Megumi Sasaki

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.

Stress coping and the adjustment process among university freshmen

The purpose of the present study was to investigate causal relationships between dispositional and situational coping and health status in university freshmen. Two hundred and twenty-nine university freshmen completed questionnaires at Time 1 (immediately after university matriculation) and at Time 2 (approximately three months later) in a short-term, prospective study. Structural equation modeling was used to analyze causal relationships between four coping strategies (i.e., emotion expression, emotional support seeking, cognitive reinterpretation, and problem solving) and four health status variables (i.e., somatic symptoms, anxiety and insomnia, social dysfunction, and depression). Increases in dispositional coping predicted increases in situational coping at certain time points. In addition, increases in dispositional emotion-focused coping, such as emotion expression and emotional support seeking, predicted poor health status. This relationship was mediated by situational coping variables. Finally, increases in dispositional problem-focused coping, such as cognitive reinterpretation and problem solving, predicted better health status. This relationship was direct or indirectly mediated by situational coping variables. Our data suggest that the use of coping skills such as cognitive reinterpretation and problem solving may promote better health and adaptation in university freshmen.

Telephone cognitive-behavioral therapy for subthreshold depression and presenteeism in workplace: a randomized controlled trial.

Background Subthreshold depression is highly prevalent in the general population and causes great loss to society especially in the form of reduced productivity while at work (presenteeism). We developed a highly-structured manualized eight-session cognitive-behavioral program with a focus on subthreshold depression in the workplace and to be administered via telephone by trained psychotherapists (tCBT). Methods We conducted a parallel-group, non-blinded randomized controlled trial of tCBT in addition to the pre-existing Employee Assistance Program (EAP) versus EAP alone among workers with subthreshold depression at a large manufacturing company in Japan. The primary outcomes were depression severity as measured with Beck Depression Inventory-II (BDI-II) and presenteeism as measured with World Health Organization Health and Work Productivity Questionnaire (HPQ). In the course of the trial the follow-up period was shortened in order to increase acceptability of the study. Results The planned sample size was 108 per arm but the trial was stopped early due to low accrual. Altogether 118 subjects were randomized to tCBT+EAP (n = 58) and to EAP alone (n = 60). The BDI-II scores fell from the mean of 17.3 at baseline to 11.0 in the intervention group and to 15.7 in the control group after 4 months (p<0.001, Effect size = 0.69, 95%CI: 0.32 to 1.05). However, there was no statistically significant decrease in absolute and relative presenteeism (p = 0.44, ES = 0.15, −0.21 to 0.52, and p = 0.50, ES = 0.02, −0.34 to 0.39, respectively). Conclusion Remote CBT, including tCBT, may provide easy access to quality-assured effective psychotherapy for people in the work force who present with subthreshold depression. Further studies are needed to evaluate the effectiveness of this approach in longer terms. The study was funded by Sekisui Chemicals Co. Ltd. Trial Registration ClinicalTrials.gov NCT00885014

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.

DISPOSITIONAL AND SITUATIONAL COPING AND MENTAL HEALTH STATUS OF UNIVERSITY STUDENTS

The results of stress coping studies do not clearly demonstrate whether dispositional and situational coping can predict health status or whether dispositional coping can predict situational coping. The present study used structural equation modeling to test proposed directional relationships. 292 Japanese university students completed questionnaires concerning dispositional and situational coping and mental health status. Analysis showed that dispositional coping predicted situational coping for some coping strategies. In women, an increase in dispositional Problem-solving predicted a reduction in mental distress via situational Problem-solving. The results suggest that, only for Problem-solving by women, dispositional coping is related to mental health status, but only through situational coping.

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/.

Interoceptive hypersensitivity as prognostic factor among patients with panic disorder who have received cognitive behavioral therapy

The efficacy of cognitive behavioral therapy (CBT) in the acute-phase treatment of panic disorder is well established. However, there are data to show CBT may not always be able to prevent recurrence after treatment. The central cognitive component of panic disorder psychopathology is thought to be hypersensitivity to physical sensations. The present study reports that some aspects of interoceptive hypersensitivity, gastrointestinal fears in particular, were predictive of the course of panic disorder after end of CBT. Clinically it is suggested that new interoceptive tasks related to gastrointestinal fears are needed.

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

Effects of positive and negative affect and emotional suppression on short-term life satisfaction

Relationships between emotional experiences and health and adjustment are influenced by many variables, with emotional suppression (ES) being one of the most influential factors. In the current study, we examined the effects of affect and ES on short-term life satisfaction (LS) measured over the previous week. We also considered the dimension of activation status for both positive affect (PA) and negative affect (NA). The final sample included data collected from 398 undergraduates (184 men and 214 women). Participants answered six questionnaires, two of which were used for another study. All of the tests were of Japanese versions and were answered with regard to the previous weeks experiences. Results showed that LS was positively associated with PA and negatively with NA, but that the positive association was stronger for activated PA than deactivated PA, while the negative association was stronger for deactivated NA than activated NA. Furthermore, an interactive effect between deactivated NA and ES on LS was significant in men, where post hoc tests demonstrated that deactivated NA was more negatively associated with LS when ES was higher. This study suggests that activated and deactivated affect differ in their effects on LS. In addition, it is likely that the detrimental effect of deactivated NA on LS is larger when NA is more strongly suppressed. The necessity of interventional research along with the limitations of this study is discussed for future research.