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Sociaal-Psychiatrisch onderzoek

BRAVEBRAVE

Background
Approximately 45% of all Dutch persons experience one form of domestic violence (DV) during their life time (1). Domestic violence can be defined as ′any incident of threatening behavior, violence or abuse (psychological, physical, sexual, financial or emotional) between adults who are or have been an intimate partner, family member, friend or otherwise closely involved. Recent studies have found a high prevalence of domestic violence among female and male psychiatric patients (2).
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Results from the Dutch nationwide study on victimization in psychiatric patients suggest a 6- fold increase of domestic violence in severe mental illness patients as compared to the general population (3). Domestic violence is associated with anxiety, depression, post-traumatic stress disorder, addiction and psychosis. Despite the numbers mentioned before, domestic violence in psychiatric patients is often not detected. Only around 10-30% of cases are detected by psychiatric service providers. As was shown in a systematic review of controlled studies, identification of victims of DV by health care professionals can increase by training and organizational change within health care systems. With the BRAVE (Better Reduction through Assessment of Violence and Evaluation) intervention we aim to train and educate professionals in health care on domestic violence. We also set up a referral pathway to specialized services in domestic violence. We hope to improve detection and referral rates of domestic violence and eventually reduce victimization of psychiatric patients.

Methods/Design
The BRAVE study is a cluster randomized controlled trial investigating detection- and referral rate of domestic violence in psychiatric patients from professionals working in FACT (Functional Assertive Community Treatment) teams. FACT teams are teams specialized in outreaching health care and municipal health service teams (GGD Rijnmond) specializing in domestic violence. All FACT- and GGD teams operating in Rotterdam and around are eligible for inclusion. FACT teams serve approximately 200-250 patients with severe mental illness. A FACT team consists of a psychiatrist, psychologist, social psychiatric nurses and social workers. The teams at the Muncipal Health Service have persons working who are specialized in domestic violence and provide their services for people living in Rotterdam and surroundings. The intervention consists of a training for FACT teams in domestic violence and setting up a referral pathway for referrals back and forth between teams at the GGD specializing in domestic violence and FACT teams. The teams at the GGD will receive education and training about psychiatric patients.

Discussion
This cluster randomized controlled trial assesses the number of detected cases of DV amongst psychiatric patients of FACT teams in the intervention condition in comparison with FACT teams providing care as usual. We expect that teams in the intervention condition will detect more cases of DV, that patients will get referred to the GGD Rijnmond teams faster and that they’ll receive more often care targeting domestic violence. We hope that, in time, with this intervention the risk of domestic violence against psychiatric patients will decrease and that the burden for psychiatric patients being victimized by domestic violence also will decrease.

Study-characteristics
  • Participating organizations: Erasmus MC, BAVO Europoort, Antesgroep, GGD Rotterdam-Rijnmond, King’s College London, Universiteit van Tilburg, Verwey-Jonker Instituut, Landelijk Platform GGZ, EMGO instituut VU Amsterdam
  • Funding: this study received a funding from NWO
  • PhD-candidate: R E Ruijne, Supervisor: A M Kamperman, Promotor: CL Mulder
  • The study starts on 01-06-2015 and the trial will run till 01-01-2019


Main contact: Drs. R.Ruijne, Phd Candidate
e-mail: r.ruijne@erasmusmc.nl

Dr. A.M. Kamperman, Supervisor
e-mail: a.kamperman@erasmusmc.nl


  1. Dijk Tv, Flight, S., Oppenhuis, E. En Duesmann, B. . Huiselijk geweld: aard, omvang en hulpverlening; 1997.
  2. Oram S TK, Feder G et al. Prevalence of experiences of domestic violence among psychiatric patients: systematic review. The British Journal of Psychiatry 2013;202:94-9.
  3. Kamperman AM, Henrichs J, Bogaerts S, Lesaffre EMEH, Wierdsma AI, Ghauharali RRR, Swildens W, Nijssen Y, van der Gaag M, Theunissen JR, Delespaul PA, van Weeghel J, van Busschbach JT, Kroon H, Teplin LA, van de Mheen D, Mulder CL. Criminal Victimisation in People with Severe Mental Illness: A Multi-Site Prevalence and Incidence Survey in the Netherlands. Plos One 2014;9.

 

CoEP-ON trialThe One for Seven Study

This open label randomized controlled trial compares penfluridol and second generation oral neuroleptics (olanzapine, risperidone) for their effects on adherence, measured as time to all-cause discontinuation (primary outcome variable) and for their effects on health related costs and Quality Adjusted Life Years (QALY’s). Other outcome variables are the reason for treatment discontinuation, efficacy, safety and tolerability, drug attitude, subjective well-being, and insight.

Trial registration: in progress
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Background
Compliance problems are present in 40-75% of psychotic disorder patients. Penfluridol (acemap) is the only long acting neuroleptic today that can be taken orally once a week for the treatment of schizophrenia and other psychotic disorders. Other oral antipsychotic drugs, including olanzapine and risperidone, have to be taken daily. Since penfluridol can be taken once weekly, we expect better compliance as compared to olanzapine and risperidone. Better compliance may be associated with less relapses, better quality of life, less crises and less or shorter hospitalisations, leading to lower costs. There have been no studies comparing penfluridol and second generation neuroleptics. Given the absence of evidence on these matters, penfluridol is not recommended in any guidelines on psychiatric treatment of psychosis, although compliance and outcome may be better and costs may be lower. We hypothesize that there will be significant differences in the overall effectiveness of penfluridol, olanzapine and risperidone that reflect variations in efficacy, safety and tolerability, and costs. We hypothesize that penfluridol as compared to oral second generation neuroleptics (olanzapine and risperidone), will show better compliance (primary outcome) and therefore lower healthcare costs.

Methods/Design
The primary aim of this multicentre study is to determine the time to all-cause discontinuation of penfluridol (acemap) as compared to second-generation oral neuroleptics (olanzapine, risperidone), using an open label randomized controlled trial design in 180 patients. The secondary objectives are to perform a cost-effectiveness analysis and a budget impact analysis to determine the cost-effectiveness of penfluridol and to estimate the impact of penfluridol on the national budget for healthcare. Other study parameters include the reason for treatment discontinuation, efficacy, safety and tolerability, drug attitude, subjective well-being, and insight. We will explore how these covariates affect the outcome of our primary analysis. Adult patients with psychotic disorder are allocated in three groups; (a) penfluridol orally once weekly, (b) olanzapine orally once daily, and (c) risperidone orally once daily. Medication is prescribed by the treating psychiatrist, according to current conventional care. At baseline, three and twelve month follow-up information about all parameters will be collected by independent raters. At 2, 4, 6, 8, 10, and 12 weeks and 6, 9 and 12 months, information about adherence will be collected from the participating centers.

Main study parameters/endpoints
The primary parameter adherence will be measured as time to all-cause medication discontinuation. Medication discontinuation will be measured by two objective and one subjective measurement. In this study we will be using two objective and one subjective scale for measuring adherence. Pill count in the healthcare setting, medication blood levels and the Brief Adherence Rating Scale will be used to determine adherence as measured by all-cause medication discontinuation rates. The secondary analyses will consist of a cost-effectiveness analysis and a budget impact analysis. These analyses will be carried out by the institute of Medical Technology Assessment (iMTA) of the Erasmus University, Rotterdam.

Study-characteristics
  • Participating organizations: AMC Amsterdam, Bavo-Europoort, Delta Psychiatrisch Centrum, GGZ West Noord Brabant, GGZ Breburg Groep, GGZ Noord Holland Noord, Universiteit Maastricht/Mondriaan GGZ Instelling, Yulius, Erasmus MC
  • Funding: ZonMW
  • PhD-candidate: J Gilden, Supervisor: AI Wierdsma, Promotors: CL Mulder, L de Haan

 

ACTE trailACTE-trial

Randomized controlled trial to compare the effects of assertive community treatment for the elderly with those of care as usual. Primary outcome measures will be the number of dropouts, the number of patients engaged in care and patient′s psychiatric symptoms, somatic symptoms, and social functioning.

Trial registration: Current Controlled Trails NTR1620
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Background
Adults aged 65 and older with severe mental illnesses are a growing segment of the Dutch population. Some of them have a range of serious problems and are also difficult to engage. While assertive community treatment is a common model for treating difficult to engage severe mental illnesses patients, no special form of it is available for the elderly. A special assertive community treatment team for the elderly is developed in Rotterdam, the Netherlands and tested for its effectiveness.

Methods/Design
We will use a randomized controlled trial design to compare the effects of assertive community treatment for the elderly with those of care as usual. Primary outcome measures will be the number of dropouts, the number of patients engaged in care and patient′s psychiatric symptoms, somatic symptoms, and social functioning. Secondary outcome measures are the number of unmet needs, the subjective quality of life and patients′ satisfaction. Other secondary outcomes include the number of crisis contacts, rates of voluntary and involuntary admission, and length of stay. Inclusion criteria are aged 65 plus, the presence of a mental disorder, a lack of motivation for treatment and at least four suspected problems with functioning (addiction, somatic problems, daily living activities, housing etc.). If patients meet the inclusion criteria, they will be randomly allocated to either assertive community treatment for the elderly or care as usual. Trained assessors will use mainly observational instruments at the following time points: at baseline, after 9 and 18 months.

Discussion
This study will help establish whether assertive community treatment for the elderly produces better results than care as usual in elderly people with severe mental illnesses who are difficult to engage. When assertive community treatment for the elderly proves valuable in these respects, it can be tested and implemented more widely, and mechanisms for its effects investigated.

Study-characteristics
  • Participating organizations: Bavo-Europoort, Erasmus MC
  • Funding: Bavo-Europoort
  • PhD-candidate: J Stobbe, Supervisor: AI Wierdsma, Promotor: CL Mulder

 

Crisiscard-trailCrisiscard-trial

Randomised controlled trial with two intervention groups and one control condition. Both interventions consist of a crisis plan, facilitated through the patient′s advocate or the clinician respectively. Primary outcomes are the number of emergency (after hour) visits, (involuntary) admissions and the length of stay in hospital.

Trial registration: Current Controlled Trails NTR1166. CCMO protocol id: NL16818.097.07 METIGG protocolnummer: 7109
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Background
Crises and (involuntary) admissions have a strong impact on patients and their caregivers. In some countries, including the Netherlands, the number of crises and (involuntary) admissions have increased in the last years. There is also a lack of effective interventions to prevent their occurrence. Previous research has shown that a form of psychiatric advance statement – joint crisis plan – may prevent involuntary admissions, but another study showed no significant results for another form. The question remains which form of psychiatric advance statement may help to prevent crisis situations. This study examines the effects of two other psychiatric advance statements. The first is created by the patient with help from a patient′s advocate (Patient Advocate Crisis Plan: PACP) and the second with the help of a clinician only (Clinician facilitated Crisis Plan: CCP). We investigate whether patients with a PACP or CCP show fewer emergency visits and (involuntary) admissions as compared to patients without a psychiatric advance statement. Furthermore, this study seeks to identify possible mechanisms responsible for the effects of a PACP or a CCP.

Methods/Design
This study is a randomised controlled trial with two intervention groups and one control condition. Both interventions consist of a crisis plan, facilitated through the patient′s advocate or the clinician respectively. Outpatients with psychotic or bipolar disorders, who experienced at least one psychiatric crisis during the previous two years, are randomly allocated to one of the three groups. Primary outcomes are the number of emergency (after hour) visits, (involuntary) admissions and the length of stay in hospital. Secondary outcomes include psychosocial functioning and treatment satisfaction. The possible mediator variables of the effects of the crisis plans are investigated by assessing the patient′s involvement in the creation of the crisis plan, working alliance, insight into illness, recovery style, social support, locus of control, service engagement and coping with crises situations. The interviews take place before randomisation, nine month later and finally eighteen months after randomisation.

Discussion
This study examines the effects of two types of crisis plans. In addition, the results offer an understanding of the way these advance statements work and whether it is more effective to include a patients′ advocate in the process of creating a psychiatric advance statement. These statements may be an intervention to prevent crises and the use of compulsion in mental health care. The strength and limitations of this study are discussed.

Study-characteristics
  • Participating organizations: Bavo-Europoort, Delta Psychiatrisch Centrum, Erasmus MC
  • Funding: ZonMw (kostenplaats 7543)
  • PhD-candidate: A Ruchlewska, Supervisor: A Kamperman, Promotor: CL Mulder

 

MotivaTe-ITMotivaTe-IT

The Motivation and Treatment Engagement Intervention Trial (MotivaTe-IT) is a multi-center cluster randomized trial investigating the effectiveness of feedback generated by clinicians regarding their patients′ treatment motivation upon the patients′ TE. The primary outcome is the patients′ treatment engagement.

Trial registration: Current Controlled Trials NTR2968.
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Background
Treatment disengagement and non-completion poses a major problem for the successful treatment of patients with severe mental illness. Motivation for treatment has long been proposed as a major determinant of treatment engagement, but exact mechanisms remain unclear. This current study serves three purposes: 1) to determine whether a feedback intervention based on the patients′ motivation for treatment is effective at improving treatment engagement (TE) of severe mentally ill patients in outpatient psychiatric treatment, 2) to gather insight into motivational processes and possible mechanisms regarding treatment motivation (TM) and TE in this patient population and 3) to determine which of three theories of motivation is most plausible for the dynamics of TM and TE in this population.

Methods/Design
The Motivation and Treatment Engagement Intervention Trial (MotivaTe-IT) is a multi-center cluster randomized trial investigating the effectiveness of feedback generated by clinicians regarding their patients′ treatment motivation upon the patients′ TE. The primary outcome is the patients′ TE. Secondary outcomes are TM, psychosocial functioning and quality of life. Patients whose clinicians generate monthly motivation feedback (additional to treatment as usual) will be compared to patients who receive treatment as usual. An estimated 350 patients, aged 18 to 65 years, with psychotic disorders and/or severe personality disorders will be recruited from outpatient community mental health care. The randomization will be performed by a computerized randomization program, with an allocation ratio of 1:1 (team vs. team or clinician vs. clinician) and patients, but not clinicians, will be blind to treatment allocation at baseline assessment. Due to the nature of the trial, follow-up assessment cannot be blinded.

Discussion
The current study can provide important insights regarding motivational processes and the way in which motivation influences the treatment engagement and clinical outcomes. The identification of possible mechanisms through which changes in the outcomes occur, offers a tool for the development of more effective future interventions to improve TM and TE.

Study-characteristics
  • Participating organizations: GGZ Westelijk Noord Brabant, GGZ Breburg, Erasmus MC
  • Funding:
  • PhD-candidate: E Jochems, Promotor: CL Mulder

 

M4M-trialM4M-trial

Patients will be randomly assigned to the experimental group receiving a financial reward for each accepted antipsychotic medication depot, or to the control group receiving treatment as usual without financial rewards. The primary goal of this study is to assess the effectiveness of providing financial inceptives in improving adherence with antipsychotic depot medication.

Trial registration: Current Controlled Trials NTR.
CCMO protocol id: NL31406.097.10
METIGG protocolnummer: 10205
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Background
Non-adherence with antipsychotic medication is a frequently occurring problem, particularly among patients with psychotic disorders and co-morbid substance abuse. Prior research has shown encouraging results for interventions based on ‘Contingency Management’, where desirable behaviour is encouraged by providing rewards contingent upon the behaviour. However, little research has been done on the effectiveness of contingency management on medication adherence in patients with psychotic disorders. An earlier pilot-study by our study group showed promising results in reducing admission days and increasing adherence. The current study is a randomized controlled trial on the effectiveness of a contingency management procedure called ‘Money for Medication’ (M4M), in improving adherence with antipsychotic depot medication in patients with psychotic disorders through financial rewards.

Methods/Design
168 patients will be randomly assigned to the experimental group (n = 84), receiving a financial reward for each accepted antipsychotic medication depot, or to the control group (n = 84), receiving treatment as usual without financial rewards. The intervention has a duration of twelve months. During the subsequent six months follow-up, the effects of discontinuing the intervention on depot acceptance will be monitored. The primary goal of this study is to assess the effectiveness of providing financial inceptives in improving adherence with antipsychotic depot medication (during and after the intervention). Our primary outcome measure will therefore be the number (percentage) of accepted depots. Secondary however, we will consider alternative measures of medication acceptance, i.e. the longest period of uninterrupted depot acceptance and the time expired before depot is taken. Additionally, the effectiveness of this intervention will be considered in terms of psychosocial functioning, substance use, side-effects, quality of life, and cost-utility, and we will assess patients and clinicians attitudes towards M4M.

Discussion
This RCT assesses the effectiveness and side-effects of financial incentives in improving adherence with antipsychotic depot medication in patients with psychotic disorders. This study is designed not only to assess whether M4M is an effective intervention to improve patients’ acceptance of their antipsychotic depot medication, but to assess how this intervention can contribute to patients functioning and wellbeing as well.

Study-characteristics
  • Participating organizations: Palier, Bavo-Europoort, Erasmus MC
  • Funding:
  • PhD-candidate: E Noordraven, Supervisor: AI Wierdsma, Promotor: CL Mulder

 

ViDIO-trialViDIO-trial

In the Vitamin D Intensive Outreach (ViDIO) stydy participants with vitamin D deficiencies of <50 nmol/L serum 25-hydroxyvitamin D (25(OH)D) are randomly allocated to one of two different strategies (VIDIO and CAU) of vitamin D supplementation. Primary outcomes are serum 25(OH)D concentrations. Prevalences of vitamin D and B1 deficiencies will be described.

Trial registration: NL 20120502 CTA (EudraCt) CCMO protocol id: NL40553.078.12 METC: MEC-2012-273.
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Background
Decreased bioavailability of vitamins may be due to inadequate dietary sources, lower intestinal absorption and/or liver dysfunction. Muscular weakness and wasting is frequently found in chronic alcoholism and might be related to severe vitamin D hypovitaminosis. Alcohol-related osteoporosis responded well to vitamin D therapy. In alcoholic myopathy, however, a clear understanding of the role of vitamin D is currently lacking.

Methods/Design
Participants are community-dwelling adults with a history of alcohol use and who are at risk of multiple vitamin deficiencies. Firstly, we seek to identify possible mediating variables of vitamin D status, by assessing baseline characteristics, liver function and other laboratory findings, help-seeking behaviour, social support, and service engagement. Secondly, participants with vitamin D deficiencies of <50 nmol/L serum 25-hydroxyvitamin D (25(OH)D) are randomly allocated to one of two different strategies (VIDIO and CAU) of vitamin D supplementation.
VIDIO: Vitamin D Intensive Outreach includes a cholecalciferol loading dose, if applicable, and subsequent bimonthly high-dose cholecalciferol through an outreach approach of the Street Doctor Service in Rotterdam. CAU: Care As Usual includes daily prescriptions of cholecalciferol 800 IU, available in combination with calcium carbonate. The VIDIO intervention is based upon general principles to enhance medication compliance for successful treatment, disease prevention, and health promotion, by means of a simple medication regime in one-on-one patient contacts. We hypothesise that vitamin D supplementation may be more effective on vitamin D levels and muscle performance when given through VIDIO, rather than CAU depending upon medication prescriptions and medication compliance of the participants.Primary outcomes are serum 25(OH)D concentrations. Secondary outcomes include the participants’ quadriceps maximal voluntary contractions, gait and balance abilities, results of cognitive screening, and a health-related quality of life evaluation. Prevalences of vitamin D and B1 deficiencies will be described.

Discussion
Comparison between the two strategies of vitamin D therapy and serum 25(OH)D levels provides insight in the effectiveness of the interventions. Progress in muscle strength in the VIDIO intervention reflects an effect of vitamin D. Possible associations between results of cognitive screening and vitamin D or B1 deficiencies are discussed.

Study-characteristics
  • Participating organizations: Slingedael, GGD Rotterdam-Rijnmond, Erasmus MC
  • Funding: Slingedael
  • PhD-candidate: J Wynia, Supervisor: AI Wierdsma, Promotor: CL Mulder