Group multi-component programme based on cognitive behavioural therapy and positive psychology for family caregivers of people with dementia: a randomised controlled study (3C study).

BACKGROUND: Caregivers of people with dementia frequently experience an elevated level of psychological distress and burden. This study aimed to examine the effectiveness of a group-format multi-component programme which is based on cognitive behavioural therapy and positive psychology. METHODS: Family caregivers of dementia were allocated (1:1) to the intervention group and the wait-list control group, stratified by age (<65 years, ≥65 years) and care status (at home or in an institution). The intervention group received a six-session, 10-week, group-format programme. The primary outcome was the Hospital Anxiety Depression Scale (HADS). Secondary outcomes were the short-version of the Zarit Burden Interview (personal strain and role strain), Neuropsychiatric Inventory Questionnaire, Dementia Caregiver Positive Feeling Scale, and Self-Compassionate Reactions Inventory. The evaluations were conducted at baseline, 10 weeks (post-intervention), and 14 weeks (follow-up). RESULTS: The analyses were performed with 64 registered participants. In the whole sample, no significant effect was observed on HADS. There was medium effect on role strain (P = 0.04, partial η2  = 0.08). Positive feelings of caregiving increased after the intervention but were not maintained at follow-up. In the subgroup analysis of caregivers under 65 years of age, a statistically significant effect was observed for personal strain (P = 0.03, partial η2 = 0.16). An interaction effect was also found for the total score of positive feelings of caregiving (P < 0.05, partial η2 = 0.02) and the meaning of caregiving (P = 0.02, partial η2 = 0.10). CONCLUSIONS: This programme did not show significant improvement in depression and anxiety of caregivers of dementia; however, it reduced the burden of their role conflict (role strain) and yielded favourable short-term effects on the positive feelings and the meaning of caregiving among the participants. Also, the programme effectively reduced the personal strain of caregivers under 65 years.

Web-Based Cognitive Behavioral Therapy Blended With Face-to-Face Sessions for Major Depression: Randomized Controlled Trial.

BACKGROUND: Meta-analyses of several randomized controlled trials have shown that cognitive behavioral therapy (CBT) has comparable efficacy to antidepressant medication, but therapist availability and cost-effectiveness is a problem. OBJECTIVE: This study aimed to evaluate the effectiveness of Web-based CBT blended with face-to-face sessions that reduce therapist time in patients with major depression who were unresponsive to antidepressant medications. METHODS: A 12-week, assessor-masked, parallel-group, waiting- list controlled, randomized trial was conducted at 3 medical institutions in Tokyo. Outpatients aged 20-65 years with a primary diagnosis of major depression who were taking ≥1 antidepressant medications at an adequate dose for ≥6 weeks and had a 17-item GRID-Hamilton Depression Rating Scale (HAMD) score of ≥14 were randomly assigned (1:1) to blended CBT or waiting-list groups using a computer allocation system, stratified by the study site with the minimization method, to balance age and baseline GRID-HAMD score. The CBT intervention was given in a combined format, comprising a Web-based program and 12 45-minute face-to-face sessions. Thus, across 12 weeks, a participant could receive up to 540 minutes of contact with a therapist, which is approximately two-thirds of the therapist contact time provided in the conventional CBT protocol, which typically provides 16 50-minute sessions. The primary outcome was the alleviation of depressive symptoms, as measured by a change in the total GRID-HAMD score from baseline (at randomization) to posttreatment (at 12 weeks). Moreover, in an exploratory analysis, we investigated whether the expected positive effects of the intervention were sustained during follow-up, 3 months after the posttreatment assessment. Analyses were performed on an intention-to-treat basis, and the primary outcome was analyzed using a mixed-effects model for repeated measures. RESULTS: We randomized 40 participants to either blended CBT (n=20) or waiting-list (n=20) groups. All patients completed the 12-week treatment protocol and were included in the intention-to-treat analyses. Participants in the blended CBT group had significantly alleviated depressive symptoms at week 12, as shown by greater least squares mean changes in the GRID-HAMD score, than those in the waiting list group (-8.9 points vs -3.0 points; mean between-group difference=-5.95; 95% CI -9.53 to -2.37; P<.001). The follow-up effects within the blended CBT group, as measured by the GRID-HAMD score, were sustained at the 3-month follow-up (week 24) and posttreatment (week 12): posttreatment, 9.4 (SD 5.2), versus follow-up, 7.2 (SD 5.7); P=.009. CONCLUSIONS: Although our findings warrant confirmation in larger and longer term studies with active controls, these suggest that a combined form of CBT is effective in reducing depressive symptoms in patients with major depression who are unresponsive to antidepressant medications. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry: UMIN000009242; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010852 (Archived by WebCite at http://www.webcitation. org/729VkpyYL).

Effectiveness of Supplementary Cognitive-Behavioral Therapy for Pharmacotherapy-Resistant Depression: A Randomized Controlled Trial.

OBJECTIVE: Antidepressant medication is efficacious in the treatment of depression, but not all patients improve with antidepressant medication alone. Despite this treatment gap, limited evidence regarding the effectiveness of supplementing psychotherapy for pharmacotherapy-resistant depression is available. Therefore, we investigated the effectiveness of supplementing usual medication management (treatment as usual [TAU]) with cognitive-behavioral therapy (CBT) in patients with pharmacotherapy-resistant depression seeking psychiatric specialty care. METHODS: A 16-week assessor-masked randomized controlled trial with a 12-month follow-up was conducted in 1 university hospital and 1 psychiatric hospital from September 2008 to December 2014. Outpatients aged 20-65 years with pharmacotherapy-resistant depression (taking antidepressant medications for ≥ 8 weeks, 17-item GRID-Hamilton Depression Rating Scale [GRID-HDRS17] score ≥ 16, Maudsley Staging Method for treatment-resistant depression score ≥ 3, and DSM-IV criteria for major depressive disorder) were randomly assigned (1:1) to CBT combined with TAU or to TAU alone. The primary outcome was the alleviation of depressive symptoms, as measured by change in the total GRID-HDRS17 score from baseline to 16 weeks; primary analysis was done on an intention-to-treat basis. RESULTS: A total of 80 patients were randomized; 78 (97.5%) were assessed for the primary outcome, and 73 (91.3%) were followed up for 12 months. Supplementary CBT significantly alleviated depressive symptoms at 16 weeks, as shown by greater least squares mean changes in GRID-HDRS17 scores in the intervention group than in the control group (-12.7 vs -7.4; difference = -5.4; 95% CI, -8.1 to -2.6; P < .001), and the treatment effect was maintained for at least 12 months (-15.4 vs -11.0; difference = -4.4; 95% CI, -7.2 to -1.6; P = .002). CONCLUSIONS: Patients with pharmacotherapy-resistant depression treated in psychiatric specialty care settings may benefit from supplementing usual medication management with CBT. TRIAL REGISTRATION: UMIN Clinical Trials Registry identifier: UMIN000001218​​.

Incidence of deep vein thrombosis in catatonic patients: A chart review.

Catatonia is a syndrome of motor and psychological disturbances, which is accompanied by blood stasis that increases the risk of deep vein thrombosis (DVT). The aim of this study was to examine the incidence of DVT in catatonic patients in comparison to that in non-catatonic physically restrained patients. We conducted a chart review of involuntarily hospitalized patients from 2010 to 2013 at Sakuragaoka Memorial Hospital in Japan. Routine screening of DVT has been conducted for catatonic patients and restrained patients in this hospital. Catatonic patients were identified based on descriptions of charts and sorted to two subtypes (i.e. retarded and excited forms). A Doppler ultrasound scanning was performed to examine the presence of DVT. The incidence of DVT was compared among retarded and excited catatonic patients and non-catatonic restrained patients. There were 79 catatonic patients, of whom 42 were retarded. The incidence of DVT was 25.3% (20/79) in the catatonic patients. The retarded catatonic patients demonstrated a significantly higher incidence rate than the restrained non-catatonic patients (35.7% [15/42] vs. 10.6% [31/272], adjusted OR, 4.47). The incidence of DVT in catatonic patients, especially in the retarded form, was considerably high, which suggests the importance of prophylaxis of DVT.

Behavioral evidence of delayed prediction signals during agency attribution in patients with schizophrenia.

Self-disturbance, a core feature of schizophrenia, recently has been explained from the standpoint of an abnormal sense of agency (SoA). Previous studies showed that aberrant SoA in schizophrenia arise from imprecise predictions about the sensory consequences of actions. However, the nature of the malfunctioning predictions remains unclear. We examined the temporally "delayed" nature of inadequate predictions. We studied 30 patients with schizophrenia and 30 healthy controls. Our original SoA task evaluates explicit experience of the temporal causal relationship between an intentional action and an effect on a computer screen under the presence of temporal biases. We introduced an adaptation with a "trial-by-trial" method that prolonged or shortened the temporal biases. We hypothesized that delayed prediction signals in schizophrenia could lead to a match in timing between predictions and actual outcomes, resulting in self-agency. The adjustment courses to changing temporal biases were evaluated. Patients with schizophrenia continued to feel self-agency even when the adjusted temporal bias was longer than 1000ms. This result indicated that patient's prediction would be delayed in each trial. Our study empirically showed behavioral evidence for "delayed" prediction signals in a SoA paradigm for the first time.

Effectiveness of cognitive behavioural therapy augmentation in major depression treatment (ECAM study): study protocol for a randomised clinical trial.

INTRODUCTION: Major depression is a serious mental disorder that causes substantial distress and impairment in individuals and places an enormous burden on society. Although antidepressant treatment is the most common therapy provided in routine practice, there is little evidence to guide second-line therapy for patients who have failed to respond to antidepressants. The aim of this paper is to describe the study protocol for a randomised controlled trial that measures the clinical effectiveness of cognitive behavioural therapy (CBT) as an augmentation strategy to treat patients with non-psychotic major depression identified as suboptimal responders to usual depression care. METHODS AND ANALYSIS: The current study is a 16-week assessor-blinded randomised, parallel-groups superiority trial with 12-month follow-up at an outpatient clinic as part of usual depression care. Patients aged 20-65 years with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Major Depressive Disorder who have experienced at least one failed trial of antidepressants as part of usual depression care, will be randomly assigned to receive CBT plus treatment as usual, or treatment as usual alone. The primary outcome is the change in clinician-rated 17-item GRID-Hamilton Depression Rating Scale (GRID-HAMD) score at 16 weeks, and secondary outcomes include severity and change in scores of subjective depression symptoms, proportion of responders and remitters, safety and quality of life. The primary population will be the intention-to-treat patients. ETHICS AND DISSEMINATION: All protocols and the informed consent form comply with the Ethics Guideline for Clinical Research (Japanese Ministry of Health, Labour and Welfare). Ethics review committees at the Keio University School of Medicine and the Sakuragaoka Memorial Hospital approved the study protocol. The results of the study will be disseminated at several research conferences and as published articles in peer-reviewed journals. The study will be implemented and reported in line with the CONSORT statement. TRIAL REGISTRATION NUMBER: UMIN Clinical Trials Registry: UMIN000001218.

Reduced sense of agency in chronic schizophrenia with predominant negative symptoms.

Self-disturbances in schizophrenia have been regarded as a fundamental vulnerability marker for this disease, and have begun to be studied from the standpoint of an abnormal "sense of agency (SoA)" in cognitive neuroscience. To clarify the nature of aberrant SoA in schizophrenia, it needs to be investigated in various clinical subtypes and stages. The residual type of chronic schizophrenia with predominant negative symptoms (NS) has never been investigated for SoA. Accordingly, we investigated SoA by an original agency attribution task in NS-predominant schizophrenia, and evaluated the dynamic interplay between the predictive and postdictive components of SoA in the optimal cue integration framework. We studied 20 patients with NS-predominant schizophrenia, and compared with 30 patients with paranoid-type schizophrenia and 35 normal volunteers. NS-predominant schizophrenia showed markedly diminished SoA compared to normal controls and paranoid-type schizophrenia, indicating a completely opposite direction in agency attribution compared with excessive SoA demonstrated in paranoid-type schizophrenia. Reduced SoA was detected in experimental studies of schizophrenia for the first time. According to the optimal cue integration framework, these results indicate that there was no increase in compensatory contributions of the postdictive processes despite the existence of inadequate predictions, contrary to the exaggerated postdictive component in paranoid-type schizophrenia.

Aberrant sense of agency in patients with schizophrenia: forward and backward over-attribution of temporal causality during intentional action.

Self-disturbances in schizophrenia have been explained and studied from the standpoint of an abnormal sense of agency. We devised an agency-attribution task that evaluated explicit experiences of the temporal causal relations between an intentional action and an external event, without any confounding from sense of ownership of body movement. In each trial, a square piece appeared on the bottom of a computer screen and moved upward. Subjects were instructed to press a key when they heard a beep. When the key was pressed, the piece jumped with various temporal biases. Subjects were instructed to make an agency judgment for each trial. We demonstrated that an excessive sense of agency was observed in patients with schizophrenia compared with normal controls. Moreover, patient groups had a greater tendency to feel a sense of agency even when external events were programmed to precede their action. Therefore, patients felt both forward and backward exaggerated causal efficacy in the temporal event sequence during the intentional action. Confusion in the experience of temporal causal relations between the self and the external world may underlie self-disturbances in schizophrenia.

Effects of zonisamide on tardive dyskinesia: a preliminary open-label trial.

Once developed, tardive dyskinesia (TD) is a challenging condition to treat. The recent evidence has indicated that zonisamide, an antiepileptic drug indicated for partial-onset seizures, may also have beneficial effects for ameliorating dyskinesia in Parkinson's disease. However, this finding has not systematically been tested in psychiatric patients with TD associated with antipsychotic treatment. The objective of this study was to examine the efficacy, tolerability, and safety of zonisamide against TD in these patients. In this 4-week open-label study, subjects who suffered TD were given 50-100 mg/day of add-on zonisamide. Severity of TD was evaluated at the baseline and endpoint, using the Abnormal Involuntary Movement Scale (AIMS). Eleven subjects (6 females; mean±SD age, 75.5±4.7 years; schizophrenia [N=6], bipolar affective disorder [N=2], schizoaffective disorder [N=1], mental retardation [N=1], mental retardation with epilepsy [N=1]; 6 were antipsychotic free at baseline) participated in this study. The AIMS total score (mean±SD) was significantly decreased from 24.1±5.5 to 19.5±5.9, with 36.4% of the subjects (N=4) demonstrating 20% or more decrease in the AIMS total score. Treatment with zonisamide was well-tolerated and no participants dropped out prematurely. In conclusion, zonisamide may be safe and effective for the treatment of TD associated with antipsychotic treatment. These preliminary findings need to be further explored by larger well-designed trials.

Symptomatological structure of volatile solvent-induced psychosis: is "solvent psychosis" a discernible syndrome?

Solvent-induced psychosis has been clinically identified among patients suffering from dependence on volatile solvents and those in psychotic state due to chronic solvent use. To clarify the symptomatological difference between solvent-induced psychosis and schizophrenia, the principal component analysis with VARIMAX rotation was applied to the point and duration estimates of symptoms observed among the solvent group and among the schizophrenic group. There were no significant group differences in age and family history of any psychosis. The study findings are as follows: (1) It is difficult to distinguish two groups based on the prevalence rates of symptoms alone. (2) However, the principal component VARIMAX rotation analysis of the prevalence and duration observing among the solvent group revealed seven factors consisting of "amotivation", "intoxication", "emotional instability", "delusion", "hallucination", "disinhibition" and "memory". The seven factors explained 75.4% of the variance of the symptoms in this group. (3) The same analysis applied to the data from the schizophrenic group showed six factors consisting of "thought progression", "emotional instability", "amotivation (or negative symptoms)", "delusion", "hallucination" and "anxiety". These factors explained 62.9% of the variance in the data of the schizophrenic group. These results support clinical observations the "amotivational syndrome" may be a characteristic feature of patients suffering from solvent-induced psychosis. The results also suggest "solvent psychosis" is a discernible syndrome, and is distinctive from psychotic symptoms of typical schizophrenia.