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Identifying the most suitable treatment for depression based on patients' attachment: study protocol for a randomized controlled trial of supportive-expressive vs. supportive treatments.

ABSTRACT: BACKGROUND:In the absence of one intervention that can cure all patients with major depressive disorder (MDD), the leading cause of disability worldwide, increased attention has been focused on selecting the best treatment based on patient characteristics. Theory-driven hypotheses for selecting the best treatments have not yet been adequately investigated. The present study tested the a priory hypothesis that attachment orientations may determine whether patients benefit more from a treatment where alliance provides a facilitative environment for the treatment to work, as in the case of supportive-expressive psychotherapy, vs. where alliance is conceptualized as an active ingredient in itself, as in the case of supportive psychotherapy. METHOD/DESIGN:To test the hypothesis that attachment orientation moderates the effect of treatment condition on outcome, we conduct a randomized controlled trial (RCT). One hundred patients are randomized to 16 sessions of either supportive-expressive or supportive psychotherapy for MDD, conducted by experienced psychologists. The primary outcome is change in the Hamilton Rating Scale for Depression. Secondary outcome measures include self-reported depressive and other symptoms, psychological and interpersonal functioning, quality of life, and the presence of the diagnosis of depression. Additional measures include hormonal levels, motion synchrony, and acoustic attributes, performance on cognitive tasks, and narrative material (collected from the sessions and from interviews). DISCUSSION:The RCT will expand our understanding of how the outcome of treatment can be optimized by identifying the most promising role of alliance in treatment, based on patients' pre-treatment attachment orientation. Results will contribute to the ongoing theoretical debate concerning the differential efficacy of various psychotherapeutic approaches for patients with different attachment orientations. The RCT will also contribute to progress toward personalized treatment by informing therapists about which of two approaches are most effective with patients based on their attachment styles. TRIAL REGISTRATION:Clinicaltrials.gov Identifier: NCT02728557 submitted on the 15.3.16. FUNDING:The Israel Science Foundation. Trial status: Recruitment is ongoing.

SUBMITTER: Zilcha-Mano S

PROVIDER: S-EPMC6233496 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Identifying the most suitable treatment for depression based on patients' attachment: study protocol for a randomized controlled trial of supportive-expressive vs. supportive treatments.

Zilcha-Mano Sigal S Dolev Tohar T Leibovich Liat L Barber Jacques P JP

BMC psychiatry 20181112 1

<h4>Background</h4>In the absence of one intervention that can cure all patients with major depressive disorder (MDD), the leading cause of disability worldwide, increased attention has been focused on selecting the best treatment based on patient characteristics. Theory-driven hypotheses for selecting the best treatments have not yet been adequately investigated. The present study tested the a priory hypothesis that attachment orientations may determine whether patients benefit more from a trea ...[more]

PMID: 30419875

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Project description:BackgroundBiomarkers have been used extensively to provide the connection between external levels of contaminant exposure, internal levels of tissue contamination, and early adverse effects in organisms.ObjectivesTo present a three-step protocol for identifying suitable biomarkers to assess fish health in coastal and marine ecosystems, using Gladstone Harbour (Australia) as a case study.MethodsPrior to applying our protocol, clear working definitions for biomarkers were developed to ensure consistency with the global literature on fish health assessment. First, contaminants of concern were identified based on the presence of point and diffuse sources of pollution and available monitoring data for the ecosystem of interest. Second, suitable fish species were identified using fisheries dependent and independent data, and prioritised based on potential pathways of exposure to the contaminants of concern. Finally, a systematic and critical literature review was conducted on the use of biomarkers to assess the health of fish exposed to the contaminants of concern.Results/discussionWe present clear working definitions for bioaccumulation markers, biomarkers of exposure, biomarkers of effect and biomarkers of susceptibility. Based on emission and concentration information, seven metals were identified as contaminants of concern for Gladstone Harbour. Twenty out of 232 fish species were abundant enough to be potentially suitable for biomarker studies; five of these were prioritised based on potential pathways of exposure and susceptibility to metals. The literature search on biomarkers yielded 5,035 articles, of which 151met the inclusion criteria. Based on our review, the most suitable biomarkers include bioaccumulation markers, biomarkers of exposure (CYP1A, EROD, SOD, LPOX, HSP, MT, DNA strand breaks, micronuclei, apoptosis), and biomarkers of effect (histopathology, TAG:ST).ConclusionOur protocol outlines a clear pathway to identify suitable biomarkers to assess fish health in coastal and marine ecosystems, which can be applied to biomarker studies in aquatic ecosystems around the world.

Project description:Limited controlled data exist to guide treatment choices for clinicians caring for patients with major depressive disorder (MDD). Although many putative predictors of treatment response have been reported, most were identified through retrospective analyses of existing datasets and very few have been replicated in a manner that can impact clinical practice. One major confound in previous studies examining predictors of treatment response is the patient's treatment history, which may affect both the predictor of interest and treatment outcomes. Moreover, prior treatment history provides an important source of selection bias, thereby limiting generalizability. Consequently, we initiated a randomized clinical trial designed to identify factors that moderate response to three treatments for MDD among patients never treated previously for the condition.Treatment-naïve adults aged 18 to 65 years with moderate-to-severe, non-psychotic MDD are randomized equally to one of three 12-week treatment arms: (1) cognitive behavior therapy (CBT, 16 sessions); (2) duloxetine (30-60 mg/d); or (3) escitalopram (10-20 mg/d). Prior to randomization, patients undergo multiple assessments, including resting state functional magnetic resonance imaging (fMRI), immune markers, DNA and gene expression products, and dexamethasone-corticotropin-releasing hormone (Dex/CRH) testing. Prior to or shortly after randomization, patients also complete a comprehensive personality assessment. Repeat assessment of the biological measures (fMRI, immune markers, and gene expression products) occurs at an early time-point in treatment, and upon completion of 12-week treatment, when a second Dex/CRH test is also conducted. Patients remitting by the end of this acute treatment phase are then eligible to enter a 21-month follow-up phase, with quarterly visits to monitor for recurrence. Non-remitters are offered augmentation treatment for a second 12-week course of treatment, during which they receive a combination of CBT and antidepressant medication. Predictors of the primary outcome, remission, will be identified for overall and treatment-specific effects, and a statistical model incorporating multiple predictors will be developed to predict outcomes.The PReDICT study's evaluation of biological, psychological, and clinical factors that may differentially impact treatment outcomes represents a sizeable step toward developing personalized treatments for MDD. Identified predictors should help guide the selection of initial treatments, and identify those patients most vulnerable to recurrence, who thus warrant maintenance or combination treatments to achieve and maintain wellness.

Project description:BackgroundTherapeutic targeting of host-cell factors required for SARS-CoV-2 entry is an alternative strategy to ameliorate COVID-19 severity. SARS-CoV-2 entry into lung epithelium requires the TMPRSS2 cell surface protease. Pre-clinical and correlative data in humans suggest that anti-androgenic therapies can reduce the expression of TMPRSS2 on lung epithelium. Accordingly, we hypothesize that therapeutic targeting of androgen receptor signaling via degarelix, a luteinizing hormone-releasing hormone (LHRH) antagonist, will suppress COVID-19 infection and ameliorate symptom severity.MethodsThis is a randomized phase 2, placebo-controlled, double-blind clinical trial in 198 patients to compare efficacy of degarelix plus best supportive care versus placebo plus best supportive care on improving the clinical outcomes of male Veterans who have been hospitalized due to COVID-19. Enrolled patients must have documented infection with SARS-CoV-2 based on a positive reverse transcriptase polymerase chain reaction result performed on a nasopharyngeal swab and have a severity of illness of level 3-5 (hospitalized but not requiring invasive mechanical ventilation). Patients stratified by age, history of hypertension, and severity are centrally randomized 2:1 (degarelix: placebo). The composite primary endpoint is mortality, ongoing need for hospitalization, or requirement for mechanical ventilation at 15 after randomization. Important secondary endpoints include time to clinical improvement, inpatient mortality, length of hospitalization, duration of mechanical ventilation, time to achieve a normal temperature, and the maximum severity of COVID-19 illness. Exploratory analyses aim to assess the association of cytokines, viral load, and various comorbidities with outcome. In addition, TMPRSS2 expression in target tissue and development of anti-viral antibodies will also be investigated.DiscussionIn this trial, we repurpose the FDA approved LHRH antagonist degarelix, commonly used for prostate cancer, to suppress TMPRSS2, a host cell surface protease required for SARS-CoV-2 cell entry. The objective is to determine if temporary androgen suppression with a single dose of degarelix improves the clinical outcomes of patients hospitalized due to COVID-19.Trial registrationClinicalTrials.gov NCT04397718. Registered on May 21, 2020.

Project description:Seasonal affective disorder (SAD) is a subtype of recurrent depression involving major depressive episodes during the fall and/or winter months that remit in the spring. The central public health challenge in the management of SAD is prevention of winter depression recurrence. Light therapy (LT) is the established and best available acute SAD treatment. However, long-term compliance with daily LT from first symptom through spontaneous springtime remission every fall/winter season is poor. Time-limited alternative treatments with effects that endure beyond the cessation of acute treatment are needed to prevent the annual recurrence of SAD.This is an NIMH-funded R01-level randomized clinical trial to test the efficacy of a novel, SAD-tailored cognitive-behavioral group therapy (CBT) against LT in a head-to-head comparison on next winter outcomes. This project is designed to test for a clinically meaningful difference between CBT and LT on depression recurrence in the next winter (the primary outcome). This is a concurrent two-arm study that will randomize 160 currently symptomatic community adults with major depression, recurrent with seasonal pattern, to CBT or LT. After 6 weeks of treatment in the initial winter, participants are followed in the subsequent summer, the next winter, and two winters later. Key methodological issues surround timing study procedures for a predictably recurrent and time-limited disorder with a focus on long-term outcomes.The chosen design answers the primary question of whether prior exposure to CBT is associated with a substantially lower likelihood of depression recurrence the next winter than LT. This design does not test the relative contributions of the cognitive-behavioral treatment components vs. nonspecific factors to CBT's outcomes and is not adequately powered to test for differences or equivalence between cells at treatment endpoint. Alternative designs addressing these limitations would have required more patients, increased costs, and reduced power to detect a difference in the primary outcome.Clinicaltrials.gov identifier NCT01714050.

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Identifying the most suitable treatment for depression based on patients' attachment: study protocol for a randomized controlled trial of supportive-expressive vs. supportive treatments.

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Identifying the most suitable treatment for depression based on patients' attachment: study protocol for a randomized controlled trial of supportive-expressive vs. supportive treatments.

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