Effective provider communication for personal agency in mental health recovery: A cross-sectional study on Japanese users' perspectives.

WHAT IS KNOWN ON THE SUBJECT?: Recovery-oriented practices in community-based mental health services are of increasing importance. The recovery journey of individuals with mental illness starts with a sense of agency, and a therapeutic relationship with the providers who support them is a prerequisite. In Japan, the construction of community-based integrated care systems for individuals with mental illness is positioned as a priority health issue, with communication with familiar individuals being particularly important for recovery in Japanese and Asian cultures. WHAT THE PAPER ADDS TO EXISTING KNOWLEDGE?: This study is the first to examine effective communication factors for personal agency in the recovery of individuals with mental illness, focusing on addressing uncertainty about treatment choices and dissatisfaction with decision-making, and considering the user's personal recovery journey. In recovery-oriented practice, it is important to prioritize addressing the emotional aspects of decision-making alongside the mental illness condition, supporting users' self-determination in their unique recovery journeys. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: The findings emphasized the need to actively engage with users' perspectives and emotions, emphasize shared life planning, and foster a therapeutic relationship based on partnership. Providers should approach dialogue as carefully as medication prescriptions, prioritizing the establishment of an effective therapeutic relationship with the user. These characteristics are essential for developing a strong therapeutic relationship and effectively facilitating users' recovery. The findings are applicable not only to nurses but to all mental health service providers, contributing to the advancement of recovery-oriented practice. ABSTRACT: INTRODUCTION: Recovery-oriented practice in community-based mental health services is crucial for individuals with mental illness, with communication with familiar individuals being important for recovery in Japanese and Asian cultures. AIM: This study aimed to examine effective communication factors for personal agency in recovery by investigating the association between perceived support provided through communication and personal agency of individuals with mental illness. METHOD: A cross-sectional study was conducted among community-dwelling Japanese mental health service users, assessing subjective agency, decisional conflict, staff support for personal recovery, activation for mental health self-management, demographic variables and living difficulties. Multiple linear regression analysis identified factors predicting subjective agency, revealing characteristics of effective provider communication for recovery. RESULTS: Data from 222 users were analysed, revealing negative correlations between uncertainty about treatment choices and ineffective decision-making with higher subjective agency, while staff support for personal recovery positively correlated with higher subjective agency. DISCUSSION: In recovery-oriented practice, prioritizing users' emotional experiences during decision-making and supporting their self-determination in their unique recovery journeys is crucial. IMPLICATIONS FOR PRACTICE: Providers should approach dialogue as carefully as medication prescriptions, prioritizing therapeutic partnerships with users. The findings extend beyond nursing to all mental health service providers, advancing the theory of recovery-oriented practice.

Remote family education and support program for parents of patients with adolescent and early adulthood eating disorders based on interpersonal psychotherapy: study protocol for a pilot randomized controlled trial.

BACKGROUND: In cases of adolescent and early adulthood eating disorders, despite the importance of the patients' relationship with their parents, conflict and confusion frequently occur among them. Interpersonal psychotherapy (IPT) is a present-focused psychotherapy that emphasizes the interpersonal context of symptoms. We developed a remote family education and support program exclusively for parents of patients with eating disorders, based on the principle of IPT. The use of IPT is expected to reduce conflicts in the patient-parent relationship. Consequently, parents will be better able to listen to patients, and patients will be better able to express their thoughts and desires. In this study, we describe the protocol for a randomized controlled trial designed to examine the effectiveness of this program in promoting effective communication in their home based on active listening skills of parents of patients with adolescent and early adulthood eating disorders. METHODS: Participants will be parents of patients aged 12-29 years with adolescent and early adulthood eating disorders. Individually randomized, parallel-group trial design will be employed. Seventy participants will be allocated to one of two treatment conditions: (1) remote family education and support program (four, 150 min weekly group sessions) for parents plus treatment-as-usual for patients (consultation by physicians or no treatment), or (2) waiting for the control condition (parents will wait to start the program for 8 weeks) plus treatment-as-usual for patients. The primary outcome measure will be parents' active listening ability as measured by the Active Listening Attitude Scale at 8 weeks after randomization. Additionally, perception of social support (Social Provision Scale-10 item), loneliness (UCLA Loneliness Scale), mental health status (K6), family function (Family Assessment Device), and parent-evaluated eating disorder symptoms (Anorectic Behavior Observation Scale) will be assessed. Data from the intention-to-treat sample will be analyzed 8 weeks after randomization. DISCUSSION: This is the first study to evaluate the effectiveness of a family education and support program for parents of patients with adolescent and early adulthood eating disorders based on IPT. If this type of intervention is effective, although indirect, it could be a new support method for this patient population. TRIAL REGISTRATION: Clinical Trials. gov ID NCT05840614.

For patients with adolescent and early adulthood eating disorders, although the relationship with their parents is an important interpersonal dynamic, conflicts and confusion often arise between patients and their parents. On the other hand, parents who live with individuals with eating disorders are frequently involved in interpersonal disputes, leading to a heavy psychological burden and elevated levels of depression and anxiety. It has been found that highly depressed or anxious parents tend to have difficulty listening carefully to their patients. Additionally, parental anxiety often promotes an overprotective response. Interpersonal psychotherapy (IPT) is a present-focused psychotherapy that emphasizes the interpersonal context of symptoms. In IPT, the patient and therapist work within interpersonal therapeutic domains, such as interpersonal role disputes with different expectations and role transitions. We developed a remote family education and support program exclusively for parents of patients with eating disorders based on IPT principles. In the present study, we describe the protocol for a randomized controlled trial designed to examine the effectiveness of this program in promoting effective communication within their homes, focusing on the active listening skills of parents of patients with adolescent and early adulthood eating disorders.

Optimization of smartphone psychotherapy for depression and anxiety among patients with cancer using the multiphase optimization strategy (MOST) framework and decentralized clinical trial system (SMartphone Intervention to LEssen depression/Anxiety and GAIN resilience: SMILE AGAIN project): a protocol for a randomized controlled trial.

BACKGROUND: Cancer patients experience various forms of psychological distress. Their distress, mainly in the form of depression and anxiety, leads to poor quality of life, increased medical spending due to frequent visits, and decrease in treatment adherence. It is estimated that 30-50% among them would require support from mental health professionals: in reality, much less actually receive such support partly due to a shortage of qualified professionals and also due to psychological barriers in seeking such help. The purpose of the present study is to develop the easily accessible and the most efficient and effective smartphone psychotherapy package to alleviate depression and anxiety in cancer patients. METHODS: Based on the multiphase optimization strategy (MOST) framework, the SMartphone Intervention to LEssen depression/Anxiety and GAIN resilience project (SMILE-AGAIN project) is a parallel-group, multicenter, open, stratified block randomized, fully factorial trial with four experimental components: psychosocial education (PE), behavioral activation (BA), assertion training (AT), and problem-solving therapy (PS). The allocation sequences are maintained centrally. All participants receive PE and then are randomized to the presence/absence of the remaining three components. The primary outcome of this study is the Patient Health Questionnaire-9 (PHQ-9) total score, which will be administered as an electronic patient-reported outcome on the patients' smartphones after 8 weeks. The protocol was approved by the Institutional Review Board of Nagoya City University on July 15, 2020 (ID: 46-20-0005). The randomized trial, which commenced in March 2021, is currently enrolling participants. The estimated end date for this study is March 2023. DISCUSSION: The highly efficient experimental design will allow for the identification of the most effective components and the most efficient combinations among the four components of the smartphone psychotherapy package for cancer patients. Given that many cancer patients face significant psychological hurdles in seeing mental health professionals, easily accessible therapeutic interventions without hospital visits may offer benefits. If an effective combination of psychotherapy is determined in this study, it can be provided using smartphones to patients who cannot easily access hospitals or clinics. TRIAL REGISTRATION: UMIN000041536, CTR. Registered on 1 November 2020  https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000047301 .

Association between social support for mothers of patients with eating disorders and mothers' active listening attitude: a cohort study.

BACKGROUND: Family members of patients with eating disorders, especially their mothers, experience heavy caregiving burdens associated with supporting the patient. We predict that increasing caregivers' support will have a positive effect on their active listening attitudes, mental health, loneliness, and self-efficacy. This study aimed to investigate differences in mothers' active listening attitudes, mental health, loneliness, and self-efficacy improvements between mothers who did and did not experience increased perceived social support. MAIN BODY: Participants were mothers of patients with eating disorders. Questionnaires for this cohort study were sent to the participants' homes at three time points (baseline, 9 months, and 18 months). The Japanese version of the Social Provision Scale (SPS-10) was used to evaluate social support, the Active Listening Attitude Scale (ALAS) for listening attitude, the UCLA Loneliness Scale (ULS) for loneliness, the General Self-Efficacy Scale (GSES) for self-efficacy, the Beck Depression Inventory (BDI-II) for depression symptoms, and the K6 for psychological distress. An unpaired t-test was used to determine whether participants' status differed between the groups that did and did not experience increased perceived social support. The mean age of the participants was 55.1 ± 6.7 (mean ± SD) years. The duration of their children's eating disorders was 7.6 ± 5.5 years. The degree of improvement for each variable (active listening attitude, loneliness, self-efficacy, depressive symptoms, and mental health) was the difference in each score (ALAS, ULS, GSES, BDI-II, and K6) from T1 to T3. The degree of improvement in active listening attitude and loneliness was significantly greater in the improved social support group than in the non-improved social support group (p < 0.002 and p < 0.012, respectively). CONCLUSIONS: Our findings indicate that increasing mothers' perceptions of social support will be associated with improving their active listening attitudes and loneliness.

Smartphone Psychotherapy Reduces Fear of Cancer Recurrence Among Breast Cancer Survivors: A Fully Decentralized Randomized Controlled Clinical Trial (J-SUPPORT 1703 Study).

PURPOSE: Fear of cancer recurrence (FCR) is a common distressing condition. We investigated the efficacy of smartphone problem-solving therapy and behavioral activation applications in breast cancer survivors. METHODS: This was a decentralized randomized trial. Participants were disease-free breast cancer survivors age 20-49 years who were randomly assigned to the smartphone-based intervention or waitlist control. Both groups received treatment as usual. The control group could access the smartphone apps during weeks 8-24. The intervention comprised smartphone problem-solving therapy and behavioral activation apps. The primary end point was the Concerns About Recurrence Scale at week 8. Secondary outcomes included the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF), the Hospital Anxiety and Depression Scale (HADS), the Short-form Supportive Care Needs Survey (SCNS-SF34), and the Posttraumatic Growth Inventory at weeks 8 and 24 (trial registration: UMIN-CTR: UMIN000031140). RESULTS: The intervention group included 223 participants, and the control group included 224 participants. Primary outcome data were obtained for 444 participants, and 213 participants in the intervention arm completed the week 24 assessment. The intervention group had statistically greater improvements than controls at week 8 on the Concerns About Recurrence Scale (difference -1.39; 95% CI, -1.93 to -0.85; P < .001), FCRI-SF (difference -1.65; 95% CI, -2.41 to -0.89; P < .001), HADS depression (difference -0.49; 95% CI, -0.98 to 0; P < .05), and SCNS-SF34 psychological domain (difference -1.49; 95% CI, -2.67 to -0.32; P < .05). These scores at week 24 were not statistically significant compared with week 8 although the HADS depression score at week 24 was significantly reduced (P = .03). CONCLUSION: Novel smartphone psychotherapy offers a promising way to reduce FCR given the large number of survivors and a limited number of therapists to competently conduct psychotherapy.

Effectiveness of family psychoeducation for major depressive disorder: systematic review and meta-analysis.

BACKGROUND: Although 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. AIMS: To assess evidence on the effectiveness of FPE on depressive symptoms in people with MDD. METHOD: We 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). RESULTS: The 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. CONCLUSIONS: FPE 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.

Association between the social support for mothers of patients with eating disorders, maternal mental health, and patient symptomatic severity: A cross-sectional study.

BACKGROUND: Although caregivers of patients with eating disorders usually experience a heavy caregiving burden, the effects of social support on caregivers of patients with eating disorders are unknown. This study aimed to investigate how social support for mothers who are caregivers of patients with an eating disorder improves the mothers' mental status and, consequently, the symptoms and status of the patients. METHODS: Fifty-seven pairs of participants were recruited from four family self-help groups and one university hospital in Japan. Recruitment was conducted from July 2017 to August 2018. Mothers were evaluated for social support using the Japanese version of the Social Provisions Scale-10 item (SPS-10), self-efficacy using the General Self-Efficacy Scale, loneliness using the University of California, Los Angeles Loneliness Scale, listening attitude using the Active Listening Attitude Scale, family functioning using the Family Assessment Device, depression symptoms using the Beck Depression Inventory (Second Edition), and psychological distress using the Kessler Psychological Distress Scale. Patients were evaluated for self-esteem using the Rosenberg Self-Esteem Scale, assertion using the Youth Assertion Scale, and their symptoms using the Eating Disorder Inventory. We divided the mothers and patients into two groups based on the mean score of the SPS-10 of mothers and compared the status of mothers and patients between the high- and low-scoring groups. RESULTS: High social support for mothers of patients with eating disorders was significantly associated with lower scores for loneliness and depression of these mothers. We found no significant differences in any patient scores based on mothers' level of social support. CONCLUSIONS: For patients with eating disorders, social support for a caregiver cannot be expected to improve their symptoms, but it may help prevent caregiver depression and loneliness.

Brief collaborative care intervention to reduce perceived unmet needs in highly distressed breast cancer patients: randomized controlled trial.

OBJECTIVES: Our newly developed brief collaborative care intervention program has been suggested to be effective in reducing breast cancer patients' unmet needs and psychological distress; however, there has been no controlled trial to investigate its effectiveness. The purpose of this study was to examine the effectiveness of the program in relation to patients' perceived needs and other relevant outcomes for patients including quality of life, psychological distress and fear of recurrence (Clinical trial register; UMIN-CTR, Clinical registration number; R5172). METHODS: Fifty-nine highly distressed breast cancer patients receiving adjuvant chemotherapy and/or hormonal therapy were randomly assigned either to a treatment as usual group or to a collaborative care intervention, consisting of four sessions that mainly included assessment of the patients' perceived needs, learning skills of problem-solving treatment for coping with unmet needs and psycho-education provided by trained nurses supervised by a psycho-oncologist. RESULTS: Although >80% of the eligible patients agreed to participate, and >90% of participants completed the intervention, there were no significant differences with regard to patients' needs, quality of life, psychological distress and fear of recurrence, both at 1 and 3 months after intervention. CONCLUSION: Newly developed brief collaborative care intervention program was found to be feasible and acceptable. The trial, however, failed to show the effectiveness of the program on patients' relevant subjective outcomes. Further intervention program having both brevity and sufficient intensity should be developed in future studies.

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

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).

Smartphone problem-solving therapy to reduce fear of cancer recurrence among breast cancer survivors: an open single-arm pilot study.

OBJECTIVES: The purpose of this study was to investigate a newly developed smartphone problem-solving therapy (PST) application's feasibility and preliminary effectiveness for reducing fear of cancer recurrence (FCR) among breast cancer survivors. METHODS: Female disease-free breast cancer survivors aged 20-49 years who were more than 6 months post-breast surgery participated in the study. The patients received the smartphone PST using an iPhone or iPad for 8 weeks. The feasibility of the intervention program was evaluated using the overall participation rate, the percentage of survivors who expressed interest in the intervention, and the percentage of completion of the study. Patients were also asked to complete the Concern About Recurrence Scale (CARS) as a primary outcome at baseline, 4 weeks and 8 weeks. RESULTS: A total of 38 patients participated in this study. The overall participation and completion rates in the study were 47.1% and 97.4%, respectively. The overall fear assessed by CARS was significantly reduced at 8 weeks compared with baseline. A pairwise comparison showed a significant decrease from 4 weeks to 8 weeks and from baseline to 8 weeks. CONCLUSIONS: Smartphone PST, a novel brief intervention to reduce FCR, was well accepted by breast cancer survivors and yielded a favorable effect on FCR. The efficacy of this newly developed smartphone PST needs to be confirmed in a future well-designed randomized controlled trial.

Smartphone problem-solving and behavioural activation therapy to reduce fear of recurrence among patients with breast cancer (SMartphone Intervention to LEssen fear of cancer recurrence: SMILE project): protocol for a randomised controlled trial.

INTRODUCTION: One of the most common distressing conditions experienced by breast cancer survivors is fear of cancer recurrence (FCR). There is, however, no standard intervention for ameliorating FCR. Our clinical experience and previous studies have suggested the potential benefits of problem-solving therapy (PST) and behavioural activation (BA). Given the huge number of cancer survivors and limited number of therapists to competently conduct PST and BA, we have developed PST and BA smartphone applications. This study aimed to evaluate the efficacy of the smartphone-based PST (Kaiketsu-App) and BA (Genki-App) apps in reducing FCR in patients with breast cancer. METHODS AND ANALYSIS: The SMartphone Intervention to LEssen fear of cancer recurrence project is an open-label, individually randomised, parallel-group trial. Allocation will be managed by a central server using a computer-generated random allocation sequence provided by an independent data centre. Participants will be randomised to smartphone-based intervention plus treatment as usual (TAU) or waitlist control with TAU alone. The primary endpoint of the study is the Japanese version of the Concerns About Recurrence Scale, which will be administered as an electronic patient-reported outcome on the patients' smartphone after 8 weeks. ETHICS AND DISSEMINATION: The present study is subject to the ethical guidelines for clinical studies published by Japan's Ministry of Education, Science and Technology and Ministry of Health, Labour and Welfare and the modified Act on the Protection of Personal Information as well as the ethical principles established for research on humans stipulated in the Declaration of Helsinki and further amendments thereto. The protocol was approved by the Institutional Review Board of Nagoya City University on 15 January 2018 (ID: 60-00-1171). TRIAL STATUS: The randomised trial, which commenced on 2 April 2018, currently enrols participants. The estimated end date for this study is in March 2020. TRIAL REGISTRATION NUMBER: UMIN000031140; Pre-results.

Brief multifamily Psychoeducation for family members of patients with chronic major depression: a randomized controlled trial.

BACKGROUND: Major depressive disorder (MDD) is a common and often chronic problem. Patients with chronic MDD often have negative impacts on the health of their families. Family psychoeducation is recognized as part of the optimal treatment for patients with psychotic disorder, and has been shown to reduce the rate of relapse in individuals with schizophrenia and to reduce the burden on their caregivers. Thus, we predict that family psychoeducation has the potential to reduce the burden on the caregivers of patients with chronic MDD. In the present study, we aimed to investigate the effects of brief multifamily psychoeducation (BMP) on the mental health status of family members of patients with chronic MDD. METHODS: We conducted a clinical trial consisting of 49 chronic MDD patients and their families. Each family was randomly assigned to either the BMP intervention group or the control group. The intervention group received four BMP sessions, once every two weeks for eight weeks. The control group received one counseling session administered by a nurse. All patients received standard treatment administered by physicians. The primary outcome measurement was the Kessler Screening Scale for Psychological Distress (K6) score of family members at 16- weeks after the first BMP session. Secondary outcomes were depressive symptoms of both family members and patients at multiple time points, as well as family functioning as evaluated by the patients. Intention-to-treat analyses were conducted. RESULTS: There was no statistically significant effect of BMP on K6 scores at 16- weeks (mean difference 1.17, 95% confidence interval: - 0.63 to 2.98, P = 0.19). Exploratory analyses revealed that BMP reduced depressive symptoms in family members at 8- weeks (difference = - 3.37, 95%CI -6.32 to - 0.43, P = 0.02) and improved family functioning at multiple time points (Role; 8 W, difference = - 0.13, 95%CI -0.26 to - 0.00, P = 0.04, Affective Responsiveness; 8 W, difference = - 0.24, 95%CI -0.43 to - 0.05, P = 0.01, 32 W, difference = - 0.22, 95%CI -0.41 to - 0.03, P = 0.02, Behavior Control; 16 W, difference = - 0.17, 95%CI -0.34 to - 0.00, P = 0.04). CONCLUSIONS: Four BMP sessions did not significantly reduce the psychological distress of family members of patients with chronic MDD. TRIAL REGISTRATION: Clinical Trials. gov NCT01734291 , retrospectively registered (Registration date: November 21, 2012).

Effectiveness of a psycho-oncology training program for oncology nurses: a randomized controlled trial.

OBJECTIVE: Oncology nurses are expected to play an important role in psychosocial care for cancer patients. The aim of this study was to examine whether a novel training program aimed at enhancing oncology nurses' ability to assess and manage common psychological problems in cancer patients would improve participants' self-reported confidence, knowledge, and attitudes regarding care of patients with common psychological problems (trial register: UMIN000008559). METHODS: Oncology nurses were assigned randomly to either the intervention group (N = 50) or the waiting list control group (N = 46). The intervention group received a 16-h program, the content of which focused on four psychological issues: normal reactions, clinically significant distress, suicidal thoughts, and delirium. Each session included a role-play exercise, group work, and didactic lecture regarding assessment and management of each problem. Primary outcomes were changes in self-reported confidence, knowledge, and attitudes toward the common psychological problems between pre-intervention and 3 months post-intervention. Secondary outcomes were job-related stress and burnout. Intervention acceptability to participants was also assessed. RESULTS: In the intervention group, confidence and knowledge but not attitudes were significantly improved relative to the control group. No significant intervention effects were found for job- related stress and burnout. A high percentage (98%) of participants considered the program useful in clinical practice. CONCLUSIONS: This psycho-oncology training program improved oncology nurses' confidence and knowledge regarding care for patients with psychological problems. Copyright © 2015 John Wiley & Sons, Ltd.

A mindfulness-based stress management program and treatment with omega-3 fatty acids to maintain a healthy mental state in hospital nurses (Happy Nurse Project): study protocol for a randomized controlled trial.

BACKGROUND: It is reported that nursing is one of the most vulnerable jobs for developing depression. While they may not be clinically diagnosed as depressed, nurses often suffer from depression and anxiety symptoms, which can lead to a low level of patient care. However, there is no rigorous evidence base for determining an effective prevention strategy for these symptoms in nurses. After reviewing previous literature, we chose a strategy of treatment with omega-3 fatty acids and a mindfulness-based stress management program for this purpose. We aim to explore the effectiveness of these intervention options for junior nurses working in hospital wards in Japan. METHODS/DESIGN: A factorial-design multi-center randomized trial is currently being conducted. A total of 120 nurses without a managerial position, who work for general hospitals and gave informed consent, have been randomly allocated to a stress management program or psychoeducation using a leaflet, and to omega-3 fatty acids or identical placebo pills. The stress management program has been developed according to mindfulness cognitive therapy and consists of four 30-minute individual sessions conducted using a detailed manual. These sessions are conducted by nurses with a managerial position. Participants allocated to the omega-3 fatty acid groups are provided with 1,200 mg/day of eicosapentaenoic acid and 600 mg/day of docosahexaenoic acid for 90 days. The primary outcome is the change in the total score of the Hospital Anxiety and Depression Scale (HADS), determined by a blinded rater via the telephone at week 26. Secondary outcomes include the change in HADS score at 13 and 52 weeks; presence of a major depressive episode; severity of depression, anxiety, insomnia, burnout, and presenteeism; utility scores and adverse events at 13, 26 and 52 weeks. DISCUSSION: An effective preventive intervention may not only lead to the maintenance of a healthy mental state in nurses, but also to better quality of care for inpatients. This paper outlines the background and methods of a randomized trial that evaluates the possible additive value of omega-3 fatty acids and a mindfulness-based stress management program for reducing depression in nurses. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02151162 (registered on 27 May 2014).

Cost-effectiveness of cognitive behavioral therapy for insomnia comorbid with depression: Analysis of a randomized controlled trial.

AIM: Although the efficacy of cognitive behavioral therapy for insomnia has been confirmed, dissemination depends on the balance of benefits and costs. This study aimed to examine the cost-effectiveness of cognitive behavioral therapy for insomnia consisting of four weekly individual sessions. METHODS: We conducted a 4-week randomized controlled trial with a 4-week follow up in outpatient clinics in Japan. Thirty-seven patients diagnosed as having major depressive disorder according to DSM-IV and suffering from chronic insomnia were randomized to receive either treatment as usual (TAU) alone or TAU plus cognitive behavioral therapy for insomnia. Effectiveness was evaluated as quality-adjusted life years (QALY) over 8 weeks' time, estimated by bootstrapping of the observed total scores of the Hamilton Depression Rating Scale. Direct medical costs for cognitive behavioral therapy for insomnia and TAU were also evaluated. We calculated the incremental cost-effectiveness ratio. RESULTS: Over the 8 weeks of the study, the group receiving cognitive behavioral therapy for insomnia plus TAU had significantly higher QALY (P = 0.002) than the TAU-alone group with an incremental value of 0.019 (SD 0.006), and had non-significantly higher costs with an incremental value of 254 (SD 203) USD in direct costs. The incremental cost-effectiveness ratio was 13 678 USD (95% confidence interval: -5691 to 71 316). Adding cognitive behavioral therapy for insomnia demonstrated an approximately 95% chance of gaining one more QALY if a decision-maker was willing to pay 60 000 USD, and approximately 90% for 40 000 USD. CONCLUSION: Adding cognitive behavioral therapy for insomnia is highly likely to be cost-effective for patients with residual insomnia and concomitant depression.

Multifamily psychoeducation for improvement of mental health among relatives of patients with major depressive disorder lasting more than one year: study protocol for a randomized controlled trial.

BACKGROUND: Major depressive disorder (MDD) is a long-lasting disorder with frequent relapses that have significant effects on the patient's family. Family psychoeducation is recognized as part of the optimal treatment for patients with psychotic disorder. A previous randomized controlled trial has found that family psychoeducation is effective in enhancing the treatment of MDD. Although MDD can easily become a chronic illness, there has been no intervention study on the families of patients with chronic depression. In the present study, we design a randomized controlled trial to examine the effectiveness of family psychoeducation in improving the mental health of relatives of patients with MDD lasting more than one year. METHODS/DESIGN: Participants are patients with MDD lasting more than one year and their relatives. Individually randomized, parallel-group trial design will be employed. Participants will be allocated to one of two treatment conditions: relatives will receive (a) family psychoeducation (four, two-hour biweekly multifamily psychoeducation sessions) plus treatment-as-usual for the patient (consultation by physicians), or (b) counseling for the family (one counseling session from a nurse) plus treatment-as-usual for the patient. The primary outcome measure will be relatives' mental health as measured by K6 that was developed to screen for DSM-IV depressive and anxiety disorder. Additionally, the severity of depressive symptoms in patients measured by the Beck Depression Inventory-II (BDI-II) scale will be assessed. Data from the intention-to-treat sample will be analyzed 16 weeks after randomization. DISCUSSION: This is the first study to evaluate the effectiveness of family psychoeducation for relatives of patients with MDD lasting more than one year. If this type of intervention is effective, it could be a new method of rehabilitation for patients with MDD lasting more than one year. TRIAL REGISTRATION: Clinical Trials.gov NCT01734291 (registration date: 18 October 2012).

A failure to confirm the effectiveness of a brief group psychoeducational program for mothers of children with high-functioning pervasive developmental disorders: a randomized controlled pilot trial.

OBJECTIVE: The purpose of this study was to examine the effectiveness of group psychoeducation to relieve the psychological distress of mothers of children with high-functioning pervasive developmental disorders (HFPDD) and to improve the behaviors of the children. METHODS: Seventy-two mothers of preschool outpatients with HFPDD were randomly assigned to a four-session brief group psychoeducational program (GP). The sessions were held every second week in addition to the usual treatment (GP + treatment as usual [TAU] group), or to a TAU-alone group. The primary outcome was self-reported symptoms of maternal mental health as assessed using the 28-item General Health Questionnaire (GHQ-28) at 21 weeks post-randomization (week 21). The GHQ-28 at the end of the intervention (week 7), Aberrant Behavior Checklist (ABC) for the behavior of the children, the Zarit Burden Interview (ZBI), and the Medical Outcomes Study 36-item Short Form Health Survey (SF-36) were carried out at weeks 7 and 21. We tested the group effects with the interaction between the intervention and the evaluation points. RESULTS: The GHQ-28 score at week 21 was significantly higher in the GP + TAU group as compared to that in the TAU-alone group, indicating a greater improvement in the TAU-alone group. There was no evidence that GP + TAU led to a greater improvement of maternal mental health than TAU-alone at week 7. Similarly, no evidence was obtained to indicate that GP + TAU led to a reduction in the ABC or ZBI scores by week 7 or 21. The adjusted scores for the RF (role emotional) and MH (mental health) subscales of the SF-36 at week 21 were also significantly lower in the GP + TAU group, indicating a similar tendency to that of the change of the GHQ-28 score at week 21. CONCLUSION: The psychoeducational program did not alleviate maternal distress, aberrant behaviors of the children, or caregiver burden.

Change in quality of life after brief behavioral therapy for insomnia in concurrent depression: analysis of the effects of a randomized controlled trial.

STUDY OBJECTIVES: The efficacy of cognitive behavioral therapy for insomnia (CBT-I) has been suggested for insomnia concomitant with depression, but its impact on quality of life (QoL) has not been adequately evaluated. The study aimed to determine which aspects of QoL could be affected by CBT-I and how any changes in QoL were mediated by changes in insomnia and depression. METHODS: We conducted a 4-week randomized controlled trial with 4-week follow-up in outpatient clinics in Japan. Thirty-seven patients with DSM-IV diagnosis of major depressive disorder concomitant with chronic insomnia were randomly assigned to the treatment-as-usual (TAU) alone arm or the TAU with brief behavioral therapy for insomnia (TAU plus psychotherapy) arm using modified CBT-I consisting of 4 weekly individual sessions. We evaluated QoL using norm-based scoring of the Short Form-36 at baseline and at 8 weeks. We also examined associations between QoL subscales and remission in insomnia or depression while controlling for baseline scores of the entire sample. RESULTS: We tested group effects while controlling for baseline scores. TAU plus psychotherapy resulted in significantly better scores on physical functioning (p = 0.006), social functioning (p = 0.002), and mental health (p = 0.041) subscales than TAU alone at 8 weeks. Patients with either remitted insomnia or depression showed higher QoL scores than non-remitted patients; scores approximated those within the normal range. CONCLUSIONS: For patients with insomnia in depression, adding CBT-I to TAU can produce substantive benefits in some aspects of QoL. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00610259, http://www.clinicaltrials.gov/.

Brief behavioral therapy for refractory insomnia in residual depression: an assessor-blind, randomized controlled trial.

OBJECTIVE: Insomnia often persists despite pharmacotherapy in depression and represents an obstacle to its full remission. This study aimed to investigate the added value of brief behavioral therapy for insomnia over treatment as usual (TAU) for residual depression and refractory insomnia. METHOD: Thirty-seven outpatients (mean age of 50.5 years) were randomly assigned to TAU alone or TAU plus brief behavioral therapy for insomnia, consisting of 4 weekly 1-hour individual sessions. The Insomnia Severity Index (ISI) scores (primary outcome), sleep parameters, and GRID-Hamilton Depression Rating Scale (GRID-HAMD) scores were assessed by blind raters and remission rates for both insomnia and depression were collected at 4- and 8-week follow-ups. The patients were recruited from February 18, 2008, to April 9, 2009. RESULTS: Brief behavioral therapy for insomnia plus TAU resulted in significantly lower ISI scores than TAU alone at 8 weeks (P < .0005). The sleep efficiency for the combination was also significantly better than that for TAU alone (P = .015). Significant differences were observed in favor of the combination group on both the total GRID-HAMD scores (P = .013) and the GRID-HAMD scores after removing the 3 sleep items (P = .008). The combination treatment produced higher rates of remission than TAU alone, both in terms of insomnia (50% vs 0%), with a number needed to treat (NNT) of 2 (95% CI, 1-4), and in terms of depression (50% vs 6%), with an NNT of 2 (95% CI, 1-5). CONCLUSIONS: In patients with residual depression and treatment refractory insomnia, adding brief behavioral therapy for insomnia to usual clinical care produced statistically significant and clinically substantive added benefits. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00610259.