1. Efficacy of a blended low-intensity internet-delivered psychological programme in patients with multimorbidity in primary care: study protocol for a randomized controlled trial
- Author
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Yolanda López-Del-Hoyo, Mª. Angeles Pérez-Ara, Fermín Mayoral, Esperanza Varela Moreno, Alberto Barceló-Soler, Javier García-Campayo, Margalida Gili, Azucena García-Palacios, Adoración Castro, Rosa M. Baños, María M Hurtado, Alicia Monreal-Bartolomé, Cristina Botella, [Monreal-Bartolomé,A] Primary Care Prevention and Health Promotion Research Network, RedIAPP, Carlos III Health Institute, Madrid, Spain. [Monreal-Bartolomé,A, Barceló-Soler,A, López-Del-Hoyo,Y] Aragon Institute for Health Research, IIS Aragon, Zaragoza, Spain. [Barceló-Soler,A, Castro,A, Pérez-Ara,MA, Gili,M, López-Del-Hoyo,Y, García-Campayo,J] Primary Care Prevention and Health Promotion Research Network, RedIAPP, Madrid, Spain. [Castro,A, Gili,M] Institut Universitari d’Investigació en Ciències de la Salut, IUNICS-IDISPA, University of the Balearic Islands, Palma, Spain. [Mayoral,F, Hurtado,MM, Varela Moreno,E] Mental Health Department, Institute of Biomedicine of Malaga, University Regional Hospital of Malaga, Malaga, Spain. [Botella,C] Jaume I University, Castellon de la Plana, Spain. [Botella,C, García-Palacios,A, Baños,RM] CIBER Physiopathology Obesity and Nutrition (CIBERobn) Carlos III Health Institute, Madrid, Spain. [García-Palacios,A] Department of Clinical and Basic Psychology and Biopsychology, Faculty of Health Sciences, University Jaume I, Castellon, Spain. [Baños,RM] Department of Psychological, Personality, Evaluation and Treatment, University of Valencia, Valencia, Spain. [López-Del-Hoyo,Y] Department of Psychology and Sociology, University of Zaragoza, Zaragoza, Spain. [García-Campayo,J] Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Zaragoza, Spain., and This research is financed by a FIS grant from the Carlos III Health Institute of the Spanish Ministry Economy and Competitiveness (PI16/00962).
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Male ,Tecnología de la información ,humanos ,Psychological intervention ,depresión ,Ensayo clínico controlado aleatorio ,law.invention ,Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings] ,dolor lumbar ,Study Protocol ,0302 clinical medicine ,Randomized controlled trial ,law ,lcsh:Psychiatry ,Depresión ,Health care ,Global health ,Medicine ,030212 general & internal medicine ,Randomized Controlled Trials as Topic ,Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic::Controlled Clinical Trials as Topic::Randomized Controlled Trials as Topic [Medical Subject Headings] ,Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Evaluation Studies as Topic::Clinical Trials as Topic::Controlled Clinical Trials as Topic::Randomized Controlled Trials as Topic [Medical Subject Headings] ,Diseases::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Disease Attributes::Chronic Disease [Medical Subject Headings] ,Depression ,ensayos clínicos controlados aleatorizados como asunto ,Multimorbilidad ,adulto ,Primary care ,Low back pain ,Health Care::Health Services Administration::Patient Care Management::Comprehensive Health Care::Primary Health Care [Medical Subject Headings] ,Psychiatry and Mental health ,diabetes mellitus ,Information Science::Information Science::Computing Methodologies::Computer Systems::Computer Communication Networks::Internet [Medical Subject Headings] ,Diseases::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Pain::Back Pain::Low Back Pain [Medical Subject Headings] ,Female ,medicine.symptom ,Adult ,medicine.medical_specialty ,enfermedad crónica ,lcsh:RC435-571 ,Check Tags::Male [Medical Subject Headings] ,03 medical and health sciences ,Information and communication technologies (ICTs) ,Atención primaria de salud ,Intervention (counseling) ,Humans ,Persons::Persons::Age Groups::Adult [Medical Subject Headings] ,Geographical Locations::Geographic Locations::Europe::Spain [Medical Subject Headings] ,Internet ,Primary Health Care ,business.industry ,Diseases::Endocrine System Diseases::Diabetes Mellitus::Diabetes Mellitus, Type 2 [Medical Subject Headings] ,Multimorbidity ,Health Care::Health Care Facilities, Manpower, and Services::Health Personnel::Physicians::Physicians, Primary Care [Medical Subject Headings] ,medicine.disease ,Comorbidity ,030227 psychiatry ,Clinical trial ,Check Tags::Female [Medical Subject Headings] ,Diabetes Mellitus, Type 2 ,Spain ,Chronic Disease ,Physical therapy ,Randomized controlled trial (RCT) ,business ,Psychiatry and Psychology::Behavior and Behavior Mechanisms::Behavior::Behavioral Symptoms::Depression [Medical Subject Headings] ,Low Back Pain - Abstract
BackgroundThe World Health Organization (WHO) has included comorbidity between depression and a chronic disease among the 10 leading global health priorities. Although there is a high prevalence of multimorbidity, health care systems are mainly designed for the management of individual diseases. Given the difficulty in delivering face-to-face psychological treatments, alternative models of treatment delivery have been proposed, emphasizing the role of technologies such as the Internet. The aim of this study is to assess the efficacy in Primary Care (PC) of a blended low-intensity psychological intervention applied using information and communication technologies (ICTs) for the treatment of multimorbidity in PC (depression and type 2 diabetes/low back pain) by means of a randomized controlled trial (RCT). Our main hypothesis is that improved usual care combined with psychological therapy applied using ICTs will be more efficacious for improvement in the symptomatology of multimorbidity, compared to a group with only improved treatment as usual six months after the end of treatment.MethodsA protocol has been designed combining a face-to-face intervention with a supporting online programme that will be tested by an RCT conducted in three different regions (Andalusia, Aragon and the Balearic Islands). The RCT will evaluate three hundred participants diagnosed with depression and type 2 diabetes/low back pain. Four highly experienced research groups specializing in clinical psychology are involved in this trial, and there will be ample possibilities for translation and transfer to usual clinical practice.DiscussionThis clinical trial will lead to improvement in financial sustainability, maximizing the use of resources and responding to principles of efficiency and effectiveness. Furthermore, based on the evaluation of the feasibility of implementing this intervention in primary care facilities, we expect to be able to suggest the intervention for incorporation into public policy. In conclusion, positive results of this study could have a significant impact on one of the most important health-related problems, multimorbidity.Trial registrationClinicalTrials.gov, NCT03426709. Registered retrospectively on 08 February 2018., The first two authors have a FI predoctoral contract awarded by the Institute of Health Carlos III (ISCIII; FI17/00180) and the Ministry of Education, Culture and Sports (Spain) (FPU014/04987) at the Institute of Health Research of Aragon (IIS) of Zaragoza.
- Published
- 2018