Shared Decision Making in mental health care using Routine Outcome Monitoring as a source of information: a cluster randomised controlled trial.

BACKGROUND: Shared Decision Making (SDM) is a way to empower patients when decisions are made about treatment. In order to be effective agents in this process, patients need access to information of good quality. Routine Outcome Monitoring (ROM) may provide such information and therefore may be a key element in SDM. This trial tests the effectiveness of SDM using ROM, primarily aiming to diminish decisional conflict of the patient while making decisions about treatment. The degree of decisional conflict, the primary outcome of this study, encompasses personal certainty about choosing an appropriate treatment, information about options, clarification of patient values, support from others and patients experience of an effective decision making process. Secondary outcomes of the study focus on the working alliance between patient and clinician, adherence to treatment, and clinical outcome and quality of life. METHODS/DESIGN: This article presents the study protocol of a multi-centre two-arm cluster randomised controlled trial (RCT). The research is conducted in Dutch specialised mental health care teams participating in the ROM Quality Improvement Collaborative (QIC), which aims to implement ROM in daily clinical practice. In the intervention teams, ROM is used as a source of information during the SDM process between the patient and clinician. Control teams receive no specific SDM or ROM instructions and apply decision making as usual. Randomisation is conducted at the level of the participating teams within the mental health organisations. A total of 12 teams from 4 organisations and 364 patients participate in the study. Prior to data collection, the intervention teams are trained to use ROM during the SDM process. Data collection will be at baseline, and at 3 and 6 months after inclusion of the patient. Control teams will implement the SDM and ROM model after completion of the study. DISCUSSION: This study will provide useful information about the effectiveness of ROM within a SDM framework. Furthermore, with practical guidelines this study may contribute to the implementation of SDM using ROM in mental health care. Reporting of the results is expected from December 2016 onwards. TRIAL REGISTRATION: Dutch trial register: TC5262. Trial registration date: 24th of June 2015.

Frequency and change mechanisms of psychotherapy among depressed patients: study protocol for a multicenter randomized trial comparing twice-weekly versus once-weekly sessions of CBT and IPT.

BACKGROUND: Cognitive behavioral therapy (CBT) and interpersonal therapy (IPT) are among the most well established therapies for the treatment of depression. However, some major questions remain unanswered. First, it is unknown what session frequency results in the most optimal (cost) effectiveness in psychotherapy. Second, the debate as to what mechanisms underlie the effect of psychotherapy has not yet been resolved. Enhancing knowledge about the optimal session frequency and mechanisms of change seems crucial in order to optimize the (cost) effectiveness of psychotherapy for depression. This study aims to compare treatment outcome of twice-weekly versus once-weekly sessions of CBT and IPT. We expect twice-weekly sessions to be more effective and lead to more rapid recovery of depressive symptoms in comparison to once-weekly sessions. Both therapy-specific and non-specific process measures will be included to unravel the mechanisms of change in psychotherapy for depression. Besides the use of self-reports and behavioral observations, this study will also examine underlying biological processes by collecting blood samples. METHOD: In a multicenter randomized trial, two hundred depressed patients will be recruited from Dutch specialized mental healthcare centers and randomized into one of the following groups, all receiving a maximum of 20 sessions in different frequencies: a) twice-weekly sessions at the start of CBT, b) twice-weekly sessions at the start of IPT, c) once-weekly sessions at the start of CBT, d) once-weekly sessions at the start of IPT. Primary outcome measures are depression severity, cost-effectiveness and quality of life. Process measures include therapeutic alliance, recall, therapy-specific skills, motivation and compliance. Assessments will take place during baseline, monthly during treatment and follow-up at month 9, 12 and 24. In addition, at 12 and 24 months, the frequency of depressive episodes in the previous year will be assessed. Blood samples will be taken pre- and post-treatment. The study has been ethically approved and registered. DISCUSSION: Finding that twice-weekly sessions are more effective or lead to more rapid recovery of depressive symptoms could lead to treatment adaptations that have the potential to reduce the personal and societal burden of depression. In addition, insight into the mechanisms of change and physiological processes in psychotherapy will enable us to optimize treatments and may help to understand human functioning beyond the context of treatment. TRIAL REGISTRATION: The study has been registered on October 21th, 2014 at the Netherlands Trial Register, part of the Dutch Cochrane Centre ( NTR4856 ).

How Can We Link General Medical and Behavioral Health Care? International Models for Practice and Policy.

A range of integration models for providing effective care to individuals with comorbid general medical and behavioral health conditions have been described and tested in varied settings internationally for several subsets of this population. This column examines models in three countries selected to showcase implementation in a variety of health systems: the national health system in England, nationally regulated individual insurance market in the Netherlands, and a mixture of employer-sponsored and government-funded health insurance plans in Japan. The authors describe a set of key practices for and challenges to the successful implementation of these models.

Systematic tailoring for the implementation of guideline recommendations for anxiety and depressive disorders in general practice: perceived usefulness of tailored interventions.

BACKGROUND: The uptake of guideline recommendations in general practice can potentially be improved by designing implementation interventions that are tailored to prospectively identify barriers. However, there is insufficient evidence regarding the most effective and efficient approaches to tailoring. Our study provides an insight into the usefulness of tailored interventions to prospectively identified barriers affecting the uptake of guideline recommendations for anxiety and depressive disorders experienced by general practitioners (GPs) in their local context. METHODS: A qualitative study was conducted, in which 23 GPs gave informed consent and 14 finally participated. To explore the barriers affecting the uptake of guideline recommendations, a face-to-face interview was conducted with each GP to generate a personalised list. In response to this list, interventions were tailored to remove the barriers experienced by the GPs. To examine the perceived usefulness of the tailored interventions, telephone interviews were conducted after one year and coded through thematic coding. The analysis was descriptive in nature. RESULTS: The most frequently perceived barriers were: a lack of knowledge and skills, no agreement on guideline recommendations, negative outcome expectancy, low self-efficacy, no consensus with patients, and a lack of information about treatments provided by mental health professionals, together with waiting lists. The tailored interventions 'peer group supervision' and 'individualised telephone consultations' were perceived as useful by most GPs. Besides the tailored interventions, a perceived benefit of using a self-rating scale, measuring depressive and anxiety symptoms, and the idea of delivering better patient care, were supportive in the uptake of guideline recommendations. CONCLUSIONS: Our findings suggest that tailoring interventions to prospectively identified barriers, affecting the uptake of guideline recommendations for anxiety and depressive disorders, as perceived by GPs, may enhance the implementation of these guideline recommendations.