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Comparative effectiveness of cognitive and dynamic therapies for major depressive disorder in a community mental health setting: study protocol for a randomized non-inferiority trial.

ABSTRACT: There is substantial evidence that cognitive therapy is an effective intervention for the treatment of major depressive disorder. Although dynamic psychotherapies have been widely studied and are commonly practiced worldwide, there are few randomized comparisons of cognitive therapy and dynamic therapy for major depressive disorder.We are completing data collection on a randomized non-inferiority trial comparing the effectiveness of cognitive therapy and short-term dynamic psychotherapy in the treatment of major depressive disorder in the community mental health setting. Therapists employed in the community setting have been recruited for training in either short-term dynamic psychotherapy or cognitive therapy. Patients seeking services at the community site who meet criteria for major depressive disorder based on a blind independent diagnostic interview are randomized to 16 sessions of treatment. All patients are assessed at baseline and months 1, 2, 4, and 5 utilizing a comprehensive battery.This study adds to the growing literature evaluating the effectiveness of short-term dynamic psychotherapy for specific diagnostic groups. These results will have implications for the dissemination of effective interventions for major depressive disorder in community mental health settings.This trial is registered at ClinicalTrials.gov, a service of the United States National Institute of Health. NIH Identifier: NCT01207271. Registered 21 September 2010.

SUBMITTER: Connolly Gibbons MB

PROVIDER: S-EPMC4270014 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Comparative effectiveness of cognitive and dynamic therapies for major depressive disorder in a community mental health setting: study protocol for a randomized non-inferiority trial.

Connolly Gibbons Mary Beth MB Mack Rachel R Lee Jacqueline J Gallop Robert R Thompson Donald D Burock Debra D Crits-Christoph Paul P

BMC psychology 20141111 1

<h4>Background</h4>There is substantial evidence that cognitive therapy is an effective intervention for the treatment of major depressive disorder. Although dynamic psychotherapies have been widely studied and are commonly practiced worldwide, there are few randomized comparisons of cognitive therapy and dynamic therapy for major depressive disorder.<h4>Methods</h4>We are completing data collection on a randomized non-inferiority trial comparing the effectiveness of cognitive therapy and short- ...[more]

PMID: 25566391

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Project description:IMPORTANCE:Dynamic psychotherapy (DT) is widely practiced in the community, but few trials have established its effectiveness for specific mental health disorders relative to control conditions or other evidence-based psychotherapies. OBJECTIVE:To determine whether DT is not inferior to cognitive therapy (CT) in the treatment of major depressive disorder (MDD) in a community mental health setting. DESIGN, SETTING, AND PARTICIPANTS:From October 28, 2010, to July 2, 2014, outpatients with MDD were randomized to treatment delivered by trained therapists. Twenty therapists employed at a community mental health center in Pennsylvania were trained by experts in CT or DT. A total of 237 adult outpatients with MDD seeking services at this site were randomized to 16 sessions of DT or CT delivered across 5 months. Final assessment was completed on December 9, 2014, and data were analyzed from December 10, 2014, to January 14, 2016. INTERVENTIONS:Short-term DT or CT. MAIN OUTCOMES AND MEASURES:Expert blind evaluations with the 17-item Hamilton Rating Scale for Depression. RESULTS:Among the 237 patients (59 men [24.9%]; 178 women [75.1%]; mean [SD] age, 36.2 [12.1] years) treated by 20 therapists (19 women and 1 man; mean [SD] age, 40.0 [14.6] years), 118 were randomized to DT and 119 to CT. A mean (SD) difference between treatments was found in the change on the Hamilton Rating Scale for Depression of 0.86 (7.73) scale points (95% CI, -0.70 to 2.42; Cohen d, 0.11), indicating that DT was statistically not inferior to CT. A statistically significant main effect was found for time (F1,198?=?75.92; P?=?.001). No statistically significant differences were found between treatments on patient ratings of treatment credibility. Dynamic psychotherapy and CT were discriminated from each other on competence in supportive techniques (t120?=?2.48; P?=?.02), competence in expressive techniques (t120?=?4.78; P?=?.001), adherence to CT techniques (t115?=?-7.07; P?=?.001), and competence in CT (t115?=?-7.07; P?=?.001). CONCLUSIONS AND RELEVANCE:This study suggests that DT is not inferior to CT on change in depression for the treatment of MDD in a community mental health setting. The 95% CI suggests that the effects of DT are equivalent to those of CT. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01207271.

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.:Cognitive impairment associated with lifetime major depressive disorder (MDD) is well-supported by meta-analytic studies, but population-based estimates remain scarce. Previous UK Biobank studies have only shown limited evidence of cognitive differences related to probable MDD. Using updated cognitive and clinical assessments in UK Biobank, this study investigated population-level differences in cognitive functioning associated with lifetime MDD. METHODS.:Associations between lifetime MDD and cognition (performance on six tasks and general cognitive functioning [g-factor]) were investigated in UK Biobank (N-range 7,457-14,836, age 45-81 years, 52% female), adjusting for demographics, education, and lifestyle. Lifetime MDD classifications were based on the Composite International Diagnostic Interview. Within the lifetime MDD group, we additionally investigated relationships between cognition and (a) recurrence, (b) current symptoms, (c) severity of psychosocial impairment (while symptomatic), and (d) concurrent psychotropic medication use. RESULTS.:Lifetime MDD was robustly associated with a lower g-factor (? = -0.10, PFDR = 4.7 × 10-5), with impairments in attention, processing speed, and executive functioning (? ? 0.06). Clinical characteristics revealed differential profiles of cognitive impairment among case individuals; those who reported severe psychosocial impairment and use of psychotropic medication performed worse on cognitive tests. Severe psychosocial impairment and reasoning showed the strongest association (? = -0.18, PFDR = 7.5 × 10-5). CONCLUSIONS.:Findings describe small but robust associations between lifetime MDD and lower cognitive performance within a population-based sample. Overall effects were of modest effect size, suggesting limited clinical relevance. However, deficits within specific cognitive domains were more pronounced in relation to clinical characteristics, particularly severe psychosocial impairment.

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Comparative effectiveness of cognitive and dynamic therapies for major depressive disorder in a community mental health setting: study protocol for a randomized non-inferiority trial.

Publications

Comparative effectiveness of cognitive and dynamic therapies for major depressive disorder in a community mental health setting: study protocol for a randomized non-inferiority trial.

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