AggressionNCT05711342
The Added Value of an Internet-based Intervention for Treatment of Forensic Psychiatric Outpatients
A study testing Aggression and Treatment as usual in people with Aggression and Psychosocial Problem, run by University of Twente at 4 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aggression, Psychosocial Problem, Forensic Psychiatry
- What is being tested?
- Aggression and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 4 sitesNetherlands
- Study dates
- 1 Feb 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- 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.
Trial locations and contacts
4 sites in 1 country.
Lisa Klein Haneveld, MSc contact
Netherlands4 sites, 4 recruiting
- Recruiting
Transfore
Deventer, Overijssel, 7416 SB
Lisa Klein Haneveld, MSc, l.kleinhaneveld@transfore.nl
Yvonne Bouman, PhD
- Not yet recruiting
De Woenselse Poort
Eindhoven, North Brabant, 5626 ND
Jannie van Melis, MSc, jannie.van.melis@ggze.nl
- Not yet recruiting
GGZ Noord-Holland-Noord
Heiloo, North Holland, 1850 BA
Bianca Roelofsen, MSc, b.roelofsen@ggz-nhn.nl
- Recruiting
Kairos
Nijmegen, Gelderland, 6503 CG
Naomi Elders, MSc, N.Elders@pompestichting.nl
About this study
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.
Read more
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?
Read the detailed description
Rationale: 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.
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 investigated 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, 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.
Study population: The target group of this study consists of forensic psychiatric outpatients, treated in four Dutch organizations for aggression regulation problems.
Intervention (if applicable): 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 earlier developed by the CE-certified company Minddistrict. The last couple of months the intervention has been cosmetically adjusted in close cooperation with therapists, patients and other stakeholders so that it fits the current design and lay-out of Minddistrict. 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.
Main study parameters/endpoints: All participants fill out three validated, short self-report questionnaires on self-efficacy, treatment readiness and aggression at four points during the study. Participants in the experimental conditions also fill out an engagement questionnaire during the use of the intervention. Dynamic risk factors are assessed via a risk assessment instrument that is already used as a standard part of treatment according to Dutch guidelines and the number of treatment sessions are retrieved from existing systems. The patient and therapist perspective is take in into account by means of semi-structured interviews.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since participants only have to fill out short questionnaires, participating in this study is not viewed as a major burden. Furthermore, 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 study, 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.
- Being tested
- Aggression, Treatment as usual
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AggressionBehavioural
Also called Minddistrict
The intervention consists of 10 lessons:
- Motivation - where are you now?
- Where do you want to go?
- Circle of aggression.
- Thoughts.
- Emotions.
- Bodily sensations.
- Techniques for self-control.
- Asking for help.
- Assertiveness.
- 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.
Treatment as usualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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: Receives: Behavioral: Aggression; Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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".
Measured: 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.
Measured: 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
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.
Measured: Assessed on T0 (Week 0) and T3 (Week 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Feb 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AggressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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'.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Twente
- Sponsor type
- University, hospital or other
- Collaborators
- Transfore, Kairos, GGZ Noord-Holland-Noord, De Woenselse Poort, Kwaliteit Forensische Zorg (KFZ)
- Responsible party
- Principal investigator, Hanneke Kip, University of Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711342
- Sponsor's protocol ID
- NL80846.091.22
- Status last verified
- Jan 2023
- First submitted
- 17 Jun 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Added Value of an Internet-based Intervention for Treatment of Aggression in Forensic Psychiatric Outpatients: A Multicentre, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05711342
- Acronym / sponsor ID
- NL80846.091.22
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of TwenteUniversity, hospital or other
- Collaborators
- Transfore, Kairos, GGZ Noord-Holland-Noord, De Woenselse Poort, Kwaliteit Forensische Zorg (KFZ)
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Rationale: 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.
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 investigated 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, 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.
Study population: The target group of this study consists of forensic psychiatric outpatients, treated in four Dutch organizations for aggression regulation problems.
Intervention (if applicable): 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 earlier developed by the CE-certified company Minddistrict. The last couple of months the intervention has been cosmetically adjusted in close cooperation with therapists, patients and other stakeholders so that it fits the current design and lay-out of Minddistrict. 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.
Main study parameters/endpoints: All participants fill out three validated, short self-report questionnaires on self-efficacy, treatment readiness and aggression at four points during the study. Participants in the experimental conditions also fill out an engagement questionnaire during the use of the intervention. Dynamic risk factors are assessed via a risk assessment instrument that is already used as a standard part of treatment according to Dutch guidelines and the number of treatment sessions are retrieved from existing systems. The patient and therapist perspective is take in into account by means of semi-structured interviews.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since participants only have to fill out short questionnaires, participating in this study is not viewed as a major burden. Furthermore, 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 study, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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'.
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual (TAU) | Active comparator | Behavioral: Treatment as usualIn 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. |
| Treatment as usual (TAU) +Internet-based intervention Aggression | Experimental | Behavioral: Aggression, Behavioral: Treatment as usualIn 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: |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AggressionAlso: MinddistrictThe 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. | Behavioural | Treatment as usual (TAU) +Internet-based intervention Aggression |
| Treatment as usualIn-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. | Behavioural | Treatment as usual (TAU), Treatment as usual (TAU) +Internet-based intervention Aggression |
Primary outcome
Aggression
Time frame: 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)
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).
Regulatory emotional self-efficacy
Time frame: 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)
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".
Treatment readiness
Time frame: 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)
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.
1 secondary outcome
Risk assessment - dynamic risk factors
Time frame: Assessed on T0 (Week 0) and T3 (Week 26)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Link to site of grant provider on the projectLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Klein Haneveld, MSc contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aggression and Treatment as usual in people with Aggression and Psychosocial Problem, run by University of Twente at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanneke Kip, PhD (+31534896536, h.kip@utwente.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aggression (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.