Casañas et al. BMC Health Services Research (2019) 19:427 https://doi.org/10.1186/s12913-019-4198-7 STUDY PROTOCOL Open Access Effectiveness of a psychoeducation group intervention conducted by primary healthcare nurses in patients with depression and physical comorbidity: study protocol for a randomized, controlled trial Rocío Casañas1,2* , Jaume Martín Royo3,4, Maria Isabel Fernandez-San-Martín4,5, Antonia Raya Tena6, Jacobo Mendioroz7,14, Glòria Sauch Valmaña7,14, Roser Masa-Font8, Marc Casajuana-Closas2,13, Eva María Fernandez Linares9, Cèlia Cols-Sagarra10, Susana Gonzalez Tejón11, Quintí Foguet-Boreu2 and Luis Miguel Martín Lopez12,13 Abstract Background: Depressive disorders are the third leading cause of consultation in primary care, mainly in patients with chronic physical illnesses. Studies have shown the effectiveness of group psychoeducation in reducing symptoms in depressive individuals. Our primary aim is to evaluate the effectiveness of an intervention based on a psychoeducational program, carried out by primary care nurses, to improve the remission/response rate of depression in patients with chronic physical illness. Secondarily, to assess the cost-effectiveness of the intervention, its impact on improving control of the physical pathology and quality of life, and intervention feasibility. Methods/design: A multicenter, randomized, clinical trial, with two groups and one-year follow-up evaluation. Economic evaluation study. Subjects: We will assess 504 patients (252 in each group) aged > 50 years assigned to 25 primary healthcare centers (PHC) from Catalonia (urban, semi-urban, and rural). Participants suffer from major depression (Beck depression inventory: BDI-II 13–28) and at least one of the following: type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma, and/or ischemic cardiopathy. Patients with moderate/severe suicide risk or severe mental disorders are excluded. Participants will be distributed randomly into the intervention group (IG) and control (CG). Intervention: The IG will participate in the psychoeducational intervention: 12 sessions of 90 min, once a week led by two Primary Care (PC) nurses. The sessions will consist of health education regarding chronic physical illness and depressive symptoms. Main measurements: Clinical remission of depression and/or response to intervention (BDI-II). (Continued on next page) * Correspondence: rocio.casanas@chmcorts.com 1 Research Department, Associació Centre Higiene Mental Les Corts, Barcelona, Spain 2 Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain Full list of author information is available at the end of the article © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Casañas et al. BMC Health Services Research (2019) 19:427 Page 2 of 9 (Continued from previous page) Secondary measurements: Improvement in control of chronic diseases (blood test and physical parameters), drug compliance (Morinsky-Green test and number of containers returned), quality of life (EQ-5D), medical service utilization (appointments and hospital admissions due to complications), and feasibility of the intervention (satisfaction and compliance). Evaluations will be blinded, and conducted at baseline, post-intervention, and 12 months follow-up. Discussion: Results could be informative for efforts to prevent depression in patients with a chronic physical illness. Trial registration: NCT03243799 (registration date August 9, 2017) Keywords: Depression, Primary healthcare, Chronic physical illness, Nurses, Psychoeducation Background interventions are better than more general ones such as Depression is considered a major public health issue in health education regarding the associated chronic path- industrialized societies [1], and has been associated with ologies [13, 14]. As an example, the DIAMOS study greater morbidity and mortality, and increased health- reported that behavioral techniques led to both a de- care utilization and costs [2–4]. In primary care, depres- crease in depressive symptoms and a reduction in blood sion is one of the most frequent causes of consultation glucose levels [15]. [5] and is particularly common in patients with physical With regard to psychoeducation, it has been demon- illnesses. The prevalence of depression worldwide is strated that it is an effective therapy in the treatment of 4.4%, in Spain it represents 5.2% [6] reaching up to 30% depression in adults [16, 17] as it decreases depressive in populations with chronic physical conditions when symptoms and risk of relapse/recurrence, and improves taking into account symptoms and disorders [2]. For in- treatment compliance [17–19]. Adherence to psychoe- stance, in diabetic patients the risk of depression is twice ducation interventions is high, according to some that of the general population [2]. According to the authors, with a reported attendance of 73–87% in all the World Health Organization (WHO) by 2030 it will be group sessions [18, 20]. Moreover, such therapy could be the principal cause of disability in the world [7]. carried out in primary care by community nurses with The concomitance of physical illness and depression previous training [18, 20]. not only decreases the patient’s response to anti- We present a study protocol of a randomized con- depressive treatment but also worsens control of their trolled trial aimed at evaluating the effectiveness of a organic pathologies, results in unhealthy habits (diet and psychoeducation group intervention carried out by pri- exercise), and leads to lower treatment compliance [8]. mary care nurses in patients with depression and As a consequence, the economic burden of healthcare is chronic physical illness (diabetes, COPD, asthma and/or greater in such individuals with depression than those ischemic cardiopathy). The main objective is to evaluate without [7]. For instance, patients with depression and whether such an intervention improves the rate of chronic obstructive pulmonary disease (COPD) can remission and response of depression in these patients. present exacerbations of common respiratory symptoms Secondary ones include assessing the cost-effectiveness which require a greater number of visits to the emer- and feasibility of the intervention, its efficacy in improv- gency room and hospitalization [9]. It is thus becoming ing control of the physical pathology, and its impact on increasingly necessary to design strategies aimed at de- health-related quality of life (HRQoL). tecting and treating depression in patients with associ- The primary hypothesis is that in patients with chronic ated physical comorbidity in order to reduce depressive physical disease pyschoeducation group therapy pro- symptoms and disorders, and improve general health. vided by primary care nurses can achieve a greater rate A number of studies has shown that preventive inter- of remission and response of depression than habitual ventions, particularly stepped-care ones, can lead to a re- clinical practice. duction of up to 25% in the rate of depression in diseases such as diabetes [10]. Most of the research, Methods/design however, has been focused on reducing depressive symp- Study design toms and disorders, and there is less directed at obtain- A randomized, multi-center, clinical trial composed of ing health benefits regarding the parameters of the two groups with blinded response variables and a one- associated medical illness [11, 12]. According to the lit- year follow-up. A cost-effectiveness study will also be erature, there are greater benefits to be had from inter- performed. When each primary healthcare center (PHC) vening rather than not [10,11,]. Nevertheless, there is has a sample of 24 patients these are randomly allocated some controversy over whether specific and specialized to either an intervention group (IG) or a control (CG). Casañas et al. BMC Health Services Research (2019) 19:427 Page 3 of 9 Data will be collected at baseline, and at 3 and 12 The objectives of the 12 sessions are depicted in Table 1. months post-intervention. The program provides: 1) health education about chronic pathology and depressive symptoms; 2) information on the relationship between depressive symptoms and chronic Sample pathology; 3) health education regarding: diet, physical ex- The participants are patients aged > 50 years assigned to ercise, sleep, pleasant activities, social skills, pharmaco- PHC from different locations: Barcelona city (1,200,066), logical treatment, and adherence to treatment; 4) breathing the central area of Catalonia (192,000), and the southern techniques; 5) problem solving, behavioral activation, and area (132,000). Such a territorial representation provides cognitive-behavioral perspective on depression; and 6) self- patients from urban, semi-urban, and rural areas. esteem and assertiveness [26]. Inclusion criteria are: 1) the presence of at least one of To enhance the active role of the patient, each session the following physical diseases: diabetes mellitus type 2, is accompanied with homework. The participants are COPD, asthma, and ischemic cardiopathy; 2) a score > 12 free to continue under pharmacological treatment. on the Beck Depression Inventory score (BDI-II) [21, 22] Spanish version adapted by Sanz et al. [23–25], and confirmation of major depression according to DSM-IV Description of the control group criteria with the Mini International Neuropsychiatric Members of the CG receive their usual treatment, that is Interview (MINI); 3) adherence to a one-year follow-up to say, they can consult their family doctor/nurse as with the same PHC team; 4) signed informed consent. needed with no set pattern. The appointments last from Exclusion criteria are: 1) diagnosis of dementia or 10 to 20 min and for both groups the healthcare profes- moderate/elevated cognitive decline (5 or more errors sionals use their own criteria (usual clinical practice) re- on the Pfeiffer scale); 2) major depressive disorder with garding the chronic pathology and depressive symptoms. psychotic symptoms or other serious psychiatric comor- The nurses receive prior training based on the inter- bidities; 3) elevated/moderate risk of suicide (a score of vention protocol [26] including the content of the 12 ≥6 on the MINI scale); 4) drug of abuse dependence sessions. It consists of 20 h (10 theory and 10 practice) disorders (including alcohol); 5) physical illness at an and is given by psychologists and nurses specialized in advanced stage; 6) inability to attend the PHC; 7) under mental health. psychological therapy from the Community Mental Health Team; 8) inability to understand Spanish/Catalan. Table 1 Content of the psychoeducational group program Patients receiving anti-depressive/anxiolytic treatment lSessions Objectives are not excluded. Their data are collected and consid- 1 • First contact with the group ered as covariables. • Identification of depressive symptoms • Information on chronic pathology versus chronicity • Information on the relationship between Sample size depressive symptoms and chronic pathology A power analysis will be conducted to determine the • Breathing techniques appropriate sample size. A previous study of psychoeduca- 2 • Behavioural Activation I: Concern and problems. tion programs [18] reported a remission rate at 9 months 3 • Behavioural Activation II: Concern and problems. follow-up of 40% in the IG and 26% in the CG. Assuming 4 • How to take care to advance I a 5 and 20% alpha and beta risk, respectively, 189 patients ➢ Healthy diet are required for each group. Due to a number of reasons, ➢ Motivation for change (resources and difficulties) an approximately 25% dropout rate is expected, conse- 5 • How to take care to advance II quently, 252 participants per group need to be recruited ➢ Physical exercise (total n = 504). In addition, 25 PHC are required each with ➢ Pleasant activities, social skills a mean of 20 patients (IG n = 10, CG n = 10). 6 • How to take care to advance III ➢ Sleep ➢ Therapeutic compliance Intervention 7 • Problem solving I Description of the psychoeducation group intervention 8 • Problem solving II In order to homogenize the interventions, the research 9 • Self-esteem and assertiveness group has developed a protocol of 12 weekly sessions 10 • Cognitive-behavioural perspective I lasting 90 min led by two primary care nurses. Each 11 • Cognitive-behavioural perspective II group is made up of 8–12 participants [26]. The sessions will be held on PHC premises which have the necessary 12 • Group farewell • Final evaluation space and equipment. Casañas et al. BMC Health Services Research (2019) 19:427 Page 4 of 9 Recruitment process 3. Risk of suicide evaluated by the MINI interview The recruitment process for the trial began in Septem- [27, 28]. ber 2017. All eligible PHC located in Barcelona city, the 4. Pfeiffer Scale to detect cognitive impairment [30, 31]. central area of Catalonia (Bagés, Berguedá, and Solsonés) This is a hetero-administered questionnaire made up and the southern area (Baix Llobregat Nord) have been of 10 items and scored from 0 to 10 (errors). From 5 contacted and encouraged to participate in the study. onwards an individual is considered to present The PHC who express interest receive a team presenta- moderate/severe cognitive decline. tion, explanatory dossiers, and informed consent papers. Those who wish to take part are required to consecu- tively recruit 16–24 patients who, after meeting inclu- Socio-demographic variables: sion criteria and signing the informed consent, will be Sex, age, civil status, educational level (without randomized into two equally sized groups (IG and CG). studies / incomplete primary ones / completed pri- Different groups of healthcare workers will be involved mary ones / secondary ones / higher education), em- in the field work: ployment status (employed / housewife / unemployed / disabled / retired). Assigned PHC: rural (doctor’s a) Recruiters: the patient’s assigned doctor and/or surgery) / semi-urban (PHC with a population < 15, nurse. 000 inhabitants) / urban (PHC with a population ≥ 15, b) Nurses leading the psycho-educational groups, two 000 inhabitants). per PHC. c) Evaluators blinded to the groups who carry out Primary outcomes interviews at baseline, and at 3 months, and 12 1. Clinical remission and/or response of depression at months post-intervention. short and long-term (one year follow-up) of the d) An external researcher in charge of patient intervention following Riedel et al. [32]: clinical randomization which is performed once all the remission considered as a reduction in the necessary number of patients have signed the rating < 13 of the BDI-II; response to the consent forms. The data gathering phases are intervention as a decrease of at least 50% in the explained in the work plan section. initial evaluation of depressive symptoms according to the BDI-II. All outcome variables will be assessed three times: prior to study commencement (baseline), after 3 months, Secondary outcomes and at 12 months after inclusion in the individual data 1. Improvement in the control of the chronic pathology collection sessions. Information about data collection at 12 months follow-up: and intervention programme timeline are detailed in the a) Diabetes mellitus: controlled with glycosylated Table 2. hemoglobin, HBA1C (%) [33, 34]. Ethical approval has been provided by the Comitè Ètic b) COPD: lung function measured by post d’Investigació (CEI), Fundació Institut Universitari per a bronchodilator expiratory volume (FEV1). Dyspnea la recerca a l’Atenció Primària de Salut Jordi Gol i Gur- evaluated by the modified score of the Medical ina (IDIAPJGol), Barcelona, Spain. Research Council (mMRC), at 5 points [35, 36] c) Asthma: lung function measured by post bronchodilator expiratory volume (FEV1). Measures Determination of peak expiratory flow (PEF) [37]. The selected variables and instruments, as well as the d) Ischemic cardiopathy: measurement of levels of evaluation program timeline, are detailed in Table 3. low-density lipoprotein cholesterol and blood Data will be imported using an online survey tool and pressure [38]. include: 2. Adherence to medication is assessed by the Diagnostic variables Morinsky-Green test [39] and the comparison 1. Diagnosis of depression according to the MINI between containers collected in the pharmacy and interview [27, 28]. those prescribed. It will be performed for all the 2. Physical diseases (code CIE-10). Diagnosis of prescribed medication for both groups. diabetes mellitus (E11-E14 and sub-groups), COPD 3. Quality of life as measured with the EuroQol (EQ- (J43-J44 and sub-groups), asthma (J45), and/or 5D-5 L) questionnaire. (Original: EuroQol Group ischemic cardiopathy (I20-I25 and sub-groups) as 1996. Spanish adaptation: Badia et al. 1999) [40, 41]. registered in the patients’ medical records and 4. Utilization of healthcare services during the study confirmed by their family doctor [29]. period. This includes: number of hospital Casañas et al. BMC Health Services Research (2019) 19:427 Page 5 of 9 Table 2 Data collection and intervention programme timeline Abbreviations: PHC primary healthcare center, IG intervention group, mo months Table 3 Outcome measures Outcome measures Timeline Pre-intervention Post-intervention 3 mo 12 mo 1. Socio-demographic variables Sex, age, marital status, educational level, employment status, reference PHC X 2. Diagnostic variables Diagnosis depression: MINI X Diagnosis chronic physical illness: ICD-10 X Suicide risk: MINI X Cognitive impairment: Pfeiffer questionnaire X 3. Clinical variables Depressive symptoms: BDI- II questionnaire X X X Anxiety symptoms: HARS questionnaire X X X Quality of life: EQ-5D-5 L questionnaire X X X Pharmacotherapy X X X Therapeutic compliance: Morinsky-Green test X X X Feasibility of the intervention X X 4. Blood test and Physical parameters Type 2 diabetes mellitus: Analytical HBA1C X X COPD: FEV1 and Medical Research Coincil (mMRC) X X Asthma: Spirometry and Peak flow X X Ischemic heart disease: Analytical cholesterol LDL and Blood pressure X X 5. Costs variables Pharmacological Treatment X X X Utilization of services: PHC and hospital X X X Other comorbidities X X Costs derived from the intervention X X X Abbreviations: mo months, BDI-II Beck Depression Inventory secondary edition, COPD Chronic obstructive pulmonary disease, EQ EuroQuol, FEV1 Forced expiratory volume, HARS Hamilton Anxiety Rating Scale, HBA1C Hemoglobin A1C test, ICS-10 International classification of diseases-10th revision, MINI Mini international neuropsychiatric interview, PHC Primary Healthcare Centers Casañas et al. BMC Health Services Research (2019) 19:427 Page 6 of 9 admissions (emergency room and ward) due to Statistical analysis complications arising from diabetes, COPD, and The analysis is performed on an intention-to-treat basis. ischemic cardiopathy (yes/no), and psychiatric All the patients who have signed the informed consent pathology (yes/no); mental health referrals (yes/no) and attended the initial interview are included. Missing and number; and consultations with the family data from the BDI-II evaluation during follow-up will be doctor/nurse (yes/no) and number. substituted by the last registered value (Last Observation 5. Variables resulting from the intervention with Carried Forward strategy). At the beginning of the study respect to its feasibility. A questionnaire with 10 descriptive statistics will be performed to evaluate the items and a Likert scale of 4 categories regarding homogeneity between the two groups (IG and CG) with satisfaction is administered to the patients on respect to demographic, clinical, and service utilization completing the intervention. Adherence is assessed variables. In order to measure the main objective (rate of through the number of sessions each IG patient remission and response) logistic regression is employed attends. An adherence variable is calculated for the in which the dependent variable is dichotomous (rate of intervention: ≥75% attendance or less. remission and response). The patient’s group is the inde- pendent variable. Raw and adjusted odds ratio (OR) are Confounding variables and effect modifiers calculated according to age, sex, pharmacologic treat- ment, and comorbidity. Repeated measure ANOVA ana- 1. Pharmacological treatment. The defined daily dose lysis will be performed to determine the evolution of the for each active ingredient is established during the dependent variables during follow-up. For the secondary follow-up period taking into account the number of resulting variables, control of the physical pathologies days, the dosage, and the route of administration. will be measured by logistic regression in which the The registered active ingredients belong to the fol- dependent variable is dichotomous (control yes/no). The lowing groups: antidepressants, anxiolytics, antidia- models will be adjusted in the same way as the principal betics (oral, insulin), bronchodilators (selective one. Variable differences in the BDI-II rating and other agonists of Beta2 - adrenergic, anticholinergic), scores with respect to baseline will be calculated. anti-inflammatories: corticosteroids, antihyperten- Student’s t test will be employed for the comparison sives, and dyslipidemics. between the groups’ variables and standardized effect 2. Other associated comorbidities: cardiac size (SES; Kazis et al.1989) [44]. insufficiency, atrial fibrillation, cardiovascular The economic analysis will be carried out with a cost- disease, peripheral vascular disease, other chronic effectiveness analysis to compare the expenses incurred diseases. from the psychoeducation intervention with those from 3. Participation in other mental health therapies given habitual clinical practice over 1 year. The QALYs (qual- by psychologists and psychiatrists. ity-adjusted life years) obtained from the EuroQol ques- 4. Anxiety evaluated with the HARS-Hamilton tionnaire will provide the variable of effectiveness. That Anxiety Rating Scale [42]. of cost will be obtained by measuring all the direct 5. History of previous depressive episodes (yes/no). expenses generated by the participants from both groups and including any other related information. For in- Cost variables stance, primary care consultations, referrals to special- Expenses included in the cost-effectiveness analysis: ists, hospitalization, additional tests, analytical tests, and medication expenses. The ratios and incremental costs 1. Use of primary care services: consultation fees for the IG versus CG will be calculated. Prices will be according to professional status and level of care. based on those of 2016 as the Oblikue database is the 2. Use of hospital services: hospitalization and most complete for that period. As the healthcare costs emergency room consultations. will be generated over various years a constant discount 3. Cost of psychotropic medication consumed during rate of 3% per year will be applied. Finally, for the items the study: anxiolytics and antidepressants according with the greatest presence in the overall cost, a deter- to the current catalogue from the Pharmacist ministic sensitivity analysis will be carried out to ensure Association. robustness and reliability of the results obtained [45]. 4. Derived costs: training and supervision of the nurses responsible for leading the sessions, their working Discussion hours spent with the groups, and expenses related This article describes a study design for investigating the to material used in the sessions and given out to the effectiveness of a psychoeducation group intervention participants. In order to calculate the cost of the carried out by PC nurses. It is aimed at reducing depres- resources 2016 Oblikue rates are employed [43]. sive symptoms in individuals with chronic physical Casañas et al. BMC Health Services Research (2019) 19:427 Page 7 of 9 disease (diabetes mellitus, COPD, asthma, ischemic car- Abbreviations diopathy) and comparing intervention results with usual BDI-II: Beck Depression inventory- Second edition; CG: Control Group; COPD: Chronic obstructive pulmonary disease; IG: Intervention Group; clinical practice. A secondary objective is to assess the MINI: Mini International Neuropsychiatric Interview; PC: Primary Care; impact of the intervention on improving control of the PHC: Primary Healthcare Center physical pathology. Acknowledgements Psychoeducation group interventions have been We would like to thank the collaboration of the Institut Universitari per a la shown to be effective in reducing depressive symptoms, Recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol) and the decreasing the risk of relapse and recurrence, and Unitat de Suport a la Recerca de Catalunya Central and Barcelona Ciutat of the Institut Català de la Salut, for their support whenever it is been required. improving treatment compliance in patients with both depression and an organic, physical disease. In com- Authors’ contributions parison with the general public, depressive patients All the authors have contributed to the design and content of the study protocol. MF and RC are responsible for the coordination of the study and present a worse control of their physical pathology, less obtaining funding. More specifically, MF, RC, RM, LMM and JM1 are adherence to treatment, and poorer fulfillment of responsible for the design of the study and writing the initial manuscript healthy lifestyle habits. draft. AR, EF, JM1 and RC have developed the content of the 12 modules of the psychoeducation group program, and they have supervised the Our results could encourage the implementation of development of the interventions in the primary healthcare centers. JM2, QF, such interventions for patients with depression and GS, SG and CC are responsible for the data collection, fieldwork, and chronic organic pathologies within the community, a fundraising. MF, RC, RM and MC oversee epidemiological and statistical expertise and the measuring instruments, and MC is responsible for the setting where most of them are attended. If its effective- economic evaluation study. All authors read and approved the final version ness is demonstrated, as a specific, brief intervention of the manuscript. that requires relatively few hours of training, it could be carried out by nurses with previous instruction. Funding The trial received a research grant from the Carlos III Institute of Health, A major strength of our work is that the results will be Ministry of Economy and Competitiveness (Spain). This was awarded in the obtained from a naturalistic study as close as possible to 2016 call for tenders under the Health Strategy Action 2013–2016, within the the usual clinical practice found in primary care. As a re- National Research Programme aimed at Societal Challenges, within the Technical, Scientific and Innovation Research National Plan 2013–2016, with sult, it is an intervention that can easily be implemented reference PI16/184, and was co-funded by European Union ERDF funds in such a setting without considerable organizational or (European Regional Development Fund). structural modifications. In addition, the trial has received a nursing research intensification grant from the Department of Health of the Generalitat de Catalunya (Spain). This Some limitations include the fact that the nurses who was awarded in the 2017 call for tenders under the Health Research and carry out the intervention are aware of the groups the Innovation Strategic Plan (PERIS) 2016–2020 with reference SLT002/17/00096. patients belong to. Nevertheless, blinding of some key Availability of data and materials stages of the study, such as randomization, evaluation of All the principal investigators of the study will have access to the complete outcomes/confounder variables, and statistical analysis dataset, and the datasets generated and analysed during the current study will be maintained. Second, for a long-term follow-up will be available from the corresponding author. Results generated during this study will be published in peer-reviewed journals and at national/inter- under normal conditions a dropout rate of 25% is national congresses. expected. In the case of missed appointments and inter- The program has been designed in accordance with CONSORT guidelines, vention sessions it is hoped that patient adherence will and registration at clinicaltrials.gov will be expected to facilitate transparency and reporting. be ensured through telephone calls (at least three times per appointment, one of which is 24 h prior to the Ethics approval and consent to participate appointment) unless the patient has stated reluctance to Ethical approval has been provided by the Comitè Ètic d’Investigació (CEI), Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut participate. Third, the patients will present varying path- Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain. This independent ethics ologies which will increase the heterogeneity of the sam- committe has approved the trial study protocol with reference number P16/ ple. Nevertheless, most of the patients attended at the 184. It has been registered at the Clinical.Trial.gov register NCT03243799 (August 9, 2017). PHC present comorbidities and their inclusion repre- Written informed consent from all patients participating in the study will be sents a greater generalization of results. Fourth, in order requested. to avoid the effect of contamination, patients assigned to Consent for publication the two nurses leading the IG from the same center will Not applicable. be excluded. Fifth, there could be some difficulty in recruiting a sufficient number of patients. Competing interests To the best of our knowledge, this is the first study The authors declare that they have no competing interests. evaluating the effectiveness of a psychoeducation group Author details intervention with patients suffering from both depression 1 Research Department, Associació Centre Higiene Mental Les Corts, and a chronic organic pathology (diabetes mellitus, COPD, Barcelona, Spain. 2Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain. 3Centre asthma, and ischemic cardiopathy) to be carried out by d’Urgències d’Atenció Primària (CUAP) Casernes, Institut Català de la Salut, community nurses in a primary care setting. Barcelona, Spain. 4Unitat de Suport a la Recerca Barcelona Ciutat, Fundació Casañas et al. BMC Health Services Research (2019) 19:427 Page 8 of 9 Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i 15. 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