Effectiveness of a peer-supported crisis intervention to reduce the proportion of compulsory admissions in acute psychiatric crisis interventions in an outreach and outpatient setting: study protocol for an exploratory cluster randomised trial combined with qualitative methods

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Abstract

Introduction

Compulsory admissions are associated with feelings of fear, humiliation and powerlessness. The number of compulsory admissions in Germany and other high-income countries has increased in recent years. Peer support has been shown to increase the self-efficacy of individuals with mental health conditions in acute crises and to reduce the use of coercive measures in clinical settings. The objective of this study is to reduce the number of compulsory admissions by involving peer support workers (PSWs) in acute mental health crises in outreach and outpatient settings.

Methods and analysis

This one-year intervention is an exploratory, cluster randomised study. Trained PSWs will join the public crisis intervention services (CIS) in two of five regions (the intervention regions) in the city of Bremen (Germany). PSWs will participate in crisis interventions and aspects of the mental health services. They will be involved in developing and conducting an antistigma training for police officers. The remaining three regions will serve as control regions. All individuals aged 18 and older who experience an acute mental health crisis during the operating hours of the regional CIS in the city of Bremen (around 2000 in previous years) will be included in the study. Semistructured interviews will be conducted with PSWs, 30 patients from control and intervention regions, as well as two focus group discussions with CIS staff. A descriptive comparison between all participants in the intervention and control regions will assess the proportion of compulsory admissions in crisis interventions during the baseline and intervention years, including an analysis of temporal changes.

Ethics and dissemination

This study was approved by the Ethics Committee of the University of Bremen (file 2022-09) on 20 June 2022. The results will be presented via scientific conferences, scientific journals and communicated to policy-makers and practitioners.

Trial registration number

DRKS00029377.

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Most cited references 35

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SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

An-Wen Chan, Jennifer Tetzlaff, Peter C. Gøtzsche … (2014)

High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.

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Evidence for effective interventions to reduce mental-health-related stigma and discrimination.

Graham Thornicroft, Nisha Mehta, Sarah Clement … (2016)

Stigma and discrimination in relation to mental illnesses have been described as having worse consequences than the conditions themselves. Most medical literature in this area of research has been descriptive and has focused on attitudes towards people with mental illness rather than on interventions to reduce stigma. In this narrative Review, we summarise what is known globally from published systematic reviews and primary data on effective interventions intended to reduce mental-illness-related stigma or discrimination. The main findings emerging from this narrative overview are that: (1) at the population level there is a fairly consistent pattern of short-term benefits for positive attitude change, and some lesser evidence for knowledge improvement; (2) for people with mental illness, some group-level anti-stigma inventions show promise and merit further assessment; (3) for specific target groups, such as students, social-contact-based interventions usually achieve short-term (but less clearly long-term) attitudinal improvements, and less often produce knowledge gains; (4) this is a heterogeneous field of study with few strong study designs with large sample sizes; (5) research from low-income and middle-income countries is conspicuous by its relative absence; (6) caution needs to be exercised in not overgeneralising lessons from one target group to another; (7) there is a clear need for studies with longer-term follow-up to assess whether initial gains are sustained or attenuated, and whether booster doses of the intervention are needed to maintain progress; (8) few studies in any part of the world have focused on either the service user's perspective of stigma and discrimination or on the behaviour domain of behavioural change, either by people with or without mental illness in the complex processes of stigmatisation. We found that social contact is the most effective type of intervention to improve stigma-related knowledge and attitudes in the short term. However, the evidence for longer-term benefit of such social contact to reduce stigma is weak. In view of the magnitude of challenges that result from mental health stigma and discrimination, a concerted effort is needed to fund methodologically strong research that will provide robust evidence to support decisions on investment in interventions to reduce stigma.

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Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions

Mary De Silva, Erica Breuer, Lucy Lee … (2014)

Background The Medical Research Councils’ framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable. Methods We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions. Results Our application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework. It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly designing an intervention that is embedded in the local context. For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework. Conclusions Incorporating a ToC approach into the MRC framework holds promise for improving the design and evaluation of complex interventions, thereby increasing the likelihood that the intervention will be ultimately effective, sustainable and scalable. We urge researchers developing and evaluating complex interventions to consider using this approach, to evaluate its usefulness and to build an evidence base to further refine the methodology. Trial registration Clinical trials.gov: NCT02160249

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2024

Publication date (Electronic): 30 May 2024

Volume: 14

Issue: 5

Electronic Location Identifier: e083385

Affiliations

[1 ] departmentDepartment of Health Services Research , Ringgold_234657Institute of Public Health and Nursing Research, Health Sciences Bremen, University of Bremen , Bremen, Germany

[2 ] departmentDepartment of Psychiatry and Psychotherapy , Hospital Bremen-Ost, Gesundheit Nord Klinikverbund Bremen gGmbH (GENO) , Bremen, Germany

[3 ] departmentDepartment of Psychiatry and Psychotherapy , Ringgold_37734University Medical Center Hamburg-Eppendorf , Hamburg, Germany

[4 ] Department of Health Bremen , Bremen, Germany

[5 ] departmentCompetence Center for Clinical Trials Bremen , Ringgold_9168University of Bremen , Bremen, Germany

[6 ] departmentDepartment of Mental Health and Addiction , Ministry of Health, Women and Consumer Protection , Bremen, Germany

Author notes

[Correspondence to ] Mrs Lena Katharina Oeltjen; lena.oeltjen@ 123456uni-bremen.de

Author information

Lena Katharina Oeltjen http://orcid.org/0009-0005-3291-7758

Article

Publisher ID: bmjopen-2023-083385

DOI: 10.1136/bmjopen-2023-083385

PMC ID: 11138285

PubMed ID: 38816053

SO-VID: f9534387-b4bf-49c7-823b-e3bbffa1ddee

License:

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

History

Date received : 18 December 2023

Date accepted : 09 May 2024

Funding

Funded by: The Federal Ministry of Health (Germany)(BMG);

Award ID: ZMI1-2521FSB30A

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ScienceOpen disciplines: Medicine

Keywords: mental health,public health,clinical trial

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ScienceOpen disciplines: Medicine

Keywords: mental health, public health, clinical trial

Effectiveness of a peer-supported crisis intervention to reduce the proportion of compulsory admissions in acute psychiatric crisis interventions in an outreach and outpatient setting: study protocol for an exploratory cluster randomised trial combined with qualitative methods

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Emerald: Healthier Lives

Most cited references 35

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

Evidence for effective interventions to reduce mental-health-related stigma and discrimination.

Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions

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