 16, 6, 467-478, doi: 10.1002/cpp.637.

Additional files

Editorial Notes