Aggression Clinical Trial
Official title:
The Added Value of an Internet-based Intervention for Treatment of Aggression in Forensic Psychiatric Outpatients: A Multicentre, Randomized Controlled Trial
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?
Status | Recruiting |
Enrollment | 128 |
Est. completion date | December 2023 |
Est. primary completion date | October 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 receives group treatment focused on aggression regulation (specifically: AR [aggressieregulatie] op maat) 4. The patient is analphabetic, i.e. being unable to read and write 5. The responsible therapists identifies any other valid reason for exclusion As 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Transfore | Deventer | Overijssel |
Netherlands | De Woenselse Poort | Eindhoven | Noord-Brabant |
Netherlands | GGZ Noord-Holland-Noord | Heiloo | Noord-Holland |
Netherlands | Kairos | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
University of Twente | De Woenselse Poort, GGZ Noord-Holland-Noord, Kairos, Kwaliteit Forensische Zorg (KFZ), Transfore |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Engagement | Engagement is a non-specific factor that can be used to predict effectiveness of and adherence to internet-based interventions. Engagement refers to the extent to which someone is involved or occupied with something, and is often related to a positive outcome, such as effectiveness.this study, 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 comprises of 9 items, all scored on a 5-point Likert scale (min. total score = 9, max. total score = 45, higher scores mean more engagement). | Assessed only in the experimental group (TAU + Aggression) on T0 (week 0), T1 (week 6) and T2 (week 14). | |
Primary | Aggression | Change on self-reported aggression is assessed by means of the Dutch version of the much-used and validated Aggression Questionnaire (Aangepaste Versie van de Agressie Vragenlijst; AVL-AV). The 12 items of the questionnaire are divided into four subscales: physical aggression, verbal aggression, anger, and hostility. Items are scored on a 5-point Likert scale (min. total score = 12, max. total score = 60, higher scores indicate higher aggression levels). | Change in aggression will be measured by assessing it on four time points before, throughout and after the use of the intervention: Assessed on T0 (Week 0), T1 (Week 6), T2 (Week 14), and T3 (Week 26) | |
Primary | Regulatory emotional self-efficacy | Change on regulatory emotional self-efficacy 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). Items are assessed via a 5-point Likert scale (min. total score = 12, max. total score = 60, higher scores indicate more regularoy emotional self-efficacy). 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". | Change in regulatory emotional self-efficacy will be measured by assessing it on four time points before, throughout and after the use of the intervention: Assessed on T0 (Week 0), T1 (Week 6), T2 (Week 14), and T3 (Week 26) | |
Primary | Treatment readiness | Treatment readiness refers to the presence of factors that contribute to engagement with treatment and therapeutic change. Change in treatment readiness is assessed by the Dutch version of the Corrections Victoria Treatment Readiness Questionnaire (CVTRQ): a validated self-reported questionnaire. The total scale consists of 20 items and uses a 5-point Likert scale (min. total score = 20, max total score = 100, higher scores indicate higher treatment readiness).
The CVTRQ is divided into four subscales. The subscale Attitude and Motivation (AM) measures attitudes and beliefs about treatment programs and the desire to change. The scale Emotional reactions (ER) measures emotional responses to the individual's offending behaviour. Offending beliefs (OB) refers to beliefs about personal responsibility for offending behaviour. The subscale Efficacy (EF) measures perceived ability to participate in treatment programs. |
Change in treatment readiness will be measured by assessing it on four time points before, throughout and after the use of the intervention: Assessed on T0 (Week 0), T1 (Week 6), T2 (Week 14), and T3 (Week 26) | |
Secondary | Risk assessment - dynamic risk factors | 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 [36]. 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. | Assessed on T0 (Week 0) and T3 (Week 26) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02552147 -
Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism
|
Phase 1 | |
Completed |
NCT02485587 -
Arousal-Biofeedback for the Treatment of Aggressive Behavior in Children and Adolescents
|
N/A | |
Active, not recruiting |
NCT01792167 -
Multi-Site Evaluation of Second Step
|
N/A | |
Completed |
NCT00361062 -
Aggressive Behavior Induced by Selective Serotonin Reuptake Inhibitors (SSRIs) During the First Month of Treatment
|
N/A | |
Completed |
NCT00455234 -
Rapid Tranquillization Trial: TREC-India II
|
Phase 3 | |
Completed |
NCT00000385 -
Long-Term Lithium Treatment for Aggressive Conduct Disorder
|
Phase 3 | |
Not yet recruiting |
NCT03672942 -
Communication Skills vs. Mindfulness for IPV
|
N/A | |
Recruiting |
NCT04732052 -
The Use of Transcranial Direct Current Stimulation (tDCS) in Adults With Developmental Disabilities
|
N/A | |
Terminated |
NCT02483572 -
Treatment of Severe Destructive Behavior: FCT Versus Wait-List Control
|
N/A | |
Completed |
NCT04097431 -
Identifying Precursors to Severe Problem Behavior
|
N/A | |
Completed |
NCT04130360 -
A Trial of an Online Problem-solving Intervention for Aggression
|
N/A | |
Completed |
NCT02563145 -
Real-time fMRI for the Treatment of Aggressive Behavior in Adolescents
|
N/A | |
Completed |
NCT00510094 -
Effectiveness of Treatment for Relational Aggression in Urban African American Girls
|
Phase 3 | |
Recruiting |
NCT03430973 -
Aggressive Driving and Road Rage: A Driving Simulation Experiment.
|
N/A | |
Completed |
NCT03693209 -
Using Implementation Intentions to Reduce Anger and Aggression in Adolescence
|
N/A | |
Recruiting |
NCT05543681 -
IGC-AD1 Trial on Agitation in Dementia Due to Alzheimer's
|
Phase 2 | |
Completed |
NCT03784846 -
Mindfulness-Based Resilience Training for Aggression, Health, and Stress Among Law Enforcement Officers
|
N/A | |
Active, not recruiting |
NCT04204759 -
Transcranial Direct Current Stimulation and Antisocial Behavior
|
N/A | |
Completed |
NCT06453070 -
Hasan Kalyoncu University
|
||
Completed |
NCT01965184 -
Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents
|
N/A |