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1. Efficacy, cost-utility and physiological effects of Acceptance and Commitment Therapy (ACT) and Behavioural Activation Treatment for Depression (BATD) in patients with chronic low back pain and depression: study protocol of a randomised, controlled trial including mobile-technology-based ecological momentary assessment (IMPACT study)

Author

Carlos Suso-Ribera, Francesco D'Amico, Antonio Cuesta-Vargas, Juan P. Sanabria-Mazo, Antoni Sanz, Juan R. Castaño-Asins, Pere Estivill-Rodríguez, Paula Cristóbal-Narváez, Albert Feliu-Soler, Adrián Pérez-Aranda, Grasa Mm, Antonio Montes-Pérez, Azucena García-Palacios, Lance M. McCracken, Carlos G. Forero, Michael Maes, Araceli Rosa, Xavier Borrás, Juan V. Luciano, Ariadna Colomer-Carbonell, Bernat Carreras-Marcos, Laura Andrés-Rodríguez, Silvia Edo, Olga Comps-Vicente, Montserrat Esteve, This study has been funded by the Institute of Health Carlos III (ISCIII, and PI19/00112 & PI16/00165 have been cofinanced with European Union ERDF funds). JVL has a 'Miguel Servet Type II' contract from the ISCIII (CPII19/00003). ISCIII did not have any role in the analysis and interpretation of data, in the writing of the manuscript and in the decision to submit the paper for publication.

Subjects
Technology, General Practice, lcsh:Medicine, Impact study, Chronic pain, R Medicine (General), Acceptance and commitment therapy, law.invention, Clinical trials, Randomized controlled trial, Terapia de aceptación y compromiso, law, Depresión, Tratamiento breve de activación conductual para la depresión, Dolor persistente, Persistent pain, Medicine, Multicenter Studies as Topic, Depressió psíquica, Depression (differential diagnoses), Applied Psychology, Randomized Controlled Trials as Topic, Ecology, Depression, Teràpia racional emotiva conductual, General Medicine, Dolor crònic, Chronic low back pain, Mental depression, Rational emotive behavior therapy, BF Psychology, Ecological Momentary Assessment, Clinical trials, Depression & mood disorders, pain management, Brief behavioral activation treatment for depression, 159.9, Health Economics, Dolor lumbar crónico, Humans, Tractament breu d’activació conductual per a la depressió, Acceptance and Commitment Therapy, Protocol (science), Dolor lumbar crònic, business.industry, lcsh:R, Teràpia d’acceptació i compromís, Dolor persistent, Tillämpad psykologi, Pain management, Clinical trial, Allmänmedicin, pain management, Spain, Depression & mood disorders, Economic evaluation, Depressió, business, Low Back Pain
Abstract

IntroductionThe IMPACT study focuses on chronic low back pain (CLBP) and depression symptoms, a prevalent and complex problem that represents a challenge for health professionals. Acceptance and Commitment Therapy (ACT) and Brief Behavioural Activation Treatment for Depression (BATD) are effective treatments for patients with persistent pain and depression, respectively. The objectives of this 12 month, multicentre, randomised, controlled trial (RCT) are (i) to examine the efficacy and cost-utility of adding a group-based form of ACT or BATD to treatment-as-usual (TAU) for patients with CLBP and moderate to severe levels of depressive symptoms; (ii) identify pre–post differences in levels of some physiological variables and (iii) analyse the role of polymorphisms in the FKBP5 gene, psychological process measures and physiological variables as mediators or moderators of long-term clinical changes.Methods and analysisParticipants will be 225 patients with CLBP and moderate to severe depression symptoms recruited at Parc Sanitari Sant Joan de Déu (St. Boi de Llobregat, Spain) and Hospital del Mar (Barcelona, Spain), randomly allocated to one of the three study arms: TAU vs TAU+ACT versus TAU+BATD. A comprehensive assessment to collect clinical variables and costs will be conducted pretreatment, post-treatment and at 12 months follow-up, being pain interference the primary outcome measure. The following physiological variables will be considered at pretreatment and post-treatment assessments in 50% of the sample: immune-inflammatory markers, hair cortisol and cortisone, serum cortisol, corticosteroid-binding globulin and vitamin D. Polymorphisms in the FKBP5 gene (rs3800373, rs9296158, rs1360780, rs9470080 and rs4713916) will be analysed at baseline assessment. Moreover, we will include mobile-technology-based ecological momentary assessment, through the Pain Monitor app, to track ongoing clinical status during ACT and BATD treatments. Linear mixed-effects models using restricted maximum likelihood, and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed.Ethics and disseminationThis study has been approved by the Ethics Committee of the Fundació Sant Joan de Déu and Hospital del Mar. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and various community engagement activities.Trial registration numberNCT04140838

Published
2020

2. Secondhand Smoking and Depressive Symptoms Among In-School Adolescents

Author

Louis Jacob, Ai Koyanagi, Sarah E Jackson, Lee Smith, Josep Maria Haro, Jae Il Shin, Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Anglia Ruskin University (ARU), University College of London [London] (UCL), ICREA Infection Biology Laboratory (Department of Experimental and Health Sciences), Universitat Pompeu Fabra [Barcelona] (UPF), Centers for Disease Control and Prevention, CDC: PI15/00862 World Health Organization, WHO Instituto de Salud Carlos III, ISCIII European Regional Development Fund, FEDER, This research was based on data from the Global School-Based Student Health Survey, which was made available for use by the Chronic Diseases and Health Promotion Department of the WHO and the U.S. Centers for Disease Control and Prevention. Ai Koyanagi's work is supported by the PI15/00862 project, integrated into the National R?+?D?+?I and funded by the ISCIII - General Branch Evaluation and Promotion of Health Research - and the European Regional Development Fund (ERDF-FEDER). LJ contributed to the design of the study, undertook the statistical analysis, managed the literature searches, wrote the first draft of the manuscript, and contributed to the correction of the manuscript. LS, SEJ, JMH, and JIS contributed to the design of the study and the correction of the manuscript. AK contributed to the design of the study, undertook the statistical analysis, and contributed to the correction of the manuscript. All authors contributed to and have approved the final manuscript. The data sets supporting the conclusions of this article are available at www.cdc.gov. No financial disclosures were reported by the authors of this paper., and Ai Koyanagi's work is supported by the PI15/00862 project, integrated into the National R + D + I and funded by the ISCIII - General Branch Evaluation and Promotion of Health Research - and the European Regional Development Fund (ERDF-FEDER).

Subjects
Male, Adolescent, Epidemiology, Cross-sectional study, [SDV]Life Sciences [q-bio], Developing country, Global Health, Logistic regression, 03 medical and health sciences, 0302 clinical medicine, 030225 pediatrics, Environmental health, Prevalence, Global health, Humans, Medicine, 030212 general & internal medicine, Students, Secondhand smoke, Developing Countries, Depressive symptoms, 2. Zero hunger, Schools, Depression, business.industry, Public Health, Environmental and Occupational Health, Health Surveys, 3. Good health, Food insecurity, Cross-Sectional Studies, Secondhand smoking, Female, Tobacco Smoke Pollution, business
Abstract

International audience; Introduction: Smoking has been linked with depressive symptoms in adolescents, but data on secondhand smoking and depressive symptoms in low- and middle-income countries are scarce. Thus, this study analyzes the association between secondhand smoking and depressive symptoms among in-school adolescents from 22 low- and middle-income countries. Methods: Data from the 2003–2008 Global School-Based Student Health Survey were analyzed in June 2019. Data on past-week exposure to secondhand smoke and past-year depressive symptoms were collected. The association between secondhand smoke and depressive symptoms was studied using multivariable logistic regressions and meta-analyses. Results: The sample consisted of 37,505 adolescents aged 12–15 years who never smoked. The prevalence of depressive symptoms increased from 23.0% in adolescents with no secondhand smoking to 28.9% in those with secondhand smoking every day in the past week. After adjusting for sex, age, food insecurity, and country, there was a dose–response relationship between secondhand smoking and depressive symptoms in the overall sample (0 days: reference; 1–2 days: OR=1.06, 95% CI=0.95, 1.18; 3–6 days: OR=1.38, 95% CI=1.20, 1.58; 7 days: OR=1.63, 95% CI=1.44, 1.86). The country-wise analysis showed that secondhand smoking on at least 3 days (versus

Published
2020

3. Does reductio ad absurdum have a place in evidence-based medicine?

Author

Florian Naudet, Bruno Falissard, Comportement et noyaux gris centraux = Behavior and Basal Ganglia [Rennes], CHU Pontchaillou [Rennes]-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université européenne de Bretagne - European University of Brittany (UEB)-Institut des Neurosciences Cliniques de Rennes (INCR), Troubles du comportement alimentaire de l'adolescent (UMR_S 669), Université Paris-Sud - Paris 11 (UP11)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), This paper was supported by the Institut National de la Santé et de la Recherche Médicale (INSERM). The sponsor had no role concerning preparation, review or approval of the manuscript., Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes = Institute of Clinical Neurosciences of Rennes (INCR), Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Lecoupe-Grainville, Marie, Comportement et noyaux gris centraux [Rennes], Université de Rennes 1 ( UR1 ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Université européenne de Bretagne ( UEB ) -CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Troubles du comportement alimentaire de l'adolescent ( UMR_S 669 ), and Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris-Sud - Paris 11 ( UP11 )

Subjects
Evidence-based medicine, media_common.quotation_subject, Major depressive disorder, Epistemology, Publication bias, Placebos, 03 medical and health sciences, 0302 clinical medicine, Nothing, [ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology, Rhetorical question, Reductio ad absurdum, Humans, Medicine, 030212 general & internal medicine, Meaning (existential), Set (psychology), Absurdity, Placebo, media_common, Medicine(all), [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Depression, business.industry, Comment, Statistics, Antidepressants, General Medicine, Antidepressive Agents, 3. Good health, Meta-analysis, Commentary, business, 030217 neurology & neurosurgery, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Medical literature
Abstract

In a meta-analysis published in BMC Medicine, we explored whether evidence-based medicine can actually be sure that ‘sucrose = sucrose’ in the treatment of depression. This paper, based upon a reductio ad absurdum, addressed an epistemological question using a ‘scientific’ approach, and could be disconcerting as suggested by Cipriani and Geddes’ commentary. However, most papers are based upon a mixture of observations and discussions about sense and meaning. Ultimately, there is nothing more than a story, told with words or numbers. Randomised controlled trials provide information about average patients that do not exist. These results ignores an entire segment of therapeutics that plays a crucial role, namely care. This information is usually set out using a ‘grammar’ that is ambiguous, since statistical tests of hypothesis have raised epistemological questions that are not as yet solved. Moreover, many of these stories remain untold, and unpublished. For these reasons evidence-based medicine is a vehicle for many paradoxes and controversies. Reductio ad absurdum can be useful in precisely this case, to underline how and why the medical literature can sometimes give an impression of absurdity of this sort. Even if the data analysis in our paper was rather rhetorical, we agree that it should comply with the classic standards of reporting and we provide the important extra data that Cipriani and Geddes have requested. Please see related articles: http://www.biomedcentral.com/1741-7015/11/230 and http://www.biomedcentral.com/1741-7015/12/105.

Published
2014

4. Improving study design for antidepressant effectiveness assessment

Author

Naudet, Florian, Millet, Bruno, Reymann, Jean-Michel, Falissard, Bruno, Troubles du comportement alimentaire de l'adolescent (UMR_S 669), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Comportement et noyaux gris centraux = Behavior and Basal Ganglia [Rennes], Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Service de Psychiatrie, Centre Hospitalier Guillaume Régnier, Service de Pharmacologie [Rennes], CHU Pontchaillou [Rennes], This paper was supported by the Institut National de la Santé et de la Recherche Médicale (INSERM)., Le Corre, Morgane, Université Paris-Sud - Paris 11 (UP11)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Troubles du comportement alimentaire de l'adolescent ( UMR_S 669 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris-Sud - Paris 11 ( UP11 ), Centre d'Investigation Clinique [Rennes] ( CIC ), Université de Rennes 1 ( UR1 ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Comportement et noyaux gris centraux [Rennes], Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Université européenne de Bretagne ( UEB ) -CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Service de Pharmacologie, and Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes = Institute of Clinical Neurosciences of Rennes (INCR)

Subjects
Depressive Disorder, Major, clinical trials, [SDV.SP.MED] Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Psychometrics, [ SDV.MHEP.PSM ] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, [ SDV.SP.MED ] Life Sciences [q-bio]/Pharmaceutical sciences/Medication, [SDV.MHEP.PSM] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, Reproducibility of Results, effectiveness, methodology, Original Articles, Personality Assessment, Antidepressive Agents, Observational Studies as Topic, Double-Blind Method, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Research Design, Surveys and Questionnaires, antidepressants, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, Outcome Assessment, Health Care, depression, Humans, Randomized Controlled Trials as Topic
Abstract

Antidepressants effectiveness in major depressive disorder (MDD) is still questioned because the extrapolation of randomized controlled trial (RCT) results to “real life” settings is problematic. The application of the RCT paradigm in a disorder of this type, where global care plays a central role, raises questions regarding the internal and external validity of this type of study. Outcome measurement, attrition rates, the ability of the double‐blind design to control for expectations, placebo response, the representativeness of trial participants and publication bias are major methodological pitfalls. This review discusses these issues. It is illustrated using original data and proposes some alternatives for assessing antidepressant effectiveness via different approaches. Some are easy to implement, such as ecological measures, qualitative approaches, improvement of analytical strategy and improvement of blinding procedures. Some are sophisticated, involving temporary deception to deal with the confounding effect of expectations, and they raise ethical issues. Others resort to external validity, this being the case in observational studies. But all are necessary to explore antidepressant effectiveness. Copyright © 2013 John Wiley & Sons, Ltd.

Published
2013