Fujika Katsuki

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.

Pre-post changes in psychosocial functioning among relatives of patients with depressive disorders after Brief Multifamily Psychoeducation: A pilot study

BackgroundDepressive disorder is often chronic and recurrent, and results in a heavy psychosocial burden on the families of patients with this disorder. This study aims to examine the effectiveness of brief multifamily psychoeducation designed to alleviate their psychosocial burden.MethodsThirty-two relatives of patients with major depressive disorder participated in an open study testing the effectiveness of brief multifamily psychoeducation. The intervention consisted of four sessions over the course of 6 weeks. Outcome measures focused on emotional distress, care burden and Expressed Emotion (EE).ResultsThe emotional distress, care burden and EE of the family all showed statistically significant improvements from baseline to after the family intervention. The proportion of relatives scoring 9 or more on K6, which indicates possible depressive or anxiety disorder, decreased from sixteen relatives (50.0%) at baseline, to only 3 relatives (9.3%) after the intervention.ConclusionsThis study suggests that brief multifamily psychoeducation is a useful intervention to reduce the psychosocial burden of the relatives of patients with depressive disorder. Further evaluation of family psychoeducation for relatives of patients with depressive disorder is warranted.

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

BackgroundIt 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/DesignA 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.DiscussionAn 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 registrationClinicaltrials.gov: NCT02151162 (registered on 27 May 2014).

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

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.

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/.

Countertransference to psychiatric patients in a clinical setting: development of the Feeling Checklist-Japanese version.

Abstract  Countertransference is an important dimension of the therapeutic alliance between care providers and patients. The Feeling Checklist (FC) is a self‐report questionnaire for the assessment of countertransference by hospital staff toward patients. The FC was translated from English into Japanese and its factor structure, reliability, and validity in the Japanese version (FC‐J) were examined. A total of 281 Japanese psychiatric nurses were tested with the FC‐J. All nurses were primarily involved in provision of psychiatric care. Principal‐component factor analysis with varimax rotation was performed to identify the potential components of the FC‐J. In a factor analysis of the FC‐J, seven factors were extracted. The five subscales that were determined and labeled included Reject, Distance, Helpfulness, Closeness, and Involvement, which collectively accounted for 56.0% of the variance. Cronbach’s α, a measure of internal consistency, for individual subscales was 0.833 for Reject, 0.763 for Distance, 0.768 for Helpfulness, 0.617 for Closeness, and 0.663 for Involvement. Notably, there was a significant correlation between the FC‐J and the Nurse Attitude Scale (P < 0.0001). Moreover, one‐way anova was performed with each FC‐J subscale to examine differences among psychiatric diagnoses in the study sample. A significant difference was found for Involvement (P < 0.001), with the total score on Involvement being the highest in the personality disorder group. These results are considered to verify the reliability and validity of the FC‐J as a scale to measure countertransference among Japanese care providers. The use of this scale allows individual care providers to recognize and be cognizant of their own countertransference objectively and thereby contributes to improve the relationship between patients and care providers.

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.

Can assessors in a psychotherapy trial be successfully blinded? Analysis of a randomized controlled trial on psychotherapy for refractory insomnia in residual depression.

individual sessions, each lasting approximately 50 min. The patients were assessed at baseline, and at 4 and at 8 weeks. An objective measure for depression, the 17-item GRID-HAMD [5] , was evaluated through a face-to-face semistructured interview by raters at each assessment. The patients, the psychotherapists, or the physicians of TAU were not blind to allocation. However, all the six raters using the GRID-HAMD, all of whom were psychiatrists, were kept blind. The raters evaluated the patient upon request from a research coordinator. All patients were asked not to reveal their allocated treatment to the raters. After each assessment at 4 and 8 weeks, the rater filled in a questionnaire guessing which group the patient had been assigned to. The outcome of the present paper depended upon the agreement between the actual and the guessed allocations. The questionnaire also included questions about the degree of confidence in guessing (slightly, moderately, or definitely) and about cues for guessing including the atmosphere during the conversation with the patient, test results of the GRID-HAMD, behaviors of the research coordinator, just intuition or others, all of which were answered as ‘yes’ or ‘no’. In addition, remission of insomnia defined by the total Insomnia Severity Index (ISI) score [6] and remission of depression defined by the total GRID-HAMD score [5] were included as possibly associated factors with agreement. The sample size was calculated a priori, based on a power analysis for the ISI scores. Agreement rates and kappa values between the actual and the guessed allocations were calculated. The χ 2 statistic was used to test a difference of agreement rates between assessment at 4 weeks and that at 8 weeks, and between the active intervention and the control groups. To explore factors associated with agreement, the variables mentioned above were entered in logistic regression models. Multivariate models started from all variables with p < 0.25 in univariate analyses with the enter method using SPSS for Windows 21.0. p values were two-tailed, and statistical significance was defined by the alpha level of 0.05. The protocol was approved by the ethics committees of all the recruiting centers and registered in ClinicalTrials.gov (NCT00610259). Thirty-seven patients satisfied the eligibility criteria, with 20 participants assigned to receive the active treatment and 17 TAU alone. All the patients completed all the study assessments at 4 and 8 weeks. Thus, 74 questionnaires were collected from the raters without any missing data. The agreement rates and kappa values for a whole sample were 63.5% and 0.28 (95% CI 0.08–0.49). Dividing the sample regarding the time point of assessment, these values were 56.7% and 0.15 (0.00–0.45) at 4 weeks and 70.2% and 0.41 (0.13–0.69) at 8 weeks, respectively (p = 0.227). The agreement rate was higher in the TAU at 76.5% than in the psychotherapy groups at 52.5% (p = 0.033). Regarding factors associated with agreement in the multivariate analyses, only the intuition of the raters was significant with an OR of 0.23 (95% CI 0.07–0.77, p = 0.018, table 1 ), which meant that Blinding is accepted to be a key element of treatment evaluation in randomized controlled trials. The recent systematic review of Baethge et al. [1] focuses on the proportion of recent randomized controlled trials that present a method of blinding procedures in psychiatric disorders. They report that only 4 of 78 papers in psychotherapy trials do so. It is considered to be more challenging to achieve successful blinding in psychotherapy trials than in pharmacotherapy trials [2] . A placebo pill can be easily prepared for pharmacotherapy trials, whereas in psychotherapy trials, a psychological placebo such as quasi-desensitization [3] is often used; however, the differences in the contents of the intervention and control arms may easily be perceived by the participants, and it is probably impossible to blind the participants or the therapists. To make the assessment in psychotherapy trials as blind as possible, objective measures are included among primary outcomes, and the raters are kept blinded to the group allocation. However, the degree of successful blinding and its associated factors in psychotherapy trials are rarely reported. We aimed to explore this by analyzing data in a randomized controlled trial on brief behavioral therapy for insomnia in depression [4] . The patients suffered from major depressive disorder diagnosed with DSM-IV and from significant insomnia, and were individually randomized to psychotherapy plus treatment as usual (TAU) or TAU alone. The psychotherapy involved four weekly Received: May 13, 2013 Accepted after revision: May 20, 2013 Published online: September 26, 2013

Contents Vol. 82, 2013

R. Balon, Detroit, Mich. A. Barbosa, Lisboa P. Bech, Hillerød M. Biondi, Roma M. Bouvard, Chambery G. Chouinard, Montréal, Qué. P.M.G. Emmelkamp, Amsterdam S. Fassino, Torino M. Fava, Boston, Mass. H.J. Freyberger, Greifswald/Stralsund S. Grandi, Bologna J.I. Hudson, Belmont, Mass. I.M. Marks, London M.W. Otto, Boston, Mass. E.S. Paykel, Cambridge P. Porcelli, Castellana Grotte C. Rafanelli, Bologna C.D. Ryff , Madison, Wisc. U. Schnyder, Zürich J. Scott, Newcastle T. Sensky, London T. Th eorell, Stockholm E. Vieta, Barcelona T. Wise, Falls Church, Va. J.H. Wright, Louisville, Ky. R. Zachariae, Aarhus Offi cial Journal of the International College of Psychosomatic Medicine (ICPM) Offi cial Journal of the International Federation for Psychotherapy (IFP)