The iCBT theory should be clearly specified and adequately investigated to design and implement highly efficacious therapeutic packages. Without considering the iCBT mechanisms of change along with iCBT efficacy, the extent to which iCBT is an empirically validated treatment remains questionable.

Cognitive and behavioral interventions (CBI) have been used for breast cancer patients with various stages of the disease or undergoing different treatments. However, no quantitative review has summarized their efficacy on the side effects of treatment, distress, and quality of life in the acute treatment setting after diagnosis. This meta-analysis synthesizes data from 19 randomized clinical trials in order to: (a) provide an estimation of overall effect of CBI in breast cancer patients during treatment for breast cancer, i.e., neo-adjuvant and adjuvant treatment; (b) provide average effect sizes on side effects of treatment, distress, and quality of life; and (c) test possible moderators of effect size. The results show that CBI yielded a small effect size overall, specifically on general side effects of treatment, nausea, vomiting, distress, and quality of life. Individual and behavioral interventions seem to elicit better results on distress and on general side effects of treatment, respectively. While more studies are needed with regard to specific side effects (i.e., fatigue, pain, and sleep disturbance), the overall results clearly support the use of CBI in breast cancer patients during treatment.

Cognitive bibliotherapy is an effective treatment of subthreshold depression. Changing automatic thoughts is important, as they mediate the bibliotherapy effect on depressive symptoms. Cognitive bibliotherapy is a potential alternative or adjunct to psychotherapy for mildly depressed adults.

BackgroundDepression is estimated to become the leading cause of disease burden globally by 2030. Despite existing efficacious treatments (both medical and psychotherapeutic), a large proportion of patients do not respond to therapy. Recent insights from evolutionary psychology suggest that, in addition to targeting the proximal causes of depression (for example, targeting dysfunctional beliefs by cognitive behavioral therapy), the distal or evolutionary causes (for example, inclusive fitness) should also be addressed. A randomized superiority trial is conducted to develop and test an evolutionary-driven cognitive therapy protocol for depression, and to compare its efficacy against standard cognitive therapy for depression.Methods/designRomanian-speaking adults (18 years or older) with elevated Beck Depression Inventory (BDI) scores (>13), current diagnosis of major depressive disorder or major depressive episode (MDD or MDE), and MDD with comorbid dysthymia, as evaluated by the Structured Clinical Interview for DSM-IV (SCID), are included in the study. Participants are randomized to one of two conditions: 1) evolutionary-driven cognitive therapy (ED-CT) or 2) cognitive therapy (CT). Both groups undergo 12 psychotherapy sessions, and data are collected at baseline, mid-treatment, post-treatment, and the 3-month follow-up. Primary outcomes are depressive symptomatology and a categorical diagnosis of depression post-treatment.DiscussionThis randomized trial compares the newly proposed ED-CT with a classic CT protocol for depression. To our knowledge, this is the first attempt to integrate insights from evolutionary theories of depression into the treatment of this condition in a controlled manner. This study can thus add substantially to the body of knowledge on validated treatments for depression.Trial registrationCurrent Controlled Trials ISRCTN64664414The trial was registered in June 2013. The first participant was enrolled on October 3, 2012.

BackgroundDepression has become one of the leading contributors to the global disease burden. Evidence-based treatments for depression are available, but access to them is still limited in some instances. As technology has become more integrated into mental health care, computerized cognitive behavioral therapy (CBT) protocols have become available and have been recently transposed to mobile environments (e.g., smartphones) in the form of “apps.” Preliminary research on some depression apps has shown promising results in reducing subthreshold or mild to moderate depressive symptoms. However, this small number of studies reports a low statistical power and they have not yet been replicated. Moreover, none of them included an active placebo comparison group. This is problematic, as a “digital placebo effect” may explain some of the positive effects documented until now. The aim of this study is to test a newly developed mobile app firmly grounded in the CBT theory of depression to determine whether this app is clinically useful in decreasing moderate depressive symptoms when compared with an active placebo. Additionally, we are interested in the app’s effect on emotional wellbeing and depressogenic cognitions.Methods/designRomanian-speaking adults (18 years and older) with access to a computer and the Internet and owning a smartphone are included in the study. A randomized, three-arm clinical trial is being conducted (i.e., active intervention, placebo intervention and delayed intervention). Two hundred and twenty participants with moderate depressive symptoms (i.e., obtaining scores >9 and ≤16 on the Patient Health Questionnaire, PHQ-9) will be randomized to the three conditions. Participants undergoing therapy, presenting serious mental health problems, or legal or health issues that would prevent them from using the app, as well as participants reporting suicidal ideation are excluded. Participants randomized to the active and placebo interventions will use the smartphone app for 6 weeks. A short therapist check-in via phone will take place every week. Participants in the delayed-intervention condition will be given access to the app after 6 weeks from randomization. The primary outcome is the level of depressive symptomatology. The intervention delivered through the app to the active condition includes psychoeducational materials and exercises based on CBT for depression, while the placebo intervention uses a sham version of the app (i.e., similar structure of courses and exercises).DiscussionTo our knowledge, this study protocol is the first to test the efficacy of a smartphone app for depressive symptomatology in the form of a randomized controlled trial (RCT) that includes an active placebo condition. As such, this can substantially add to the body of evidence supporting the use of apps designed to decrease depression.Trial registrationClinicalTrials.gov, identifier: NCT03060200. Registered on 1 February 2017. The first participant was enrolled on 17 February 2017.Electronic supplementary materialThe online ...