When a test is more than just a test: Findings from patient interviews and survey in the trial of a technology to measure antidepressant medication response (the PReDicT Trial).

BACKGROUND: A RCT of a novel intervention to detect antidepressant medication response (the PReDicT Test) took place in five European countries, accompanied by a nested study of its acceptability and implementation presented here. The RCT results indicated no effect of the intervention on depression at 8 weeks (primary outcome), although effects on anxiety at 8 weeks and functioning at 24 weeks were found. METHODS: The nested study used mixed methods. The aim was to explore patient experiences of the Test including acceptability and implementation, to inform its use within care. A bespoke survey was completed by trial participants in five countries (n = 778) at week 8. Semi-structured interviews were carried out in two countries soon after week 8 (UK n = 22, Germany n = 20). Quantitative data was analysed descriptively; for qualitative data, thematic analysis was carried out using a framework approach. Results of the two datasets were interrogated together. OUTCOMES: Survey results showed the intervention was well received, with a majority of participants indicating they would use it again, and it gave them helpful extra information; a small minority indicated the Test made them feel worse. Qualitative data showed the Test had unexpected properties, including: instigating a process of reflection, giving participants feedback on progress and new understanding about their illness, and making participants feel supported and more engaged in treatment. INTERPRETATION: The qualitative and quantitative results are generally consistent. The Test's unexpected properties may explain why the RCT showed little effect, as properties were experienced across both trial arms. Beyond the RCT, the qualitative data sheds light on measurement reactivity, i.e., how measurements of depression can impact patients.

Comparison of the Working Alliance in Blended Cognitive Behavioral Therapy and Treatment as Usual for Depression in Europe: Secondary Data Analysis of the E-COMPARED Randomized Controlled Trial.

BACKGROUND: Increasing interest has centered on the psychotherapeutic working alliance as a means of understanding clinical change in digital mental health interventions in recent years. However, little is understood about how and to what extent a digital mental health program can have an impact on the working alliance and clinical outcomes in a blended (therapist plus digital program) cognitive behavioral therapy (bCBT) intervention for depression. OBJECTIVE: This study aimed to test the difference in working alliance scores between bCBT and treatment as usual (TAU), examine the association between working alliance and depression severity scores in both arms, and test for an interaction between system usability and working alliance with regard to the association between working alliance and depression scores in bCBT at 3-month assessments. METHODS: We conducted a secondary data analysis of the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment versus Treatment-as-usual) trial, which compared bCBT with TAU across 9 European countries. Data were collected in primary care and specialized services between April 2015 and December 2017. Eligible participants aged 18 years or older and diagnosed with major depressive disorder were randomized to either bCBT (n=476) or TAU (n=467). bCBT consisted of 6-20 sessions of bCBT (involving face-to-face sessions with a therapist and an internet-based program). TAU consisted of usual care for depression. The main outcomes were scores of the working alliance (Working Alliance Inventory-Short Revised-Client [WAI-SR-C]) and depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]) at 3 months after randomization. Other variables included system usability scores (System Usability Scale-Client [SUS-C]) at 3 months and baseline demographic information. Data from baseline and 3-month assessments were analyzed using linear regression models that adjusted for a set of baseline variables. RESULTS: Of the 945 included participants, 644 (68.2%) were female, and the mean age was 38.96 years (IQR 38). bCBT was associated with higher composite WAI-SR-C scores compared to TAU (B=5.67, 95% CI 4.48-6.86). There was an inverse association between WAI-SR-C and PHQ-9 in bCBT (B=-0.12, 95% CI -0.17 to -0.06) and TAU (B=-0.06, 95% CI -0.11 to -0.02), in which as WAI-SR-C scores increased, PHQ-9 scores decreased. Finally, there was a significant interaction between SUS-C and WAI-SR-C with regard to an inverse association between higher WAI-SR-C scores and lower PHQ-9 scores in bCBT (b=-0.030, 95% CI -0.05 to -0.01; P=.005). CONCLUSIONS: To our knowledge, this is the first study to show that bCBT may enhance the client working alliance when compared to evidence-based routine care for depression that services reported offering. The working alliance in bCBT was also associated with clinical improvements that appear to be enhanced by good program usability. Our findings add further weight to the view that the addition of internet-delivered CBT to face-to-face CBT may positively augment experiences of the working alliance. TRIAL REGISTRATION: ClinicalTrials.gov NCT02542891, https://clinicaltrials.gov/study/NCT02542891; German Clinical Trials Register DRKS00006866, https://drks.de/search/en/trial/DRKS00006866; Netherlands Trials Register NTR4962, https://www.onderzoekmetmensen.nl/en/trial/25452; ClinicalTrials.Gov NCT02389660, https://clinicaltrials.gov/study/NCT02389660; ClinicalTrials.gov NCT02361684, https://clinicaltrials.gov/study/NCT02361684; ClinicalTrials.gov NCT02449447, https://clinicaltrials.gov/study/NCT02449447; ClinicalTrials.gov NCT02410616, https://clinicaltrials.gov/study/NCT02410616; ISRCTN Registry ISRCTN12388725, https://www.isrctn.com/ISRCTN12388725?q=ISRCTN12388725&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10; ClinicalTrials.gov NCT02796573, https://classic.clinicaltrials.gov/ct2/show/NCT02796573. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-016-1511-1.

Dimensionality of the system usability scale among professionals using internet-based interventions for depression: a confirmatory factor analysis.

BACKGROUND: The System Usability Scale (SUS) is used to measure usability of internet-based Cognitive Behavioural Therapy (iCBT). However, whether the SUS is a valid instrument to measure usability in this context is unclear. The aim of this study is to assess the factor structure of the SUS, measuring usability of iCBT for depression in a sample of professionals. In addition, the psychometric properties (reliability, convergent validity) of the SUS were tested. METHODS: A sample of 242 professionals using iCBT for depression from 6 European countries completed the SUS. Confirmatory Factor Analysis (CFA) was conducted to test whether a one-factor, two-factor, tone-model or bi-direct model would fit the data best. Reliability was assessed using complementary statistical indices (e.g. omega). To assess convergent validity, the SUS total score was correlated with an adapted Client Satisfaction Questionnaire (CSQ-3). RESULTS: CFA supported the one-factor, two-factor and tone-model, but the bi-factor model fitted the data best (Comparative Fit Index = 0.992, Tucker Lewis Index = 0.985, Root Mean Square Error of Approximation = 0.055, Standardized Root Mean Square Residual = 0.042 (respectively χ2diff (9) = 69.82, p < 0.001; χ2diff (8) = 33.04, p < 0.001). Reliability of the SUS was good (ω = 0.91). The total SUS score correlated moderately with the CSQ-3 (CSQ1 rs = .49, p < 0.001; CSQ2 rs = .46, p < 0.001; CSQ3 rs = .38, p < 0.001), indicating convergent validity. CONCLUSIONS: Although the SUS seems to have a multidimensional structure, the best model showed that the total sumscore of the SUS appears to be a valid and interpretable measure to assess the usability of internet-based interventions when used by professionals in mental healthcare.

Behind the Scenes of Online Therapeutic Feedback in Blended Therapy for Depression: Mixed-Methods Observational Study.

BACKGROUND: In Internet-delivered cognitive behavioral therapies (iCBT), written feedback by therapists is a substantial part of therapy. However, it is not yet known how this feedback should be given best and which specific therapist behaviors and content are most beneficial for patients. General instructions for written feedback are available, but the uptake and effectiveness of these instructions in iCBT have not been studied yet. OBJECTIVE: This study aimed to identify therapist behaviors in written online communication with patients in blended CBT for adult depression in routine secondary mental health care, to identify the extent to which the therapists adhere to feedback instructions, and to explore whether therapist behaviors and adherence to feedback instructions are associated with patient outcome. METHODS: Adults receiving blended CBT (10 online sessions in combination with 5 face-to-face sessions) for depression in routine mental health care were recruited in the context of the European implementation project MasterMind. A qualitative content analysis was used to identify therapist behaviors in online written feedback messages, and a checklist for the feedback instruction adherence of the therapists was developed. Correlations were explored between the therapist behaviors, therapist instruction adherence, and patient outcomes (number of completed online sessions and symptom change scores). RESULTS: A total of 45 patients (73%, 33/45 female, mean age 35.9 years) received 219 feedback messages given by 19 therapists (84%, 16/19 female). The most frequently used therapist behaviors were informing, encouraging, and affirming. However, these were not related to patient outcomes. Although infrequently used, confronting was positively correlated with session completion (ρ=.342, P=.02). Therapists adhered to most of the feedback instructions. Only 2 feedback aspects were correlated with session completion: the more therapists adhere to instructions containing structure (limiting to 2 subjects and sending feedback within 3 working days) and readability (short sentences and short paragraphs), the less online sessions were completed (ρ=-.340, P=.02 and ρ=-.361, P=.02, respectively). No associations were found with depression symptom change scores. CONCLUSIONS: The therapist behaviors found in this study are comparable to previous research. The findings suggest that online feedback instructions for therapists provide sufficient guidance to communicate in a supportive and positive manner with patients. However, the instructions might be improved by adding more therapeutic techniques besides the focus on style and form.

Feasibility and Effectiveness of Memory Specificity Training in Depressed Outpatients: A Pilot Study.

BACKGROUND: Research has shown that depressed patients suffer from reduced autobiographical memory specificity (rAMS). This cognitive phenomenon is associated with the maintenance and recurrence of depressive symptoms. OBJECTIVES: This pilot study aims to investigate the feasibility and effectiveness of a relatively new group-based intervention (Memory Specificity Training; MeST) that aims to reduce rAMS in an outpatient setting. METHODS: Twenty-six depressed outpatients received MeST during the waiting period prior to psychotherapy. The Client Satisfaction Questionnaire (CSQ-8) was used to measure client satisfaction after the training. The Autobiographical Memory Test (AMT) was used to measure memory specificity before and after the training. Depressive symptoms were measured using the Beck Depression Inventory (BDI-II) and the Montgomery Asberg Depression Rating Scale (MADRS), before and after the training, and at a 3-month follow-up. RESULTS: Participants as well as trainers were positive about the use of MeST. Participants also showed an increase in memory specificity and a decrease in depressive symptoms. CONCLUSIONS: This study suggests that MeST is feasible in an outpatient setting, that it increases autobiographical memory specificity and that it may decrease depressive symptoms. A randomized controlled trial is recommended to examine MeST and its effects on autobiographical memory specificity, depressive symptoms and depressive relapse more extensively. Copyright © 2015 John Wiley & Sons, Ltd. Key Practitioner Message: Research suggests that modification of rAMS can advance recovery and reduce the chance of developing a depression relapse. However, most existing psychotherapies for depression do not include these specific interventions. This is the first study to show that MeST in an outpatient setting is feasible and can lead to an increase in autobiographical memory specificity and that it may decrease depressive symptoms. A larger scale randomized controlled trial is required to examine whether the addition of MeST to care as usual decreases depressive symptoms more effectively than care as usual without MeST, and to examine whether subgroups of patients benefit specifically from this intervention (e.g. patients with more severely decreased memory specificity).

Non-fatal disease burden for subtypes of depressive disorder: population-based epidemiological study.

BACKGROUND: Major depression is the leading cause of non-fatal disease burden. Because major depression is not a homogeneous condition, this study estimated the non-fatal disease burden for mild, moderate and severe depression in both single episode and recurrent depression. All estimates were assessed from an individual and a population perspective and presented as unadjusted, raw estimates and as estimates adjusted for comorbidity. METHODS: We used data from the first wave of the second Netherlands-Mental-Health-Survey-and-Incidence-Study (NEMESIS-2, n = 6646; single episode Diagnostic and Statistical Manual (DSM)-IV depression, n = 115; recurrent depression, n = 246). Disease burden from an individual perspective was assessed as 'disability weight * time spent in depression' for each person in the dataset. From a population perspective it was assessed as 'disability weight * time spent in depression *number of people affected'. The presence of mental disorders was assessed with the Composite International Diagnostic Interview (CIDI) 3.0. RESULTS: Single depressive episodes emerged as a key driver of disease burden from an individual perspective. From a population perspective, recurrent depressions emerged as a key driver. These findings remained unaltered after adjusting for comorbidity. CONCLUSIONS: The burden of disease differs between the subtype of depression and depends much on the choice of perspective. The distinction between an individual and a population perspective may help to avoid misunderstandings between policy makers and clinicians.

Cost-effectiveness of nurse-led self-help for recurrent depression in the primary care setting: design of a pragmatic randomised controlled trial.

BACKGROUND: Major Depressive Disorder is a leading cause of disability, tends to run a recurrent course and is associated with substantial economic costs due to increased healthcare utilization and productivity losses. Interventions aimed at the prevention of recurrences may reduce patients' suffering and costs. Besides antidepressants, several psychological treatments such as preventive cognitive therapy (PCT) are effective in the prevention of recurrences of depression. Yet, many patients find long-term use of antidepressants unattractive, do not want to engage in therapy sessions and in the primary care setting psychologists are often not available. Therefore, it is important to study whether PCT can be used in a nurse-led self-help format in primary care. This study sets out to test the hypothesis that usual care plus nurse-led self-help for recurrent depression in primary care is feasible, acceptable and cost-effective compared to usual care only. DESIGN: Patients are randomly assigned to 'nurse-led self-help treatment plus usual care' (134 participants) or 'usual care' (134 participants). Randomisation is stratified according to the number of previous episodes (2 or 3 previous episodes versus 4 or more). The primary clinical outcome is the cumulative recurrence rate of depression meeting DSM-IV criteria as assessed by the Structured-Clinical-Interview-for-DSM-IV- disorders at one year after completion of the intervention. Secondary clinical outcomes are quality of life, severity of depressive symptoms, co-morbid psychopathology and self-efficacy. As putative effect-moderators, demographic characteristics, number of previous episodes, type of treatment during previous episodes, age of onset, self-efficacy and symptoms of pain and fatigue are assessed. Cumulative recurrence rate ratios are obtained under a Poisson regression model. Number-needed-to-be-treated is calculated as the inverse of the risk-difference. The economic evaluation is conducted from a societal perspective, both as a cost-effectiveness analysis (costs per depression free survival year) and as a cost-utility analysis (costs per quality adjusted life-year). DISCUSSION: The purpose of this paper is to outline the rationale and design of a nurse-led, cognitive therapy based self-help aimed at preventing recurrence of depression in a primary care setting. Only few studies have focused on psychological self-help interventions aimed at the prevention of recurrences in primary care patients. TRIAL REGISTRATION: NTR3001 (http://www.trialregister.nl).

A Web-Based Stress Management Intervention for University Students in Indonesia (Rileks): Feasibility Study Using a Pretest-Posttest Design.

BACKGROUND: University students are susceptible to excessive stress. A web-based stress management intervention holds promise to improve stress but is still at a novel stage in Indonesia. OBJECTIVE: The aim of this paper was to report the feasibility of the intervention we developed-Rileks-among university students in Indonesia in terms of acceptability and usability, and to propose recommendations for future improvements. METHODS: A single-group pretest and posttest design was used. Participants with scores of 15 or higher on the stress subscale of the 42-item Depression Anxiety Stress Scales were given access to the intervention (N=68). The main outcome measures were the 8-item Client Satisfaction Questionnaire (CSQ-8) score, the System Usability Scale (SUS) score, and intervention uptake. Participants' experience in each session was evaluated using closed- and open-ended questions for future improvements. Descriptive statistics were used to examine primary outcome and qualitative session evaluations. Participants' responses to each topic of the open questions were summarized. RESULTS: The intervention was evaluated as being satisfactory (CSQ-8 mean score 21.89, SD 8.72; range 8-32). However, the intervention's usability was still below expectation (SUS mean score 62.8, SD 14.74; range 0-100). The core modules were completed by 10 out of 68 participants (15%), and the study dropout rate was 63% (43/68) at postassessment. In general, the module content was rated positively, with some notes for improvement covering content and technical aspects. CONCLUSIONS: This study indicates that Rileks is potentially feasible for Indonesian university students. In order to be optimally applied in such a context and before scaling up web-based interventions in Indonesia, in general, further development and refinement are needed. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/11493.

The clinical effectiveness of using a predictive algorithm to guide antidepressant treatment in primary care (PReDicT): an open-label, randomised controlled trial.

Depressed patients often do not respond to the first antidepressant prescribed, resulting in sequential trials of different medications. Personalised medicine offers a means of reducing this delay; however, the clinical effectiveness of personalised approaches to antidepressant treatment has not previously been tested. We assessed the clinical effectiveness of using a predictive algorithm, based on behavioural tests of affective cognition and subjective symptoms, to guide antidepressant treatment. We conducted a multicentre, open-label, randomised controlled trial in 913 medication-free depressed patients. Patients were randomly assigned to have their antidepressant treatment guided by a predictive algorithm or treatment as usual (TaU). The primary outcome was the response of depression symptoms, defined as a 50% or greater reduction in baseline score of the QIDS-SR-16 scale, at week 8. Additional prespecified outcomes included symptoms of anxiety at week 8, and symptoms of depression and functional outcome at weeks 8, 24 and 48. The response rate of depressive symptoms at week 8 in the PReDicT (55.9%) and TaU (51.8%) arms did not differ significantly (odds ratio: 1.18 (95% CI: 0.89-1.56), P = 0.25). However, there was a significantly greater reduction of anxiety in week 8 and a greater improvement in functional outcome at week 24 in the PReDicT arm. Use of the PReDicT test did not increase the rate of response to antidepressant treatment estimated by depressive symptoms but did improve symptoms of anxiety at week 8 and functional outcome at week 24. Our findings indicate that personalisation of antidepressant treatment may improve outcomes in depressed patients.

Getting under the skin: Does biology help predict chronicity of depression?

BACKGROUND: Depressed patients are at risk of an unfavourable course including chronic episodes. Various psychiatric characteristics have shown to be predictive of depression's course trajectory, but whether indicators of somatic health further contribute to course prediction remains unclear. This study aimed to identify somatic health indicators (i.e. biomarkers, health status and lifestyle) that predict 2-year chronicity above and beyond an extensive list of sociodemographic and psychiatric characteristics. METHODS: Data are from patients with current depression at baseline (n = 903) and available 2-year follow-up participating in a longitudinal cohort study. Baseline demographic, psychiatric and somatic health indicators were associated with 2-year course trajectories, classified as non-chronic versus chronic RESULTS: At 2-year follow up, 40% of the patients showed a chronic course. Of the twenty tested somatic health indicators, short sleep and high interleukin-6 improved the regression model predicting chronicity with a significant, but modest, effect (ROC = 0.78; p = 0.03). LIMITATIONS: Due to the observational design we did not have the ability to reliably consider the impact of psychiatric treatment. More elaborate information on somatic health such as dietary patterns would strengthen the study. CONCLUSIONS: This study showed that short sleep duration and high interleukin-6 contributed significantly to the regression model as independent predictors, suggestive of clinical implications for patients with sleep disturbances and elevated inflammation levels. Other somatic health indicators did not add to the model. Overall, somatic health indicators showed modest additive value for predicting chronic course above and beyond sociodemographic and psychiatric indicators.

Unraveling the Black Box: Exploring Usage Patterns of a Blended Treatment for Depression in a Multicenter Study.

BACKGROUND: Blended treatments, combining digital components with face-to-face (FTF) therapy, are starting to find their way into mental health care. Knowledge on how blended treatments should be set up is, however, still limited. To further explore and optimize blended treatment protocols, it is important to obtain a full picture of what actually happens during treatments when applied in routine mental health care. OBJECTIVE: The aims of this study were to gain insight into the usage of the different components of a blended cognitive behavioral therapy (bCBT) for depression and reflect on actual engagement as compared with intended application, compare bCBT usage between primary and specialized care, and explore different usage patterns. METHODS: Data used were collected from participants of the European Comparative Effectiveness Research on Internet-Based Depression Treatment project, a European multisite randomized controlled trial comparing bCBT with regular care for depression. Patients were recruited in primary and specialized routine mental health care settings between February 2015 and December 2017. Analyses were performed on the group of participants allocated to the bCBT condition who made use of the Moodbuster platform and for whom data from all blended components were available (n=200). Included patients were from Germany, Poland, the Netherlands, and France; 64.5% (129/200) were female and the average age was 42 years (range 18-74 years). RESULTS: Overall, there was a large variability in the usage of the blended treatment. A clear distinction between care settings was observed, with longer treatment duration and more FTF sessions in specialized care and a more active and intensive usage of the Web-based component by the patients in primary care. Of the patients who started the bCBT, 89.5% (179/200) also continued with this treatment format. Treatment preference, educational level, and the number of comorbid disorders were associated with bCBT engagement. CONCLUSIONS: Blended treatments can be applied to a group of patients being treated for depression in routine mental health care. Rather than striving for an optimal blend, a more personalized blended care approach seems to be the most suitable. The next step is to gain more insight into the clinical and cost-effectiveness of blended treatments and to further facilitate uptake in routine mental health care.

Web-Based Stress Management Program for University Students in Indonesia: Systematic Cultural Adaptation and Protocol for a Feasibility Study.

BACKGROUND: The number of university students experiencing stress is increasing, which often leads to adverse effects such as poor grades, academic probation, and emotional problems. Unfortunately, most of these problems remain untreated because of limited professional resources and fear of stigma. Several Web-based stress management interventions are now available for student populations, but these treatments are not yet available in Indonesia. To make treatment for stress more acceptable in Indonesia, a cultural adaptation process is needed, and part of the process is assessing the feasibility of the adapted intervention. OBJECTIVE: This paper describes the first two stages of a cultural adaptation process and the protocol of a feasibility study that will assess the acceptability of a culturally adapted stress management intervention for university students in Indonesia. METHODS: Focus group discussions with Indonesian university students were held, and input from Indonesian psychologists was gathered for developing the adapted intervention. A single-group feasibility study with a pre-post design will be conducted. We will recruit at minimum 50 university students who have an elevated level of stress (Depression, Anxiety, and Stress Scales-42 stress subscale score ≥15), identify themselves as being of Indonesian culture (eg, able to speak Bahasa Indonesia fluently), and are studying at a university in Indonesia. The primary endpoints of this study will be rates of participant satisfaction, system usability, dropout rates, and level of adherence. We will also use qualitative data to assess the adapted intervention more thoroughly. Secondary study endpoints will be quality of life, stress, anxiety, and depression levels. Feasibility parameters (eg, participant satisfaction, system usability, and level of adherence) will be summarized with descriptive statistics. Two-tailed paired within-group t tests will be used to analyze stress, anxiety, depression, and quality of life. RESULTS: The enrollment of pilot study is currently ongoing. First results are expected to be ready for analysis in the second half of 2019. The project was funded as part of a PhD trajectory in 2015 by the Indonesian Endowment Fund for Education. CONCLUSIONS: This is one of the first studies to assess the feasibility of a culturally adapted Web-based stress management intervention for university students in Indonesia. Strengths and limitations of the study are discussed. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11493.

The effects of using the PReDicT Test to guide the antidepressant treatment of depressed patients: study protocol for a randomised controlled trial.

BACKGROUND: Antidepressant medication is commonly used to treat depression. However, many patients do not respond to the first medication prescribed and improvements in symptoms are generally only detectable by clinicians 4-6 weeks after the medication has been initiated. As a result, there is often a long delay between the decision to initiate an antidepressant medication and the identification of an effective treatment regimen. Previous work has demonstrated that antidepressant medications alter subtle measures of affective cognition in depressed patients, such as the appraisal of facial expression. Furthermore, these cognitive effects of antidepressants are apparent early in the course of treatment and can also predict later clinical response. This trial will assess whether an electronic test of affective cognition and symptoms (the Predicting Response to Depression Treatment Test; PReDicT Test) can be used to guide antidepressant treatment in depressed patients and, therefore, hasten treatment response compared to a control group of patients treated as usual. METHODS/DESIGN: The study is a randomised, two-arm, multi-centre, open-label, clinical investigation of a medical device, the PReDicT Test. It will be conducted in five European countries (UK, France, Spain, Germany and the Netherlands) in depressed patients who are commencing antidepressant medication. Patients will be randomised to treatment guided by the PReDicT Test (PReDicT arm) or to Treatment as Usual (TaU arm). Patients in the TaU arm will be treated as per current standard guidelines in their particular country. Patients in the PReDicT arm will complete the PReDicT Test after 1 (and if necessary, 2) weeks of treatment. If the test indicates non-response to the treatment, physicians will be advised to immediately alter the patient's antidepressant therapy by dose escalation or switching to another compound. The primary outcome of the study is the proportion of patients showing a clinical response (defined as 50% or greater decrease in baseline scores of depression measured using the Quick Inventory of Depressive Symptoms - Self-Rated questionnaire) at week 8. Health economic and acceptability data will also be collected and analysed. DISCUSSION: This trial will test the clinical efficacy, cost-effectiveness and acceptability of using the novel PReDicT Test to guide antidepressant treatment selection in depressed patients. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02790970 . Registered on 30 March 2016.

European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries.

BACKGROUND: Effective, accessible, and affordable depression treatment is of high importance considering the large personal and economic burden of depression. Internet-based treatment is considered a promising clinical and cost-effective alternative to current routine depression treatment strategies such as face-to-face psychotherapy. However, it is not clear whether research findings translate to routine clinical practice such as primary or specialized mental health care. The E-COMPARED project aims to gain knowledge on the clinical and cost-effectiveness of blended depression treatment compared to treatment-as-usual in routine care. METHODS/DESIGN: E-COMPARED will employ a pragmatic, multinational, randomized controlled, non-inferiority trial in eight European countries. Adults diagnosed with major depressive disorder (MDD) will be recruited in primary care (Germany, Poland, Spain, Sweden, and the United Kingdom) or specialized mental health care (France, The Netherlands, and Switzerland). Regular care for depression is compared to "blended" service delivery combining mobile and Internet technologies with face-to-face treatment in one treatment protocol. Participants will be followed up at 3, 6, and 12 months after baseline to determine clinical improvements in symptoms of depression (primary outcome: Patient Health Questionnaire-9), remission of depression, and cost-effectiveness. Main analyses will be conducted on the pooled data from the eight countries (n = 1200 in total, 150 participants in each country). DISCUSSION: The E-COMPARED project will provide mental health care stakeholders with evidence-based information and recommendations on the clinical and cost-effectiveness of blended depression treatment. TRIAL REGISTRATION: France: ClinicalTrials.gov NCT02542891 . Registered on 4 September 2015; Germany: German Clinical Trials Register DRKS00006866 . Registered on 2 December 2014; The Netherlands: Netherlands Trials Register NTR4962 . Registered on 5 January 2015; Poland: ClinicalTrials.Gov NCT02389660 . Registered on 18 February 2015; Spain: ClinicalTrials.gov NCT02361684 . Registered on 8 January 2015; Sweden: ClinicalTrials.gov NCT02449447 . Registered on 30 March 2015; Switzerland: ClinicalTrials.gov NCT02410616 . Registered on 2 April 2015; United Kingdom: ISRCTN registry, ISRCTN12388725 . Registered on 20 March 2015.

Bridging the gap for ethnic minority adult outpatients with depression and anxiety disorders by culturally adapted treatments.

BACKGROUND: Culturally adapted guideline driven depression and anxiety treatments have been developed for ethnic minority patients in Western countries to boost effectiveness for these growing and vulnerable groups. The aims of this study are to systematically review the empirical literature of outcomes associated with culturally adapted guideline driven depression and anxiety interventions, to describe the cultural adaptation and to identify the contribution of the cultural adaptation and approach as such. METHOD: Comprehensive search of the major bibliographical databases (Cochrane Central Register of Controlled Trials, Pubmed; Psychinfo) for randomized controlled trials. RESULTS: Nine eligible studies were identified and all were conducted in the USA. The pooled random standardized differences in means of the culturally adapted depression and anxiety treatment on clinical outcome was 1.06 (CI 95% 0.51-1.62, P=0.00). Two studies demonstrated effectiveness of the population specific cultural adaptation per se. All studies incorporated a focus on cultural values and beliefs as a cultural adaptation. LIMITATION: We only identified a small number of USA studies so generalisation of the findings to other western countries can be discussed. CONCLUSION: Culturally adapted guideline driven depression and anxiety treatment was effective for USA minority patients from different cultural backgrounds. There is some evidence for the effectiveness of the population specific cultural adaptation as such.

Psychological treatment of depression in primary care: a meta-analysis.

BACKGROUND: Although most depressive disorders are treated in primary care and several studies have examined the effects of psychological treatment in primary care, hardly any meta-analytic research has been conducted in which the results of these studies are integrated. AIM: To integrate the results of randomised controlled trials of psychological treatment of depression in adults in primary care, and to compare these results to psychological treatments in other settings. DESIGN OF STUDY: A meta-analysis of studies examining the effects of psychological treatments of adult depression in primary care. SETTING: Primary care. METHOD: An existing database of studies on psychological treatments of adult depression that was built on systematic searches in PubMed, PsychINFO, EMBASE, and Dissertation Abstracts International was used. Randomised trials were included in which the effects of psychological treatments on adult primary care patients with depression were compared to a control condition. RESULTS: In the 15 included studies, the standardised mean effect size of psychological treatment versus control groups was 0.31 (95% CI = 0.17 to 0.45), which corresponds with a numbers-needed-to-treat (NNT) of 5.75. Studies in which patients were referred by their GP for treatment had significantly higher effect sizes (d = 0.43; NNT = 4.20) than studies in which patients were recruited through systematic screening (d = 0.13, not significantly different from zero; NNT = 13.51). CONCLUSIONS: Although the number of studies was relatively low and the quality varied, psychological treatment of depression was found to be effective in primary care, especially when GPs refer patients with depression for treatment.

Interpersonal psychotherapy for elderly patients in primary care.

OBJECTIVE: Interpersonal psychotherapy (IPT) is recommended in most depression treatment guidelines, but little is known about its effectiveness in real-life practice. This study investigates whether IPT, delivered by mental health workers to elderly patients with major depressive disorder, is more effective than usual general practitioners' care (CAU). METHODS: A pragmatic randomized, controlled trial was conducted in which 143 patients were allocated to IPT (10 sessions) or to CAU. PRIMary care Evaluation of Mental Disorders (PRIME-MD) and Montgomery Asberg Depression Rating Scale (MADRS) assessments were used as primary outcomes. RESULTS: IPT was significantly more effective in reducing the percentage of patients with a diagnosis of depression (PRIME-MD), but not in inducing remission (MADRS <10). Among treatment completers, IPT was superior in improving social and overall mental functioning. A post hoc analysis revealed that IPT was superior to CAU in moderately to severely depressed patients, but not significantly so in mildly depressed patients. CONCLUSIONS: IPT was more effective than CAU for elderly patients with moderate to severe major depressive disorder in general practice. Future research should focus on determinants of treatment outcome.