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Effectiveness of the Japanese standard family psychoeducation on the mental health of caregivers of young adults with schizophrenia: a randomised controlled trial.

ABSTRACT: BACKGROUND:This study examined the effects of the standard model of family psychoeducation (SM-FPE) in Japan on the mental health of relatives who care for young patients with a psychotic disorder. METHODS:Stratified by recent-onset/chronic psychosis, 74 caregivers of outpatients aged 30.1?years (mean) were randomly assigned to receive TAU (treatment as usual) alone or TAU plus SM-FPE. All outcomes were measured at baseline, at the end of the intervention (10?weeks), and 1?month post-intervention (14?weeks). The primary outcome was the trait anxiety of caregivers at 14?weeks. Secondary outcomes included caregivers' state anxiety, psychological distress, care burden, and expressed emotion. Integrating these secondary outcomes, a conceptual framework of caregivers' health state was assessed via structural equation modelling. RESULTS:Compared with TAU alone, SM-FPE plus TAU did not significantly improve all caregivers' individual outcomes. Direct effects of the intervention were observed in the caregivers of chronic patients as significant improvements of their overall mental health state at 10?weeks, which indirectly continued until 14?weeks. However, such intervention effects were not observed in the caregivers of recent-onset patients. CONCLUSIONS:The lack of effectiveness in the recent-onset stage suggests that the usefulness of the SM-FPE needs to be corroborated by further research. TRIAL REGISTRATION:The study protocol was retrospectively registered at ClinicalTrials.gov (registration number: NCT01731977; date of registration: 22 November 2012).

SUBMITTER: Shiraishi N

PROVIDER: S-EPMC6719377 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Effectiveness of the Japanese standard family psychoeducation on the mental health of caregivers of young adults with schizophrenia: a randomised controlled trial.

Shiraishi Nao N Watanabe Norio N Katsuki Fujika F Sakaguchi Hajime H Akechi Tatsuo T

BMC psychiatry 20190902 1

<h4>Background</h4>This study examined the effects of the standard model of family psychoeducation (SM-FPE) in Japan on the mental health of relatives who care for young patients with a psychotic disorder.<h4>Methods</h4>Stratified by recent-onset/chronic psychosis, 74 caregivers of outpatients aged 30.1 years (mean) were randomly assigned to receive TAU (treatment as usual) alone or TAU plus SM-FPE. All outcomes were measured at baseline, at the end of the intervention (10 weeks), and 1 month p ...[more]

PMID: 31477061

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Project description:IntroductionSchizophrenia is recognized for its severe impact on both patients and caregivers. In a 12-month follow-up randomized clinical trial, we aimed to measure the efficacy of a brief family psychoeducation program in terms of reducing relapse risk and improving medication adherence in patients, as well as reducing caregiver burden, depression and increasing knowledge of the illness.MethodsA total of 25 days of patients with schizophrenia (DSM-IV-TR) and family primary caregivers were recruited in a single regional psychiatric outpatient facility located in Bordeaux. In the active group, caregivers received a psychoeducational intervention consisting of six sessions spread over 1.5 months, while the control group was placed on a waiting list. Sociodemographic, symptom severity (PANSS) and medication adherence (MARS) from patients were assessed at baseline and relapse rates was recorded during the 12 months follow-up period. Caregivers' burden (ZBI), depression (CES-D), quality of life (S-CGQoL), knowledge of the disease (KAST) and therapeutic alliance (4PAS-C) were assessed at baseline, three and 6 months.ResultsOn the 25 patients included, the mean age was 33.3 years (SD = 9.7) with a mean duration of disease of 7.48 years (SD = 7.1). On the 25 caregivers included, the mean age was 50.6 years (SD = 14.0). Twenty-one were female (84.0%), 12 were married (48.0%) and 11 lived alone (44.0%). For patients, the family psychoeducation intervention significantly reduced the risk of relapse with a significant effect found at 12 months follow-up (p = 0.014). No change was observed on medication adherence. For caregivers, the intervention reduced the burden (p = 0.031), decreased the depression (p = 0.019), and increased the knowledge on schizophrenia (p = 0.024). Analyzes for repeated measures showed a statistically significant difference in therapeutic alliance (p = 0.035).ConclusionAs confirmed by previous studies, the brief multifamily program (consisting of six sessions over a period of 1.5 months) was found to be effective in improving outcomes for caregivers (e.g., burden, depression, knowledge) and patients (e.g., preventing relapse) in the context of routine care. Given its short duration, this program is expected to be easily implementable within the community.Clinical trial registrationhttps://clinicaltrials.gov/, NCT03000985.

Project description:INTRODUCTION:Development of a support system for families caring for people with schizophrenia in routine psychiatric care settings is an important issue worldwide. Regional mental health systems are inadequate for delivering effective services to such family members. Despite evidence that family psychoeducation (FPE) alleviates the burden of schizophrenia on families, its dissemination in routine clinical practice remains insufficient, suggesting the need for developing an effective and implementable intervention for family caregivers in the existing mental health system setting. In Japan, the visiting nurse service system would be a practical way of providing family services. Visiting nurses in local communities are involved in the everyday lives of people with schizophrenia and their families. Accordingly, visiting nurses understand their needs and are able to provide family support as a service covered by national health insurance. The purpose of this study is to discover whether a brief FPE programme provided by visiting nurses caring for people with schizophrenia will alleviate family burden through a cluster randomised controlled trial (cRCT). METHODS AND ANALYSIS:The study will be a two-arm, parallel-group (visiting nurse agency) cRCT. Forty-seven visiting nurse agencies will be randomly allocated to the brief FPE group (intervention group) or treatment as usual group (control group). Caregivers of people with schizophrenia will be recruited by visiting nurses using a randomly ordered list. The primary outcome will be caregiver burden, measured using the Japanese version of Zarit Burden Interview. Outcome assessments will be conducted at baseline, 1-month follow-up and 6-month follow-up. Multiple levels of three-way interactions in mixed models will be used to examine whether the brief FPE programme will alleviate the burden on caregivers relative to treatment as usual. ETHICS AND DISSEMINATION:The Research Ethics Committee of the Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Japan (No 2019065NI) approved this study. The results will be published in a scientific peer-reviewed journal. TRIAL REGISTRATION NUMBER:UMIN000038044.

Project description:BACKGROUND:Schizophrenia can be a severe and chronic illness characterised by lack of insight and poor compliance with treatment. Psychoeducational approaches have been developed to increase patients' knowledge of, and insight into, their illness and its treatment. It is supposed that this increased knowledge and insight will enable people with schizophrenia to cope in a more effective way with their illness, thereby improving prognosis. OBJECTIVES:To assess the effects of psychoeducational interventions compared with standard levels of knowledge provision. SEARCH STRATEGY:We searched the Cochrane Schizophrenia Group Trials Register (February 2010). SELECTION CRITERIA:All relevant randomised controlled trials focusing on psychoeducation for schizophrenia and/or related serious mental illnesses involving individuals or groups. We excluded quasi-randomised trials. DATA COLLECTION AND ANALYSIS:At least two review authors extracted data independently from included papers. We contacted authors of trials for additional and missing data. We calculated risk ratios (RR) and 95% confidence intervals (CI) of homogeneous dichotomous data. We used a fixed-effects model for heterogeneous dichotomous data. Where possible we also calculated the numbers needed to treat (NNT), as well as weighted means for continuous data. MAIN RESULTS:This review includes a total of 5142 participants (mostly inpatients) from 44 trials conducted between 1988 and 2009 (median study duration ˜ 12 weeks, risk of bias - moderate). We found that incidences of non-compliance were lower in the psychoeducation group in the short term (n = 1400, RR 0.52 CI 0.40 to 0.67, NNT 11 CI 9 to 16). This finding holds for the medium and long term. Relapse appeared to be lower in psychoeducation group (n = 1214, RR 0.70 CI 0.61 to 0.81, NNT 9 CI 7 to 14) and this also applied to readmission (n = 206, RR 0.71 CI 0.56 to 0.89, NNT 5 CI 4 to 13). Scale-derived data also suggested that psychoeducation promotes better social and global functioning. In the medium term, treating four people with schizophrenia with psychoeducation instead of standard care resulted in one additional person showing a clinical improvement. Evidence suggests that participants receiving psychoeducation are more likely to be satisfied with mental health services (n = 236, RR 0.24 CI 0.12 to 0.50, NNT 5 CI 5 to 8) and have improved quality of life. AUTHORS' CONCLUSIONS:Psychoeducation does seem to reduce relapse, readmission and encourage medication compliance, as well as reduce the length of hospital stay in these hospital-based studies of limited quality. The true size of effect is likely to be less than demonstrated in this review - but, nevertheless, some sort of psychoeducation could be clinically effective and potentially cost beneficial. It is not difficult to justify better, more applicable, research in this area aimed at fully investigating the effects of this promising approach.

Project description:The aim of this study was to evaluate the effect of psychoeducation on return to work as an adjunct to standard case management in individuals on sick leave at risk of having a mental disorder. The participants could have different diagnoses but were all at risk of having a mental disorder.Between 2012 and 2014, 430 participants on sick leave were randomly allocated to either an intervention or control group. The psychoeducation consisted of 2-h sessions once a week for 6 weeks. The sessions focused on stress and work life and was based on problem-solving techniques and coping strategies. The main outcome, the relative risk (RR) of a full return to work based on register data from the job centres, was determined during the first 3 and 6 months after participation in the psychoeducation programme. At baseline and at 3 and 6 months after the intervention, the participants received a questionnaire on psychological symptoms, mental health-related quality of life, and locus of control.During the first 6 months after inclusion, the two groups had almost the same RR of a full return to work (RR:0.97, 95% CI: 0.78;1.21), but during the first 3 months, the individuals in the intervention group had a significantly higher risk of not having fully returned to work (RR:0.68, 95% CI:0.47;0.98). The individuals in the intervention group who had participated in at least four of the six psychoeducational sessions returned to work considerably slower at both time points than did the control group. The intervention did not decrease the level of psychological symptoms or improve mental health-related quality of life; however, individuals in the intervention group improved their scores on internal locus of control at both 3 and 6 months.Offering psychoeducation to individuals on sick leave at risk of having a mental disorder had no influence on the chance of a full return to work during the first 6 months; however, it did result in a higher relative risk of not returning to work after 3 months. Therefore, we do not recommend offering psychoeducation in this form to facilitate return to work.Clinical Trial.gov NCT01637363. Registered 6 July 2012.

Project description:BackgroundEmotion dysregulation has emerged as a transdiagnostic factor that potentially exacerbates the risk of early-onset, maintenance, and relapse of psychosis. Mindfulness is described as the awareness that emerges from paying attention to the present moment without judgment. It gently pulls the mind out of the negative emotions induced by the disparity between expectation and reality by focusing on the present moment, instead of worrying about the future or regretting the past. However, only a few research has ever focused on the efficacy of using a mindfulness-based intervention to improve emotion regulation in schizophrenia spectrum disorders.PurposeThe purpose of this study was to examine the effectiveness of a Mindfulness-Based Psychoeducation Programme (MBPP) on the emotion regulation of individuals with schizophrenia, in particular, to access emotion regulation strategies. The objective of this study was to find out whether MBPP is feasible for improving emotion regulation strategies, in terms of rumination, cognitive reappraisal, and expressive suppression, with a sustainable effect at a three-month follow-up.Patients and methodsA single-blinded pilot randomised controlled trial with repeated-measures designs was adopted. Forty-six participants diagnosed with schizophrenia and its subtypes were randomised in either the 8-week mindfulness-based psychoeducation programme or treatment-as-usual (control) group.ResultsThe results of the Generalised Estimating Equations test indicated that the MBPP group showed a significant improvement in reappraisal at a three-month follow-up (β = -6.59, Wald's χ 2=4.55, p=0.033), and a significant reduction in rumination across time. However, the Generalised Estimating Equations indicated no significant difference in rumination and expressive suppression in the MBPP group. Two participants reported having unwanted experiences, including feelings of terror and distress during the mindfulness practice.ConclusionThe MBPP appeared to be effective for improving emotion regulation, which will contribute to future large-scale RCT to confirm the treatment effects in more diverse groups of schizophrenic patients.

Project description:BackgroundAlthough its effect has not been verified, family therapy - such as family psychoeducation (FPE) - is a widely used intervention for treating major depressive disorder (MDD). To our knowledge, no systematic review and meta-analysis exists that examines the effect of FPE on MDD.AimsTo assess evidence on the effectiveness of FPE on depressive symptoms in people with MDD.MethodWe searched several databases - including PubMed, MEDLINE and Web of Science, among others - to identify eligible studies on the topic published up to March 2022. Our criteria included studies on participants with a primary MDD diagnosis and their family members and excluded studies on people with bipolar disorders and other mental illnesses. In the included studies, family members in the control groups did not receive FPE. Participants in both the intervention and control groups received standard treatment. Two researchers independently selected relevant publications, extracted data and evaluated methodological quality using the Cochrane risk of bias assessment tool and GRADE evaluation. The protocol was registered with PROSPERO (no. CRD42020185884).ResultsThe meta-analysis included five studies with 301 patients with MDD and their family members. The effect of FPE on patients' symptom severity, compared with the control condition, at 16 weeks was available for five comparisons of four randomised control trials (RCTs); a final follow-up was available for six comparisons of five RCTs. The meta-analysis showed a statistically significant improvement in patients' symptoms, compared with control, at 16 weeks (s.m.d. = -0.52, 95% CI -1.03 to -0.01) and at a final follow-up (s.m.d. = -0.53, 95% CI -0.98 to -0.08). The meta-analysis on the effect of FPE on family functioning showed a non-significant improvement both at 16 weeks and at final follow-up.ConclusionsFPE had a small but statistically significant effect on depressive symptoms in people with MDD, in both the short and long term. However, according to the GRADE framework, all outcomes are graded very low on certainty; therefore, more high-quality research is needed.

Project description:BackgroundObservational evidence suggests that community-based services for people with schizophrenia can be successfully provided by community health workers, when supervised by specialists, in low-income and middle-income countries. We did the COmmunity care for People with Schizophrenia in India (COPSI) trial to compare the effectiveness of a collaborative community-based care intervention with standard facility-based care.MethodsWe did a multicentre, parallel-group, randomised controlled trial at three sites in India between Jan 1, 2009 and Dec 31, 2010. Patients aged 16-60 years with a primary diagnosis of schizophrenia according to the tenth edition of the International Classification of Diseases, Diagnostic Criteria for Research (ICD-10-DCR) were randomly assigned (2:1), via a computer-generated randomisation list with block sizes of three, six, or nine, to receive either collaborative community-based care plus facility-based care or facility-based care alone. Randomisation was stratified by study site. Outcome assessors were masked to group allocation. The primary outcome was a change in symptoms and disabilities over 12 months, as measured by the positive and negative syndrome scale (PANSS) and the Indian disability evaluation and assessment scale (IDEAS). Analysis was by modified intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN 56877013.Findings187 participants were randomised to the collaborative community-based care plus facility-based care group and 95 were randomised to the facility-based care alone group; 253 (90%) participants completed follow-up to month 12. At 12 months, total PANSS and IDEAS scores were lower in patients in the intervention group than in those in the control group (PANSS adjusted mean difference -3.75, 95% CI -7.92 to 0.42; p=0.08; IDEAS -0.95, -1.68 to -0.23; p=0.01). However, no difference was shown in the proportion of participants who had a reduction of more than 20% in overall symptoms (PANSS 85 [51%] in the intervention group vs 44 [51%] in the control group; p=0.89; IDEAS 75 [48%] vs 28 [35%]). We noted a significant reduction in symptom and disability outcomes at the rural Tamil Nadu site (-9.29, -15.41 to -3.17; p=0.003). Two patients (one in each group) died by suicide during the study, and two patients died because of complications of a road traffic accident and pre-existing cardiac disease. 18 (73%) patients (17 in the intervention group) were admitted to hospital during the course of the trial, of whom seven were admitted because of physical health problems, such as acute gastritis and vomiting, road accident, high fever, or cardiovascular disease.InterpretationThe collaborative community-based care plus facility-based care intervention is modestly more effective than facility-based care, especially for reducing disability and symptoms of psychosis. Our results show that the study intervention is best implemented as an initial service in settings where services are scarce, for example in rural areas.FundingWellcome Trust.

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Effectiveness of the Japanese standard family psychoeducation on the mental health of caregivers of young adults with schizophrenia: a randomised controlled trial.

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Effectiveness of the Japanese standard family psychoeducation on the mental health of caregivers of young adults with schizophrenia: a randomised controlled trial.

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