Intensity of Treatment as Usual and Its Impact on the Effects of Face-to-Face and Internet-Based Psychotherapy for Depression: A Preregistered Meta-Analysis of Randomized Controlled Trials.

INTRODUCTION: Treatment as usual (TAU) is the most frequently used control group in randomized trials of psychotherapy for depression. Concerns have been raised that the heterogeneity of treatments in TAU leads to biased estimates of psychotherapy efficacy and to an unclear difference between TAU and control groups like waiting list (WL). OBJECTIVE: We investigated the impact of control group intensity (i.e., amount and degree to which elements of common depression treatments are provided) on the effects of face-to-face and internet-based psychotherapy for depression. METHODS: We conducted a preregistered meta-analysis (www.osf.io/4mzyd). We included trials comparing psychotherapy with TAU or WL in patients with symptoms of unipolar depression. Six indicators were used to assess control group intensity. PRIMARY OUTCOME: Standardized mean difference (SMD) of psychotherapy and control in depressive symptoms at treatment termination. RESULTS: We included 89 trials randomizing 14,474 patients to 113 psychotherapy conditions and 89 control groups (TAU in 42 trials, WL in 47 trials). Control group intensity predicted trial results in preregistered (one-sided ps < 0.042) and exploratory analyses. Psychotherapy effects were significantly smaller (one-sided p = 0.002) in trials with higher intensity TAU (SMD = 0.324, CI 0.209 to 0.439) than in trials with lower intensity TAU (SMD = 0.628, CI 0.455 to 0.801). Psychotherapy effects against lower intensity TAU did not differ from effects against WL (two-sided p = 0.663). CONCLUSIONS: Our results suggest that variation in TAU intensity impacts the outcome of trials. More scrutiny in the design of control groups for clinical trials is recommended.

Body dysmorphic disorder of female genitalia: a qualitative study of Swiss obstetrician-gynecologists' experiences and practices.

PURPOSE: This work focuses on the experiences and practices of obstetrician-gynecologists (ob-gyns) with patients suffering from body dysmorphic disorder (BDD) and issues with their aesthetics, specifically focusing on female genitalia. Ob-gyns are likely to play an important role in the recognition and treatment of women facing such issues. METHODS: This study took a qualitative, explorative approach. Semi-structured interviews were conducted with 11 ob-gyns about their experiences with patients who presented symptoms of BDD of female genitalia, their treatments, and interest in further education and supportive material. Interviews were analyzed through qualitative content analysis. RESULTS: A categorization system was created. The results showed that the participating ob-gyns are often confronted with genital dissatisfaction of patients. The study sample demonstrated a lack of mental health literacy concerning BDD. The treatments that the ob-gyns of this sample suggested for BDD of female genitalia were not in line with what evidence suggests. Finally, interest in further education and supportive material for consultation was evidenced in this sample. CONCLUSIONS: The findings encourage further studies to identify the recognition of BDD concerning genitalia or etiological factors. Furthermore, practical implications (e.g., need of supportive material) can be derived from the results.

Prevalence of symptoms of body dysmorphic disorder (BDD) and associated features in Swiss military recruits: a self-report survey.

BACKGROUND: Body dysmorphic disorder (BDD), defined as the obsessive idea that some aspect of one's own body or appearance is severely flawed/deformed, is relatively common in the general population and has been shown to have strong associations with mood and anxiety disorders and substance abuse disorders. Furthermore, a previous study on symptoms of BDD among people in the military showed that muscles are an important area of preoccupation. Hence, this study aimed to 1. assess the prevalence of BDD symptoms in Swiss military recruits, 2. specify the areas of preoccupation, and 3. analyze associated features (depression and alcohol/drug abuse). METHOD: A total of 126 Swiss male military recruits (age: M = 20.12, SD = 1.09, range: 18-24) were examined using self-report measurements to assess symptoms of BDD, depression, alcohol/drug abuse. RESULTS: The results showed that symptoms of BDD were relatively common (9.5% reached the cutoff value for probable BDD, 84% reported some symptoms), with the muscles as the most common area of preoccupation. A positive correlation (r = .38, p < .001) between depressive symptoms and symptoms of BDD was found, thus no correlation between alcohol/drug abuse and symptoms of BDD. CONCLUSION: The results indicate a need to develop and implement measures for prevention (e.g. raising awareness among the military) and intervention in this specific population.

Cost-effectiveness of guideline-based stepped and collaborative care versus treatment as usual for patients with depression - a cluster-randomized trial.

BACKGROUND: Depression is associated with major patient burden. Its treatment requires complex and collaborative approaches. A stepped care model based on the German National Clinical Practice Guideline "Unipolar Depression" has been shown to be effective. In this study we assess the cost-effectiveness of this guideline based stepped care model versus treatment as usual in depression. METHODS: This prospective cluster-randomized controlled trial included 737 depressive adult patients. Primary care practices were randomized to an intervention (IG) or a control group (CG). The intervention consisted of a four-level stepped care model. The CG received treatment as usual. A cost-utility analysis from the societal perspective with a time horizon of 12 months was performed. We used quality-adjusted life years (QALY) based on the EQ-5D-3L as effect measure. Resource utilization was assessed by patient questionnaires. Missing values were imputed by 'multiple imputation using chained equations' based on predictive mean matching. We calculated adjusted group differences in costs and effects as well as incremental cost-effectiveness ratios. To describe the statistical and decision uncertainty cost-effectiveness acceptability curves were constructed based on net-benefit regressions with bootstrapped standard errors (1000 replications). The complete sample and subgroups based on depression severity were considered. RESULTS: We found no statically significant differences in costs and effects between IG and CG. The incremental total societal costs (+€5016; 95%-CI: [-€259;€10,290) and effects (+ 0.008 QALY; 95%-CI: [- 0.030; 0.046]) were higher in the IG in comparison to the CG. Significantly higher costs were found in the IG for outpatient physician services and psychiatrist services in comparison to the CG. Significantly higher total costs and productivity losses in the IG in comparison to the CG were found in the group with severe depression. Incremental cost-effectiveness ratios for the IG in comparison to the CG were unfavourable (complete sample: €627.000/QALY gained; mild depression: dominated; moderately severe depression: €645.154/QALY gained; severe depression: €2082,714/QALY gained) and the probability of cost-effectiveness of the intervention was low, except for the group with moderate depression (ICER: dominance; 70% for willingness-to-pay threshold of €50,000/QALY gained). CONCLUSIONS: We found no evidence for cost-effectiveness of the intervention in comparison to treatment as usual. TRIAL REGISTRATION: NCT, NCT01731717 . Registered 22 November 2012 - Retrospectively registered.

Barriers to access to outpatient mental health care for refugees and asylum seekers in Switzerland: the therapist's view.

BACKGROUND: More than 120,000 refugees and asylum seekers are currently living in Switzerland. The prevalence of mental disorders among this population is significantly higher than that in the general population. While effective treatment options and cross-cultural, specialized treatment centers exist, they tend to be overloaded by their target populations. General outpatient primary health care providers might be able to compensate for the lack of specialized treatment slots. To date, however, it is unknown how often and under what conditions (e.g., length of waiting lists) refugees and asylum seekers are treated outside of specialized centers and whether there are barriers that prevent providers in outpatient settings from treating more patients in this subgroup. The present study aimed to assess the challenges and barriers faced by psychiatrists and psychotherapists working in outpatient settings in Switzerland in treating refugees and asylum seekers to determine the potential capacity of this group to provide mental health care. METHODS: An online survey was conducted during the winter of 2017/2018. The survey was constructed in three official languages and took 10-15 min to complete. Spearman's correlations, Mann-Whitney U-Tests, and Chi-squared tests were conducted to analyze the data. RESULTS: Eight hundred and sixty-seven (N = 867) psychotherapists and psychiatrists working in outpatient settings completed the survey: 43% of them reported having treated between 1 and 9 refugees or asylum seekers in the past 12 months, and a further 13% reported treating 10 or more. Interpreters were used for almost every other patient with a refugee or asylum-seeker background. At the same time, the funding of interpreters, as well as the funding of treatment in general, were reported to be the biggest hurdles to treating more refugees and asylum seekers. CONCLUSIONS: Given the low number of patients rejected for capacity reasons (between 2 and 5%) and the median waiting times for the admission of new patients ranging between 2 and 3 weeks, outpatient primary mental health care providers might treat more refugees and asylum seekers and relieve specialized treatment centers. However, barriers such as lack of funding of interpreters seem to hinder them. Appropriate steps by the authorities are needed to improve the current situation.

Effectiveness of Telephone-Administered Cognitive-Behavioral Psychotherapy for Depression With Versus Without Additional Letters: A Randomized Controlled Trial.

Background: Telephone-administered cognitive-behavioral psychotherapy (T-CBT) can effectively treat patients with depressive symptoms. Introduction: We investigated whether adding letters (via postal mail) to T-CBT reduces depressive symptoms and increases response and remission. Additionally, we assessed whether T-CBT reduced all patients' symptoms in the first depression-specific T-CBT sample in German healthcare. Materials and Methods: Primary care patients were randomized to T-CBT with versus without letters. All received 1 face-to-face and 8-12 telephone-administered sessions. An intention-to-treat sample was analyzed. Between-groups differences in symptom change and the total sample's symptom change were computed using linear mixed models with group as fixed effect, referring general practice as random effect and several covariates. Differences in response and remission were assessed using logistic regressions. Results: Fifty-nine patients were referred to T-CBT and randomized. Twenty-six patients actually participated in T-CBT with letters and 21 without letters. The groups did not differ significantly regarding symptom change (Patient Health Questionnaire [PHQ-9]) from baseline to end: T-CBT without letters showed 1.05 points greater reduction (95% confidence interval: -4.72 to 2.62; p = 0.56; Cohen's d = -0.12) (adjusted mean change). The groups did not differ significantly regarding symptom change from baseline to 6-month follow-up nor odds of response or remission. The total sample's PHQ-9 showed significant adjusted mean reduction from baseline to end of T-CBT and to 6-month follow-up. Discussion: Additional letters did not lead to greater symptom reduction. Overall results for the first German T-CBT intervention for depression appear promising but require further assessment using a control condition. Conclusions: Additional letters do not appear to enhance the effectiveness of T-CBT.

[Advice Literature on Depression: How Evidence-Based is it?] / Patientenratgeber bei Depression: Wie evidenzbasiert sind sie?

INTRODUCTION: Advice literature on depression for patients and their relatives is a widespread and low-threshold source of information. In terms of empowerment of the patients it can contribute to the early detection and effective treatment of the disorder. An evaluation of its content quality, particularly its evidence base, is still missing. Considering this, the content of advice literature on depression is reviewed by comparing it systematically with content and recommendations from the German S3-/NV-guideline on unipolar depression. METHODS: Based on a systematic search within the data base of the book trade, the 30 most widespread German advice books were analysed. For this purpose a rating instrument (RLP-D) with 54 items on diagnostics and treatment was derived from the current S3-/NV-guideline. With the help of the RLP-D one rater analysed both elaboration and accuracy of the 30 books' content. RESULTS: Between 7.4 and 81.5% of the items i. e. of the guideline content, are missing in the analysed advice books (Mdn=25.9%, IQR=22.7%). On average a third of the 54 items is covered extensively as well as without contradictions to the guideline (Mdn=36.1%, IQR=17.1%, Range: 1.9-64.8%). A fifth of the covered items (Mdn=20.4%; IQR=19.0%, Range: 2.9-47.6%) shows clinically relevant contradictions to the guideline content. Information about psychotherapy and pharmacotherapy as treatment options is the content which is covered extensively and correctly most often: The information is given in more than 83% of the books. DISCUSSION: There is a substantial variability concerning the elaboration and accuracy of the diagnostics and treatment content in advice literature. This also applies to the especially concerning erroneous content in advice literature. The further evaluation of the rating instrument RLP-D is a next important step. An application and reduction to the core contents of the guideline could facilitate the currently rather complex and laborious rating system. CONCLUSION: Although some basic information is given in almost all of the analysed books, advice literature on depression cannot be recommended per se due to the large differences in quality. Systematic evaluations of quality should be established in order to facilitate a well-grounded choice of literature in order to improve the information for patients.

Antidepressant prescription practice and related factors in Switzerland: a cross-sectional analysis of health claims data.

BACKGROUND: The aim of the study was to examine the prevalence of and factors associated with antidepressant (AD) prescriptions in order to draw a comprehensive picture of prescribing practices in Switzerland. METHOD: We conducted a population-based, cross-sectional descriptive study using a large Swiss healthcare claims database, covering approximately 13% of the Swiss population. AD prescription was determined by identifying patients (N = 105,663) with health claims data of at least 1 AD prescription in the year 2016. AD medication was identified using ATC-codes classified by the World Health Organisation. Univariate, bivariate and multivariate analyses using logistic regression were performed. RESULTS: The extrapolated 1-year prevalence of AD prescription was 8.7% (95% CI, 8.7-8.8) with two thirds of AD recipients being female and the average age being 59 years (SD = 19.1). The regional distribution of prescription rates varied between cantons and ranged from 6.5 to 11.7%. Logistic regression revealed higher prescription rates among females compared to males (OR: 1.52) and an increased probability of AD prescription by age up until 54 years (OR: 2.25) and ≥ 85 years (OR: 2.32). Comorbidity is associated with higher odds (OR: 3.26 with 1-2 comorbidities) and enrollment in a managed care plan (compared to standard care) with lower odds for an AD prescription (OR: 0.85). CONCLUSION: This study is the first in Switzerland to describe the prevalence of and factors associated with AD prescription based on a large health claims database reflecting routine care. The results provide important information about regional variation, prescription source, and potential over-prescription in the treatment of depressive disorders.

Comparative effectiveness of continuation and maintenance treatments for persistent depressive disorder in adults.

BACKGROUND: Persistent depressive disorder (PDD) is defined as a depressive disorder with a minimum illness duration of two years, including four diagnostic subgroups (dysthymia, chronic major depression, recurrent major depression with incomplete remission between episodes, and double depression). Persistent forms of depression represent a substantial proportion of depressive disorders, with a lifetime prevalence ranging from 3% to 6% in the Western world. Growing evidence indicates that PDD responds well to several acute interventions, such as combined psychological and pharmacological treatments. Yet, given the high rates of relapse and recurrences of depression following response to acute treatment, long-term continuation and maintenance therapy are of great importance. To date, there has been no evidence synthesis available on continuation and maintenance treatments of PDDs. OBJECTIVES: To assess the effects of pharmacological and psychological (either alone or combined) continuation and maintenance treatments for persistent depressive disorder, in comparison with each other, placebo (drug/attention placebo/non-specific treatment control), and treatment as usual (TAU). Continuation treatments are defined as treatments given to currently remitted people (remission is defined as depressive symptoms dropping below case level) or to people who previously responded to an antidepressant treatment. Maintenance therapy is given during recovery (which is defined as remission lasting longer than six months). SEARCH METHODS: We searched Ovid MEDLINE (1950- ), Embase (1974- ), PsycINFO (1967- ) and the Cochrane Central Register of Controlled Trials (CENTRAL) to 28 September 2018. An earlier search of these databases was also conducted for RCTs via the Cochrane Common Mental Disorders Controlled Trial Register (CCMD-CTR) (all years to 11 Dec 2015). In addition we searched grey literature resources as well as the international trial registers ClinicalTrials.gov and ICTRP to 28 September 2018. We screened reference lists of included studies and contacted the first author of all included studies. SELECTION CRITERIA: We included randomized (RCTs) and non-randomized controlled trials (NRCTs) in adults with formally diagnosed PDD, receiving pharmacological, psychological, or combined continuation and maintenance interventions. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies and extracted and analyzed data. The primary efficacy outcome was relapse/recurrence rate of depression. The primary acceptance outcome was dropout due to any reason other than relapse/recurrence. We performed random-effects meta-analyses using risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes, with 95% confidence intervals (CI). MAIN RESULTS: We included 10 studies (seven RCTs, three NRCTs) involving 840 participants in this review, from which five studies investigated continuation treatments and five studies investigated maintenance treatments. Overall, the included studies were at low-to-moderate risk of bias. For the three NRCTs, the most common source of risk of bias was selection of reported results. For the seven RCTs, the most common sources of risk of bias was non-blinding of outcome assessment and other bias (especially conflict of interest due to pharmaceutical sponsoring).Pharmacological continuation and maintenance therapiesThe most common comparison was antidepressant medication versus tablet placebo (five studies). Participants taking antidepressant medication were probably less likely to relapse or to experience a recurrent episode compared to participants in the placebo group at the end of the intervention (13.9% versus 33.8%, RR 0.41, 95% CI 0.21 to 0.79; participants = 383; studies = 4; I² = 54%, moderate quality evidence). Overall dropout rates may be similar between participants in the medication and placebo group (23.0% versus 25.5%, RR 0.90, 95% CI 0.39 to 2.11; RCTs = 4; participants = 386; I² = 64%, low quality evidence). However, sensitivity analyses showed that the primary outcome (rate of relapse/recurrence) showed no evidence of a difference between groups when only including studies with low risk of bias.None of the studies compared pharmacological or psychological treatments versus TAU.Psychological continuation and maintenance therapiesOne study compared psychological therapies versus attention placebo/non-specific control. One study compared psychotherapy with medication. The results of the studies including psychotherapy might indicate that continued or maintained psychotherapy could be a useful intervention compared to no treatment or antidepressant medication. However, the body of evidence for these comparisons was too small and uncertain to draw any high quality conclusions.Combined psychological and pharmacological continuation and maintenance therapiesThree studies compared combined psychological and pharmacological therapies with pharmacological therapies alone. One study compared combined psychological and pharmacological therapies with psychotherapeutic therapies alone. However, the body of evidence for these comparisons was too small and uncertain to draw any high quality conclusionsComparison of different antidepressant medications Two studies reported data on the direct comparison of two antidepressants. However, the body of evidence for this comparison was too small and uncertain to draw any high quality conclusions. AUTHORS' CONCLUSIONS: Currently, it is uncertain whether continued or maintained pharmacotherapy (or both) with the reviewed antidepressant agents is a robust treatment for preventing relapse and recurrence in people with PDD, due to moderate or high risk of bias as well as clinical heterogeneity in the analyzed studies.For all other comparisons, the body of evidence was too small to draw any final conclusions, although continued or maintained psychotherapy might be effective compared to no treatment. There is need for more high quality trials of psychological interventions. Further studies should address health-related quality of life and adverse events more precisely, as well as assessing follow-up data.

"Unrigging the support wheels" - A qualitative study on patients' experiences with and perspectives on low-intensity CBT.

BACKGROUND: Low-intensity treatments imply reduced therapist contact due to an emphasis on self-help and the use of technologies to deliver treatment. The role of the remoteness, the reduced therapist contact, and the interplay of these components has not been differentiated from a patients' perspective so far. This study's purpose is to capture patients' experiences with telephone-based self-help cognitive behavioural therapy (tel-CBT). METHODS: A subsample of mildly to moderately depressed patients (N = 13) who finished tel-CBT as part of a larger randomised controlled trial (RCT) in routine care were interviewed using a semi-structured questionnaire. Interviews were audiotaped, transcribed verbatim, and independently coded by two coders blind to treatment outcome. Using qualitative content analysis with deductive and inductive procedures, a two-level category system was established. RESULTS: The category system contains four category clusters regarding expectations, self-help related aspects, telephone-related aspects, and implications for patients' treatment pathway, and subsumes a total of 15 categories. Self-help related aspects circulate around the interplay between written materials and professional input, trust and support in the therapeutic relationship and its relation to the initial personal contact, as well as CBT principles. Telephone-related aspects entail perceived advantages and disadvantages of the telephone on an organisational and content level as well as a discourse around distance and closeness in the interaction. Although patients raised doubts regarding the long-term effect of the intervention on symptomatology, patients expressed satisfaction with the treatment and reported an immediate as well as a longer lasting personal impact of the treatment. These results indicate user acceptance with tel-CBT. CONCLUSIONS: This qualitative analysis captures patients' experiences with tel-CBT and the perceived helpfulness of the diverse treatment components. This can facilitate refining aspects of low-intensity treatments and might improve dissemination. TRIAL REGISTRATION: ClinicalTrials.gov NCT02667366. Registered on 3 December 2015.

Effectiveness of case management as a cross-sectoral healthcare provision for women with breast cancer.

OBJECTIVE: Case management (CM) programs are intended to improve care coordination for cancer patients. This quasi-experimental, controlled study evaluated whether such a program was effective in improving health-related quality of life and reducing the psychological distress of breast cancer patients. METHODS: For the study, 126 patients with CM and 118 patients with treatment as usual (TAU) were surveyed at baseline, a 6-month follow-up and a 12-month follow-up. Comparisons of the two groups with regard to quality of life (Short Form-8, European Organization for Research and Treatment of Cancer-11; primary outcome) and psychological distress (Hospital Anxiety and Depression Scale, distress thermometer; secondary outcome) were conducted. RESULTS: Univariate t-tests regarding the primary and secondary outcomes demonstrated improvements in the relevant outcomes at the 6-month and 12-month follow-ups for the intervention group as well as for the control group. An analysis of covariance revealed that the controls showed a higher level of physical quality of life at the 12-month follow-up than the other time points and no differences at 6 months after the baseline. CONCLUSIONS: The tested CM model did not improve the quality of life or psychological well-being of the patients beyond treatment as usual. Possible reasons include that the treatment was already of high standards in the control group or that there are possibly different impacts than found in the literature regarding different forms of organization in CM. The need for and the tailoring of this CM model as well as the transfer of CM to other oncological indications remain to be clarified. Copyright © 2016 John Wiley & Sons, Ltd.

Effectiveness and cost-effectiveness of telephone-based cognitive-behavioural therapy in primary care: study protocol of TIDe - telephone intervention for depression.

BACKGROUND: Despite the availability of evidence-based treatments for depression, a large proportion of patients remains untreated or adequate treatment is initiated with delay. This situation is particularly critical in primary care, where not only most individuals first seek help for their mental health problems, but also depressive disorders - particularly mild to moderate levels of severity - are highly prevalent given the high comorbidity of chronic somatic conditions and depression. Improving the access for evidence-based treatment, especially in primary care, is hence a priority challenge in the mental health care agenda. Telephone usage is widespread and has the potential of overcoming many barriers that individuals suffering from mental health problems are facing: Its implementation for treatment delivery presents an option for optimisation of treatment pathways and outcomes. METHODS/DESIGN: This paper details the study protocol for a randomised controlled trial (RCT) evaluating the effectiveness of a telephone-administered short-term cognitive-behavioural therapy (T-CBT) for depression as compared to treatment as usual (TAU) in the Swiss primary care setting. The study aims at randomising a total of 216 mildly to moderately depressed patients, which are either identified by their General Practitioners (GPs) or who self-refer to the study programme in consultation with their GP. The trial will examine whether telephone-delivered, manualised treatment leads to clinically significant reduction in depression at follow-up. It will further investigate the cost-effectiveness and acceptability of the intervention in the primary care setting. DISCUSSION: Conducting a low-intensity treatment on the telephone allows for greater flexibility for both patient and therapist, can grant more anonymity and can thus lead to less hesitation in the patient about whether to attempt treatment or not. In order to benefit from this approach, large-scale studies need to prove superior effectiveness and cost-effectiveness of telephone-delivered therapy over routine care for patients with mild to moderate depression. TRIAL REGISTRATION: ClinicalTrials.gov NCT02667366 . Registered on 3 December 2015.

Effectiveness of case management-based aftercare coordination by phone for patients with depressive and anxiety disorders: study protocol for a randomized controlled trial.

BACKGROUND: Depressive and anxiety disorders are highly prevalent, but only a small percentage (approximately 50%) of patients receive appropriate treatment. Relevant barriers include communication and coordination gaps between different providers that result from the lack of integration between different care-giving systems. Aftercare following inpatient treatment represents one of these gaps because systematic follow-up care does not exist. Case management-based aftercare coordination by phone might be a promising approach to overcoming this gap and improving long-term treatment outcomes. Case management is a patient-centered and situation-based approach comprising systematic tracking and support of patients by a case manager. The aim of this study is to evaluate the effectiveness of aftercare coordination by phone for patients with depressive and anxiety disorders. METHODS/DESIGN: The effectiveness of aftercare coordination will be investigated in a prospective randomized controlled trial in four psychotherapeutic inpatient routine care units (St. Franziska-Stift Bad Kreuznach, MediClin Seepark Klinik Bad Bodenteich, Segeberger Kliniken Gruppe Bad Segeberg and Luisenklinik Bad Dürrheim). The patients receiving aftercare coordination (intervention group; IG) will be compared with those who receive treatment as usual (TAU control group; CG). Eligible patients will be required to have a diagnosis of an anxiety and/or depressive disorder and a recommendation for follow-up outpatient psychotherapy. The aftercare coordination consists of six phone contacts at intervals of two weeks that are performed by therapists in the inpatient units. The patients will complete questionnaires at discharge (t1), 3 months after discharge (i.e., at the end of the intervention (t2)) and 9 months after discharge (t3). The primary outcome will be change in symptom severity from t1 to t3, the secondary outcomes will be health-related quality of life and the proportion of patients who manage to begin outpatient psychotherapy by t3. DISCUSSION: This study will determine whether case management-based aftercare coordination by phone is an adequate approach for overcoming treatment barriers in the clinical pathways of patients with depressive and anxiety disorders. If proven effective, an accessible supplementary treatment approach that will help to maintain and even improve long-term treatment outcomes will be made available for patients following inpatient treatment. TRIAL REGISTRATION: ClinicalTrials.gov: ( NCT02044913 ).

[Collaborative and stepped care for depression: Development of a model project within the Hamburg Network for Mental Health (psychenet.de)]. / Collaborative und Stepped Care bei depressiven Erkrankungen : Entwicklung eines Modellprojektes im Hamburger Netz psychische Gesundheit (psychenet.de).

BACKGROUND: Depression is one of the most widespread mental disorders in Germany and causes a great suffering and involves high costs. Guidelines recommend stepped and interdisciplinary collaborative care models for the treatment of depression. OBJECTIVES: Stepped and collaborative care models are described regarding their efficacy and cost-effectiveness. A current model project within the Hamburg Network for Mental Health exemplifies how guideline-based stepped diagnostics and treatment incorporating innovative low-intensity interventions are implemented by a large network of health care professionals and clinics. MATERIALS AND METHODS: An accompanying evaluation using a cluster randomized controlled design assesses depressive symptom reduction and cost-effectiveness for patients treated within "Health Network Depression" ("Gesundheitsnetz Depression", a subproject of psychenet.de) compared with patients treated in routine care. RESULTS: Over 90 partners from inpatient and outpatient treatment have been successfully involved in recruiting over 600 patients within the stepped care model. Communication in the network was greatly facilitated by the use of an innovative online tool for the supply and reservation of treatment capacities. The participating professionals profit from the improved infrastructure and the implementation of advanced training and quality circle work. CONCLUSIONS: New treatment models can greatly improve the treatment of depression owing to their explicit reference to guidelines, the establishment of algorithms for diagnostics and treatment, the integration of practices and clinics, in addition to the implementation of low-intensity treatment alternatives. These models could promote the development of a disease management program for depression.

Effectiveness and cost-effectiveness of a guideline-based stepped care model for patients with depression: study protocol of a cluster-randomized controlled trial in routine care.

BACKGROUND: Depression is a widespread and serious disease often accompanied by a high degree of suffering and burden of disease. The lack of integration between different care providers impedes guideline-based treatment. This constitutes substantial challenges for the health care system and also causes considerable direct and indirect costs. To face these challenges, the aim of this project is the implementation and evaluation of a guideline-based stepped care model for depressed patients with six treatment options of varying intensity and setting, including low-intensity treatments using innovative technologies. METHODS/DESIGN: The study is a randomized controlled intervention trial of a consecutive sample of depressive patients from primary care assessed with a prospective survey at four time-standardized measurement points within one year. A cluster randomization at the level of participating primary care units divides the general practitioners into two groups. In the intervention group patients (n = 660) are treated within the stepped care approach in a multiprofessional network consisting of general practitioners, psychotherapists, psychiatrists and inpatient care facilities, whereas patients in the control condition (n = 200) receive routine care. The main research question concerns the effectiveness of the stepped-care model from baseline to t3 (12 months). Primary outcome is the change in depressive symptoms measured by the PHQ-9; secondary outcomes include response, remission and relapse, functional quality of life (SF-12 and EQ-5D-3 L), other clinical and psychosocial variables, direct and indirect costs, and the incremental cost-effectiveness ratio. Furthermore feasibility and acceptance of the overall model as well as of the separate treatment components are assessed. DISCUSSION: This stepped care model integrates all primary and secondary health care providers involved in the treatment of depression; it elaborates innovative and evidence-based treatment elements, follows a stratified approach and is implemented in routine care as opposed to standardized conditions. In case of positive results, its sustainable implementation as a collaborative care model may significantly improve the health care situation of depressive patients as well as the interaction and care delivery of different care providers on various levels. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov, number NCT01731717 (date of registration: 24 June 2013).

Prognostic Risk Factors in Randomized Clinical Trials of Face-to-Face and Internet-Based Psychotherapy for Depression: A Systematic Review and Meta-Regression Analysis.

Importance: Variables such as severe symptoms, comorbidity, and sociodemographic characteristics (eg, low educational attainment or unemployment) are associated with a poorer prognosis in adults treated for depressive symptoms. The exclusion of patients with a poor prognosis from RCTs is negatively associated with the generalizability of research findings. Objective: To compare the prognostic risk factors (PRFs) in patient samples of RCTs of face-to-face therapy (FTF) and internet-based therapy (IBT) for depression. Data Sources: PsycINFO, Cochrane CENTRAL, and reference lists of published meta-analyses were searched from January 1, 2000, to December 31, 2021. Study Selection: RCTs that compared FTF (individual or group therapy) and IBT (guided or self-guided interventions) against a control (waitlist or treatment as usual) in adults with symptoms of depression were included. Data Extraction and Synthesis: Data were extracted by 2 independent observers. The Cochrane revised risk-of-bias tool was used to assess the risk of bias. The study was preregistered with OSF Registries and followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. Main Outcomes and Measures: The primary outcome was the standardized mean difference (Hedges g effect size) in depressive symptoms at treatment termination (assessed with standard patient self-report questionnaires), with a positive standardized mean difference indicating larger improvements in the intervention compared with those in the control group. Meta-regression analyses were adjusted for the type of control group. Three preregistered and 2 exploratory sensitivity analyses were conducted. A prognostic risk index (PROG) was created that calculated the sum of 12 predefined individual indicators, with scores ranging from 0 to 12 and higher scores indicating that a sample comprised patients with poorer prognoses. Results: This systematic review and meta-regression analysis identified 105 eligible RCTs that comprised 18 363 patients. In total, 48 studies (46%) examined FTF, and 57 studies (54%) examined IBT. The PROG was significantly higher in the RCTs of FTF than in the RCTs of IBT (FTF: mean [SD], 3.55 [1.75]; median [IQR], 3.5 [2.0-4.5]; IBT: mean [SD], 2.27 [1.66]; median [IQR], 2.0 [1.0-3.5]; z = -3.68, P < .001; Hedges g = 0.75; 95% CI, 0.36-1.15). A random-effects meta-regression analysis found no association of the PROG with the effect size. Sensitivity analyses with outliers excluded and accounting for risk of bias or small-study effects yielded mixed results on the association between the PROG and effect size. Conclusions and Relevance: The findings of this systematic review and meta-regression analysis suggest that samples of RCTs of FTF vs IBT differ with regard to PRFs. These findings have implications for the generalizability of the current evidence on IBT for depression. More RCTs of internet-based interventions with clinically representative samples are needed, and the reporting of PRFs must be improved.

Self-efficacy and fear of cancer progression during the year following diagnosis of breast cancer.

OBJECTIVE: The aim of this study was to investigate fear of disease progression (FoP) during the year following diagnosis of breast cancer and its association with general self-efficacy (SE). METHODS: In a prospective study, 118 breast cancer patients were recruited shortly after diagnosis disclosure (response rate: 54%) and at 1-year follow-up (follow-up rate: 90%). Participants completed self-report measures of general self-efficacy (General Self-Efficacy Scale) and fear of progression (short form of the Fear of Progression Questionnaire). RESULTS: Cross-sectional regression analysis revealed that high FoP is significantly associated with low SE, even when controlling for demographic and medical characteristics (total R² = 0.17). Having children and a relatively short time since diagnosis also significantly predicted higher FoP. Longitudinal analyses showed that FoP decreased significantly over time (p = 0.001; d = 0.25), but a significant decrease was only observed for patients with high initial FoP (p < 0.001; d = 0.74) and not for those with low initial FoP (p = 0.688; d = 0.08). SE was not a significant predictor of FoP at follow-up when controlling for initial FoP and other patient characteristics (incremental R² = 0.001; p = 0.674; total R² = 0.47). Overall, only initial FoP significantly predicted FoP at follow-up (p < 0.001; ß = 0.671). CONCLUSION: Findings that low SE is associated with high FoP can help to improve the treatment of dysfunctional fears in breast cancer patients. As FoP changes only slightly over time, treatment to enhance SE and reduce FoP should be initiated soon after disease disclosure.

Innovative moments in low-intensity, telephone-based cognitive-behavioral therapy for depression.

Background: Innovative moments (IMs), defined as moments in psychotherapy when patients' problematic patterns change toward more elaborated and adaptive patterns, have been shown to be associated with a clinical change in patients with depression. Thus, far IMs have been studied in face-to-face settings but not in telephone-based cognitive-behavioral therapy (t-CBT). This study investigates whether IMs occur in t-CBT and examines the association between IMs and symptom improvement, and reconceptualization and symptom improvement. Methods: The therapy transcripts of n = 10 patients with mild to moderate depression (range: 7-11 sessions, in total 94 sessions) undergoing t-CBT were qualitatively and quantitatively analyzed. Symptom severity (Patient Health Questionnaire-9) and IMs (levels and proportions) were assessed for each therapy session. Hierarchical linear models were used to test the prediction models. Results: The rating of IMs was shown to be feasible and reliable using the Innovative Moments Coding System (IMCS) (84.04% agreement in words coded), which is indicative of the applicability of the concept of IMs in t-CBT. Only reconceptualization IMs were shown to have a predictive value for treatment success (R2 = 0.05, p = 0.01). Discussion: The results should be interpreted with caution due to the exploratory nature of this study. Due to the telephone setting, it was necessary to adapt the IMCS. Nonetheless, the extent of IMs identified in the low-intensity t-CBT investigated was comparable to IMs in face-to-face therapy. Further studies are needed to clarify the association between IMs and treatment success as a change process, especially for low-intensity treatments.

Human contact in internet-based interventions for depression: A pre-registered replication and meta-analysis of randomized trials.

Introduction: Internet-based self-help interventions have shown to be effective in the treatment of depression. Several meta-analyses indicated that human contact has a crucial impact on adherence and outcome. While most research focused on the role of guidance during interventions, a review by Andersson and Johansson (2012) suggested that contact before the intervention too may play an important role. Objective: We investigated the impact of the degree of contact in internet-based interventions (IBIs) for depression on outcome in adults suffering from elevated symptoms of depression. Methods: We conducted a preregistered meta-analysis (www.osf.io/4mzyd) and included trials comparing IBIs for depression against control conditions (treatment as usual [TAU] or waiting list [WL]) in patients with symptoms of unipolar depression searching the databases PsycINFO and Cochrane's Central Register of Controlled Trials (CENTRAL) limited to entries from EMBASE and PubMed. Following Andersson and Johansson (2012), contact before an intervention was defined as having had a diagnostic interview before the IBI, and contact during intervention was defined as having received guidance during the IBI. IBIs were grouped as providing (0) no contact, (1) contact before the IBI, (2) contact during the IBI, or (3) contact both before and during the IBI. The primary outcome was standardized mean difference (SMD) of the IBI and control in depressive symptoms at treatment termination. Secondary outcomes were study dropout and adherence to the IBI. Results: We included 56 eligible trials that randomized 13,335 patients to 75 internet-based intervention conditions and control groups (TAU in 23 trials, WL in 33 trials). In total, 44 trials (78.57 %) were judged to show some concerns or a high risk of bias. Overall heterogeneity was high regarding the primary outcome (I2s < 66 %) and even higher for secondary outcomes (I2s < 91 %). Degree of contact was a robust predictor of outcome and adherence in all pre-registered and exploratory analyses. We found the effect of the IBI to increase with higher degree of contact. However, in pair-wise contrasts, only IBIs offering both contact before and during the intervention (SMD = 0.573, 95 % CI: 0.437, 0.709) significantly outperformed interventions offering no contact (SMD = 0.224, 95 % CI: 0.090, 0.340). Conclusions: The results suggest that contact before and during an intervention increases the effects of IBIs. The combination of contact before and during the intervention seems to a pivotal role regarding adherence as well as treatment outcome for patients suffering from depression.

Rationale and content of psychenet: the Hamburg Network for Mental Health.

With the public-funded research and development project psychenet: the Hamburg Network for Mental Health (2011-2014), the Federal Ministry of Education and Research contributes to strengthening healthcare regions in Germany by establishing new trans-sectoral cooperations and implement and evaluate selected innovations. More than 60 partners from research, health care, health industry and government in the Free and Hanseatic City of Hamburg are promoting innovative measures to improve the treatment for mental disorders. The main objective is to implement integrated healthcare networks based on evidence for effective treatment methods, deriving from high-quality research throughout five indications such as psychosis, depression, somatoform and functional syndromes, anorexia and bulimia and addiction illnesses in adolescence. Those networks are accompanied by additional measures, for example, for improving information and education, addressing occupational health or strengthening the participation of patients and their families suffering from mental illness.