Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Not specified
Study 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
Primary outcome measure
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 study start date
01/06/2005
Overall study end date
01/09/2006
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
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
Study 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/
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2009 | Yes | No |