Main: The primary objective of this study will be to discover patients* characteristics that predict the outcome of *Aggression Replacement Therapy*. Our main question of enquiry here is: what profiles regarding aggressive behavior and correlates…
ID
Source
Brief title
Condition
- Personality disorders and disturbances in behaviour
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome of aggressive behavior will be the score on the Modified Overt
Aggression Scale for Outpatient Use (MOAS) and the Social Dysfunction and
Aggression Scale (SDAS), which will be completed by the patient, and the
Clinical Global Impression Scale for severity (CGI-s). Efficacy measures will
be assessed at baseline, 6 and 12 weeks. A decrease of aggression of 50% on the
MOAS and/or SDAS will be considered as a response to treatment, a decrease
between 20% and 50% as a partial response and a decrease of less than 20% will
be considered as a non response.
Secondary outcome
n.v.t.
Background summary
Inappropriate aggressive behavior poses a great burden on society and is the
main reason for referral to a forensic psychiatric setting. Interventions based
on principles of cognitive behavioral therapy (CBT) are the treatment of
choice. Although CBT has been shown (moderate) effectiveness in the treatment
of aggressive behavior in adolescents, little is known about the effectiveness
in adults and it is clear to only a subgroup of patients benefits. The question
is: what are the characteristics of those who are responsive to the therapy?
Therefore, in the present study individual characteristics of patients with
aggression regulation problems will be investigated and related to outcome of
therapy.
Study objective
Main: The primary objective of this study will be to discover patients*
characteristics that predict the outcome of *Aggression Replacement Therapy*.
Our main question of enquiry here is: what profiles regarding aggressive
behavior and correlates relating to aggressive behavior can be found among
responders and non responders? A profile will be based on the following
variables of interest: type of aggression (proactive vs. reactive),
psychological traumas in childhood and MAOA genotype.
Secondary: A secondary objective will be the evaluation of associations between
type of aggression, psychological traumas in childhood, cognitive
characteristics and MAOA, COMT and 5/HTTLPR genotypes within patients with
aggression regulation disorders.
Study design
Cross-sectional treatment efficacy study among patients with aggression
regulation disorders in a forensic psychiatric outpatient setting.
Study burden and risks
Burden has been kept to a minimum and no risks are involved in participation.
Therapy will be given once a week during a 10/12 week treatment phase. All
participants will be asked to fill in a number of questionnaires before
treatment phase for the benefit of the main and secondary objectives. At the
endpoint a number of questionnaires will be repeated. Previous efficacy studies
have pointed out that quality of life of aggressive individuals improves due to
this intervention: less contacts with judicial services or reduction of
convictions, inclusion in work trajectories.
Reinier Postlaan 10
Nijmegen 6525 GC
NL
Reinier Postlaan 10
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
- Age 18-55 years
- Men and women
- Outpatient
- Meeting DSM-IV criteria for antisocial personality disorder, borderline personality disorder or the integrated research criteria for Intermittent Explosive Disorder (IED-IR):
- Recurrent incidents of aggression manifest as either;
Verbal or physical aggression towards other people, animals, or property occurring twice weekly
on average for one month, or
- Three episodes involving physical assault against other people or destruction of property over one-year period
- The degree of aggressiveness expressed is grossly out of proportion to the provocation or any precipitating psychosocial stressors
- The aggressive behavior is generally not premeditated (e.g., is impulsive) and is not committed in order to achieve some tangible objective (e.g., money, power, intimidation, etc.)
- The aggressive behavior causes either marked distress in the individual or impairment in occupational or interpersonal functioning
- The aggressive behavior is not better accounted for by another mental disorder (e.g., Major Depressive/Manic/Psychotic Disorder; ADHD); General Medical Condition (e.g., Head Trauma, Senile Dementia Alzheimer*s Type); or to the direct physiological effects of a substance
- Score on Overt Aggression Scale-Modified for Outpatient Use (MOAS) of >= 15 and/or a score of >= 5 on the Social Dysfunction Aggression Scale (SDAS)
Exclusion criteria
- Lifetime history of (hypo)mania, schizophrenia, or delusional disorder
- Current major depression
- Current alcohol or substance dependence
- Starting or changing pharmacotherapy relating to aggressive behavior
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43642.091.13 |