The primary objective of this study is to investigate whether the addition of the internet-based intervention *Aggression* to forensic psychiatric outpatient treatment as usual (TAU) results in better treatment outcomes in terms of self-reported…
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Health condition
reactieve agressieregulatie problematiek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure of this study is regulatory emotional
self-efficacy. This construct is measured by means of the validated, 12-item
Regulatory Emotional Self-efficacy (RESE) scale. The RESE scale assesses
self-efficacy in managing negative emotions (8 items) and in expressing
positive emotions (4 items). Negative emotional self-efficacy refers to the
perceived *capability to ameliorate negative emotional states once they are
aroused in response to adversity or frustrating events and to avoid being
overcome by emotions such as anger, irritation, despondency, and
discouragement*. Positive self-efficacy is defined as the perceived capability
*to experience and to allow oneself to express positive emotions such as joy,
enthusiasm and pride in response to success or pleasant events*. Earlier
research has demonstrated the validity and reliability of the RESE scale.
Because the RESE scale consists of only 12 items, it is easy to administer and
does not require much effort of participants.
Secondary outcome
The secondary outcomes are treatment readiness, aggression, risk assessment and
engagement. Treatment readiness and aggression are measured by the validated
Dutch version of the Corrections Victoria Treatment Readiness Questionnaire
(20-items) and the much-used and validated Aggression Questionnaire (12 items).
In treatment of all forensic psychiatric patients, risk assessment has to be
conducted by means of evidence-based risk assessment instruments. In forensic
psychiatric outpatient care, the Dutch standard is the Forensisch Ambulante
Risico Evaluatie (FARE), version 2. The FARE is not only used to estimate the
risk on recidivism, but also to monitor changes in dynamic risk factors and
risk of recidivism during treatment. Research into inter-reliability and
convergent validity has shown promising results. The FARE is part of Dutch
guidelines on risk assessment of forensic psychiatric outpatients. According to
these guidelines, the FARE is administered twice a year, i.e. once each six
months.
In the FARE, 6 static and 11 dynamic risk factors are assessed. Static risk
factors refer to *unchangeable* characteristics, such as age of the first
offense. While they predict the risk of recidivism, they are not changeable by
means of targeted interventions. Dynamic risk factors however are more related
to the individual behaviour of the person and their social and living
situation. Because these 11 factors are influenceable by interventions, they
will be included in the analyses of this study.
Finally, engagement is measured with the TWente Engagement with Ehealth and
Technologies Scale (TWEETS). The scale employs a definition of engagement that
incorporates behaviour, cognition, and affect, and has been shown to have a
good validity and reliability. The TWEETS contains only 9 items - with three
items per component of engagement - and has three slightly different versions:
one for expected engagement, to be used when someone starts using an
intervention, one for current engagement, to be used during the use of an
intervention, and one for past engagement, to be used when a user has completed
or stopped using an intervention.
Background summary
While internet-based interventions have been used for over ten years in Dutch
forensic psychiatric outpatient care, no thorough evaluation study has been
conducted yet. Studies on internet-based interventions in other mental
healthcare sectors show promising results: they can increase the quality and
efficiency of care. However, it is not clear if, why and for whom these
interventions work in forensic mental healthcare. It is especially important to
study whether these interventions are of added value for this complex patient
population, known for its low treatment motivation, co-morbidity and low
literacy levels.
Study objective
The primary objective of this study is to investigate whether the addition of
the internet-based intervention *Aggression* to forensic psychiatric outpatient
treatment as usual (TAU) results in better treatment outcomes in terms of
self-reported regulatory emotional self-efficacy, treatment readiness, and
aggression. Additionally, it is studied whether the experimental group requires
fewer treatment sessions and improves more on dynamic risk factors.
Furthermore, to gain more insight into for whom these interventions work, it is
investigated whether engagement with the internet-based intervention predicts
adherence and effectiveness. Finally, this study aims to explore reasons for
the (in)effectiveness of the intervention according to patients and therapists.
Study design
To investigate if the use of internet-based interventions is of added value for
treatment of forensic psychiatric outpatients, a multicenter, non-blinded,
parallel groups, mixed-methods randomized controlled trial design is used.
Patients fill out three short self-report questionnaires four times: at
baseline, mid-treatment (+6 weeks), post-treatment (+14 weeks) and at follow-up
(+26 weeks). Semi-structured interviews with a randomly selected sample of 20
patients from the experimental condition and with all participating therapists
are conducted to explain the results of the RCT.
Intervention
This study investigates the existing internet-based intervention Aggression,
which was introduced in forensic mental healthcare over ten years ago. However,
as is the case with other internet-based interventions, uptake in practice
remains relatively low. *Aggression* is used as an addition to treatment as
usual, and thus does not replace any part of treatment in this study. The
intervention is developed by the company Minddistrict, in close cooperation
with therapists, patients and other stakeholders. The goals of this
intervention are to (1) increasing the motivation to change, (2) acquiring
skills for dealing with conflict, and (3) breaking the cycle of aggression by
providing knowledge on situational, emotional, cognitive and physical triggers.
It contains ten lessons, each containing written texts, videos and audio files,
and short written assignments on which the therapist can give feedback.
Study burden and risks
Since participants only have to fill out short questionnaires and are
compensated for their time, participating in this study is not viewed as a
major burden. Furthermore, the interventions of Minddistrict have been used for
over ten years in mental healthcare, during which no risks or adverse events
have been observed. Because not all forensic psychiatric patients receive
internet-based interventions as part of their standard care and because these
interventions are not yet evaluated and are thus not evidence-based,
participants in the control condition are not deprived of effective treatment.
During the entire treatment, experienced therapists monitor the patient*s
progress. Finally, multiple precautions are taken to ensure that patients are
aware that the decision to participate does not have any effect on their
treatment progress. Consequently, the burdens and risks associated with this
study are low or even non-existent.
Nico Bolkesteinlaan 1
Deventer 7416 SB
NL
Nico Bolkesteinlaan 1
Deventer 7416 SB
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1) The patient is 18 years or older
2) The patient is treated at an outpatient clinic
3) The patient receives one-on-one treatment
4) During the intake, improvement of aggression regulation has been selected as
one of the treatment objectives
5) The patient indicates that they are able to read and write simple texts
6) The therapist responsible for treatment of the patient indicates that
participating will not result in any harm for the patient
7) The patient voluntarily consents to participation
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1) The patient has a current psychosis
2) The patient resides in any type of psychiatric inpatient clinic - this can
be a forensic, but also another type of clinic
3) The patient is analphabetic, i.e. being unable to read and write
4) The responsible therapists identifies any other valid reason for exclusion
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 | NL80846.091.22 |