The Added Value of an Internet-based Intervention for Treatment of Forensic Psychiatric Outpatients

NCT05711342 | Unknown

• 1 other identifier: NL80846.091.22
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 4

Brief 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?

Conditions

Aggression; Psychosocial Problem; Forensic Psychiatry; Internet-based Intervention

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (1)

• Risk assessment - dynamic risk factors

  Assessed on T0 (Week 0) and T3 (Week 26)

Other Outcomes (1)

• Engagement

  Assessed only in the experimental group (TAU + Aggression) on T0 (week 0), T1 (week 6) and T2 (week 14).

Study Arms (2)

Treatment as usual (TAU)

ACTIVE COMPARATOR

In this control condition, participants receive in-person aggression treatment as usual (TAU). No changes to the way treatment is provided as usual are made. In general, this refers to any form of psychotherapy that is delivered by a licenced psychologist to a patient in a one-on-one setting. The main focus of treatment as usual should lie on aggression regulation. Additionally, patients should receive individual, one-on-one treatment and should not participate in group treatment of aggression during data collection.

Behavioral: Treatment as usual

Treatment as usual (TAU) +Internet-based intervention Aggression

EXPERIMENTAL

In the experimental condition, participants receive TAU, and additionally work on the 10-week internet-based intervention 'Aggression', on which they can work in their own time, i.e. outside of treatment sessions. Consequenlty, the intervention is used in a blended way. The intervention is focused on three main objectives: (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. The module consists of 10 lessons:

Behavioral: Aggression; Behavioral: Treatment as usual

Interventions

Aggression BEHAVIORAL

The intervention consists of 10 lessons: 1. Motivation - where are you now? 2. Where do you want to go? 3. Circle of aggression. 4. Thoughts. 5. Emotions. 6. Bodily sensations. 7. Techniques for self-control. 8. Asking for help. 9. Assertiveness. 10. Relapse-prevention. Each lesson consists of multiple components, i.e. written text, assignments and videos with therapists and/or experts by experience. After each lesson, the therapist sends written feedback on the assignments to the patient. Because 'Aggression' is a blended intervention, each lesson is briefly discussed in an in-person treatment session. Generally, participants work on one lesson per week.

Also known as: Minddistrict

Treatment as usual (TAU) +Internet-based intervention Aggression

Treatment as usual BEHAVIORAL

In-person aggression treatment as usual (TAU), as delivered by the organization. This refers to any form of psychotherapy that is delivered by a licenced psychologist to a patient. The main focus of treatment as usual should lie on aggression regulation.

Treatment as usual (TAU); Treatment as usual (TAU) +Internet-based intervention Aggression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• The patient is 18 years or older
• The patient is treated at an outpatient clinic
• The patient receives one-on-one treatment
• During the intake, improvement of aggression regulation has been selected as one of the treatment objectives
• The patient indicates that they are able to read and write simple texts
• The therapist responsible for treatment of the patient indicates that participating will not result in any harm for the patient
• The patient voluntarily consents to participation

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• The patient has a current psychosis
• The patient resides in any type of psychiatric inpatient clinic - this can be a forensic, but also another type of clinic
• The patient receives group treatment focused on aggression regulation (specifically: AR \[aggressieregulatie\] op maat)
• The patient is analphabetic, i.e. being unable to read and write

Sponsors & Collaborators

• University of Twente: lead
• Transfore: collaborator
• Kairos: collaborator
• GGZ Noord-Holland-Noord: collaborator
• De Woenselse Poort: collaborator
• Kwaliteit Forensische Zorg (KFZ): collaborator

Study Sites (4)

Kairos

Nijmegen, Gelderland, 6503 CG, Netherlands

RECRUITING

De Woenselse Poort

Eindhoven, North Brabant, 5626 ND, Netherlands

NOT YET RECRUITING

GGZ Noord-Holland-Noord

Heiloo, North Holland, 1850 BA, Netherlands

NOT YET RECRUITING

Transfore

Deventer, Overijssel, 7416 SB, Netherlands

RECRUITING

Related Links

• Link to site of grant provider on the project

MeSH Terms

Conditions

Aggression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Central Study Contacts

Hanneke Kip, PhD

CONTACT

+31534896536; h.kip@utwente.nl

Lisa Klein Haneveld, MSc

CONTACT

l.kleinhaneveld@utwente.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because an internet-based intervention is used, patients, therapists and researchers cannot be blinded to the condition to which the participant is allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial (RCT) with a control condition that receives treatment as usual in forensic outpatient clinics, and an experimental condition that receives treatment as ususal plus the 10-week internet-based intervention 'Aggression'.

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: February 3, 2023
• Study Start: February 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (4)