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NCT05711342
The Added Value of an Internet-based Intervention for Treatment of Forensic Psychiatric Outpatients
Conditions: Aggression, Psychosocial Problem, Forensic Psychiatry, Internet-based Intervention
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 128
Sponsor: University of Twente
Location: Netherlands
Summary
Even though internet-based interventions have been used in treatment of forensic psychiatric outpatients for over ten years, no robust research into their effectiveness has taken place.
Multiple potential benefits and barriers have been observed in clinical practice, such as the possibility to increase a patient's treatment readiness, self-efficacy and thus reduce undesired behaviour such as reactive aggression.
However, therapists indicate that these interventions do not seem to work for all forensic psychiatric patients, and that uptake is generally quite low.
There is an urgent need to evaluate if and how these internet-based interventions are of added value for treatment of forensic psychiatric outpatients.The main goal of this study is to investigate whether the addition of the existing internet-based intervention 'Aggression' to treatment as usual of forensic psychiatric outpatients leads to better treatment outcomes than treatment as usual that is delivered solely in-person.This study uses a multicentre mixed methods randomized controlled trial (RCT) design, with four participating Dutch forensic psychiatric outpatient care organizations.
Patients are included if they receive outpatient treatment for aggression regulation problems and will be randomized into an experimental condition, in which the internet-based intervention is added to treatment as usual (TAU), or a control condition, with only TAU.
Participants are assessed four times: at baseline (T0), halfway during the 10-week intervention (T1), after completing the intervention (T2), and after three months (T3).
Primary outcome measures are regulatory emotional self-efficacy, treatment readiness, and aggression, assessed via validated self-report questionnaires.
Secondary outcome measures are the number of in-person treatment sessions during the data collection, and dynamic risk factors.
Adherence to and engagement will be studied as potential predictors for effectiveness via respectively log data and a self-report questionnaire.
Perceived benefits, barriers and points of improvement will be identified via qualitative interviews with participating patients and therapists.This will be the first experimental study to investigate an internet-based intervention in a forensic psychiatric outpatient sample.
By using a mixed-methods design and by adding adherence and engagement as potential predictors, this study can not only answer questions about if, but also why and for whom this intervention works.
Consequently, this study will answer an important question from clinical practice: are these types of interventions - which have been used in practice for over ten years - actually of added value for treatment?
Eligibility Criteria
Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria:The patient is 18 years or olderThe patient is treated at an outpatient clinicThe patient receives one-on-one treatmentDuring the intake, improvement of aggression regulation has been selected as one of the treatment objectivesThe patient indicates that they are able to read and write simple textsThe therapist responsible for treatment of the patient indicates that participating will not result in any harm for the patientThe patient voluntarily consents to participationExclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:The patient has a current psychosisThe patient resides in any type of psychiatric inpatient clinic - this can be a forensic, but also another type of clinicThe patient receives group treatment focused on aggression regulation (specifically: AR [aggressieregulatie] op maat)The patient is analphabetic, i.e. being unable to read and writeThe responsible therapists identifies any other valid reason for exclusionAs can be seen in the in- and exclusion criteria, the responsible therapist is actively involved in determining whether participating in the study is safe and possible for the patient.
This will first be discussed during the MDO.
If, after several treatment sessions, the therapist identifies any reasons for exclusion, this will be communicated to the researcher and the patient will not be invited to participate.
Source: ClinicalTrials.gov (NCT05711342). StuddyBuddy aggregates publicly available trial information.