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PRO*MDD Study Protocol: Effectiveness of Outpatient Treatment Programs for Major Depressive Disorder: Metacognitive Therapy vs. Behavioral Activation a Single-Center Randomized Clinical Trial.

ABSTRACT: Background: Major depressive Disorder (MDD) is a severe mental disorder associated with considerable disability and high costs. Over the last decades, various psychotherapies for MDD have been developed and researched, among others Behavioral Activation (BA) and Metacognitive Therapy (MCT). MCT and BA target different maintaining factors of MDD and have not been compared to date. The PRO*MDD randomized controlled trial will compare MCT and BA in the routine clinical setting of an outpatient clinic. Methods and Design: We aim to recruit 128 MDD patients, who will be randomly assigned to either MCT or BA. In both conditions, patients will receive one individual therapy session and one group therapy session per week for a maximum of 6 months. Assessments will take place at baseline, pre-treatment, mid-treatment, post-treatment as well as at 12, 18, and 30 months after start of treatment as follow-up. The primary outcome is reduction of depression severity assessed with the Hamilton Rating Scale for Depression; secondary outcomes address quality of life, psychosocial functioning and participation as well as comorbidity. Discussion: The PRO*MDD study is the first randomized controlled trial to compare the effectiveness of MCT and BA. The outcome of this trial will increase our knowledge on the effectiveness and applicability of both treatment modalities and therefore contribute to the improvement of treatment for depressive patients. Ethics and dissemination: The study has been reviewed and approved on 11 August 2016 by the Ethics Committee of the Lübeck University (reference number: 16-176). The results will be discussed through peer-reviewed publications. Trial registration: German Clinical Trials Register DRKS-ID: DRKS00011536 (retrospectively registered).

SUBMITTER: Schaich A

PROVIDER: S-EPMC6252351 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Project description:Depressive symptoms are related to abnormalities in the autonomic nervous system (ANS), and physiological signals that can be used to measure and evaluate such abnormalities have previously been used as indicators for diagnosing mental disorder, such as major depressive disorder (MDD). In this study, we investigate the feasibility of developing an objective measure of depressive symptoms that is based on examining physiological abnormalities in individuals when they are experiencing mental stress. To perform this, we recruited 30 patients with MDD and 31 healthy controls. Then, skin conductance (SC) was measured during five 5-min experimental phases, comprising baseline, mental stress, recovery from the stress, relaxation, and recovery from the relaxation, respectively. For each phase, the mean amplitude of the skin conductance level (MSCL), standard deviations of the SCL (SDSCL), slope of the SCL (SSCL), mean amplitude of the non-specific skin conductance responses (MSCR), number of non-specific skin conductance responses (NSCR), and power spectral density (PSD) were evaluated from the SC signals, producing 30 parameters overall (six features for each phase). These features were used as input data for a support vector machine (SVM) algorithm designed to distinguish MDD patients from healthy controls based on their physiological responses. Statistical tests showed that the main effect of task was significant in all SC features, and the main effect of group was significant in MSCL, SDSCL, SSCL, and PSD. In addition, the proposed algorithm achieved 70% accuracy, 70% sensitivity, 71% specificity, 70% positive predictive value, 71% negative predictive value in classifying MDD patients and healthy controls. These results demonstrated that it is possible to extract meaningful features that reflect changes in ANS responses to various stimuli. Using these features, detection of MDD was feasible, suggesting that SC analysis has great potential for future diagnostics and prediction of depression based on objective interpretation of depressive states.

Project description:Objective: To examine the dose-dependent relationship of different types of statins with the occurrence of major depressive disorder (MDD) and prescription of antidepressant medication. Methods: This cross-sectional study used medical claims data for the general Austrian population (n = 7,481,168) to identify all statin-treated patients. We analyzed all patients with MDD undergoing statin treatment and calculated the average defined daily dose for six different types of statins. In a sub-analysis conducted independently of inpatient care, we investigated all patients on antidepressant medication (statin-treated patients: n = 98,913; non-statin-treated patients: n = 789,683). Multivariate logistic regression analyses were conducted to calculate the risk of diagnosed MDD and prescription of antidepressant medication in patients treated with different types of statins and dosages compared to non-statin-treated patients. Results: In this study, there was an overrepresentation of MDD in statin-treated patients when compared to non-statin-treated patients (OR: 1.22, 95% CI: 1.20-1.25). However, there was a dose dependent relationship between statins and diagnosis of MDD. Compared to controls, the ORs of MDD were lower for low-dose statin-treated patients (simvastatin>0- < =10 mg:OR: 0.59, 95% CI: 0.54-0.64; atorvastatin>0- < =10 mg:OR:0.65, 95%CI: 0.59-0.70; rosuvastatin>0- < =10 mg:OR: 0.68, 95% CI: 0.53-0.85). In higher statin dosages there was an overrepresentation of MDD (simvastatin>40- < =60 mg:OR: 2.42, 95% CI: 2.18-2.70, >60-80 mg:OR: 5.27, 95% CI: 4.21-6.60; atorvastatin>40- < =60 mg:OR: 2.71, 95% CI: 1.98-3.72, >60- < =80 mg:OR: 3.73, 95% CI: 2.22-6.28; rosuvastatin>20- < =40 mg:OR: 2.09, 95% CI: 1.31-3.34). The results were confirmed in a sex-specific analysis and in a cohort of patients taking antidepressants, prescribed independently of inpatient care. Conclusions: This study shows that it is important to carefully re-investigate the relationship between statins and MDD. High-dose statin treatment was related to an overrepresentation, low-dose statin treatment to an underrepresentation of MDD.

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PRO*MDD Study Protocol: Effectiveness of Outpatient Treatment Programs for Major Depressive Disorder: Metacognitive Therapy vs. Behavioral Activation a Single-Center Randomized Clinical Trial.

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