Correction: Smartphone Cognitive Behavioral Therapy as an Adjunct to Pharmacotherapy for Refractory Depression: Randomized Controlled Trial.

[This corrects the article DOI: 10.2196/jmir.8602.].

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression?

BACKGROUND: Behavioral activation (BA) is receiving renewed interest as a stand-alone or as a component of cognitive-behavior therapy (CBT) for depression. However, few studies have examined which aspects of BA are most contributory to its efficacy. METHODS: This is a secondary analysis of a 9-week randomized controlled trial of smartphone CBT for patients with major depression. Depression severity was measured at baseline and at end of treatment by the Patient Health Questionnaire-9. All aspects of behavioral activation tasks that the participants had engaged in, including their expected mastery and pleasure and obtained mastery and pleasure, were recorded in the web server. We examined their contribution to improvement in depression as simple correlations and in stepwise multivariable linear regression. RESULTS: Among the 78 patients who completed at least one behavioral experiment, all aspects of expected or achieved mastery or pleasure correlated with change in depression severity. Discrepancy between the expectation and achievement, representing unexpected gain in mastery or pleasure, was not correlated. In stepwise regression, expected mastery and pleasure, especially the maximum level of the latter, emerged as the strongest contributing factors. LIMITATIONS: The study is observational and cannot deduce cause-effect relationships. CONCLUSIONS: It may be the expected and continued sense of pleasure in planning activities that are most meaningful and rewarding to individuals, and not the simple level or amount of obtained pleasure, that contributes to the efficacy of BA.

Smartphone Cognitive Behavioral Therapy as an Adjunct to Pharmacotherapy for Refractory Depression: Randomized Controlled Trial.

BACKGROUND: In the treatment of major depression, antidepressants are effective but not curative. Cognitive behavioral therapy (CBT) is also effective, alone or in combination with pharmacotherapy, but accessibility is a problem. OBJECTIVE: The aim is to evaluate the effectiveness of a smartphone CBT app as adjunctive therapy among patients with antidepressant-resistant major depression. METHODS: A multisite, assessor-masked, parallel-group randomized controlled trial was conducted in 20 psychiatric clinics and hospitals in Japan. Participants were eligible if they had a primary diagnosis of major depression and were antidepressant-refractory after taking one or more antidepressants at an adequate dosage for four or more weeks. After a 1-week run-in in which participants started the medication switch and had access to the welcome session of the app, patients were randomized to medication switch alone or to medication switch plus smartphone CBT app via the centralized Web system. The smartphone app, called Kokoro-app ("kokoro" means "mind" in Japanese), included sessions on self-monitoring, behavioral activation, and cognitive restructuring presented by cartoon characters. The primary outcome was depression severity as assessed by masked telephone assessors with the Patient Health Questionnaire-9 (PHQ-9) at week 9. The secondary outcomes included the Beck Depression Inventory-II (BDI-II) and Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER). RESULTS: In the total sample (N=164), 81 participants were allocated to the smartphone CBT in addition to medication change and 83 to medication change alone. In the former group, all but one participant (80/81, 99%) completed at least half, and 71 (88%) completed at least six of eight sessions. In the intention-to-treat analysis, patients allocated the CBT app scored 2.48 points (95% CI 1.23-3.72, P<.001; standardized mean difference 0.40) lower on PHQ-9 than the control at week 9. The former group also scored 4.1 points (95% CI 1.5-6.6, P=.002) lower on BDI-II and 0.76 points (95% CI -0.05 to 1.58, P=.07) lower on FIBSER. In the per-protocol sample (comfortable with the smartphone app, still symptomatic, and adherent to medication with mild or less side effects after run-in), the intervention group (n=60) scored 1.72 points (95% CI 0.25-3.18, P=.02) lower on PHQ-9, 3.2 points (95% CI -0.01 to 6.3, P=.05) lower on BDI-II, and 0.75 points (95% CI 0.03-1.47, P=.04) lower on FIBSER than the control (n=57). The treatment benefits were maintained up to week 17. CONCLUSIONS: This is the first study to demonstrate the effectiveness of a smartphone CBT in the treatment of clinically diagnosed depression. Given the merits of the mobile mental health intervention, including accessibility, affordability, quality control, and effectiveness, it is clinically worthwhile to consider adjunctive use of a smartphone CBT app when treating patients with antidepressant-resistant depression. Research into its effectiveness in wider clinical contexts is warranted. TRIAL REGISTRATION: Japanese Clinical Trials Registry UMIN CTR 000013693; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ ctr_view.cgi?recptno=R000015984 (Archived by WebCite at http://www.webcitation.org/6u6pxVwik).

Gradations of clinical severity and sensitivity to change assessed with the Beck Depression Inventory-II in Japanese patients with depression.

Knowledge of what constitutes a minimal clinically important difference and change on a psychiatric rating scale is essential in interpreting its scores. The present study examines the Beck Depression Inventory-II (BDI-II), a recently revised successor to the world's most popular self-rating instrument for depression. BDI-II was administered to 85 patients with major depression, diagnosed with DSM-IV along with its severity specifiers. It was again administered to 40 first-visit patients from the original sample when they returned 14 or more days later. The Clinical Global Impression-Change Scale was rated at the same time. All the ratings were done independent of each other. The BDI-II was able to distinguish between all grades of depression severity. An approximate 10-point difference existed between each severity specifier. The BDI-II was also sensitive to change in depression: a 5-point difference corresponded to a minimally important clinical difference, 10-19 points to a moderate difference, and 20 or more points to a large difference. Given the already established high reliability, content validity, construct validity and factorial validity, and the high sensitivity to between-subject differences and within-subject changes demonstrated in the present study, the BDI-II promises to continue to be a leading self-rating instrument to assess depression severity worldwide.

Childhood parental separation experiences and depressive symptomatology in acute major depression.

The aim of this study was to examine the pathoplastic effects of childhood parental separation experiences on depressive symptoms. Patients with acute major depression were identified in a large 31-center study of affective disorders in Japan. Information regarding the patients' childhood losses was collected using a semistructured interview, and their depressive symptomatology was assessed by the Center for Epidemiologic Studies Depression Scale (CES-D). Patients reported significantly higher CES-D total scores when they had experienced early object loss of the same-sex parent. In terms of the CES-D subscores derived by factor analysis, early object loss significantly aggravated symptoms that people normally could cope with but could no longer cope with when depressed (e.g. 'poor appetite', 'cannot shake off the blues' and 'everything an effort.'). Once depression develops, early object loss may act as a pathoplastic factor by making it severer especially by rendering people less able to perform what they normally could do.