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).

Potential predictors of delay in initial treatment contact after the first onset of depression in Japan: a clinical sample study.

BACKGROUND: A growing body of evidence shows that reducing the duration of untreated illness (DUI) correlates with improved clinical outcome and course of depression. However, the factors involved in delaying treatment contact after the first onset of lifetime depression are not fully understood. This cross-sectional study aims to identify the characteristics that may predict the delay in initial treatment contact after the first onset of lifetime depression by comparing the socio-demographics and clinical characteristics between those with longer and shorter DUI in a well-characterized Japanese clinical sample. METHODS: Ninety-five patients with depression with longer (>12 months) and shorter DUI (≤12 months) at three Japanese outpatient clinics were studied. Subjects received a comprehensive evaluation, including semi-structured clinical interviews and assessment battery, and their clinical charts were reviewed. RESULTS: Of the total sample, the median of DUI was 4 months (interquartile range (IQR) 25th-75th percentile, 2-13). We found that 72.6% of patients seek treatment contact within the first year of depression onset. Multivariate logistic regression analysis showed that longer DUI in patients was associated with marital status (never married). Further, the DSM-IV melancholic features approached significance. CONCLUSIONS: Our findings suggest that most Japanese patients with depression are likely to seek treatment within 1 year of onset, and that marital status and melancholia may be potential predictors of the delay in the initial treatment contact after the first onset of lifetime depression.