Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05711342
Status:
RECRUITING
Last Update Posted:
2023-02-03
First Post:
2022-06-17
Brief Title:
The Added Value of an Internet-based Intervention for Treatment of Forensic Psychiatric Outpatients
Sponsor:
University of Twente
Organization:
University of Twente
Study Overview
Official Title:
The Added Value of an Internet-based Intervention for Treatment of Aggression in Forensic Psychiatric Outpatients A Multicentre Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 ineffectiveness 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 parametersendpoints 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 patients 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
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 ineffectiveness 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 parametersendpoints 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None