Comparison of the Working Alliance in Blended Cognitive Behavioral Therapy and Treatment as Usual for Depression in Europe: Secondary Data Analysis of the E-COMPARED Randomized Controlled Trial.

BACKGROUND: Increasing interest has centered on the psychotherapeutic working alliance as a means of understanding clinical change in digital mental health interventions in recent years. However, little is understood about how and to what extent a digital mental health program can have an impact on the working alliance and clinical outcomes in a blended (therapist plus digital program) cognitive behavioral therapy (bCBT) intervention for depression. OBJECTIVE: This study aimed to test the difference in working alliance scores between bCBT and treatment as usual (TAU), examine the association between working alliance and depression severity scores in both arms, and test for an interaction between system usability and working alliance with regard to the association between working alliance and depression scores in bCBT at 3-month assessments. METHODS: We conducted a secondary data analysis of the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment versus Treatment-as-usual) trial, which compared bCBT with TAU across 9 European countries. Data were collected in primary care and specialized services between April 2015 and December 2017. Eligible participants aged 18 years or older and diagnosed with major depressive disorder were randomized to either bCBT (n=476) or TAU (n=467). bCBT consisted of 6-20 sessions of bCBT (involving face-to-face sessions with a therapist and an internet-based program). TAU consisted of usual care for depression. The main outcomes were scores of the working alliance (Working Alliance Inventory-Short Revised-Client [WAI-SR-C]) and depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]) at 3 months after randomization. Other variables included system usability scores (System Usability Scale-Client [SUS-C]) at 3 months and baseline demographic information. Data from baseline and 3-month assessments were analyzed using linear regression models that adjusted for a set of baseline variables. RESULTS: Of the 945 included participants, 644 (68.2%) were female, and the mean age was 38.96 years (IQR 38). bCBT was associated with higher composite WAI-SR-C scores compared to TAU (B=5.67, 95% CI 4.48-6.86). There was an inverse association between WAI-SR-C and PHQ-9 in bCBT (B=-0.12, 95% CI -0.17 to -0.06) and TAU (B=-0.06, 95% CI -0.11 to -0.02), in which as WAI-SR-C scores increased, PHQ-9 scores decreased. Finally, there was a significant interaction between SUS-C and WAI-SR-C with regard to an inverse association between higher WAI-SR-C scores and lower PHQ-9 scores in bCBT (b=-0.030, 95% CI -0.05 to -0.01; P=.005). CONCLUSIONS: To our knowledge, this is the first study to show that bCBT may enhance the client working alliance when compared to evidence-based routine care for depression that services reported offering. The working alliance in bCBT was also associated with clinical improvements that appear to be enhanced by good program usability. Our findings add further weight to the view that the addition of internet-delivered CBT to face-to-face CBT may positively augment experiences of the working alliance. TRIAL REGISTRATION: ClinicalTrials.gov NCT02542891, https://clinicaltrials.gov/study/NCT02542891; German Clinical Trials Register DRKS00006866, https://drks.de/search/en/trial/DRKS00006866; Netherlands Trials Register NTR4962, https://www.onderzoekmetmensen.nl/en/trial/25452; ClinicalTrials.Gov NCT02389660, https://clinicaltrials.gov/study/NCT02389660; ClinicalTrials.gov NCT02361684, https://clinicaltrials.gov/study/NCT02361684; ClinicalTrials.gov NCT02449447, https://clinicaltrials.gov/study/NCT02449447; ClinicalTrials.gov NCT02410616, https://clinicaltrials.gov/study/NCT02410616; ISRCTN Registry ISRCTN12388725, https://www.isrctn.com/ISRCTN12388725?q=ISRCTN12388725&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10; ClinicalTrials.gov NCT02796573, https://classic.clinicaltrials.gov/ct2/show/NCT02796573. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-016-1511-1.

Effect of Sleep Disturbance Symptoms on Treatment Outcome in Blended Cognitive Behavioral Therapy for Depression (E-COMPARED Study): Secondary Analysis.

BACKGROUND: Sleep disturbance symptoms are common in major depressive disorder (MDD) and have been found to hamper the treatment effect of conventional face-to-face psychological treatments such as cognitive behavioral therapy. To increase the dissemination of evidence-based treatment, blended cognitive behavioral therapy (bCBT) consisting of web-based and face-to-face treatment is on the rise for patients with MDD. To date, no study has examined whether sleep disturbance symptoms have an impact on bCBT treatment outcomes and whether it affects bCBT and treatment-as-usual (TAU) equally. OBJECTIVE: The objectives of this study are to investigate whether baseline sleep disturbance symptoms have an impact on treatment outcomes independent of treatment modality and whether sleep disturbance symptoms impact bCBT and TAU in routine care equally. METHODS: The study was based on data from the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment Versus Treatment-as-Usual) study, a 2-arm, multisite, parallel randomized controlled, noninferiority trial. A total of 943 outpatients with MDD were randomized to either bCBT (476/943, 50.5%) or TAU consisting of routine clinical MDD treatment (467/943, 49.5%). The primary outcome of this study was the change in depression symptom severity at the 12-month follow-up. The secondary outcomes were the change in depression symptom severity at the 3- and 6-month follow-up and MDD diagnoses at the 12-month follow-up, assessed using the Patient Health Questionnaire-9 and Mini-International Neuropsychiatric Interview, respectively. Mixed effects models were used to examine the association of sleep disturbance symptoms with treatment outcome and treatment modality over time. RESULTS: Of the 943 patients recruited for the study, 558 (59.2%) completed the 12-month follow-up assessment. In the total sample, baseline sleep disturbance symptoms did not significantly affect change in depressive symptom severity at the 12-month follow-up (ß=.16, 95% CI -0.04 to 0.36). However, baseline sleep disturbance symptoms were negatively associated with treatment outcome for bCBT (ß=.49, 95% CI 0.22-0.76) but not for TAU (ß=-.23, 95% CI -0.50 to 0.05) at the 12-month follow-up, even when adjusting for baseline depression symptom severity. The same result was seen for the effect of sleep disturbance symptoms on the presence of depression measured with Mini-International Neuropsychiatric Interview at the 12-month follow-up. However, for both treatment formats, baseline sleep disturbance symptoms were not associated with depression symptom severity at either the 3- (ß=.06, 95% CI -0.11 to 0.23) or 6-month (ß=.09, 95% CI -0.10 to 0.28) follow-up. CONCLUSIONS: Baseline sleep disturbance symptoms may have a negative impact on long-term treatment outcomes in bCBT for MDD. This effect was not observed for TAU. These findings suggest that special attention to sleep disturbance symptoms might be warranted when MDD is treated with bCBT. Future studies should investigate the effect of implementing modules specifically targeting sleep disturbance symptoms in bCBT for MDD to improve long-term prognosis.

Resilience as a predictor of quality of life in participants with borderline personality disorder before and after treatment.

BACKGROUND: Studies have suggested that psychotherapy improves the Quality of Life (QoL) of participants with Borderline Personality Disorder (BPD). However, there are no studies on the differential efficacy of treatments on the QoL of participants with BPD. Moreover, the relationship between QoL and resilience has rarely been studied in participants with BPD. OBJECTIVES: a) to examine whether people with BPD have worse QoL than the non-clinical population; b) to examine whether there are statistically significant differences between Dialectical Behavioural Therapy (DBT), Systems Training for Emotional Predictability and Problem Solving (STEPPS), or Cognitive Behavioural Therapy-Treatment at Usual (CBT-TAU) in the improvement of QoL; c) to examine whether participants show clinically significant improvements in QoL after treatment; d) to analyse whether resilience is associated with QoL before and after the BPD treatment; e) to analyse whether resilience is a predictor of QoL at pre-treatment and posttreatment. METHOD: The sample comprised 403 participants (n = 202 participants diagnosed with BPD and n = 201 non-clinical). Participants filled out the Quality of Life Index, Resilience Scale, and Beck Depression Inventory. The clinical participants received one of these possible treatments, DBT, STEPPS, or CBT-TAU. MANOVA and regression analyses were performed. RESULTS: a) participants diagnosed with BPD had statistically significant lower resilience than the non-clinical population; b) all three forms of psychotherapy statistically improved QoL, but there were no statistically significant differences between DBT, STEPPS, and CBT-TAU in the improvement of QoL; c) participants did not show clinically significant improvements in QoL after treatment; d) resilience was associated with QoL before and after treatment; and e) resilience was a predictor of QoL before and after treatment. CONCLUSION: It is necessary to assess QoL and Resilience in studies on psychotherapy with BPD patients.

Theoretical adequacy, methodological quality and efficacy of online interventions targeting resilience: a systematic review and meta-analysis.

BACKGROUND: There is a growing interest in the promotion of mental health, and concepts as resilience are re-emerging and taking relevance. In addition, Information and Communication Technologies can provide potential benefits in the field of mental health, and the treatment of mental disorders in particular. This study aims to synthesize the evidence of internet-based resilience interventions, analyzing the theoretical adequacy, methodological quality and efficacy. METHODS: A systematic search was performed. The eligibility criteria stated for this article were: randomized controlled trials targeted at adults or adolescents and including any psychological intervention focussing on resilience in its rationale or design. Studies with direct (e.g. resilience scales) and proximal resilience measures (e.g. scales on well-being) were included. Risk of bias was assessed for each trial using Cochrane's Collaboration Tool. Two reviewers worked independently in order to identify potential articles. A total of 11 articles were selected. A random-effects pooling model using the Hartung-Knapp-Sidik-Jonkman method based on direct and proximal resilience measures at post-test was used. RESULTS: The overall effects of online resilience training compared to control groups at post-test were not significant; the effect size concerning the improvement of resilience was g=0.12 (95% CI: -0.14 to 0.38). In addition, a potential association between the type of outcome and the effect size could be revealed. CONCLUSIONS: The results of the present meta-analysis showed that the overall effect of online resilience trainings was not significant. Nonetheless, a tendency for a higher benefit for resilience was found in the studies with a clear assessment theory, indicating some promising effects. REGISTRATION NUMBER: PROSPERO CRD42018083339.

Online interventions to prevent mental health problems implemented in school settings: the perspectives from key stakeholders in Austria and Spain.

BACKGROUND: Schools are key settings for delivering mental illness prevention in adolescents. Data on stakeholders' attitudes and factors relevant for the implementation of Internet-based prevention programmes are scarce. METHODS: Stakeholders in the school setting from Austria and Spain were consulted. Potential facilitators (e.g. teachers and school psychologists) completed an online questionnaire (N=50), policy makers (e.g. representatives of the ministry of education and health professional associations) participated in semi-structured interviews (N=9) and pupils (N=29, 14-19 years) participated in focus groups. Thematic analysis was used to identify experiences with, attitudes and needs towards Internet-based prevention programmes, underserved groups, as well as barriers and facilitators for reach, adoption, implementation and maintenance. RESULTS: Experiences with Internet-based prevention programmes were low across all stakeholder groups. Better reach of the target groups was seen as main advantage whereas lack of personal contact, privacy concerns, risk for misuse and potential stigmatization when implemented during school hours were regarded as disadvantages. Relevant needs towards Internet-based programmes involved attributes of the development process, general requirements for safety and performance, presentation of content, media/tools and contact options of online programmes. Positive attitudes of school staff, low effort for schools and compatibility to schools' curriculum were seen as key factors for successful adoption and implementation. A sound implementation of the programme in the school routine and continued improvement could facilitate maintenance of online prevention initiatives in schools. CONCLUSIONS: Attitudes towards Internet-based mental illness prevention programmes in school settings are positive across all stakeholder groups. However, especially safety concerns have to be considered.

Online prevention programmes for university students: stakeholder perspectives from six European countries.

BACKGROUND: Students beginning university are at a heightened risk for developing mental health disorders. Online prevention and early intervention programmes targeting mental health have the potential to reduce this risk, however, previous research has shown uptake to be rather poor. Understanding university stakeholders' (e.g. governing level and delivery staff [DS] and students) views and attitudes towards such online prevention programmes could help with their development, implementation and dissemination within university settings. METHODS: Semi-structured interviews, focus groups and online surveys were completed with staff at a governing level, university students and DS (i.e. student health or teaching staff) from six European countries. They were asked about their experiences with, and needs and attitudes towards, online prevention programmes, as well as the factors that influence the translation of these programmes into real-world settings. Results were analyzed using thematic analysis. RESULTS: Participating stakeholders knew little about online prevention programmes for university settings; however, they viewed them as acceptable. The main themes to emerge were the basic conditions and content of the programmes, the awareness and engagement, the resources needed, the usability and the responsibility and ongoing efforts to increase reach. CONCLUSIONS: Overall, although these stakeholders had little knowledge about online prevention programmes, they were open to the idea of introducing them. They could see the potential benefits that these programmes might bring to a university setting as a whole and the individual students and staff members.

Negative and Positive Affect Regulation in a Transdiagnostic Internet-Based Protocol for Emotional Disorders: Randomized Controlled Trial.

BACKGROUND: Emotional disorders (EDs) are among the most prevalent mental disorders. Existing evidence-based psychological treatments are not sufficient to reduce the disease burden of mental disorders. It is therefore essential to implement innovative solutions to achieve a successful dissemination of psychological treatment protocols, and in this regard, the use of information and communication technologies such as the internet can be very useful. Furthermore, the literature suggests that not everyone with an ED receives the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which attempts to address the underlying processes common to EDs. Most of these transdiagnostic interventions focus primarily on downregulating negative affectivity (NA), and less attention has been paid to strengths and the upregulation of positive affectivity, despite its importance for well-being and mental health. OBJECTIVE: This study aims to evaluate the efficacy of a transdiagnostic internet-based treatment for EDs in a community sample. METHODS: A 3-armed randomized controlled trial was conducted. A total of 216 participants were randomly assigned to a transdiagnostic internet-based protocol (TIBP), a TIBP+ positive affect (PA) component, or a waiting list (WL) control group. The treatment protocol contained core components mainly addressed to downregulate NA (ie, present-focused emotional awareness and acceptance, cognitive flexibility, behavioral and emotional avoidance patterns, and interoceptive and situational exposure) as well as a PA regulation component to promote psychological strengths and enhance well-being. Data on depression, anxiety, quality of life, neuroticism and extraversion, and PA/NA before and after treatment were analyzed. Expectations and opinions of treatment were also analyzed. RESULTS: Within-group comparisons indicated significant pre-post reductions in the two experimental conditions. In the TIBP+PA condition, the effect sizes were large for all primary outcomes (d=1.42, Beck Depression Inventory [BDI-II]; d=0.91, Beck Anxiety Inventory [BAI]; d=1.27, Positive and Negative Affect Schedule-Positive [PANAS-P]; d=1.26, Positive and Negative Affect Schedule-Negative [PANAS-N]), whereas the TIBP condition yielded large effect sizes for BDI-II (d=1.19) and PANAS-N (d=1.28) and medium effect sizes for BAI (d=0.63) and PANAS-P (d=0.69). Between-group comparisons revealed that participants who received one of the two active treatments scored better at posttreatment than WL participants. Although there were no statistically significant differences between the two intervention groups on the PA measure, effect sizes were consistently larger in the TIBP+PA condition than in the standard transdiagnostic protocol. CONCLUSIONS: Overall, the findings indicate that EDs can be effectively treated with a transdiagnostic intervention via the internet, as significant improvements in depression, anxiety, and quality of life measures were observed. Regarding PA measures, promising effects were found, but more research is needed to study the role of PA as a therapeutic component. TRIAL REGISTRATION: ClinicalTrials.gov NCT02578758; https://clinicaltrials.gov/ct2/show/NCT02578758. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-017-1297-z.

Integrating virtual realities and psychotherapy: SWOT analysis on VR and MR based treatments of anxiety and stress-related disorders.

The use of virtual reality (VR) and mixed reality (MR) technology in clinical psychology is growing. Efficacious VR-based treatments for a variety of disorders have been developed. However, the field of technology-assisted psychotherapy is constantly changing with the advancement in technology. Factors such as interdisciplinary collaboration, consumer familiarity and adoption of VR products, and progress in clinical science all need to be taken into consideration when integrating virtual technologies into psychotherapies. We aim to present an overview of current expert opinions on the use of virtual technologies in the treatment of anxiety and stress-related disorders. An anonymous survey was distributed to a select group of researchers and clinicians, using an analytic framework known as Strengths, Weaknesses, Opportunities, and Threats (SWOT). Overall, the respondents had an optimistic outlook regarding the current use as well as future development and implementation of technology-assisted interventions. VR and MR psychotherapies offer distinct advantages that can overcome shortcomings associated with traditional therapy. The respondents acknowledged and discussed current limitations of VR and MR psychotherapies. They recommended consolidation of existing knowledge and encouraged standardisation in both theory and practice. Continued research is needed to leverage the strengths of VR and MR to develop better treatments.Abbreviations: AR: Augmented Reality; MR: Mixed Reality; RCT: Randomised Controlled Trial; SWOT: Strengths, Weaknesses, Opportunities, and Threats; VR: Virtual Reality; VR-EBT: Virtual Reality Exposure-Based Therapy.

Interventions for Family Members and Carers of Patients with Borderline Personality Disorder: A Systematic Review.

Carers of patients with borderline personality disorder (BPD) experience high levels of distress. Several studies have been carried out on interventions designed to decrease their burden. However, the evidence from these studies has not been summarized. The objective of this work is to explore the clinical utility of interventions developed for family members of patients with BPD. A systematic review was conducted following the PRISMA guidelines (registration number CRD42018107318), including psychological interventions focused on relatives of patients with BPD. The following databases were used: PsycINFO, PubMed, EBSCOhost, and Web of Science. Two independent researchers reviewed the studies to determine whether the eligibility criteria were met. A total of 2,303 abstracts were identified. After duplicates had been removed, 1,746 studies were screened. Finally, 433 full-text articles were reviewed, yielding 11 studies that satisfied the inclusion criteria. Results show that these interventions with different clinical formats and settings are effective. The quality of the included studies varies, and the empirical support for these programs is still preliminary. The results help to establish a general framework for interventions specifically developed for family members of patients with BPD, but additional efforts should be made to improve the methodological quality of this field of research and more solidly determine the utility of these interventions. Given the paucity of data so far, this information may open up new lines of research to improve the effectiveness of future programs for carers of patients with BPD and help to reduce their burden.

Los familiares de pacientes con trastorno límite de la personalidad (TLP) experimentan elevados niveles de estrés. Se han llevado a cabo varios estudios sobre intervenciones diseñadas para disminuir su carga. Sin embargo, los datos obtenidos de estos estudios no se han expuesto. El objetivo de este trabajo es explorar la utilidad clínica de las intervenciones desarrolladas para los familiares de los pacientes con TLP. Se realizó una revisión sistemática siguiendo las directrices de PRISMA (número de registro CRD42018107318), que incluyó intervenciones psicológicas centradas en los familiares de los pacientes con TLP. Se utilizaron las siguientes bases de datos: PsycINFO, PubMed, EBSCOhost, y Web of Science. Dos investigadores independientes revisaron los estudios para determinar si se cumplían los criterios de elegibilidad. Se identificaron un total de 2303 resúmenes. Después de extraer los duplicados, se evaluaron 1746 estudios. Finalmente, se revisaron 433 artículos de texto completo, lo que dio lugar a 11 estudios que cumplían los criterios de inclusión. Los resultados demuestran que estas intervenciones con diferentes formatos y orientaciones clínicas son eficaces. La calidad de los estudios incluidos varía, y el apoyo empírico para estos programas es todavía preliminar. Los resultados contribuyen a establecer un marco general para las intervenciones desarrolladas específicamente para los familiares de los pacientes con TLP, pero se deberían realizar esfuerzos adicionales para mejorar la calidad metodológica de este campo de investigación y determinar con mayor solidez la utilidad de estas intervenciones. Dada la escasez de datos hasta el momento, esta información puede abrir nuevas líneas de investigación para mejorar la eficacia de los futuros programas para los cuidadores de los pacientes con TLP y ayudar a reducir su carga.

Virtual reality for the enhancement of emotion regulation.

In recent decades, a growing body of literature has focused on emotion regulation (ER), which refers to the ability to implement strategies in order to modulate emotional responses and reach desirable goals. To date, impaired ER (i.e., emotion dysregulation) has been identified as a transdiagnostic factor across a wide range of psychopathological conditions, which shows the importance of improving patients' ability to regulate negative and positive emotions in clinical practice. In addition to the increasing evidence showing its efficacy in the treatment of several clinical conditions, virtual reality (VR) has recently emerged as a potentially powerful tool for enhancing ER, thus breaking new ground in the development of cutting-edge transdiagnostic interventions. In the present narrative review, we will provide an overview of the existing evidence about VR-based interventions in the field of ER, emphasizing the promising findings and the barriers that still have to be addressed. To this aim, the available VR-based literature will be analysed in relation to four categories of ER strategies: situational strategies, attentional strategies, cognitive strategies, and response modulation strategies. Furthermore, new emerging fields of research targeting innovative aspects of ER will be highlighted, including the use of VR to promote positive emotions and interpersonal ER skills. Besides, its cost-effectiveness will be discussed, taking into account the costs for both developers (e.g., clinicians and researchers) and end-users. Finally, future directions in this promising field of research will be outlined.

A guided Internet-delivered intervention for adjustment disorders: A randomized controlled trial.

Evidence of self-help interventions for adjustment disorder (AjD) is limited. This study aims at testing in a randomized controlled trial (RCT) the effectiveness of a disorder-specific, Internet-delivered cognitive-behavioural therapy (ICBT) intervention for AjD. Participants were randomly allocated to either an ICBT with brief weekly telephone support (n = 34) or a waiting list group (n = 34). Beck's inventories for depression and anxiety were used as primary outcomes. The secondary outcomes were AjD symptoms, post-traumatic growth, positive and negative affect, and quality of life. In all, 76.5% of the participants completed the intervention. Compared with the control group, participants in the intervention condition showed significantly greater improvement in all outcomes (Cohen's d ranged from 0.54 to 1.21) except in anxiety symptoms measured by Beck Anxiety Inventory (d = 0.27). Only ICBT group showed a significant improvement in post-traumatic growth, positive and negative affect, and quality of life. The number of cases that achieved clinically meaningful change in all outcome measures was also higher in the ICBT group. All therapeutic gains were maintained at 3-, 6- and 12-month follow-ups. The current study provides evidence on the effectiveness of ICBT interventions to reduce the impact of AjD. Results suggest that brief self-help intervention with minimal therapist support is more effective than the mere passage of time in reducing the distress symptoms associated to the disorder and also can confer additional benefits.

Implementation of a positive psychology group program in an inpatient eating disorders service: a pilot study.

CONTEXT: Eating disorders (ED) are very difficult conditions to treat. Therefore, interventions in this field are shifting their main target towards the disorder's impact in quality of life, rather than ED symptomatology in itself. In this sense, a focus in the promotion of positive emotions and well-being is emerging to ameliorate the harmful effects caused by ED. However, evidence of the potential benefits of this type of interventions is still scarce. PURPOSE: This study introduces a 4-week positive psychology group program specifically designed for ED patients' needs and to present data about feasibility and acceptability. METHOD: Seven female inpatients of an eating disorder service aged from 13 to 38 years old attended the group. Measures of affect and optimistic thinking were taken before the program and after each session. RESULTS: The program was very well rated by participants, and there was no attrition. Furthermore, possible benefits were found in terms of optimistic thinking at the end of the group program, and these benefits were noticeable, but non-significant, in the case of affect. CONCLUSIONS: This study opens the door to conduct larger and controlled studies for testing interventions aimed at promoting positive emotions and well-being in ED populations. Thus, these interventions could support the efficacy of current treatments in order to improve patients' quality of life. LEVEL OF EVIDENCE: Level IV, multiple time series analysis, with the intervention.

Efficacy of "Family Connections", a program for relatives of people with borderline personality disorder, in the Spanish population: study protocol for a randomized controlled trial.

BACKGROUND: Patients with borderline personality disorder (BPD) experience significant affect regulation difficulties that cause serious consequences in their work, emotional, and social environments. This dysfunctional pattern also produces great suffering and a heavy burden on their relatives. Fortunately, some studies show that treatment of relatives of people with BPD begins to be important in the patients' recovery and in improving family dynamics. One of the treatments that has obtained the most empirical support is Family connections (FC). This 12-session program is an adaptation of different Dialectical Behavior Therapy strategies. To test the efficacy of FC, five uncontrolled clinical trials were conducted, with pre-post treatment and follow-up assessments. The results of these studies and subsequent replications showed an improvement in family attitudes and caregiver burnout. Our research team adapted FC for delivery in the Spanish population. We intend to test the efficacy of this program versus a treatment as usual condition. Moreover, we aim to test the efficacy of this program and study its effectiveness (in terms of participants' acceptance). This paper presents the study protocol. METHODS: The study is a randomized controlled trial. The participants will be recruited in a Personality Disorders Unit and randomly assigned to one of two treatment conditions: Family Connections group (FC) or Treatment As Usual (TAU). Primary outcome measures will be the BAS and FAD-GFS. Secondary outcomes will include DASS-21, FES, GS, and QLI. Participants' treatment acceptance and degree of satisfaction will also be measured. Participants will be assessed at pre-, post-treatment, and 6-month follow-up. Intention to treat and per protocol analyses will be performed. DISCUSSION: This is the first study on FC for relatives of people with borderline personality disorder (BPD) compared to an active condition (TAU), and this is the first time relatives' and patients' data will be analyzed. In addition, it is the first study to test the efficacy of the program in Spain. This intervention could contribute to improving the efficiency and effectiveness of current treatment programs for relatives of people with BPD, help to decrease burden, and improve the family connection. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04160871. Registered November 15th 2019.

Positive and Negative Affect Schedule (PANAS): psychometric properties of the online Spanish version in a clinical sample with emotional disorders.

BACKGROUND: The Positive and Negative Affect Schedule (PANAS) is the most widely and frequently used scale to assess positive and negative affect. The PANAS has been validated in several languages, and it has shown excellent psychometric properties in the general population and some clinical samples, such as forensic samples, substance users, and adult women with fibromyalgia. Nevertheless, the psychometric properties of the scale have not yet been examined in clinical samples with anxiety, depressive, and adjustment disorders. In addition, the proliferation of Internet-based treatments has led to the development of a wide range of assessments conducted online with digital versions of pen and paper self-report questionnaires. However, no validations have been carried out to analyze the psychometric properties of the online version of the PANAS. The present study investigates the psychometric properties of the online Spanish version of the PANAS in a clinical sample of individuals with emotional disorders. METHODS: The sample was composed of 595 Spanish adult volunteers with a diagnosis of depressive disorder (n = 237), anxiety disorder (n = 284), or adjustment disorder (n = 74). Factor structure, construct validity, internal consistency, and sensitivity to change were analyzed. RESULTS: Confirmatory factor analysis yielded a latent structure of two independent factors, consistent with previous validations of the instrument. The analyses showed adequate convergent and discriminant validity, good internal consistency as well as sensitivity to change. CONCLUSIONS: Overall, the results obtained in this study show that the online version of the PANAS has adequate psychometric properties for the assessment of positive and negative affect in a Spanish clinical population.

Efficacy of a self-applied online program to promote resilience and coping skills in university students in four Spanish-speaking countries: study protocol for a randomized controlled trial.

BACKGROUND: There is evidence of a high prevalence of depression and anxiety in university students. Therefore, college time is a key period where prevention of mental disorders through interventions that promote resilience and mental health can be relevant. Currently, there are interventions available, but these are insufficient for those who need them. Online interventions are tools that can facilitate global accessibility and are easy for young people to use. CORE (Cultivating Our Resilience) is a self-administered online program, based on Ryff's psychological well-being model, to promote resilience and coping skills in university students at risk of developing symptoms of depression or anxiety. The objective is to evaluate the effectiveness of this intervention protocol in comparison with an active control condition targeting healthy lifestyle, and a waiting list control condition. The study will be conducted in four populations of Spanish-speaking university students (Spain, Argentina, Colombia, and Mexico). METHODS: The study design is a randomized controlled trial (RCT). At least 324 university students will be randomly assigned to three conditions: 1) CORE, a 6-week training program to improve resilience; 2) HLP, a 6-week training to promote a healthy lifestyle; and 3) WL, waiting list control condition. The primary outcome measure will be the Connor-Davidson resilience scale. Additionally, measures of anxiety, depression, quality of life and socio-demographic variables (age, sex, incomes, marital status, among others) will be collected. Participants will be evaluated at pre-treatment, after each module, 6 weeks after allocation, and at 3-month follow-up. Intention-to-treat and per-protocol analyses will be performed. DISCUSSION: The results of this study will contribute to research on Internet-administered interventions and the implementation of a protocol that includes a series of components designed to improve resilience and coping skills, increase psychological well-being, and prevent depression and anxiety disorders in Spanish-speaking university students. In addition, avenues will be opened up for new research on the effectiveness of these interventions focused on the prevention and promotion of mental health in Spanish-speaking countries. TRIAL REGISTRATION: Registered at ClinicalTrials.gov NCT03903978 on April 2, 2019.

Effectiveness of a Transdiagnostic Guided Internet-Delivered Protocol for Emotional Disorders Versus Treatment as Usual in Specialized Care: Randomized Controlled Trial.

BACKGROUND: Anxiety disorders and depression (emotional disorders) are highly prevalent mental disorders. Extensive empirical evidence supports the efficacy of cognitive behavioral therapy (CBT) for the treatment of these disorders. However, there are still some barriers related to their dissemination and implementation, which make it difficult for patients to receive these treatments, especially in public health care settings where resources are limited. Recent advances in improving CBT dissemination encompass different perspectives. One is the transdiagnostic approach, which offers treatment protocols that can be used for a range of emotional disorders. Another approach is the use of the internet to reach a larger number of people who could benefit from CBT. OBJECTIVE: This study aimed to analyze the effectiveness and acceptability of a transdiagnostic internet-delivered protocol (EmotionRegulation) with human and automated guidance in patients from public specialized mental health care settings. METHODS: A 2-armed randomized controlled trial (RCT) was conducted to compare the effectiveness of EmotionRegulation with treatment as usual (TAU) in specialized mental health care. In all, 214 participants were randomly assigned to receive either EmotionRegulation (n=106) or TAU (n=108). Measurement assessments were conducted at pre- and postintervention and at a 3-month follow-up. RESULTS: The results revealed the superiority of EmotionRegulation over TAU on measures of depression (d=0.41), anxiety (d=0.35), and health-related quality of life (d=-0.45) at posttreatment, and these gains were maintained at the 3-month follow-up. Furthermore, the results for expectations and opinions showed that EmotionRegulation was well accepted by participants. CONCLUSIONS: EmotionRegulation was more effective than TAU for the treatment of emotional disorders in the Spanish public mental health system. The implications of this RCT, limitations, and suggestions for future research are discussed. TRIAL REGISTRATION: ClinicalTrials.gov NCT02345668; https://clinicaltrials.gov/ct2/show/NCT02345668.

Impact of a Web-Based Exercise and Nutritional Education Intervention in Patients Who Are Obese With Hypertension: Randomized Wait-List Controlled Trial.

BACKGROUND: Internet-based interventions are a promising strategy for promoting healthy lifestyle behaviors. These have a tremendous potential for delivering electronic health interventions in scalable and cost-effective ways. There is strong evidence that the use of these programs can lead to weight loss and can lower patients' average blood pressure (BP) levels. So far, few studies have investigated the effects of internet-based programs on patients who are obese with hypertension (HTN). OBJECTIVE: The aim of this study is to investigate the short- and long-term efficacy, in terms of body composition and BP parameters, of a self-administered internet-based intervention involving different modules and learning techniques aimed at promoting lifestyle changes (both physical activity and healthy eating) in patients who are obese with HTN. METHODS: A randomized wait-list controlled trial design was used. We recruited 105 adults with HTN who were overweight or obese and randomly assigned them to either a 3-month internet-based intervention group (n=55) or the wait-list control group (n=50). We assessed BMI (primary outcome), body fat mass (BFM), systolic (S)BP and diastolic (D)BP, blood glucose and insulin levels, physical activity levels, and functional capacity for aerobic exercise at Time 0 (preintervention) and Time 1 (postintervention). All the patients in the wait-list control group subsequently received the intervention, and a secondary within-group analysis, which also included these participants, was conducted at Time 2 (12-month follow-up). RESULTS: A 2-way mixed analysis of covariance showed a significant decrease in BMI, BFM, and blood glucose at 3 months in the internet-based intervention group; the effect size for the BMI and BFM parameters was moderate to large, and there was also a borderline significant trend for DBP and insulin. These results were either maintained or improved upon at Time 2 and showed significant changes for BMI (mean difference -0.4, 95% CI -0.1 to -0.6; P=.005), BFM (mean difference -2.4, 95% CI -1.1 to -3.6; P<.001), DBP (mean difference -1.8, 95% CI -0.2 to -3.3; P=.03), and blood glucose (mean difference -2, 95% CI 0 to -4; P=.04). CONCLUSIONS: Implementation of our self-administered internet-based intervention, which involved different learning techniques aimed to promote lifestyle changes, resulted in positive short- and long-term health benefits in patients who are obese with HTN. TRIAL REGISTRATION: ClinicalTrials.gov NCT03396302; https://clinicaltrials.gov/ct2/show/NCT03396302.

Efficacy of Three Low-Intensity, Internet-Based Psychological Interventions for the Treatment of Depression in Primary Care: Randomized Controlled Trial.

BACKGROUND: Primary care is a major access point for the initial treatment of depression, but the management of these patients is far from optimal. The lack of time in primary care is one of the major difficulties for the delivery of evidence-based psychotherapy. During the last decade, research has focused on the development of brief psychotherapy and cost-effective internet-based interventions mostly based on cognitive behavioral therapy (CBT). Very little research has focused on alternative methods of treatment for depression using CBT. Thus, there is a need for research into other therapeutic approaches. OBJECTIVE: This study aimed to assess the effectiveness of 3 low-intensity, internet-based psychological interventions (healthy lifestyle psychoeducational program [HLP], focused program on positive affect promotion [PAPP], and brief intervention based on mindfulness [MP]) compared with a control condition (improved treatment as usual [iTAU]). METHODS: A multicenter, 4-arm, parallel randomized controlled trial was conducted between March 2015 and March 2016, with a follow-up of 12 months. In total, 221 adults with mild or moderate major depression were recruited in primary care settings from 3 Spanish regions. Patients were randomly distributed to iTAU (n=57), HLP (n=54), PAPP (n=56), and MP (n=54). All patients received iTAU from their general practitioners. The main outcome was the Spanish version of the Patient Health Questionnaire-9 (PHQ-9) from pretreatment (time 1) to posttreatment (time 2) and up to 6 (time 3) and 12 (time 4) months' follow-up. Secondary outcomes included the visual analog scale of the EuroQol, the Short-Form Health Survey (SF-12), the Positive and Negative Affect Schedule (PANAS), and the Pemberton Happiness Index (PHI). We conducted regression models to estimate outcome differences along study stages. RESULTS: A moderate decrease was detected in PHQ-9 scores from HLP (ß=-3.05; P=.01) and MP (ß=-3.00; P=.01) compared with iTAU at posttreatment. There were significant differences between all intervention groups and iTAU in physical SF-12 scores at 6 months after treatment. Regarding well-being, MP and PAPP reported better PHI results than iTAU at 6 months post treatment. PAPP intervention significantly decreased PANAS negative affect scores compared with iTAU 12 months after treatment. CONCLUSIONS: The low-intensity, internet-based psychological interventions (HLP and MP) for the treatment of depression in primary care are more effective than iTAU at posttreatment. Moreover, all low-intensity psychological interventions are also effective in improving medium- and long-term quality of life. PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression. Nevertheless, it is important to examine possible reasons that could be implicated for PAPP not being effective in reducing depressive symptomatology; in addition, more research is still needed to assess the cost-effectiveness analysis of these interventions. TRIAL REGISTRATION: ISRCTN Registry ISRCTN82388279; http://www.isrctn.com/ISRCTN82388279. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-015-0475-0.

Study on the Acceptability of an ICT Platform for Older Adults with Mild Cognitive Impairment.

EhcoBUTLER is an Information and Communication Technology (ICT) solution funded by the European Union (H2020; ID: 643566) and intended especially for elderly people with mild cognitive impairment (MCI) to improve their health, independence and quality of life, particularly at the social level. The purpose of this study is to assess the acceptability of ehcoBUTLER based on a survey delivered to potential users and actors involved in their care, exploring their expectations and preferences, while anticipating the system's functional requirements. The survey was delivered online to 313 participants (11% end users, 25% informal caregivers, 48% formal caregivers and 16% administration/management staff) from eight countries. Participants rated the different functionalities of ehcoBUTLER positively, 86.1% perceiving it as an interesting and useful system. Likewise, they assessed it as a commercially attractive product (75.1%). End users expressed a stronger preference for the social module. Nevertheless, they would be ready to pay a low monthly price for ehcoBUTLER. Professionals would be willing to pay choosing its functionalities modularly, but they would also expect it to be funded by the National Health System, centres or businesses. The conclusion is that all participants found ehcoBUTLER interesting, useful and ergonomic. However, to effectively implement it, it is necessary to bridge the digital gap and address the issue of insufficient investment in products aimed at older adults with cognitive impairment. To supplement cognitive training systems with social, emotional or entertainment functionalities could improve adherence to their use.

Efficacy of an internet-based exposure treatment for flying phobia (NO-FEAR Airlines) with and without therapist guidance: a randomized controlled trial.

BACKGROUND: Internet-based treatments appear to be a promising way to enhance the in vivo exposure approach, specifically in terms of acceptability and access to treatment. However, the literature on specific phobias is scarce, and, as far as we know, there are no studies on Flying Phobia (FP). This study aims to investigate the effectiveness of an Internet-based exposure treatment for FP (NO-FEAR Airlines) that includes exposure scenarios composed of images and sounds, versus a waiting-list control group. A secondary aim is to explore two ways of delivering NO-FEAR Airlines, with and without therapist guidance. METHODS: A randomized controlled trial (RCT) was conducted in which 69 participants were allocated to: 1) NO-FEAR Airlines totally self-applied, 2) NO-FEAR Airlines with therapist guidance, 3) a waiting-list control group. Primary outcome measures were the Fear of Flying Questionnaire-II and the Fear of Flying Scale. Secondary outcomes included the Fear and Avoidance Scales, Clinician Severity Scale, and Patient's Improvement scale. Behavioral outcomes (post-treatment flights and safety behaviors) were also included. Mixed-model analyses with no ad hoc imputations were conducted for primary and secondary outcome measures. RESULTS: NO-FEAR Airlines (with and without therapist guidance) was significantly effective, compared to the waiting list control group, on all primary and secondary outcomes (all ps < .05), and no significant differences were found between the two ways of delivering the intervention. Significant improvements on diagnostic status and reliable change indexes were also found in both treatment groups at post-treatment. Regarding behavioral outcomes, significant differences in safety behaviors were found at post-treatment, compared to the waiting list. Treatment gains were maintained at 3- and 12-month follow-ups. CONCLUSION: FP can be treated effectively via the Internet. NO-FEAR Airlines helps to enhance the exposure technique and provide access to evidence-based psychological treatment to more people in need. These data are congruent with previous studies highlighting the usefulness of computer-assisted exposure programs for FP, and they contribute to the literature on Internet-based interventions. To the best of our knowledge, this is the first RCT to investigate the effectiveness of an Internet-based treatment for FP and explore two ways of delivering the intervention (with and without therapist guidance). TRIAL REGISTRATION: Clinicaltrials.gov: NCT02298478 ( https://clinicaltrials.gov/ct2/show/NCT02298478 ). Trial registration date 3 November 2014.