Psychological interventions for early-phase schizophrenia: protocol for a systematic review and network meta-analysis.

Introduction: Treating the early phase of schizophrenia is crucial for preventing further episodes and improving quality of life, functioning, and social inclusion. Pharmacotherapies are first-line treatments, but have limitations. There is consensus on the need for non-pharmacological interventions for individuals in the early phase of schizophrenia. Several psychological interventions have shown promising effects; however, their comparative effectiveness remains largely unknown. To address this issue, a network meta-analysis will be performed. We aim to develop a hierarchy of existing psychological treatments concerning their efficacy and tolerability, which will inform treatment guidelines. Protocol: Randomized controlled trials (RCTs) investigating psychological interventions for first-episode psychosis, first-episode schizophrenia, or early phase schizophrenia will be included. The primary outcome will be overall schizophrenia symptoms (measured up to 6 and 12 months, and at the longest follow-up) and relapse as a co-primary outcome. Secondary outcomes are premature discontinuation; change in positive, negative, and depressive symptoms of schizophrenia; response; quality of life; overall functioning; satisfaction with care; adherence; adverse events; and mortality. The study selection and data extraction are performed by two independent reviewers. We will assess the risk of bias of each study using the Cochrane Risk of Bias tool 2 and evaluate the confidence in the results using Confidence in Network Meta-Analysis (CINeMA). Subgroup and sensitivity analyses will be conducted to explore heterogeneity and assess the robustness of our findings. Discussion: This systematic review and network meta-analysis aims to compare multiple existing psychological interventions, establishing which are best for symptom reduction, relapse prevention, and other important outcomes in early phase schizophrenia. Our results may provide practical guidance concerning the most effective psychological intervention to reduce symptom severity and the societal burden associated with the disorder.

An embedded qualitative study of the experiences of people with dementia, their caregivers and volunteer older adults who participated in the CREST resilience-building psychosocial intervention.

BACKGROUND: A novel Complex REsilience-building psychoSocial intervenTion (CREST) targeted at people with dementia, their informal carers, general practitioners and the wider community with the aim of increasing resilience and strengthening the personal attributes or external assets of people with dementia living at home, in the community, was developed. It included three components: cognitive stimulation therapy (CST), physical exercise and dementia education. A non-randomised feasibility study was conducted of the CREST intervention, the aim of which was to inform the design of a future randomised controlled trial. This article presents the findings from the qualitative component of the CREST intervention feasibility study, describing the experience of the people with dementia and their caregivers who participated and the volunteer older adults who supported the intervention. METHODS: A descriptive qualitative research approach using semi-structured interviews was undertaken. Key stakeholders (people with dementia (n = 9), their caregivers (n = 9) and the volunteer older adults from the physical exercise component (n = 9)) were interviewed about the intervention and the perceived impact of their participation. RESULTS: The social aspect of the CREST intervention proved to be important for all three groups. Attendance remained high throughout the intervention. The people with dementia spoke positively about their participation in the CST and exercise components of the CREST intervention. The caregivers liked receiving coping strategies focused on how to communicate better with the person they cared for and how to better manage their own self-care and they liked the group element of the programme. The volunteer older adults supported the people with dementia in taking part in the exercise component, motivating them to do the exercises and helping with social interaction within the group. The volunteers gained exposure to the illness and as a result understood more about dementia and felt better equipped to communicate and deal with people with dementia. CONCLUSION: Participation in the CREST intervention produced a positive impact on all three groups. The social element of the intervention was noted by everybody and was regarded as being beneficial. Qualitative insights emphasised the value of embedding qualitative research within feasibility studies to inform future intervention design. Further research should focus on conducting a full-scale randomised controlled trial to evaluate CREST's effectiveness and explore its application to individuals with more advanced dementia. TRIAL REGISTRATION: ISRCTN25294519.

Effectiveness of structured, multidisciplinary long-term care for pediatric cancer survivors: protocol of the multicenter, randomized-controlled AELKI study.

BACKGROUND: In Germany, around 2.250 children and adolescents are diagnosed with cancer each year. Despite generally positive long-term survival rates, many patients must cope with late effects of the disease and its treatment. This highlights the need for a well-structured, long-term approach addressing both physical and mental health issues. Currently, the German healthcare system lacks such comprehensive structures. Our study aims to evaluate the effectiveness of a structured, multidisciplinary long-term approach compared to conventional "treatment as usual" (TAU). METHODS: A prospective, multicenter study with ten pediatric university clinics in Germany will be conducted. The cluster-randomization takes place at the clinic level. Children and adolescents who completed their cancer treatment at least five years ago and their parents will be eligible to participate. While the control group (CG) receives TAU, the intervention group (IG) participates in a structured program. This program includes risk-based medical treatment and psychosocial interventions tailored to each patient's individual needs within a two-month timeframe. The primary outcome is the improvement of self-efficacy. Secondary outcomes are satisfaction with health care, improvement of health-related quality of life (HRQoL), reduction of mental health problems, and improvement of transition readiness. DISCUSSION: This approach has the potential to optimize the health care for individuals who survived cancer during childhood or adolescence. It addresses the challenges of overuse, underuse, and misuse of health care resources. By considering both medical and psychosocial factors and promoting increased self-efficacy, independent from parental involvement, it may facilitate a smoother transition to adult medicine and enhance adherence to lifelong aftercare. If proven successful, this approach will contribute to the integration of multidisciplinary strategies into standard healthcare practice. TRIAL REGISTRATION: German Clinical Trials Register DRKS00029269. Registered on December 23, 2022.

Supporting Carers: Study Protocol of a Meta-Review of Psychosocial Interventions for Carers of People With Cancer.

BACKGROUND: While there is a clear need for psychosocial interventions that promote the well-being of carers of patients with cancer, the corresponding evidence base is disparate, complex, and difficult for end users to navigate and interpret. Carers remain undersupported with a lack of dedicated, effective, evidence-based programs. We will conduct a meta-review to synthesize this evidence and determine the state of science in this field. OBJECTIVE: This study aims to address the question, "what psychosocial interventions are available to promote the well-being of carers for people with cancer?" METHODS: A meta-review will synthesize the relevant reviews of psychosocial interventions that have been developed and evaluated with carers for people with cancer. A total of 4 electronic databases (PsycInfo, MEDLINE, CINAHL, and Cochrane Database of Systematic Reviews) will be searched for reviews published between January 2013 and December 2023. A team-based approach will be taken for screening and assessment of the returned records against the eligibility criteria to determine inclusion. Included reviews will be critically appraised using the Joanna Briggs Institute Critical Appraisal Checklist for Systematic Reviews and Research Syntheses. Relevant data on study characteristics, carer and patient populations, intervention details, and psychosocial outcomes will be extracted, synthesized, and the findings will be presented in a narrative format. RESULTS: It is anticipated that the study will be completed by October 2024. CONCLUSIONS: Ensuring that carers have access to evidence-based programs that promote their well-being as they care for loved ones is critical. This meta-review will contribute to program development and translation efforts by providing a clear picture of the intervention evidence base of carers of patients with cancer and identifying notable strengths, weaknesses, and gaps across the literature. The findings are anticipated to offer future directions to advance research in the field. TRIAL REGISTRATION: PROSPERO (CRD42023403219); https://tinyurl.com/4tnzv49s. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56403.

Putting person-centred psychosocial diabetes care into practice: two psychosocial care pathways based on outcome preferences of people with diabetes and healthcare professionals.

BACKGROUND: Diabetes increases the risk of psychosocial health problems. Person-centred psychosocial care is therefore advocated. However, several barriers to implementation exist, including uncertainty about how to approach psychosocial problems in consultations. OBJECTIVE: We aimed to explore which psychosocial outcomes patients and healthcare professionals consider important and whether certain characteristics are associated with this. We propose strategies for facilitating psychosocial diabetes care on this basis. METHODS: The results of an international Delphi study aimed at achieving multi-stakeholder consensus on a diabetes outcome set were analysed. We compared the importance ratings of the two stakeholder groups for each psychosocial outcome. A multivariable linear regression analysis tested whether certain characteristics would predict the importance attributed to outcomes that were not generally considered important. FINDINGS: Patients and healthcare professionals agreed on the importance of regularly assessing psychological well-being, diabetes distress and diabetes-specific quality of life, while they regarded it as less important to monitor depression, anxiety, eating problems, social support and sexual health. Being a woman, younger and living with type 1 diabetes were associated with considering it important to assess eating problems. CONCLUSIONS: We propose two psychosocial care pathways that reflect the outcome preferences of patients and healthcare providers. They follow a stepped approach, starting with the assessment of psychological well-being and quality of life and proceeding from there. CLINICAL IMPLICATIONS: Adopting this approach can facilitate the implementation of person-centred psychosocial diabetes care by reducing the burden and making psychosocial issues more accessible. This approach should be tested for feasibility, safety and effectiveness.

Effectiveness of psychological interventions to decrease cognitive fusion in patients with chronic pain: A systematic review and meta-analysis.

OBJECTIVE: While there is sufficient evidence of Acceptance and Commitment Therapy's effectiveness in allowing patients to deal with chronic pain, the effectiveness in cognitive fusion, one of the six core components of the Psychology Flexibility Model, has yet to be established. The aim of this article is to assess whether psychological interventions decrease cognitive fusion. METHODS: The Web of Science, SCOPUS, Medline, and PsycINFO databases were searched for primary studies up to June 2024. Studies with a cognitive fusion measure in which chronic pain patients received a psychological intervention were included. A methodological quality scale was applied to the selected studies and the average effect sizes (Hedges g) were calculated. RESULTS: This review included 18 articles with 24 studies (19 pre-post/follow-up studies and five randomized control trials). Cognitive fusion decreased significantly after the intervention. The effect sizes were small/medium at post-test, g = -0.39, p < .001, 95% CI [-0.52, -0.26]; and medium at long-term follow-up, g = -0.55, p < .001, 95% CI [-0.74, -0.36]. A similar tendency was found for studies with RCTs at post-test, g = -0.61, p = .006, 95% CI [-1.05, -0.17], short-term follow-up, g = -0.79, p < .001, 95% CI [-1.18, -0.40] and long-term follow-up, g = -0.58, p = .003, 95% CI [-0.95, -0.20]). Moderator variables such as unemployment, gender, pain intensity, level of depression before the intervention, and duration and intervention modality were identified. CONCLUSION: Psychological interventions tended to decrease cognitive fusion in chronic pain patients. Nonetheless, more clinical trials are needed to establish the role of cognitive fusion in psychological flexibility.

Psychosocial interventions for improving the physical health of young people and adults with attention deficit hyperactivity disorder: a scoping review.

BACKGROUND: Young people and adults with ADHD are at risk of a range of physical health problems. There is limited guidance on how to approach health problems in ADHD, and especially around 16-25 year olds who will be transitioning from paediatric to adult care. The aim of this scoping review was to identify psychosocial interventions that target physical health in young people and adults with ADHD. METHODS: We constructed searches in MEDLINE, PsycInfo, EMBASE of adolescents, young people and adults. Inclusion criteria were; studies of psychosocial interventions examining a component of physical health, applicable to people aged 16-25, with clinical or research diagnoses of ADHD. Data were extracted using a data extraction tool and tabulated, including study intervention framing/aims, population, intervention, and relevant outcomes (including specific statistics where relevant). RESULTS: Our search identified 22 unique papers covering, psychosocial interventions targeting at least one of sleep (n=7), smoking (n=3), substance/alcohol use (n=4), physical health/exercise (n=6) and general health (n=3). Studies examined psychotherapy/behaviour interventions (n=12), psychoeducation (n=4), digital (n=2) and social interventions (n=4). There was significant heterogeneity in intervention framing, outcome measures and population. CONCLUSION: Further work on the impact of targeted physical health interventions, with explicit reference to a conceptual framework of poor health in ADHD is required. Furthermore, future work standardising reporting of physical health outcomes in ADHD is crucial for the development of an evidence base in this field.

Psychological intervention based on cognitive behavioral therapy for patients with orthopedic surgical anxiety.

To develop a set of cognitive behavioral therapies (CBTs) to alleviate anxiety in orthopedic surgery (OS) patients, to explore the intervention effects of CBTs on the indicators of anxiety, sleep quality, and pain sensation in OS patients, and to promote them. A total of 68 qualified subjects were selected from among the 103 patients with orthopedic diseases who were hospitalized in the orthopedic department of the hospital between June 2022 and November 2023. According to the different nursing methods, they were divided into a psychological intervention (PI) group and a control intervention group. Among them, 34 patients received hospital-developed CBT for OS in the PI group, and 34 patients received standard orders from the medical staff in the control intervention group. Tools such as self-assessment of anxiety, Athens insomnia scale, state anxiety scale, visual analog pain method, and self-management level scale were utilized to assess the change in anxiety levels, sleep quality, pain perception, and self-management level of the 2 groups of patients before and after the surgery. Following the CBT intervention, patients in the PI group had significantly lower Athens insomnia scale (5.32 ±â€…0.42), state anxiety scale (38.21 ±â€…1.12), and visual analog pain method (3.93 ±â€…1.24) scores than those in the control intervention group. This difference was statistically significant (P < .05). In the meantime, patients in the PI group had a substantially higher correct rate of illness cognition assessment (98.21%) than patients in the control intervention group (65.12%), and this difference was statistically significant (P < .05). The study collated the factors affecting anxiety in OS patients through questionnaire survey and statistical analysis experiment and then formulated a detailed CBT strategy for specific problems. Finally, CBT is a valuable tool for reducing anxiety in OS patients. As such, it deserves to be promoted and used in clinical settings.

Exploring the return-on-investment for scaling screening and psychosocial treatment for women with common perinatal mental health problems in Malawi: Developing a cost-benefit-calculator tool.

This study sought to develop a user-friendly decision-making tool to explore country-specific estimates for costs and economic consequences of different options for scaling screening and psychosocial interventions for women with common perinatal mental health problems in Malawi. We developed a simple simulation model using a structure and parameter estimates that were established iteratively with experts, based on published trials, international databases and resources, statistical data, best practice guidance and intervention manuals. The model projects annual costs and returns to investment from 2022 to 2026. The study perspective is societal, including health expenditure and productivity losses. Outcomes in the form of health-related quality of life are measured in Disability Adjusted Life Years, which were converted into monetary values. Economic consequences include those that occur in the year in which the intervention takes place. Results suggest that the net benefit is relatively small at the beginning but increases over time as learning effects lead to a higher number of women being identified and receiving (cost­)effective treatment. For a scenario in which screening is first provided by health professionals (such as midwives) and a second screening and the intervention are provided by trained and supervised volunteers to equal proportions in group and individual sessions, as well as in clinic versus community setting, total costs in 2022 amount to US$ 0.66 million and health benefits to US$ 0.36 million. Costs increase to US$ 1.03 million and health benefits to US$ 0.93 million in 2026. Net benefits increase from US$ 35,000 in 2022 to US$ 0.52 million in 2026, and return-on-investment ratios from 1.05 to 1.45. Results from sensitivity analysis suggest that positive net benefit results are highly sensitive to an increase in staff salaries. This study demonstrates the feasibility of developing an economic decision-making tool that can be used by local policy makers and influencers to inform investments in maternal mental health.

A Systematic Review and Narrative Synthesis Examining the Facilitators and Barriers of Psychological Intervention Delivery in Crisis Resolution Home Treatment Teams.

BACKGROUND: Mental health crisis rates in the United Kingdom are on the rise. The emergence of community mental health models, such as Crisis Resolution Home Treatment Teams (CRHTTs), offers a vital pathway to provide intensive assessment and treatment to individuals in their homes, including psychological interventions. Previous qualitative literature has identified facilitators and barriers to the implementation of psychological interventions within CRHTT settings; however, a synthesis of this literature has not yet been conducted. To address this gap, a systematic review was undertaken with the aim of identifying the reported facilitators and barriers of implementing evidence-based psychological interventions in CRHTTs. METHOD: A systematic review and narrative synthesis were conducted. Studies were included if they examined the implementation of evidence-based psychological interventions in a CRHTT setting. The study population had to be 18 and over and could include healthcare professionals working in CRHTTs, service users of CRHTTs, or family and carers of CRHTT service users. Studies of any formal research methodology were included. Four databases were searched (MEDLINE, CINAHL Plus, Embase and PsycINFO), along with Google Scholar, to identify eligible studies. RESULTS: Six studies were identified, using mixed qualitative and quantitative methodologies, with the predominant focus being the exploration of stakeholder perspectives on care implementation within CRHTTs, encompassing aspects including but not restricted to psychological care implementation. The literature was deemed to be of moderate to high quality. Facilitators included adapting psychological therapies, prioritizing the therapeutic relationship, increasing psychological skills and training of CRHTT staff and psychologically informed CRHTT models. The barriers identified included a medical model bias within teams, resource constraints and elements pertaining to CRHTT services. CONCLUSIONS: Further robust research in this area is imperative. We recommend that future research be implemented in the form of service evaluations and randomized controlled trials (RCTs) and that the principles of implementation science be used to assess and develop the evidence base for psychological intervention delivery in CRHTTs.

[Psychological interventions in the field of neurotraumatology during the acute care].

Neurotrauma means head or spine injury caused by an external force. Neurotraumatology care requires coordinated teamwork on the part of specialists, including psychological care as part of the multidisciplinary treatment team. Psychological interventions in the field of neurotraumatology aim to address the psychological consequences and challenges associated with head or spine injury. These interventions play a vital role in crisis intervention, promoting recovery, enhancing quality of life, and supporting individuals and their families in coping with the psychological impact of neurotrauma. Serious physical injuries always cause severe psychological consequences, both in short and long term. A critical accident is a sudden, unexpected, often directly life-threatening event that exceeds the individual's ability to respond and can create a potential crisis response, including suicidal risk, as well as the development of psychological disorders, in most cases acute stress disorder, adjustment disorder and post-traumatic stress disorder. Psychological interventions in neurotraumatology are often provided by a multidisciplinary team that may include psychologists, psychiatrists, social workers, and other healthcare professionals. These interventions are tailored to the unique needs and circumstances of each individual, with the goal of reducing psychological symptomps, promoting psychological well-being, adjustment, and overall recovery following neurotrauma. It is essential that not only patients who have experienced severe physical trauma, but also their family members have access to expert psychological support. This study summarizes psychological interventions during the treatment of neurotaruma patients at the intensive care unit.

[Multidimensional supportive psychological intervention in clinical practice teaching of andrological nursing].

OBJECTIVE: To examine the application of a novel pedagogical approach multidimensional supportive psychological intervention (MSPI) in the clinical practice teaching of andrological nursing care. METHODS: Using the Hamilton Depression Scale (HAMD), we assessed the psychology of 100 nursing interns about to enter clinical practice in the Department of Andrology from December 2021 to December 2022. We equally randomized the subjects into an experimental and a control group, the former receiving MSPI and the latter trained on the conventional teaching model without any psychological support intervention. RESULTS: Compared with the baseline, the HAMD scores were significantly decreased in the experimental group after intervention (12.4±2.1 vs 8.9±2.4, P<0.01), but increased in the controls (13.1±1.8 vs 14.7±1.9, P<0.01); the skill scores dramatically increased in the experimental group (82.6±4.7 vs 91.2±2.4, P<0.01), but decreased in the control group after intervention (81.0±3.5 vs 80.4±2.7, P = 0.28). CONCLUSION: MSPI can significantly enhance the learning enthusiasm of nursing students in a short period, reduce their psychological stress and improve teaching outcomes. This approach, combining psychology with teaching, can also strengthen the mental resilience of nursing students and better confront them with future professional challenges.

Barriers and facilitators to implementing psychosocial digital health interventions for older adults presenting to emergency departments: a scoping review protocol.

INTRODUCTION: Older adults can face challenges when seeking care from emergency departments (EDs) due to presenting with multiple comorbidities and non-specific symptoms. Psychosocial care is a possible target to help improve ED care for this population. It is possible that digital health technologies can be implemented within emergency settings to improve the provision of psychosocial care. However, it is unclear what the barriers and facilitators are to implementing digital psychosocial interventions for older adults presenting to the ED. Therefore, the scoping review aims to determine what are these barriers and facilitators. METHODS AND ANALYSIS: The scoping review will be conducted in line with the Joanna Briggs Institute guidelines and will use the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist. The databases Medline, Embase, PsycINFO and Scopus will be searched. The search strategy will be developed in consultation with a specialist research librarian and will cover three key concepts: EDs, digital health technologies and older adults. Additionally, the first 100 hits of a Google Scholar search will be screened for inclusion. We will include both qualitative and quantitative studies that investigate ED digital interventions for psychosocial care where the primary focus is the views, attitudes, experiences and perceptions of patients, families and staff. After extracting all data, analysis and synthesis will follow the 'best-fit framework synthesis' approach and the Theoretical Domains Framework will be used to identify barriers and facilitators. ETHICS AND DISSEMINATION: Ethics approval is not required for this scoping review since only publicly available data will be analysed and appraised. The findings of the scoping review will be disseminated through peer-reviewed publications and conference presentations.

Psychological Interventions for PTSD, Depression, and Anxiety in Child, Adolescent and Adult Forced Migrants: A Systematic Review and Frequentist and Bayesian Meta-Analyses.

OBJECTIVE: The number of forced migrants has been rising for years. Many forced migrants suffer from post-traumatic stress disorder (PTSD), depression, and/or anxiety and need treatment. Here, we evaluate the effectiveness of psychological interventions (CBT, EMDR, expressive/art, mindfulness, mixed elements, NET and psychoeducation) in reducing symptoms of PTSD, depression, and anxiety in forced migrants. DESIGN AND DATA SOURCES: Systematic searches in PubMed and Web of Science and searches of preprint servers and grey literature were performed (final search date: 1 September 2023). Random-effects frequentist and Bayesian meta-analyses were used for data synthesis. RESULTS: We included 84 studies on treatment effects in adults (pooled N = 6302) and 32 on children and adolescents (pooled N = 1097). Our data show a reduction in symptoms of PTSD, depression and anxiety symptoms in both adults and child/adolescent forced migrants. Pooled pre- to post-treatment effects (effect size Cohen's d) ranged from -1.03 to -0.26 for PTSD, from -0.91 to -0.11 for depression and from -0.91 to -0.60 for anxiety, without there being differences in outcome per study design (i.e., RCT comparison vs. non-RCT comparison vs. single arm treatment study). Treatment effects remained evident over follow-up, and not a single type of treatment stood out as being superior to other treatment types. Structural differences in populations (e.g., regarding country of origin) over studies, however, could have hampered the validity of the comparisons between study characteristics such as treatment type. CONCLUSION: Our findings support the effectiveness of psychological treatment in adult and child/adolescent forced migrants.

Protocol of a randomized controlled trial examining psychosocial enhancement and standard medication treatment for co-occurring opioid use and mental health disorders: A half fractional factorial randomized controlled trial.

BACKGROUND: The opioid epidemic disproportionately affects individuals with co-occurring opioid use and mental health disorders (COD), who often have poor treatment engagement. Multicomponent treatment models are popular solutions to increase treatment access and engagement for those with COD. Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking (MISSION) is a hybrid multicomponent linkage and treatment approach that provides assertive community outreach combined with psychosocial treatment. This protocol paper describes a randomized controlled trial comparing MISSION and medication for opioid use disorder (MOUD), its multicomponent parts along with MOUD, and MOUD treatment as usual (TAU) to assess improvements in health and social outcomes. METHODS: This study will use a half fractional factorial design and randomize 1000 patients with COD to one of five treatment conditions: (1) the full MISSION intervention plus MOUD; (2-4) a combination of two out of three MISSION components plus MOUD; or (5) TAU. Secondary aims include examination of mechanisms of action, economic evaluation of the implementation of MISSION and/or its components plus MOUD versus TAU, and exploratory predictive modeling to match optimal MISSION parts with patient needs. DISCUSSION: This randomized controlled trial will help determine the effectiveness of MISSION (or its parts) and MOUD compared to TAU to improve engagement in treatment, substance use, and mental health symptoms. This trial is the first to compare MISSION and its parts with MOUD versus TAU in a real-world treatment scenario to determine which components are necessary and sufficient to drive treatment outcomes according to patient needs.

Process evaluation of a New psychosocial goal-setting and manualised support intervention for Independence in Dementia (NIDUS-Family).

INTRODUCTION: We report a mixed-methods process evaluation embedded within a randomised controlled trial. We aimed to test and refine a theory of change model hypothesising key causal assumptions to understand how the New Interventions for Independence in Dementia Study (NIDUS)-Family (a manualised, multimodal psychosocial intervention), was effective relative to usual care, on the primary outcome of Goal Attainment Scaling (GAS) over 1 year. METHODS: In 2021-2022, intervention-arm dyads completed an acceptability questionnaire developed to test causal assumptions. We conducted qualitative interviews with dyads and intervention facilitators, purposively selected for diverse follow-up GAS scores. We collected observational data from intervention session recordings. We thematically analysed data, then integrated qualitative and quantitative data. RESULTS: 174/204 (85.3%) dyads allocated to NIDUS-Family, fully completed it, 18 partially completed, while 12 received no intervention. We interviewed 27/192 (14%) of dyads receiving any sessions, and 9/10 facilitators; and observed 12 sessions. 47/192 (24.5%) of carers completed the acceptability questionnaire. We identified four themes: (A) 'Someone to talk to helps dyads feel supported'; (B) 'NIDUS-Family helps carers change their perspective'; (C) 'Personalisation helps people living with dementia maintain their identity' and (D) 'Small steps help dyads move forward'. CONCLUSION: Key causal pathway mechanisms were: a respectful, trusting and impartial relationship with the facilitator: supporting the development of meaningful goals and support to find manageable solutions. Core implementation factors were delivery of the modules from a consistent facilitator across regular sessions. Core contextual factors influencing these mechanisms were dyadic participation and understanding of abilities.

Addressing mental illness stigma in German higher education: study protocol for a mixed-methods evaluation of a psychosocial setting-based intervention.

INTRODUCTION: Mental illness stigma is associated with a range of negative consequences, such as reduced help-seeking for mental health problems. Since stigma affects individual, social, and structural aspects, multilevel interventions such as the Canadian programme The Working Mind have been proven to be the most effective. Given the solid evidence base for The Working Mind, it is our aim to implement and evaluate culturally adapted versions of the programme in German higher education, targeting students, employees and managers. METHODS AND ANALYSIS: We will evaluate the programme with regard to its effect on mental illness stigma, openness to mental health problems, willingness to seek help, and positive mental health outcomes. Further, we will investigate the programme's effectiveness dependent on gender and personal values, various mechanisms of change, and factors facilitating and hindering implementation. The study uses a sequential explanatory mixed-methods evaluation design (QUAN → qual) that consists of three steps: (1) quasi-experimental online survey with programme participants, (2) focus groups with programme participants, and (3) qualitative interviews with programme stakeholders. The quantitative data collected in step 1 will be analysed using 2×3 analysis of variances and a parallel multiple mediation analysis. The results will inform the qualitative data to be collected in steps 2 and 3, which will be analysed using qualitative content analysis. ETHICS AND DISSEMINATION: The study was approved by the local Ethics Committee (Ethics Committee of University Medicine Greifswald; BB 098/23). Participants have to provide written consent before taking part in a focus group or interview. As for the online survey, participants have to give their consent by agreeing to an online data protection form before they can start completing the survey. We will publish central results and the anonymised data in an Open Access Journal. Further, the statistical code will be included as a supplement to the paper(s) documenting the results of the study. TRIAL REGISTRATION NUMBER: DRKS00033523.

Multiple mediation analysis of a task-shared psychosocial intervention for perinatal anxiety: Exploratory findings from a randomized controlled trial in Pakistan.

BACKGROUND: The "Healthy Mother Healthy Baby" (HMHB) study is a phase three, single-blind randomized clinical trial conducted at Holy Family Hospital (HFH) in association with Rawalpindi Medical University (RMU). We aimed to examine the mediators of a specialized psychosocial approach based on Cognitive Behavioural Therapy principles, targeting pregnant women experiencing anxiety. The HMHB intervention was effective in treating perinatal anxiety symptoms and preventing future depressive episodes. METHODS: The trial randomized participants into two arms: the HMHB intervention or Enhanced Usual Care (EUC), following World Health Organization guidelines. The HMHB intervention comprised strategies to strengthen social support networks, improving mother-baby bonding and strategies to deal with interpersonal conflicts, economic challenges, and societal gender preferences using cognitive and behavioural techniques and culturally resonant illustrations. Participants underwent rigorous data collection at three pivotal timepoints: baseline, third trimester, and 6-weeks postnatal. The primary outcome was anxiety symptom severity scores using the Hospital Anxiety and Depression Scale (HADS) at 6-weeks post-childbirth. Four potential mediators - social support, behavioural activation, perceived stress, and pregnancy experience - were assessed in the third trimester of pregnancy. RESULTS: A total of 1200 participants were randomized to the HMHB and EUC arms. In the six-week follow-up time point, 379 participants remained in the EUC group, and 387 continued in the HMHB group. Post-intervention, HMHB participants displayed significant improvements in postnatal anxiety and depression scores. Mediation analyses revealed social support and pregnancy hassles as significant mediators of the intervention's effect on postnatal anxiety outcomes, while only social support emerged as a significant mediator for depression outcomes. CONCLUSION: The HMHB intervention showed promising results in improving anxiety and depression scores among pregnant women. Significant mediation effects suggest the importance of targeting social support and managing pregnancy-related hassles for optimal intervention effectiveness.