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Reducing symptoms of major depressive disorder through a systematic training of general emotion regulation skills: protocol of a randomized controlled trial.

ABSTRACT: BACKGROUND:Major Depressive Disorder is one of the most challenging mental health problems of our time. Although effective psychotherapeutic treatments are available, many patients fail to demonstrate clinically significant improvements. Difficulties in emotion regulation have been identified as putative risk and maintaining factors for Major Depressive Disorder. Systematically enhancing adaptive emotion regulation skills should thus help reduce depressive symptom severity. However, at this point, no study has systematically evaluated effects of increasing adaptive emotion regulation skills application on symptoms of Major Depressive Disorder. In the intended study, we aim to evaluate stand-alone effects of a group-based training explicitly and exclusively targeting general emotion regulation skills on depressive symptom severity and assess whether this training augments the outcome of subsequent individual cognitive behavioral therapy for depression. METHODS/DESIGN:In the evaluation of the Affect Regulation Training, we will conduct a prospective randomized-controlled trial. Effects of the Affect Regulation Training on depressive symptom severity and outcomes of subsequent individual therapy for depression will be compared with an active, common factor based treatment and a waitlist control condition. The study sample will include 120 outpatients meeting criteria for Major Depressive Disorder. Depressive symptom severity as assessed by the Hamilton Rating Scale will serve as our primary study outcome. Secondary outcomes will include further indicators of mental health and changes in adaptive emotion regulation skills application. All outcomes will be assessed at intake and at 10 points in time over the course of the 15-month study period. Measures will include self-reports, observer ratings, momentary ecological assessments, and will be complemented in subsamples by experimental investigations and the analysis of hair steroids. DISCUSSION:If findings should support the hypothesis that enhancing regulation skills reduces symptom severity in Major Depressive Disorder, systematic emotion regulation skills training can enhance the efficacy and efficiency of current treatments for this severe and highly prevalent disorder. TRIAL REGISTRATION:This study is registered with ClinicalTrials.gov, number NCT01330485.

SUBMITTER: Ehret AM

PROVIDER: S-EPMC3946025 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

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Reducing symptoms of major depressive disorder through a systematic training of general emotion regulation skills: protocol of a randomized controlled trial.

Ehret Anna M AM Kowalsky Judith J Rief Winfried W Hiller Wolfgang W Berking Matthias M

BMC psychiatry 20140127

<h4>Background</h4>Major Depressive Disorder is one of the most challenging mental health problems of our time. Although effective psychotherapeutic treatments are available, many patients fail to demonstrate clinically significant improvements. Difficulties in emotion regulation have been identified as putative risk and maintaining factors for Major Depressive Disorder. Systematically enhancing adaptive emotion regulation skills should thus help reduce depressive symptom severity. However, at t ...[more]

PMID: 24467807

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Project description:Background: Major Depressive Disorder (MDD) is a moderately heritable disorder with a high lifetime prevalence. At present, laboratory blood tests to support MDD diagnosis are not available. Methods: We used a classifier approach on blood gene expression profiles of a unique set of non-medicated subjects (MDD patients and controls) to select genes of which expression is predictive for disease status. To reveal blood gene expression changes related to MDD disease, we applied a powerful ex vivo stimulus to the blood, i.e. incubation with lipopolysaccharide (LPS; 10 ng/ml blood). Results: Based on LPS-stimulated blood gene expression using whole-genome microarrays in 42 subjects (primary cohort; 21 MDD patients (mean age 42.3 years), 21 healthy controls (mean age 41.9 years)), we identified a set of genes (CAPRIN1, CLEC4A, KRT23, MLC1, PLSCR1, PROK2, ZBTB16) that serves as a molecular signature of MDD. These findings were validated for the primary cohort using an independent quantitative PCR method (P = 0.007). The difference between depressive patients and controls was confirmed (P = 0.019) in a replication cohort of 13 patients with MDD (mean age 42.8 years) and 14 controls (mean age 45.6 years). The MDD-signature score comprised of expression levels of 7 genes could discriminate depressive patients from controls with sensitivity of 76.9% and specificity of 71.8%. Conclusions: We show for the first time that molecular analysis of stimulated blood cells can be used as an endophenotype for MDD diagnosis, which is a milestone in establishing biomarkers for neuropsychiatric disorders with moderate heritability in general. Our results may provide a new entry point for following and predicting treatment outcome, as well as prediction of severity and recurrence of MDD. In total, 33 MDD patients and 34 healthy controls were analyzed using basal gene expression in whole blood, and gene expression from whole blood that was stimulated with LPS for 5-6 h, using microarrays. Patients were arbitrarily selected from all patients to serve as primary cohort (nMDD = 21 (MDD01-MDD21); nControls = 21 (Con01-Con21)), or replication cohort (nMDD = 12 (MDD22-MDD35); nControls = 13 (Con22-Con37)) using microarrays. This submission does not include Samples CON21_LPS or CON30_LPS.

Project description:BACKGROUND:Living with elevated symptoms of depression can have debilitating consequences for an individual's psychosocial and physical functioning, quality of life, and health care utilization. A growing body of evidence demonstrates that skills for increasing positive emotion can be helpful to individuals with depression. Although Web-based interventions to reduce negative emotion in individuals with depression are available, these interventions frequently suffer from poor retention and adherence and do not capitalize on the potential benefits of increasing positive emotion. OBJECTIVE:The aim of this study was to develop and test a Web-based positive emotion skills intervention tailored for individuals living with elevated depressive symptoms, as well as to develop and test enhancement strategies for increasing retention and adherence to that intervention. METHODS:This study protocol describes the development and testing for Mobile Affect Regulation Intervention with the Goal of Lowering Depression (MARIGOLD), a Web-based positive emotion skills intervention, adapted for individuals with elevated depressive symptomatology. The intervention development is taking place in three phases. In phase 1, we are tailoring an existing positive emotion skills intervention for individuals with elevated symptoms of depression and are pilot testing the tailored version of the intervention in a randomized controlled trial with two control conditions (N=60). In phase 2, we are developing and testing three enhancements aimed at boosting retention and adherence to the Web-based intervention (N=75): facilitator contact, an online discussion board, and virtual badges. In phase 3, we are conducting a multifactorial, nine-arm pilot trial (N=600) to systematically test these enhancement strategies, individually and in combination. The primary outcome is depressive symptom severity. Secondary outcomes include positive and negative emotion, psychological well-being, and coping resources. RESULTS:The project was funded in August 2014, and data collection was completed in May 2018. Data analysis is currently under way, and the first results are expected to be submitted for publication in 2018. CONCLUSIONS:Findings from this investigation will enable us to develop an optimal package of intervention content and enhancement strategies for individuals with elevated symptoms of depression. If this intervention proves to be effective, it will provide a cost-effective, anonymous, appealing, and flexible approach for reducing symptoms of depression and improving psychological adjustment through increasing positive emotion. TRIAL REGISTRATION:ClinicalTrials.gov NCT01964820 (Phase 1); https://clinicaltrials.gov/ct2/show/NCT01964820 (Archived by WebCite at http://www.webcitation.org/6zpmKBcyX). ClinicalTrials.gov NCT02861755 (Phase 2); https://clinicaltrials.gov/ct2/show/NCT02861755 (Archived by WebCite at http://www.webcitation.org/6zpmLmy8k). REGISTERED REPORT IDENTIFIER:RR1-10.2196/10494.

Project description:Major depressive disorder (MDD) is associated with chronic biases in the allocation of attention and recollection of personal memories. Impaired flexibility in attention and autobiographical memory retrieval is seen to both maintain current symptoms and predict future depression. Development of innovative interventions to reduce maladaptive cognitive patterns and improve cognitive flexibility in the domain of memory may therefore advance current treatment approaches for depression. Memory specificity training and cognitive bias modification techniques have both shown some promise in improving cognitive flexibility. Here we outline plans for a trial of an innovative memory flexibility training programme, MemFlex, which advances current training techniques with the aim of improving flexibility of autobiographical memory retrieval. This trial seeks to estimate the efficacy of MemFlex, provide data on feasibility, and begin to explore mechanisms of change.We plan a single-blind, randomised, controlled, patient-level trial in which 50 individuals with MDD will complete either psychoeducation (n?=?25) or MemFlex (n?=?25). After completing pre-treatment measures and an orientation session, participants complete eight workbook-based sessions at home. Participants will then be assessed at post-treatment and at 3 month follow-up. The co-primary outcomes are depressive symptoms and diagnostic status at 3 month follow-up. The secondary outcomes are memory flexibility at post-treatment and number of depression free days at 3 month follow-up. Other process outcomes and mediators of any treatment effects will also be explored.This trial will establish the efficacy of MemFlex in improving memory flexibility, and reducing depressive symptoms. Any effects on process measures related to relapse may also indicate whether MemFlex may be helpful in reducing vulnerability to future depressive episodes. The low-intensity and workbook-based format of the programme may improve access to psychological therapies, and, if encouraging, the results of this study will provide a platform for later-phase trials.NCT02371291 (ClinicalTrials.gov), registered 9 February 2015.

Dataset Information

Reducing symptoms of major depressive disorder through a systematic training of general emotion regulation skills: protocol of a randomized controlled trial.

Publications

Reducing symptoms of major depressive disorder through a systematic training of general emotion regulation skills: protocol of a randomized controlled trial.

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