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Effectiveness and implementation of Self-Help Plus (SH+) and Doing What Matters in Times of Stress (DWMS): protocol of a systematic review and meta-analysis

Por: Thakur · H. K. · Schäfer · C. G. · Kunzler · A. M. · Burmeister · C. F. · Michael · T. · Equit · M. · Möhler · E. · Lieb · K. · Schäfer · S. K.
Introduction

Global increases in armed conflict, forced displacement, pandemics and economic instability have contributed to rising levels of psychological distress worldwide, placing relevant segments of the population at increased risk of developing mental health conditions. This burden is particularly pronounced in humanitarian and low-resource settings where access to specialist mental health services is limited. Scalable, low-intensity, evidence-based psychological interventions are therefore urgently needed. In response, the WHO has developed transdiagnostic programmes, including Self-Help Plus (SH+) and Doing What Matters in Times of Stress (DWMS). Although these interventions are increasingly implemented across humanitarian and public health contexts, evidence for their effectiveness and implementation has not yet been systematically synthesised.

Methods and analysis

This preregistered systematic review and meta-analysis will be conducted in accordance with Cochrane Collaboration standards and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We will include randomised controlled trials evaluating the effectiveness of SH+ or DWMS, alongside qualitative and mixed-methods studies examining their implementation among stressor-exposed individuals of any age. Outcomes will include symptoms of depression and anxiety, general distress and post-traumatic stress symptoms. Moreover, we will examine effects on well-being, psychosocial functioning, adverse events and implementation outcomes (eg, acceptability, feasibility, fidelity). We will search Cochrane CENTRAL, APA PsycNet, Web of Science Core Collection, Embase and Scopus for records published from 2016 onwards. Searches will be supplemented by hand-searching preprint repositories and citation tracking. Risk of bias will be assessed using the Revised Cochrane Risk of Bias Tool and a customised appraisal tool for studies on implementation. Quantitative data will be synthesised using random-effects multilevel meta-analyses, with meta-regression models applied to examine moderators. Bayesian meta-analyses will be conducted where appropriate as sensitivity analyses to assess the robustness of the findings. Certainty of evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.

Ethics and dissemination

Ethical approval is not required. Findings will be disseminated through an open-access peer-reviewed publication, a plain-language summary, and the Open Science Framework, where all materials will be made publicly available.

PROSPERO registration number

CRD420251168521.

Long-term effects of psychotherapy in children and adolescents: protocol for database development and a systematic review in the LaKiJu META project

Por: Schäfer · S. K. · Burmeister · C. F. · Lottermoser · E. · Schäfer · C. G. · Cascant Ortolano · L. · Stoffers-Winterling · J. · Flasinksi · T. · Equit · M. · Schneider · S. · Lieb · K. · de Haan · A.
Introduction

Approximately one in every six children and adolescents is affected by mental disorders, which impose significant costs on patients, their families and societies. Psychotherapy is the first-line treatment for many of these disorders, and systematic reviews of post-intervention effects show small to moderate favourable outcomes compared with control groups. However, the long-term effects of psychotherapy remain less well understood.

Methods and analysis

The LaKiJu META project aims to address this gap by developing an open-access database, which will subsequently be used for data synthesis. This database will be established through literature searches in nine databases for (cluster) randomised controlled trials (RCTs) investigating the long-term effects (≥6 months) of any type of psychotherapy in school-aged children and adolescents (ages 6;00 to 17;11 years) with mental disorders. Outcomes will be prioritised based on their relevance to patients, caregivers and clinicians and will encompass a broad range of measures, including symptom changes, response rates and reliable changes. Syntheses will use multilevel meta-analyses to compare intervention and control groups at follow-up assessments, across both transdiagnostic and disorder-specific symptom outcomes. In secondary analyses, we will examine changes within intervention groups over time. Moderator analyses will focus on the effects of study-, intervention- and patient-level characteristics.

Ethics and dissemination

Ethical approval for public involvement was obtained from the ethics committee of the Faculty of Psychology of the Ruhr University Bochum. For dissemination, we will employ tailored strategies to reach researchers, clinicians, patients and their caregivers, with all groups involved in the development of dissemination plans.

PROSPERO registration number

CRD420251003208 (preregistered on 10 March 2025).

Integrating equity into hospital incident reporting and patient concerns systems: study protocol for a mixed methods study

Introduction

Preventable hospital patient harm events disproportionally affect certain patient populations. For some, harm extends beyond physical injury to include cultural, emotional or spiritual impacts. While these disparities are linked to socio-demographics (eg, race, education), they are driven by structural factors (eg, procedures and policies). Patient safety monitoring systems (eg, incident reporting, patient concerns) were not originally designed to identify equity-related harms and may inadvertently obscure or reinforce the injustices they should address. This study will examine how equity is currently considered within hospital incident reporting and patient concerns systems across Canada and will identify opportunities to strengthen these systems’ responsiveness to inequities in patient safety.

Methods and analysis

This 3-year exploratory sequential mixed-method study began in September 2024. Phase one involves qualitative interviews with patient safety and equity leads, patients/families/caregivers and leaders of innovative initiatives to explore current practices, gaps and innovations in how equity-related factors are identified and addressed within incident reporting and patient concerns systems. Findings will inform Phase 2, a modified Delphi process with patient safety and equity experts and persons with lived experience of equity-related harm events to refine and reach consensus on key equity-promoting features, considerations and recommendations for these systems. In Phase 3, consensus items will be used to develop a national cross-sectional survey assessing the extent to which equity is integrated into hospital incident reporting and patient concerns systems in Canada. A patient advisory committee will inform data collection, interpretation of findings and dissemination.

Ethics and dissemination

Ethics approval has been received for Phase 1, with subsequent approvals to be sought for later phases. Dissemination plans include peer-reviewed publications, presentations at international conferences and knowledge exchange activities to inform patient engagement, the design of incident reporting and patient concerns systems and policy development.

Support on four paws--does the integration of a therapy dog reduce anxiety and increase positive affect in spider phobics during in vivo exposure therapy?: study protocol for a parallel randomised controlled trial of two groups to compare one-session in v

Por: Braun · M. N. · Michael · T. · Equit · M. · Lass-Hennemann · J.
Introduction

Exposure is a central component in the treatment of a range of mental disorders. However, despite high efficacy and efficiency, dissemination of exposure-based treatments is limited. Important factors that contribute to this limited dissemination are negative beliefs about exposure on the part of the public, the therapists, and the patients. While patients perceive exposure therapy as burdensome, therapists are concerned about putting too much strain on their patients during exposure, leading to suboptimal delivery of exposure. In a previous study, in which healthy participants underwent a differential fear conditioning paradigm, we found initial evidence that the integration of a therapy dog into exposure reduces participants’ anxiety and increases participants’ positive affect without causing poor treatment outcome. Thus, the integration of a therapy dog into exposure might be a promising approach to address patients’ and therapists’ concerns and, thus, to (1) foster dissemination of exposure that is (2) delivered in an optimal manner. To scrutinise our findings in a clinical sample, we designed the present study. We test the following hypotheses: (H1) participants in the dog group report significantly less anxiety during the course of the treatment than participants in the control group. (H2) Participants in the dog group report significantly more positive affect during the course of the treatment than participants in the control group. (H3) Participants in the dog group report significantly higher therapy motivation than participants in the control group. (H4) Participants in the dog group report significantly lower anticipatory anxiety than participants in the control group. (H5) The treatment in the dog group is not inferior to the treatment in the control group.

Methods and analysis

In this parallel randomised controlled trial of two groups, n=88 participants (spider phobics without: a current diagnosis of a mental disorder other than a specific phobia, insect bite allergy, dog hair allergy, fear of dogs, current psychopharmacological treatment, and current psychotherapeutic treatment; the sample size calculation is based on the results from our previous study) are randomly allocated (with a 1:1 allocation as per a computer-generated randomisation schedule) to either an ambulant one-session in vivo exposure treatment of spider phobia with a therapy dog (dog group) or without a dog (control group). Due to the nature of the intervention, neither participants nor therapists can be blinded once participants are allocated to one of the two groups. However, the person conducting screening and diagnostics is blind to the allocation, participants are blind to the hypotheses and the respective other group, and the researchers are blind to the allocation while analysing the data. We will test (H1) and (H2), concerned with our primary outcomes, by means of 2x4 mixed analyses of variance with the between-subjects factor group (dog group vs. control group), the within-subjects factor time (with four levels, one for each time point anxiety and affect are measured during treatment), and anxiety or positive affect as the dependent variable, respectively. We will test (H3) and (H4) by means of an analyses of covariance with therapy motivation/anticipatory anxiety at baseline as the covariate, the between-subjects factor group (dog group vs. control group) and therapy motivation/anticipatory anxiety at pre-treatment as the dependent variable, respectively. We will test (H5) by means of 95% CIs and non-inferiority zones.

Ethics and dissemination

This trial was approved by our university’s ethics committee (reference number 24–11). Any deviations from this study protocol or the preregistrations as well as any adverse events potentially arising in the course of the trial, will be made explicit in the publication of the trial results. All participants provided written informed consent prior to the inclusion into the trial. The findings from this trial will be disseminated by means of common academic pathways, including peer-reviewed publications and conference presentations. Following common open science practices, data and analysis code will also be made publicly available in anonymised form on the Open Science Framework (osf.io).

Trial registration number

On 18 June 2024, this study was registered at the German Clinical Trials Register (ID: DRKS00034494; https://drks.de/search/de/trial/DRKS00034494) and preregistered at AsPredicted (https://aspredicted.org/JRP_SCF).

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