1 Introduction
Schizophrenia is an incapacitating, long-lasting psychiatric disorder which has serious consequences for both the patient and caregivers [Reference Whiteford, Degenhardt, Rehm, Baxter, Ferrari and Erskine1]. During the asylum period, families were usually excluded from care. However, the process of deinstitutionalization and the development of community psychiatry in the 1960s and 1970s changed the pattern of care of many severe psychiatric patients, placing in the family the burden of care. Usually a family member, known as the primary or main caregiver, assumed most of the care [Reference Thornicroft and Tansella2].
This main caregiver become responsible of the patient care, helping them to solve tasks related with different areas of care; for instance his/her physical and emotional support (i.e. adherence to treatment), socio-economic aspects (i.e. social integration, occupational issues), or activities of daily life (ADLs) [Reference Magliano, Fadden, Madianos, de Almeida, Held and Guarneri3].
Caring for a person with schizophrenia can lead to substantial physical and psychological burden, including negative physical and emotional effects as well as costs in terms of time and use of economical resources [Reference Awad and Voruganti4]. This complex situation has been defined as “caregiver burden”: a negative psychological state experienced by informal caregivers produced by physical, psychological/emotional, social, economic difficulties derived from the care of patients [Reference Zarit, Reever and Bach-Peterson5,Reference Grad and Sainsbury6].
Although positive experiences also appear [Reference Szmukler7], between 83 to 95% of relatives or friends of patients with schizophrenia might experience significant burden that may reduce the quality of care provided, endangering both patients and caregivers alike [Reference Perlick, Ra, Kaczynski, Swartz, Canive and Lieberman8,Reference van Wijngaarden, Schene, Koeter, Becker, Knapp and Knudsen9]. It is therefore important that a comprehensive treatment of schizophrenia include interventions intended for reducing the negative impact of the illness on caregivers. However, with some exceptions [Reference Magliano, Fiorillo, Fadden, Gair, Economou and Kallert10], most research supporting the efficacy of family interventions has focused on patient outcomes, and only marginally has considered the situation of the caregiver as an adequate target for intervention [Reference Sin and Norman11]. Accordingly, the NICE guideline highlights lack of evidence on interventions specifically targeting caregiver burden in schizophrenia [12]. The EDUCA-III trial, presented here, is a multicentre randomized controlled trial designed to assess the effect of a psychoeducational intervention program (PIP) on caregiver's burden and other relevant mental health outcomes. The PIP was administered in a group format and focused on the didactically and skilful communication of key information to the caregiver within the framework of a cognitive-behavioural approach [Reference Baüml, Froböse, Kraemer, Rentrop, Pitschel-Walz and Psychoeducation:13].
1.1 Aims of the trial
To assess the efficacy of a PIP versus standard care on the reduction of caregiver burden at the end of trial (4 months since baseline), and to assess the maintenance of the therapeutic effect at follow-up (8 months since baseline).
2 Methods
2.1 Hypothesis and design
The main hypothesis of the trial was that caregivers allocated to a PIP would present lower subjective burden at postintervention endpoint (4 months), and at further follow-up (8 months) than caregivers allocated to control condition. A secondary hypothesis was that caregivers allocated to PIP would also present better mental health according to self-reported indicators at endpoint and follow-up than caregivers allocated to control condition.
The design was a two-arm, evaluator blind, international, multicentre, randomized controlled trial. All research sites had 2 investigators: one trained in the application of the PIP, and other–blinded to the allocated intervention–who assessed the caregiver outcomes. Throughout the trial, a central research committee oversight the correct management of trial procedures and adherence to protocol. The trial protocol was approved by appropriate Institutional Review Boards of Spain and Portugal (Ethical and Scientific Research Committees of Navarra, Spain; and Sisters Hospitallers, Portugal). All participants (caregivers and patients) signed an informed consent form prior to randomization and trial inclusion.
2.2 Participants, inclusion and exclusion criteria
Dyads of patients diagnosed with schizophrenia or schizoaffective disorder (DSM-IV criteria) and family primary caregivers were recruited from 21 outpatient psychiatric centres in Spain and from 3 outpatient psychiatric centres in Portugal.
Persons caring for a relative were eligible for the trial if they met the following inclusion criteria:
• males or females (18+ years) currently caring for a relative with a diagnosis of schizophrenia or schizoaffective disorder;
• the caregiver should not be professionally paid (i.e., he/she should be an informal caregiver) and spend a minimum of 4 h/week caring for the patient;
• the patient should have been diagnosed at least 2 years before trial recruitment and was receiving appropriate outpatient clinical care.
The following were considered exclusion criteria:
• caregivers without time to attend the weekly sessions of PIP training;
• caregivers currently receiving, or having recently received (last year), any standardized psychoeducational intervention similar to the one administered in the trial;
• the patient cared for had an hospitalization in the month before randomization, or was on residential care;
• the patient presented mental retardation, dementia or any other organic cognitive disorder.
On the other hand, the following criteria for ending the trial before completion were established:
• caregiver decision;
• change from outpatient to inpatient status or residential care for the patient being cared for;
• patient being discharged from the original health care service;
• protocol deviations as assessed by the central research committee.
2.3 Interventions
The caregivers allocated to the control group received the usual support from the outpatient psychiatric service where the patients were treated, and had periodical interviews and information about the situation and clinical course of the patient. The caregivers allocated to the intervention group received the same usual support plus the PIP. The PIP was developed by a group of psychiatric, psychologist and mental health experts with practical knowledge in patient and caregiver interventions. It is based on the principles of the psychoeducational program developed in REACH-II study [Reference Wisniewski, Belle and Coon14] for dementia caregivers, subsequently adapted to the characteristics of caregivers of people with schizophrenia. Underlying the PIP is a behavioural-cognitive approach to provide caregivers with education, skills to manage troublesome behaviors, social support, cognitive strategies for reframing negative emotional responses, and strategies for enhancing healthy behaviors and managing stress. The PIP was administered over 12 weekly group sessions lasting 90–120 mins each. To avoid fatigue or inattention there was a time-break of 15 mins at the middle of each session.
On the PIP sessions the caregiver received standardized information about the clinical course of schizophrenia and was trained on cognitive and behavioural skills. These included general caregiving abilities, communication skills, the ability to seek and enjoy pleasant events, to seek support, as well as relaxation techniques. The PIP required active participation from caregivers (i.e. role playing, applying new skills to conflict, etcetera). It applied cognitive-behavioural techniques focused on identifying and challenging negative beliefs and developing a new style to deal with caregiving demands. All sessions had the same formal structure:
• an introduction to review the progress of the homework tasks;
• information about the topic to be deal with;
• exercises to practice the new knowledge or skills. The PIP was applied by mental health professionals (psychologist or psychiatrist) trained in the program by the same researchers who developed it. We provided a manual for the therapist and a manual for the caregiver to follow and apply the PIP throughout the trial. The whole intervention is available online (http://www.fundacion-iip.org/IIP/). Table 1 presents the contents of the PIP by session.
Table 1 Contents of the Psychoeducational Intervention Program (PIP).
2.4 Outcome assessment
The trial included three evaluations conducted at visit #1 (baseline), visit #2 (postintervention, ∼ 4 months since trial inception), and visit #3 (follow-up, ∼ 8 months since trial inception). All outcomes were based on self-reported scales applied and assessed by a researcher blind to intervention allocation.
2.5 Primary outcome measures
Change scores since baseline to postintervention endpoint and follow-up in the caregiver burden assessed by the Zarit Burden Interview (ZBI) [Reference Zarit, Reever and Bach-Peterson5] and the Involvement Evaluation Questionnaire (IEQ) [Reference van Wijngaarden, Schene, Koeter, Vázquez-Barquero, Knudsen and Lasalvia15]. The ZBI includes 22 statements recorded in a 0–4 Likert scale (total score range 0 to 88), that rates the subjective component of burden. Although it has been mainly used in dementia rather than in schizophrenia caregivers [Reference Gonçalves-Pereira and Zarit16], we thought the ZBI was an appropriate outcome assessment [Reference Awad and Voruganti4]. Its sensibility to change has been reported in dementia [Reference Chien and Lee17] but also in schizophrenia caregivers [Reference Navidian, Kermansaravi and Rigi18,Reference Tanrıverdi and Ekinci19]. The ZBI has been translated and validated in Spanish [Reference Martin-Carrasco, Otermin, Pérez-Camo, Pujol, Agüera and Martín20] and Portuguese [Reference Gonçalves-Pereira, Carmo, Da-Silva, Papoila, Mateos and Zarit21]. The IEQ is now recognized as one of the leading caregiving measures in severe mental illness [Reference van Wijngaarden, Schene, Koeter, Becker, Knapp and Knudsen9]. It includes a 31-item core module questionnaire recorded in a 0–4 Likert scale that rates the consequences of caregiving experienced in the previous 4 weeks, including the negative impact on caregivers. Beyond its total score (computed from 27 of the 31 items), the IEQ includes four subscales: worrying (6 items), urging (8 items), tension (9 items) and supervision (6 items) [Reference van Wijngaarden, Schene, Koeter, Becker, Knapp and Knudsen9,Reference Schene, van Wijngaarden and Koeter22]. For both the ZBI and the IEQ, higher scores mean higher burden, thus negative score changes mean better outcomes. The IEQ has been translated and validated in Spanish [Reference van Wijngaarden, Schene, Koeter, Vázquez-Barquero, Knudsen and Lasalvia15] and Portuguese [Reference Gonçalves-Pereira, van Wijngaarden, Xavier, Papoila, Caldas-de-Almeida and Schene23].
2.6 Secondary outcome measures
Change scores since baseline to postintervention endpoint and follow-up on the caregiver mental health rated by the General Health Questionnaire, 28 items (GHQ-28) [Reference Goldberg and Hillier24], and the Center for Epidemiologic Studies Depression Scale (CES-D) [Reference Radloff25]. The GHQ-28 includes 4 subscales with 7-item each. Items present a 0–3 Likert scale giving a total subscale range from 0 to 21, and a total score range of 0 to 84. Higher score means higher level of psychological distress, thus negative score changes mean better outcomes. The underlying domains for the subscales are somatic symptoms, anxiety and insomnia, social dysfunction, and severe depression. The GHQ-28 has been validated in Spanish [Reference Lobo, Pérez-Echeverría and Artal26] and Portuguese [Reference Pais-Ribeiro and Antunes27]. The CES-D is a 20-item questionnaire that rates depressive feelings and related behaviours during the past week. Items present a 0–3 Likert scale. Higher score means higher level of depressive symptoms, thus negative score changes mean better outcomes. There are Spanish and Portuguese versions of CES-D [Reference Pérez-Sola, Puigdemont, Pérez-Blanco, Figueres and Alvarez28,Reference Gonçalves and Fagulha29].
2.7 Sample size
We assumed the comparison between groups would present a moderate effect size favouring the PIP over the control group in the ZBI scale (standardised mean difference = 0.40). With such estimate and a baseline ZBI score of 55 with SD of 15, 200 caregivers randomized in 1:1 ratio would be needed to attain 85% power with α level of 5%.
2.8 Randomization
The randomization was done centrally. The sequence generation for each research site was obtained by block randomisation using block sizes of 1 to 4. The R package “blockrand” was used [30]. None of the site investigators participated or had access to the randomization process. The randomisation sequence was known only by the investigator responsible for developing the PIP. The investigator who applied and assessed the caregiver self-reported outcomes at visits #1 to #3 was blind to the intervention allocation throughout the trial length.
2.9 Statistical methods
Means and SDs describe continuous variables. Frequencies and percentages describe categorical variables. Main results were analyzed by between-group differences in the change scores since baseline at visits #2 and #3 for the primary and secondary outcomes. Two analyses were performed. A complete case analyses (CC) that included caregivers providing full information at the corresponding times. Results are reported by mean differences, SDs and/or 95% confidence intervals (CI), and standardised effect sizes (SMD). We used the usual Cohen's cut-off points to interpret SMD estimates: values ∼ 0.2 for a small effect, values ∼ 0.5 for a medium effect, and values ∼ 0.8 for a large effect [Reference Cohen31]. To allow for the attrition rates throughout the trial length, we also analysed the data using a mixed linear model for repeated measures (MLM) assuming missing at random (MAR) at visits #2 and #3 [Reference Pinheiro and Bates32]. We assessed the effect of the intervention by testing the interaction term of intervention by visit. We compared the full model including the main factors (intervention, visit) and their interaction with the nested and reduced model excluding the interaction.
In addition to the main analysis, a subgroup analysis within the experimental group was conducted to find clinical and sociodemographic variables associated to the reduction on the caregiver burden. The a priori selected variables were the ZBI and GHQ-28 scores at baseline; the number of PIP sessions attended by the caregivers; the diagnosis of the person cared for, the gender, age, educational level, and marital status of the caregiver; the time the caregiver was providing care as well as the weekly hours dedicated; and the external help provided. After simple and multiple regression analysis, a backward stepwise linear regression analysis was performed (P-value to retain of 0.10) to obtain the most parsimonious model able to explain the variability in the change of ZBI scores since baseline to end of trial at 8 months. We run the analyses with Stata v13 (StataCorp, College Station, TX, 2013) and R v3.0.2 (R Foundation for Statistical Computing, Vienna, Austria, 2013).
3 Results
3.1 Recruitment and losses to follow-up
The trial recruited 223 caregivers (109 randomized to PIP and 114 to control condition) from March to May 2012. The last visit took place along the period September 2012–January 2013. Fig. 1 shows the trial flowchart. Data from 21 research sites from Spain and 2 from Portugal were included in the analyses. The median recruitment by research site was 9 caregivers (range 5 to 19).
Fig. 1 Trial flowchart.
The mean elapsed time between baseline and visit #2 was 4.5 months (SD = 1.2). The mean elapsed time between baseline and visit #3 was 8.6 months (SD = 1.3). In the PIP group, 21 caregivers (19.3%) were lost to follow-up at visit #2. The corresponding figure in the control group was 11 (9.6%). The difference was not significant (Fisher exact test, P = 0.39). At visit #3, 4 additional caregivers in the PIP group were lost to follow-up (4.5%). The corresponding figure in the control group was 5 (4.8%). The difference was not significant (Fisher exact test, P = 0.43).
The patients being cared for were predominantly male (71 [65%] and 89 [78%] in the PIP and control arm respectively), and had a mean age of 38.7 years (SD = 11.1) in the PIP group and 39.3 years (SD = 9.1) in the control group. Most patients presented a diagnosis of schizophrenia (92 patients [84%] in the PIP group and 100 patients [88%] in the control group), with 17 patients (16%) in the PIP group, and 14 patients (12%) in the control group with a diagnosis of schizoaffective disorder. Table 2 presents the baseline characteristics of the caregivers by intervention. Overall, caregivers were predominantly married women caring for their child, with a mean age of 60 years, had a low to medium educational level, and presented a mean caring exposure of 15 years. The current caring load was 5 h per week and half the recruited carers had external help.
Table 2 Sociodemographic and baseline clinical data for caregivers.
ZBI: Zarit Burden Interview; IEQ: Involvement evaluation Questionnaire; CES-D: Center for Epidemiologic Studies-Depression Scale; GHQ-28: General Health Questionnaire-28 items.
3.2 Primary outcomes
Table 3 shows the ZBI and the IEQ differences among interventions through time. The CC analysis for the ZBI showed a significant effect favouring the PIP with a moderate effect size at 4 and 8 months since trial inception (SMD = −0.35 and −0.40). The MLM analysis assuming MAR showed a significant interaction of intervention arm by time (P = 0.006) in favour of the PIP. The CC analysis for the IEQ showed a non-significant effect favouring the PIP with a small effect size (SMD = −0.23). The MLM analysis did not show a significant interaction of intervention arm by time (P = 0.12). Of the IEQ subscales, the tension domain showed the bigger effect at 4 and 8 months since trial inception (SMD = −0.26 and −0.25) without attaining significance at the 5% level (MLM analysis, P = 0.08). The MLM analyses for the rest of IEQ subscales do not show a significant difference of efficacy over time by intervention arm (IEQ supervision, P = 0.33; IEQ worries, P = 0.27; IEQ motivation, P = 0.42).
Table 3 Efficacy outcomes (change scores from baseline). Complete case analyses and mixed linear model for repeated measures.
PIP: Psychoeducational Intervention Program; SMD: Standardized Mean Difference; IEQ: Involvement Evaluation Questionnaire; CES-D: Center for Epidemiologic Studies–Depression Scale; GHQ-28: General Health Questionnaire Scaled (28 items).
a P-values for the interaction of intervention by time from the mixed linear mixed model for repeated measures.
3.3 Secondary outcomes
Table 3 also shows the CES-D and GHQ-28 differences among interventions. For the CES-D the CC analysis showed a significant effect favouring the PIP with a small size at 4 and 8 months (SMD = −0.34 and −0.21 respectively). The MLM analysis showed a significant interaction of intervention arm by time (P = 0.023) in favour of the PIP. For the GHQ-28 the CC analysis showed a significant effect for its total score favouring the PIP with a small size at 4 but not at 8 months (SMD = −0.30 and −0.18 respectively). The MLM analysis showed a non-significant interaction of intervention arm by time (P = 0.11). Most of the GHQ-28 subscales did not show a significant interaction of intervention arm by time (somatic symptoms P = 0.19; anxiety & insomnia P = 0.17; severe depression P = 0.67). On the contrary the social dysfunction subscale showed a significant interaction favouring the PIP (P = 0.005). However it seems to be mainly explained by the moderate effect size attained at 4 months (SMD = −0.46) that disappeared at 8 months (SMD = −0.11). None of the patients required inpatient or residential care throughout the trial length.
3.4 Subgroup analysis within the experimental group
Table 4 shows the results of the linear regression analyses performed. Only 2 variables, the ZBI score at baseline and the provision of external help (professional support or economical benefits) are significantly associated with the improvement in ZBI scores at end of trial. The ZBI at baseline is positively associated with the reduction on burden what means that those caregivers experiencing more burden at baseline will be also those who will improve more by the end of trial. Conversely, the provision of external help is negatively associated with burden reduction. Those caregivers with external help present 5 points less in the ZBI change scores than caregivers without external support (95% CI: 0.25 to 10 points less).
Table 4 Associations among change scores since baseline of the Zarit Burden Inventory and baseline clinical and sociodemographic variables. Results from linear regressions.
ZBI: Zarit Burden Inventory; GHQ-28: General Health Questionnaire-28 items.
* P-value < 0.05; ** P-value < 0.01; *** P-value < 0.001.
4 Discussion
The main results of this study, those related with primary outcomes, support a moderate efficacy of a PIP administered in a group format to reduce the subjective burden associated with caregiving tasks in caregivers of patients with schizophrenia or schizoaffective disorder. The ZBI reduction at postintervention presents a moderate effect in favour of the intervention group (SMD: −0.35; 95% CI: −0.64 to −0.06) and the improvement is maintained at follow-up (SMD: −0.40; 95% CI: −0.70 to −0.10), with a significant interaction of treatment by time (P = 0.006). The same trend of caregiver burden reduction over time was found with the IEQ tension domain that overlaps with the burden domain of the ZBI (SMD at end of trial: −0.26; 95% CI: −0.55 to 0−03; SMD at follow-up: −0.25; 95% CI: −0.55 to 0.05). However, this trend did not attain statistical significance (P = 0.118). Part of the discrepancy observed between the results of both scales could be explained by the different constructs they measure. Whereas the ZBI focus is on the perceived and thus subjective component of burden, the IEQ rates also objective and behavioural domains of burden [Reference Vella and Pai33]. Accordingly, the efficacy of the PIP intervention might be explained by reducing the subjective component of burden.
As far as secondary outcomes are concerned, our results also suggest that the PIP intervention is useful to reduce depressive symptoms over time as measured by the CES-D (P = 0.023), but not according to the GHQ-28 (P = 0.109). As before, this discrepancy could be explained because both scales measure different depression domains. Whereas the GHQ depression items assess severe and likely unchangeable symptoms, the CES-D items include other dominions more changeable with the PIP training (i.e. motor and physiological symptoms).
Focusing on the caregivers who had the PIP intervention, those more likely to reduce the burden would be the ones with higher levels of burden at the beginning of the intervention. On the other hand, caregivers with external help do not seem to reduce the burden as much as caregivers who had no access to external resources (mainly professional support by paid caregivers, or economic benefits for caring). Probably, they represent caregiver clusters with different demands on caring related with severity of the disease.
4.1 Limitations and strengths of the research
Our trial present several limitations that could overestimate the efficacy of the PIP intervention. According to the risk of bias, the most important relates to the blinding and concealment of subjects to interventions, and also to ascertainment bias throughout the trial. In studies like the EDUCA-III with interventions that are hard, if not impossible, to mask and blind to both the patient and professionals, selection and performance bias cannot be excluded. In this trial, ascertainment bias was managed by blinding assessment evaluators. Also, in this trial selection bias seems unlikely since no violations to the random assignment were detected. However, we cannot guarantee that information cross-contamination between groups did not happened over the trial, and that knowing the assignment to intervention or control, has not biased the self-perception of caregivers to the questions posed in the assessment scales. Thus performance bias cannot be ruled out completely and, if present, could have lead to an overestimation of the results. On the other hand, attrition bias seems unlike since there are not recorded different dropouts and causes of attrition between-groups, either at end of trial, or at follow-up.
Even if we cannot rule out the possibility of overestimating the efficacy of the PIP assessed in this trial because of the risk of bias previously discussed, our results on the moderate positive effect of the PIP seem to agree with previous studies. We have found six studies with similar design (randomized assignment to interventions), intervention (psychoeducational intervention including both stress management and coping), and aims (efficacy trials) [Reference Navidian, Kermansaravi and Rigi18,Reference Chien, Chan and Thompson34–Reference Sharif, Shaygan and Mani38] and included in a recent systematic review and meta-analysis [Reference Yesufu-Udechuku, Harrison, Mayo-Wilson, Young, Woodhams and Shiers39]. We have combined the primary outcomes of those studies, and found that our main result on the postintervention burden efficacy of the PIP is smaller than the weighted combination result (−0.35 versus −0.78), but, nevertheless, fits well within the 95% CI of the pooled studies (−1.37 to −0.20). Therefore, we think our overall results support the effectiveness of a psychoeducational intervention to reduce caregiver burden in schizophrenia. However we need also to stress that the effects so far reported for our primary outcomes are moderate according to the effect sizes obtained.
Because of being a multicentre trial including research sites from two countries (Portugal and Spain), the findings of our trial could present better generalisability, and possibly external validity, than single centre studies. Current guidelines on schizophrenia treatment, stress the need for family interventions with goals aimed at the adoption of adaptive copying styles (how to handle psychological reactions to the experience of the illness in a relative, how to improve or acquire the abilities to manage stress and communicate with the other, how to manage the appropriate health resources over the illness periods) [Reference Kuipers, Yesufu-Udechuku, Taylor and Kendall40]. In this sense, the PIP reported in this trial fits such requirements and presents a moderate effect size with clinical relevance.
5 Conclusions
An analysis of 223 informal caregivers of patients with schizophrenia or schizoaffective disorder showed the efficacy of a PIP administered in a group format to reduce the subjective burden and depression associated with caregiving tasks. These results were maintained at follow-up at 8 months. Caregivers presenting higher levels of burden at the beginning of the intervention and those who do not have access to external help were more likely to improve in the burden as consequence of the PIP intervention.
Disclosure of interest
The authors declare that they have no competing interest.
Acknowledgements
The EDUCA-III trial was funded by a research grant from Instituto de Salud Carlos III, Spain (PI10/01049). The role of the funding source was limited to economic support. It was not involved in the study process, preparation or submission of the manuscript.
The EDUCA-III research sites and the researchers involved are: Jesús Moraza, Arkaitz De La Cruz, Vicente Hueso (Hospital de Día y CRPS Beasain- Hospital Aita Menni, Mondragón); Asunción Lizarazu, María Blanca Fernández de Corres, Paz Lander, Nuria Grivé, Isabel Alonso, Marixa Larreina, Elvira Castellano (Hospital Psiquiátrico de Álava, Vitoria); Rosario Beguiristain, Pablo Malo (CSM Bombero Etxaniz, Bilbao); Rocío del Pino, Zita Blanco, Janire Garay (Universidad de Deusto); Juan Carlos Irurzun, Karmele Iribar, Karmele Zarraga (CSM Donostia Amara, San Sebastián); Marta Arrieta, Rosario Bengochea, Silvia Pérez, Mariola Palacios (CRPS Santander y CRPS Torrelavega- Centro Hospitalario Padre Menni); Luis Alberto Cuellar, Rebeca López (Centro Hospitalario Benito Menni, Valladolid); Mireia González, Mireia Segarra (Hospital Sagrat Cor, Martorell); Mónica Guasch, Inma Esteve (Hospital Marè de Deu de La Mercé, Barcelona); Jaime Grácio, Susana Pestana, Filipa Nunes (Clínica Psiquiátrica de São José, Lisboa, Portugal); Catarina Vidigal, Rita Ribeiro (Casa de Saúde da Idanha, Belas, Portugal); Patrícia Godinho, Mariana Gil (Casa de Saúde do Bom Jesus, Braga, Portugal); María Carmen Hurtado, María Nieves Tapiador, Ana Carolina Martínez (CD -EASC Villaverde, Madrid); Manuela Guimón, Raúl González, José María Pinedo, Verónica Robles, Marta Mora, Paola Fernández (CD-EASC-CRPS-CRL Vallecas, Madrid); Rocío Fernández, Carolina Mogollón (CRPS Badajoz); Ana Fuentes, Beatriz Rodríguez, María Mora (CD San Miguel -EASC Salamanca- EASC Chamartín, Madrid); Urbano Barrientos, Carlos Rebolleda, Eva Ojalvo, Lourdes Soladana (CRPS-CD-EASC Aranjuez, Madrid); Laura Romero, Roberto Martín, María Amores, Vanesa Rodríguez, Sara González (CRPS-CD-EASC Retiro, Madrid); María Ángeles Polo, Virginia López (Centro Inicia, Santander); Oriol Imbernon, Blanca Perisé, María Rosario Hernándo, Ana Belén Lardies (Benito Menni CASM, Sant Boi; Unidad Polivalente de Salud Mental de Hospitalet, L'Hospitalet de Llobregat).
Manuel Martin-Carrasco, MD PhD.
Affiliation: Psychiatric Research Institute.
Ma Josefa Recio Foundation, Bilbao, Spain.
Position: Director of the Psychiatric Research Institute (Maria Josefa Recio Foundation, Bilbao). Associate Professor of the Faculty of Medicine of the University of Navarra (Pamplona, Spain).
Research interests: Care of people with dementia and their relatives, severe mental illness, and psychometry.
Paola Fernández-Catalina, MPsychol.
Affiliation: Psychosocial Rehabilitación Program of Sisters Hospitalliers, Madrid, Spain.
Position: Director of residential and out-patient mental health services in Madrid.
Research interests: Psychotherapy interventions, psychosocial rehabilitation of patients with mental disease and with family intervention.
Ana I. Domínguez-Panchón, MPsychol.
Affiliation: Aita Menni Hospital, Gipuzkoa, Spain. Psychiatric Research Institute.
Ma Josefa Recio Foundation, Bilbao, Spain.
Position: Clinical psychologist at Aita Menni Hospital in Mondragón (Basque Country). Associate Professor at Deusto University.
Research interests: Psychometric assessment of caregiver burden and development of new psychoeducational program interventions.
M. Gonçalves-Pereira, MD, PhD.
Affiliation: Clínica Psiquiátrica de S. José (Sisters Hospitallers), Lisboa, Portugal. CEDOC, NOVA Medical School, Faculdade de Ciências Médicas, Universidade NOVA de Lisboa, Lisboa, Portugal.
Position: Professor of Medical Psychology at NOVA Medical School (Faculdade de Ciências Médicas, Universidade Nova de Lisboa).
Research interests: Geriatric psychiatry and family interventions.
Eduardo González-Fraile, MPsychol, PhD.
Affiliation: Psychiatric Research Institute.
Ma Josefa Recio Foundation, Bilbao, Spain. Associated Professor at International University of La Rioja (UNIR).
Position: PhD Psychologist.
Research interests: Psychoeducational interventions, informal caregiver, statistical methods, meta-analyses and risk of bias.
Paula Muñoz-Hermoso, BPsychol.
Affiliation: Clínica Psiquiatrica Padre Menni, Pamplona, Spain.
Position: Clinical psychologist at Clínica Psiquiatrica Padre Menni in Pamplona (Spain).
Research interests: Assessment and intervention of burden in caregivers. Mental health and family interventions.
Javier Ballesteros, MD, PhD.
Affiliation: University of the Basque Country, UPV/EHU. Psychiatric Research Institute.
Ma Josefa Recio Foundation, Bilbao, Spain.
Position: Professor in the Department of Neuroscience–Psychiatry, at the University of the Basque Country, UPV/EHU.
Research interests: Methodological and practical issues on evidence based psychiatry: efficacy of pharmacological and non-pharmacological interventions on mental health problems, assessment of outcomes with patient-related-outcomes, risk of bias, handling of likely publication biases, systematic reviews and meta-analysis.
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