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).

In-situation safety behaviors among patients with panic disorder: descriptive and correlational study.

AIM: In-situation safety behaviors play an important role in the maintenance of anxiety because they prevent patients from experiencing unambiguous disconfirmation of their unrealistic beliefs about feared catastrophes. Strategies for identifying particular safety behaviors, however, have not been sufficiently investigated. The aims of the present study were to (i) develop a comprehensive list of safety behaviors seen in panic disorder and to examine their frequency; and (ii) correlate the safety behaviors with panic attack symptoms, agoraphobic situations and treatment response. METHODS: The subjects consisted of 46 consecutive patients who participated in group cognitive behavioral treatment (CBT) for panic disorder. All the patients completed a Safety Behavior List that was developed based on experiences with panic disorder patients. RESULTS: Carrying medications, distracting attention, carrying a plastic bottle, and drinking water were reported by more than half of the patients. The strongest correlations between panic symptoms and safety behaviors were found between symptoms of derealization and listening to music with headphones, paresthesia and pushing a cart while shopping, and nausea and squatting down. The strongest association between agoraphobic situations and safety behaviors was found between the fear of taking a bus or a train alone and moving around. Staying still predicted response to the CBT program, while concentrating on something predicted lack of response. CONCLUSION: An approximate guideline has been developed for identifying safety behaviors among patients with panic disorder and should help clinicians use CBT more effectively for these patients.

Cognitive-behavioral therapy modifies the naturalistic course of social anxiety disorder: findings from an ABA design study in routine clinical practices.

AIMS: While randomized evidence appears to have established efficacy of cognitive-behavioral therapy (CBT) and some pharmacotherapy for social anxiety disorder (SAD), their real-world effectiveness has been called into question by long-term naturalistic cohort studies of patients with SAD as they show very low probability of recovery and sustained social dysfunctions despite some drug and psychological therapies. METHOD: The present study examines the effectiveness of group CBT for SAD in real-world settings (n=62) by examining the course of patients' symptomatology and social functions through approximately 6 months on the waiting list, through 6 months receiving the manualized group CBT intervention consisting of 16 2-h sessions, and for 12 months after the treatment. RESULTS: We found: (i) that the patients with SAD changed little or possibly worsened through the 6 months on the waiting list, although two in three of them were on antidepressants, benzodiazepines or both; (ii) that both their symptomatology and social function improved significantly and substantively through the group CBT; and (iii) that this improvement was maintained through the 3- and 12-month follow ups. CONCLUSIONS: We can implement and must disseminate evidence-based, effective CBT for more patients with SAD to lessen their suffering and stop the perpetuation of their symptoms.

Change in quality of life and their predictors in the long-term follow-up after group cognitive behavioral therapy for social anxiety disorder: a prospective cohort study.

BACKGROUND: Social anxiety disorder (SAD) is one of the most common anxiety disorders. The efficacy of cognitive behaviour therapy (CBT) has been examined but to date its effects on Quality of Life (QoL) have not been appropriately evaluated especially in the long term.The study aimed to examine, in the long term, what aspects of Quality of Life (QoL) changed among social anxiety disorder (SAD) patients treated with group cognitive behaviour therapy (CBT) and what predictors at baseline were associated with QoL. METHODS: Outpatients diagnosed with SAD were enrolled into group CBT, and assessed at follow-ups for up to 12 months in a typical clinical setting. QoL was evaluated using the Short Form 36. Various aspects of SAD symptomatology were also assessed. Each of the QoL domains and scores on symptomatology were quantified and compared with those at baseline. Baseline predictors of QoL outcomes at follow-up were investigated. RESULTS: Fifty-seven outpatients were enrolled into group CBT for SAD, 48 completed the whole program, and 44 and 40 completed assessments at the 3-month and 12-month follow-ups, respectively. All aspects of SAD symptomatology and psychological subscales of the QoL showed statistically significant improvement throughout follow-ups for up to 12 months. In terms of social functioning, no statistically significant improvement was observed at either follow-up point except for post-treatment. No consistently significant pre-treatment predictors were observed. CONCLUSIONS: After group CBT, SAD symptomatology and some aspects of QoL improved and this improvement was maintained for up to 12 months, but the social functioning domain did not prove any significant change statistically. Considering the limited effects of CBT on QoL, especially for social functioning, more powerful treatments are needed.

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.

Video feedback with peer ratings in naturalistic anxiety-provoking situations for social anxiety disorder: Preliminary report.

The present study aimed to examine how video feedback can affect perceived performance and anticipatory anxiety in various naturalistic social anxiety-provoking situations among clinical patients diagnosed with social anxiety disorder (SAD) and to examine predictors that might influence response to video feedback. Participants were 52 consecutive patients with DSM-IV SAD who participated in a group-based CBT program. Our results demonstrated that video feedback was associated with a decrease in the underestimation of own performance as well as the perception of feared outcomes. Moreover, anticipatory anxiety decreased after video feedback combined with peer feedback. Male sex, comorbidity with other anxiety disorders, and benzodiazepine prn, as well as patients' initial anxiety and avoidance were negative predictors of the effect of video feedback.

Videotaped experiments to drop safety behaviors and self-focused attention for patients with social anxiety disorder: do they change subjective and objective evaluations of anxiety and performance?

Safety behavior (SB) and self-focused attention (SFA) have been posited as important maintenance factors in the cognitive model of social anxiety disorder (SAD). The present study reports the results of experiments to drop SB and SFA among clinically diagnosed patients with SAD employing their own idiosyncratic anxiety-provoking situations. The ratings for observable anxiety, belief in feared outcome and overall performance were better for role plays without SB and SFA than for role plays with them. The degree of drop in SFA predicted drop in observable anxiety and belief in feared outcome. Dropping SB and SFA, however, was unable to completely correct the cognitive distortion because the subjective ratings were still significantly worse than the objective ratings.

Cognitive-behavior therapy for Japanese patients with panic disorder: acute phase and one-year follow-up results.

AIM: The aim of this paper is to report the outcomes and follow-up data of our cognitive behavioral therapy program for Japanese patients with panic disorder and to examine the baseline predictors of their outcomes. METHODS: Seventy outpatients with panic disorder with or without agoraphobia were treated with manualized group cognitive behavioral therapy. RESULTS: Fourteen patients (20%) did not complete the program. Among the completers, the average Panic Disorder Severity Scale score fell from 12.8 at baseline to 7.1 post-therapy (44.7% reduction). This effectiveness was sustained for 1 year. While controlling for the baseline severity, the duration of illness and the baseline social dysfunction emerged as significant predictors of the outcome. CONCLUSIONS: Our data suggest that group cognitive behavioral therapy for panic disorder can bring about as much symptom reduction among Japanese patients with panic disorder as among Western patients.

Group cognitive behavior therapy for Japanese patients with social anxiety disorder: preliminary outcomes and their predictors.

BACKGROUND: A number of studies have provided strong evidence for the use of cognitive behavior therapy (CBT) in the treatment of social anxiety disorder (SAD). However, all of the previous reports were from Europe and North America and it is unknown whether Western psychological therapies are effective for SAD in non-Western cultures. The present pilot study aimed to evaluate CBT program for SAD which was originally developed for Western patients, among Japanese patients. METHODS: Fifty-seven outpatients who participated in group CBT for SAD were evaluated using eight self-reported and one clinician-administered questionnaires to measure various aspects of SAD symptomatology at the beginning and at the end of the program. Pre- and post-treatment scores were compared and the magnitude of treatment effect was quantified as well based once on the intention-to-treat (ITT) and once among the completers only. We also examined baseline predictors of the CBT outcomes. RESULTS: Seven patients (12%) did not complete the program. For the ITT sample, the percentage of reduction was 20% to 30% and the pre to post treatment effect sizes ranged from 0.37 to 1.01. Among the completers, the respective figures were 20% to 33% and 0.41 to 1.19. We found no significant pretreatment predictor of the outcomes. CONCLUSION: Group CBT for SAD is acceptable and can bring about a similar degree of symptom reduction among Japanese patients with SAD as among Western patients.

Sensitization of catastrophic cognition in cognitive-behavioral therapy for panic disorder.

BACKGROUND: Cognitive model of panic disorder have proposed that panic attacks result from the catastrophic misinterpretation of certain bodily sensations. Cognitive-Behavioral Therapy (CBT) for panic disorder aims to change these catastrophic cognitions. CBT intervention successfully caused reduction of catastrophic cognitions and symptomatic improvement in the majority of cases. However there are some patients who fail to modify their catastrophic cognitions or rather experience an increase in them during CBT treatment. It is clinically and theoretically important to understand about cognitive sensitization of panic disorder during CBT sessions. The purpose of the present study is 1) to clarify the baseline characteristics of panic patients who would experience sensitization of their catastrophic cognitions through the CBT treatment, and 2) to examine the course of symptomatic changes for them. METHODS: Of ninety-five outpatients with panic disorder started the group CBT program for treatment of panic disorder, seventy-nine completer were classified as "cognitively sensitized (CS)" or "cognitive responding (CR)" or "no-responder" according to the difference of the Agoraphobic Cognitions Questionnaire score across treatment. We compared the CS and CR patients in terms of their baseline clinical characteristics. Then we assessed the symptomatic and functional changes for both groups. RESULTS: At the start of the CBT program, despite of the same degree of panic disorder severity, CS scored significantly lower on ACQ score than CR. CS also showed significantly lower score on anticipatory anxiety compared to CR. At the end of treatment CS showed significant improvement in severity of panic disorder, although the degree of improvement was smaller than that for CR. Then CS would progressively reduce their agoraphobic fear and avoidance, and would improve their functional impairment up to three month of follow-up. CONCLUSION: Panic patients who would experience sensitization of their catastrophic cognitions through the CBT treatment could nonetheless gradually improve. They showed a relatively low level of catastrophic cognition and anticipatory anxiety before starting the CBT program. We might conclude that temporary sensitization of catastrophic cognition may be necessary before improvement especially among those with initially low catastrophic body sensation fears and that we need not be concerned too much with temporary increase in catastrophic cognition in the process of CBT for panic disorder.

Interoceptive hypersensitivity and interoceptive exposure in patients with panic disorder: specificity and effectiveness.

BACKGROUND: Interoceptive exposure has been validated as an effective component of cognitive behavioral therapy (CBT) for the treatment of panic disorder but has hitherto received little research attention. We examined the effectiveness of various interoceptive exposure exercises using the Body Sensations Questionnaire (BSQ) (Chambless et al., 1984). METHODS: We first performed an exploratory principal factor analysis of all the items contained in the BSQ to obtain meaningful dimensions of interoceptive fears. Next, we examined the correlations between each interoceptive exposure task's degree of similarity to panic attacks and each BSQ factor and then examined whether the BSQ factor scores decreased in comparison with the baseline values when the corresponding exposure tasks were successfully completed by the subjects. RESULTS: The factor analyses revealed four factors, which we named "pseudoneurological fears", "gastrointestinal fears", "cardiorespiratory fears" and "fears of dissociative feelings." Among the nine interoceptive exposure tasks, 'hyperventilation', 'shaking head', 'holding breath' and 'chest breathing' were considered to reproduce pseudoneurological symptoms, 'breathing through a straw' was considered to reproduce gastrointestinal symptoms, and 'spinning' was considered to reproduce both pseudoneurological and dissociative symptoms; none of the interoceptive exercises were found to reproduce cardiorespiratory symptoms. Among each group of patients for whom 'hyperventilation', 'holding breath', 'spinning' or 'chest breathing' was effective, a significant improvement in the BSQ pseudoneurological fears factor scores was observed. On the other hand, no significant difference between the baseline and endpoint values of the BSQ gastrointestinal fears or the BSQ fears of dissociative feelings factor scores were observed among the patients for whom 'spinning' or 'breathing through a straw' was effective. CONCLUSION: Several interoceptive exposure tasks were particularly effective in reducing pseudoneurological fears. New interoceptive tasks, especially tasks related to cardiorespiratory and dissociative feelings, are needed.