Condition category
Mental and Behavioural Disorders
Date applied
16/02/2016
Date assigned
30/03/2016
Last edited
06/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People with a psychotic disorder are at in increased risk of becoming victim of a crime. Research has revealed that there are several possible reasons, or risk factors, for this, including impaired social cognition (how they perceive information about other people and social situations), aggression problems, assertiveness, self-stigma and self-esteem) . To address these risk factors and prevent victimization, a body-oriented resilience training with elements of kickboxing (the intervention) has been developed. The present study aims to test how well this intervention works.

Who can participate?
Adults (aged at least 18) diagnosed with a psychotic disorder.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 (body-orientated training group) are taught the basic techniques of kickboxing by a body-orientated therapist, once a week over 20 weeks. Participants in group 2 (control group) attend befriending sessions, the main goal of which is to create a welcoming atmosphere in which participants can socially interact with each other, once a week over 20 weeks. All participants are asked to fill out questionnaires just before and after the 20 week intervention period. Further follow-ups occur after 6, 18 and 20 months, where the effect of the intervention on victimization is investigated. Some participants are also asked to have fMRI scans before and after the intervention period in order to assess potential haemodynamic changes (blood flow changes) associated with the effects of the training.

What are the possible benefits and risks of participating?
Benefits associated with participation in the body-oriented resilience training are taking part in supportive, fun kickboxing lessons in which basic kickboxing techniques are learned. Kickboxing may have positive effect on physical health because of endurance and muscle training. Benefits with regard to the befriending meetings are meeting new people and weekly social interactions in a warm setting. Benefits associated with participation in this study in general is contribution to clinical research which eventually may result in better care and compensation for all of the measurements.

Where is the study run from?
University of Groningen (Netherlands)

When is the study starting and how long is it expected to run for?
February 2016 to March 2020

Who is funding the study?
Netherlands Organisation for Scientific Research

Who is the main contact?
1. Mrs Marieke Pijnenborg (scientific)
g.h.m.pijnenborg@rug.nl
2. Mrs Jooske van Busschbach (scientific)
j.t.van.busschbach@umcg.nl

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Marieke Pijnenborg

ORCID ID

Contact details

Grote Kruisstraat 2/1
Groningen
9712 TS
Netherlands
050 363 4637
g.h.m.pijnenborg@rug.nl

Type

Scientific

Additional contact

Mrs Jooske van Busschbach

ORCID ID

Contact details

Hanzeplein 1
Groningen
9713 GZ
Netherlands
050 361 2069
j.t.van.busschbach@umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ABR NL52202.042.15

Study information

Scientific title

A body-oriented resilience training with elements of kickboxing: a novel intervention to reduce victimization in individuals with a psychotic disorder: a multi-center RCT.

Acronym

BeatVic

Study hypothesis

1. The primary objective of this study is to investigate whether the body-oriented resilience training with elements of kickboxing reduces the risk of victimization.
2. The secondary objective of this study is to investigate whether the body-oriented resilience training with elements of kickboxing has a positive effect on risk factors of victimization in individuals with a psychotic disorder, such as aggression regulation, self-stigma, self-esteem, social behavior (behavioral level) and social cognition (behavioral and cerebral level).
Furthermore the effect on quality of life, recovery and societal participation will be investigated at the long term.

Ethics approval

Medisch Ethische Commissie - University Medical Center Groningen (Medical Ethical Committee), 29/02/2015, ref: NL52202.042.15, METc nr 2015/303

Study design

Multicenter randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Individuals with a diagnosis in the psychosis spectrum

Intervention

Participants are randomly allocated to one of two groups:
1. Individuals allocated to the treatment condition receive a body-oriented resilience training with elements of kickboxing. This training consists of 20 weekly sessions during which basic kickboxing techniques are taught and risk factors of victimization are addressed by means of various exercises
2. Participants allocated to the control condition receive 20 weekly befriending sessions, during which social interaction is most important
Follow-ups are at 6, 18 and 30 months.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Victimization, measured using the Integrale Veiligheidsmonitor (IVM) and the Conflicts Tactics Scale - revised (CTS2) at baseline (pre), directly after the intervention-period (post) and 6/18/30 months following the intervention.

Mediating factors:
We expect that the effect of the intervention on victimization is mediated by several risk factors, on which our intervention is based. Mediation factors will be measured at baseline (pre), directly after the intervention-period (post) and at 6 months follow-up. Mediating factors we defined in our study are:
1. Social cognition (Faux Pas task)
2. Aggression regulation (Self-Expression and Control Scale, ZECV)
3. Internalized stigma (Internalized Stigma of Mental Ilness Scale, ISMI)
4.Social behavior (Interpersonal Behavior Scale, SIG)
5. Self-esteem (Self-esteem Rating Scale - Short Form, SERS-SF)
6. Insight (Psychosis Insight Scale, PI)

Secondary outcome measures

1. Quality of live (MANSA)
2. Recovery (National Recovery Scale, NHS)
3. Societal participation (Social Functioning Scale, SFS)
4. Symptoms (Brief Negative Symptom Scale, BNSS)
5. Trauma (Trauma Screening Questionnaire)
6. Physical activation (Pedometer, Yamax EX 510)
7. Endurance (Modified Shuttle Test, MST)

Measured at baseline, directly after the intervention and at 6, 18 and then 30 months follow-up.

Overall trial start date

22/02/2016

Overall trial end date

01/03/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. A diagnosis in the psychosis spectrum according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition
2. 18 years or older

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

96

Participant exclusion criteria

1. Severe psychotic symptoms (mean positive symptoms > 5 measured by PANSS)
2. Substance dependence (not substance abuse), verified by Miniscan.
3. Co-morbid neurological disorder, verified by onsite therapist.
4. Co-morbid personality disorder, verified by onsite therapist.
5. Estimated IQ < 70, onsite therapist decides if the patients’ intelligence is sufficient for participation.
6. Pregnancy.

Recruitment start date

22/02/2016

Recruitment end date

01/12/2016

Locations

Countries of recruitment

Netherlands

Trial participating centre

University of Groningen
Grote Kruisstraat 2/1
Groningen
9712 TS
Netherlands

Sponsor information

Organisation

University Medical Center Groningen

Sponsor details

Hanzeplein 1
Groningen
9713 GZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

www.umcg.nl

Funders

Funder type

Government

Funder name

Nederlandse Organisatie voor Wetenschappelijk Onderzoek

Alternative name(s)

Netherlands Organisation for Scientific Research, Dutch National Scientific Foundation, Dutch National Science Foundation, NWO

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Netherlands

Results and Publications

Publication and dissemination plan

Study protocol paper published in 2016

Intention to publish date

30/06/2016

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

The registration was initiated on 16/02/2016 and finalised on 30/03/2016. The recruitment started on 22/02/2016, after initiation of public registration. 06/06/2016: the recruitment end date was changed from 01/03/2016 to 01/12/2016.