Alessa von Wolff

Combination of pharmacotherapy and psychotherapy in the treatment of chronic depression: A systematic review and meta-analysis

BackgroundChronic depression represents a substantial portion of depressive disorders and is associated with severe consequences. This review examined whether the combination of pharmacological treatments and psychotherapy is associated with higher effectiveness than pharmacotherapy alone via meta-analysis; and identified possible treatment effect modifiers via meta-regression-analysis.MethodsA systematic search was conducted in the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, ISI Web of Science, BIOSIS, PsycINFO, and CINAHL. Primary efficacy outcome was a response to treatment; primary acceptance outcome was dropping out of the study. Only randomized controlled trials were considered.ResultsWe identified 8 studies with a total of 9 relevant comparisons. Our analysis revealed small, but statistically not significant effects of combined therapies on outcomes directly related to depression (BR = 1.20) with substantial heterogeneity between studies (I² = 67%). Three treatment effect modifiers were identified: target disorders, the type of psychotherapy and the type of pharmacotherapy. Small but statistically significant effects of combined therapies on quality of life (SMD = 0.18) were revealed. No differences in acceptance rates and the long-term effects between combined treatments and pure pharmacological interventions were observed.ConclusionsThis systematic review could not provide clear evidence for the combination of pharmacotherapy and psychotherapy. However, due to the small amount of primary studies further research is needed for a conclusive decision.

Effectiveness of a web-based, individually tailored decision aid for depression or acute low back pain: A randomized controlled trial

OBJECTIVE To evaluate the effectiveness of a web-based, individually tailored decision aid (Patient Dialogue) on depression or acute low back pain for insurees of a German sickness fund. METHODS Patient Dialogue (PD) was compared to the non-tailored Static Patient Information (SPI) in an online randomized controlled trial (RCT). The primary outcome was decisional conflict; secondary outcomes included knowledge, preparation for decision-making, preference for participation, involvement in decision-making, decision regret, and adherence. RESULTS Out of 2480 randomized participants, 657 (26.5%) provided analyzable data immediately after using the system. Three months later, data from 131 (5.3%) participants could be included in the analysis. The PD group reported a significantly lower overall decisional conflict than the SPI group (38.7 vs. 45.1; p=0.028 via multiple imputation estimator). The largest standardized effect (Cohens d 0.56) resulted from the preparation for decision-making (PD 59.4 vs. SPI 46.8; p<0.001). CONCLUSION PD may be an effective tool to reduce decisional conflict and prepare participants for treatment decision-making. However, the large dropout rate needs to be taken into account. PRACTICE IMPLICATIONS This study shows how a health insurance fund can support shared decision-making and how a decision aid can be evaluated in a RCT under routine care conditions.

Effectiveness of psychotherapeutic, pharmacological, and combined treatments for chronic depression: a systematic review (METACHRON)

BackgroundChronic depressions represent a substantial part of depressive disorders and are associated with severe consequences. Several studies were performed addressing the effectiveness of psychotherapeutic, pharmacological, and combined treatments for chronic depressions. Yet, a systematic review comparing the effectiveness of multiple treatment options and considering all subtypes of chronic depressions is still missing.Methods/DesignAim of this project is to summarize empirical evidence on efficacy and effectiveness of treatments for chronic depression by means of a systematic review. The primary objectives of the study are to examine, which interventions are effective; to examine, if any differences in effectiveness between active treatment options exist; and to find possible treatment effect modifiers. Psychotherapeutic, pharmacological, and combined treatments will be considered as experimental interventions and no treatment, wait-list, psychological/pharmacological placebo, treatment as usual, and other active treatments will be seen as comparators. The population of patients will include adults with chronic major depression, dysthymia, double depression, or recurrent depression without complete remission between episodes. Outcomes of the analyses are depressive symptoms, associated consequences, adverse events, and study discontinuation. Only randomized controlled trials will be considered.DiscussionGiven the high prevalence and serious consequences of chronic depression and a considerable amount of existing primary studies addressing the effectiveness of different treatments the present systematic review may be of high relevance. Special attention will be given to the use of current methodological standards. Findings are likely to provide crucial information that may help clinicians to choose the appropriate treatment for chronically depressed patients.

Not as golden as standards should be: Interpretation of the Hamilton Rating Scale for Depression

BACKGROUND The Hamilton Rating Scale for Depression (HRSD) is one of the most frequently used instruments in antidepressant trials. METHODS We examined different recommendations for classification of subjects according to depression severity by the HRSD. RESULTS Several differences between recommendations were identified leading to the conclusion that a consensus on interpretation is largely missing. LIMITATIONS Brief narrative review. CONCLUSIONS Widely accepted standards for the interpretation of scores on the HRSD are needed.

Effectiveness of a Web-Based Tailored Interactive Health Communication Application for Patients With Type 2 Diabetes or Chronic Low Back Pain: Randomized Controlled Trial

Background The prevalence of chronic diseases such as type 2 diabetes and chronic low back pain is rising. Patient empowerment is a key strategy in the management of chronic diseases. Patient empowerment can be fostered by Web-based interactive health communication applications (IHCAs) that combine health information with decision support, social support, and/or behavioral change support. Tailoring the content and tone of IHCAs to the needs of individual patients might improve their effectiveness. Objective The main objective was to test the effectiveness of a Web-based, tailored, fully automated IHCA for patients with type 2 diabetes or chronic low back pain against a standard website with identical content without tailoring (control condition) on patients’ knowledge and empowerment. Methods We performed a blinded randomized trial with a parallel design. In the intervention group, the content was delivered in dialogue form, tailored to relevant patient characteristics. In the control group, the sections of the text were presented in a content tree without any tailoring. Participants were recruited online and offline and were blinded to their group assignments. Measurements were taken at baseline (t0), directly after the first visit (t1), and at 3-month follow-up (t2). The primary hypothesis was that the tailored IHCA would have larger effects on knowledge and patient empowerment (primary outcomes) than the control website. The secondary outcomes were decisional conflict and preparation for decision making. All measurements were conducted by online self-report questionnaires. Intention-to-treat (ITT) and available cases (AC) analyses were performed for all outcomes. Results A total of 561 users agreed to participate in the study. Of these, 179 (31.9%) had type 2 diabetes and 382 (68.1%) had chronic low back pain. Usage was significantly higher in the tailored system (mean 51.2 minutes) than in the control system (mean 37.6 minutes; P<.001). Three months after system use, 52.4% of the sample was retained. There was no significant intervention effect in the ITT analysis. In the AC analysis, participants using the tailored system displayed significantly more knowledge at t1 (P=.02) and more emotional well-being (subscale of empowerment) at t2 (P=.009). The estimated mean difference between the groups was 3.9 (95% CI 0.5-7.3) points for knowledge and 25.4 (95% CI 6.3-44.5) points for emotional well-being on a 0-100 points scale. Conclusions The primary analysis did not support the study hypothesis. However, content tailoring and interactivity may increase knowledge and reduce health-related negative effects in persons who use IHCAs. There were no main effects of the intervention on other dimensions of patient empowerment or decision-related outcomes. This might be due to our tailored IHCA being, at its core, an educational intervention offering health information in a personalized, empathic fashion that merely additionally provides decision support. Tailoring and interactivity may not make a difference with regard to these outcomes. Trial Registration International Clinical Trials Registry: DRKS00003322; http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00003322 (Archived by WebCite at http://www.webcitation.org/6WPO0lJwE).

Adverse event methods were heterogeneous and insufficiently reported in randomized trials on persistent depressive disorder.

OBJECTIVES To investigate adverse event (AE) reporting practices in a systematic review of randomized controlled trials for persistent depressive disorder (PDD). STUDY DESIGN AND SETTING A systematic electronic database search was conducted up to October 2014 to identify randomized controlled trials investigating pharmacologic, psychotherapeutic, and combined treatments for PDD in adults. We calculated the number and percentage of studies that reported predefined AE information. All calculations were carried out including all studies and stratified for study type (pharmacologic, psychotherapeutic, and mixed) and publication year [before and after the publication of the Consolidated Standards of Reporting Trials (CONSORT) extension for harms in 2004], respectively. RESULTS Sixty studies, reported in 126 publications, were included. Across all studies, reporting of AE information was insufficient. Substantial differences between studies that investigated different treatments emerged. Most pharmacologic studies (39/42) and mixed studies (7/9) reported any AE information, although the amount of information varied and the reported methods to assess and analyze AEs were heterogeneous. We found no substantial change in reporting practices after the publication of the CONSORT extension. Psychotherapeutic studies, although almost entirely published after the CONSORT extension, largely neglected reporting of any AE information (1/9). CONCLUSIONS There is a strong need to improve the current practice of assessing, analyzing, and reporting AEs, especially for psychotherapeutic studies.

Incomplete Medication Adherence of Chronically Ill Patients in German Primary Care

Background Incomplete medication adherence is a major problem in health care worldwide. Patients who adhere to medical treatment have a better prognosis and create fewer costs. Objective To assess the degree of incomplete adherence of chronically ill routine primary care patients in a German setting and analyze the association between incomplete medication adherence, as well as clinical and sociodemographic patient characteristics. Methods: In a cross-sectional survey, chronically ill patients were asked to assess their adherence in primary care retrospectively using the Medication Adherence Report Scale (MARS-D) questionnaire. To investigate the association of incomplete adherence with sociodemographic and clinical data, univariate and multivariate analyses were conducted. Results In total, 62.1% of 190 patients were categorized as incompletely adherent. The mean MARS-D score was 23.5 (standard deviation = 2.7). Analyses revealed no statistically significant associations at P < 0.05 between degree of adherence and patient characteristics. The total explained variance amounted to 11.8% (Nagelkerke’s R2 = 0.118) in the multivariate analysis. Conclusion Previously reported results regarding associations of sociodemographic and clinical data with incomplete medication adherence could not be confirmed for this sample of chronically ill patients. In order to be able to provide guidelines for the reduction of incomplete medication adherence in German primary care, further research is needed.

Efficiency and Contribution of Strategies for Finding Randomized Controlled Trials: A Case Study from a Systematic Review on Therapeutic Interventions of Chronic Depression

Background Identifying all existing evidence is a crucial aspect in conducting systematic reviews. Since the retrieval of electronic database searches alone is limited, guidelines recommend the use of additional search strategies. The aim of this investigation was to assess the efficiency and contribution of additional search strategies for identifying randomized controlled trials in conducting a systematic review on interventions after performing a sensitive electronic database search. Design and Methods Seven electronic databases, 3 journals and 11 systematic reviews were searched. All first authors of the included studies were contacted; citation tracking and a search in clinical trial registers were performed. A priori defined evaluation criteria were calculated for each search strategy. Results A total of 358 full-text articles were identified; 50 studies were included in the systematic review, wherefrom 84.0% (42) were acquired by the sensitive electronic database search and 16.0% (8) through additional search strategies. Screening reference lists of related systematic reviews was the most beneficial additional search strategy, with an efficiency of 31.3% (5) and a contribution of 10.0% (5/50), whereas hand-searching and author contacts contributed two and one additional studies, respectively. Citation tracking and searching clinical trial registers did not lead to any further inclusion of primary studies. Conclusions Based on our findings, hand-searching contents of relevant journals and screening reference lists of related systematic reviews may be helpful additional strategies to identify an extensive body of evidence. In case of limited resources, a sensitive electronic database search may constitute an appropriate alternative for identifying relevant trials. Significance for public health Systematic reviews provide the strongest form of evidence synthesis for therapeutic interventions and are of high relevance for decision makers in public health. Preparing high quality systematic reviews can be very time-consuming since all existing evidence should be identified, but the retrieval of electronic database searches is limited and therefore additional search strategies are recommended. However, the time needed for conducting full systematic reviews does often not address the need for urgent evidence. Thus, priorities of summarizing all available evidence and providing fast evidence-based recommendations may conflict. So far, no consensus exists regarding which additional search strategies are beneficial and sparsely time-consuming for conducting systematic reviews. We examined the efficiency and contribution of additional search strategies performed after a sensitive electronic database search. Our results provide highly relevant information for researchers conducting systematic reviews in various fields of public health research and for establishing guidelines for conducting rapid reviews.

[Risk factors for non-response in inpatient depression treatment].

OBJECTIVE The aim of this study was to identify predictors of non-response in inpatient depression treatment by means of routinely collected data from 10 psychiatric clinics. METHODS Evaluation was carried out through univariate analyses first; subsequently a model was developed by means of multivariate analyses. RESULTS About one third (31.5 %) of the 511 patients included in the study was classified as non-responder. Concerning patient level, psychic comorbidity, severity of depression symptoms and serious impairment of lifestyle as indication for hospitalisation have an impact on treatment outcome. In contrast, socio-demographic characteristics are not suitable as predictors. On the level of process characteristics, psychotherapy and patient compliance to medication enhanced the chance of profiting from inpatient treatment. CONCLUSIONS The results can be integrated into a well interpretable model of the current inpatient depression treatment. Non-response is not yet sufficiently predictable through routine data.

Comparative Safety of Pharmacologic Treatments for Persistent Depressive Disorder: A Systematic Review and Network Meta-Analysis

We aimed to compare the safety of antidepressants for the treatment of persistent depressive disorder (PDD) with each other and with placebo. We conducted a systematic electronic search and included randomized controlled trials that investigated antidepressants for the treatment of PDD in adults. Outcomes were the incidence of experiencing any adverse event, specific adverse events and related treatment discontinuations. We analyzed the data using traditional and network meta-analyses. Thirty-four studies that comprised 4,769 patients and examined 20 individual agents in nine substance classes were included. Almost all analyzed substance classes were associated with higher discontinuation rates than placebo including tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), antipsychotics, and the serotonin antagonist and reuptake inhibitor (SARI) trazodone. The odds of experiencing any adverse event were significantly higher for TCAs and serotonin noradrenaline reuptake inhibitors (SNRIs) compared to placebo. Pairwise comparisons among the substance classes revealed that more patients receiving TCAs or SNRIs experienced any adverse event and that more patients receiving TCAs or the SARI trazodone discontinued treatment. The complementary treatment with acetyl-l-carnitine showed lower rates of experiencing any adverse event and related discontinuations than all other comparators. TCAs were primarily associated with (anti-)cholinergic and sedating adverse events. SSRIs primarily showed gastrointestinal adverse events. Patients treated with the antipsychotic amisulpride were more likely to manifest weight gain and endocrine adverse events. The comparative evidence for further agents was insufficient or lacking. The identified safety differences may be used to inform the selection among the antidepressants.