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

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

Interventions

BEHAVIORAL

Aggression

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.

BEHAVIORAL

Treatment as usual

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.

Sponsors & Collaborators

• Transfore

  collaborator UNKNOWN

• Kairos

  collaborator UNKNOWN

• GGZ Noord-Holland-Noord

  collaborator OTHER

• De Woenselse Poort

  collaborator UNKNOWN

• Kwaliteit Forensische Zorg (KFZ)

  collaborator UNKNOWN

• University of Twente

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-01

Primary Completion

2023-10-31

Completion

2023-12-31

Countries

• Netherlands

Study Locations