A Self-Applied Psychological Treatment for Gambling-Related Problems via The Internet: A Pilot, Feasibility Study.

The main purpose of this study was to evaluate the feasibility of an online psychological intervention for individuals with gambling-related problems, supported by ecological momentary assessments and interventions (EMAs and EMIs), along with weekly phone-calls, before conducting a randomized controlled trial. Participants were required to complete 3 of the 8 modules of the program based on cognitive-behavioral therapy (CBT) and extensions and innovations of CBT. The study measured the outcomes of feasibility (i.e., reach, appropriateness, technology literacy and technology usability, fidelity, and adherence). In terms of reach, 19.8% (n = 11) of the initial population met the inclusion criteria and completed the three modules (mean age = 41; 90.9% men). The perceived appropriateness and the technology usability after the first use were both excellent, fidelity and adherence to the online treatment (73.3%) were adequate. Adherence to the EMAs and the weekly phone calls were more modest (54.51% and 66.67%, respectively). The results of the present study show that an online treatment for gambling problems enhanced by EMA and EMI might be feasible but challenges were noted in terms of reach and adherence to these assessments and calls. These challenges are important to consider for future trials and the scalability of treatments for individuals with gambling disorders.

Validation of a Spanish Adaptation of the Gambling Symptom Assessment Scale (G-SAS) in Persons with Recent History of Gambling.

Gambling is becoming increasingly frequent and problematic, especially due to the explosion of online alternatives. Evaluating the severity of gambling symptomatology is therefore more important than ever. However, innovations in the gambling field have generally focused on its treatment rather than its evaluation. The Gambling Symptom Assessment Scale (G-SAS) is a well-established measure of gambling-related symptomatology (e.g., gambling urges, gambling-related thoughts and behaviours, and interpersonal functioning). The aim of this study is to validate a Spanish adaptation of the G-SAS so that individual differences in gambling symptomatology can be assessed by clinicians and researchers. The internal structure of the G-SAS was investigated using an exploratory factor analysis with a sample of 364 individuals from the general population in Spain (mean age = 28.84 years, SD = 11.73; 54% males). A four-factor structure was preferred considering fit indices (Chi-square = 22.62, p = .162, RMSEA = 0.030, CFI = 0.998, TLI = 0.995) and internal consistency estimates (0.67 ≤ α ≤ 0.89). The factors were labelled gambling-related symptoms, control of gambling urges/thoughts, interference, and arousal. Regarding construct validity, the four factors of the G-SAS were positively and significantly (all p < .001) correlated with measures of problematic gambling severity (0.40 ≤ r ≤ .73), problematic gambling diagnostic (0.40 ≤ r ≤ .67), gambling cognitions (0.48 ≤ r ≤ .57), impulsivity (0.26 ≤ r ≤ .42), anxiety (0.22 ≤ r ≤ .38), and depression (0.16 ≤ r ≤ .42), and negatively with quality of life (-0.24 ≤ r≤-.42). In sum, this study provides Spanish clinicians and researchers with a tool that serves to assess the status of individuals in relation to gambling symptomatology, which can be used to screen for at-risk profiles and evaluate treatment response.

Ecological momentary intervention to enhance emotion regulation in healthcare workers via smartphone: a randomized controlled trial protocol.

BACKGROUND: CUIDA-TE is an APP that offers transdiagnostic cognitive behavioral therapy focused on enhancing emotion regulation. As a novelty, it incorporates ecological momentary interventions (EMI), which can provide psychological support in real time, when suffering arises. The main goal of the study is to evaluate the efficacy of CUIDA-TE to improve emotion regulation in healthcare workers, a population that has been particularly emotionally impacted by the COVID-19 pandemic. METHODS: In this three-arm, randomized controlled trial (RCT) the study sample will be composed of a minimum of 174 healthcare workers. They will be randomly assigned to a 2-month EMI group (CUIDA-TE APP, n ≥ 58), a 2-month ecological momentary assessment (EMA) only group (MONITOR EMOCIONAL APP, n ≥ 58), or a wait-list control group (no daily monitoring nor intervention, n ≥ 58). CUIDA-TE will provide EMI if EMA reveals emotional problems, poor sleep quality/quantity, burnout, stress, or low perceived self-efficacy when regulating emotions. Depression will be the primary outcome. Secondary outcomes will include emotion regulation, quality of life, and resilience. Treatment acceptance and usability will also be measured. Primary and secondary outcomes will be obtained at pre- and post-intervention measurements, and at the 3-month follow-up for all groups. DISCUSSION: To our knowledge, this is the first RCT that evaluates the efficacy of an APP-based EMI to improve emotion regulation skills in healthcare workers. This type of intervention might ultimately help disseminate treatments and reach a larger number of individuals than traditional face-to-face individual therapies. TRIAL REGISTRATION: ClinicalTrial.gov : NCT04958941 Registered 7 Jun 2021. STUDY STATUS: Participant recruitment has not started.

Family connections vs treatment at usual optimized in the treatment of relatives of people with suicidal behavior disorder: study protocol of a randomized control trial.

BACKGROUND: Relatives of people diagnosed with suicidal behavior disorder (SBD) feel guilty, afraid, hopeless, depression and anxiety. It is necessary to help the relatives of people with SBD to reduce their discomfort and burden. Family Connections (FC) is a program that has been shown to be effective in reducing burden, depression, and anxiety, and increasing dominance and validating behaviors in relatives of people with borderline personality disorder. However, there are no RCTs that demonstrate the efficacy of the FC program in patients with SBD. Our research team adapted FC for relatives of people with SBD for delivery in the Spanish population (FC-SBD). The FC-SBD program contains 12 two-hour sessions held once a week. The first aim is to verify the efficacy of the FC-SBD intervention for relatives of people diagnosed with SBD in a randomized control trial with a Spanish sample. The second objective is to analyze the feasibility and acceptance of FC-SBD in relatives. The third aim is to analyze whether the changes produced in the psychological variables in the relatives after the intervention are related to changes in the psychological variables of the patients. This paper presents the study protocol. METHODS: The study design consists of a two-arm randomized controlled trial with two conditions: FC-SBD or Treatment as usual optimized (TAU-O). Participants will be relatives of patients who meet DSM-5 criteria for SBD. The caregivers` primary outcome measures will be the BAS. Secondary outcomes will be DASS-21, FES, DERS, QoL. The patient's primary outcome measures will be the frequency of critical incidents with the family member with SBD. Secondary measures will be the INQ, PHQ-9, OASIS. Participants will be assessed at pretreatment, post-treatment, and 6-month follow-up. The intention-to-treat principle will be used when analyzing the data. DISCUSSION: This study will provide results that confirm the efficacy of the FC-SBD in relatives of people with SBD. These results will also confirm its good acceptance by family members and help us to find out whether it is a good program to improve the prevention of suicidal behaviors in the family environment. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT05157607 . Registered 15 December 2021.

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.

Is there evidence that emotional reasoning processing underlies emotional disorders in adults? A systematic review.

The prevalence of emotional disorders has increased in recent times. Emotional Reasoning (ER), which is a transdiagnostic process, occurs when feelings, rather than objective evidence, are used as a source of information to make judgements about the valence of a situation. Differences in ER may explain the existence and maintenance of emotional disorders. The objective is to systematically review the role of ER in the occurrence and severity of emotional disorders. Following PRISMA guidelines, we searched through: PubMed, PsycInfo, Scopus and The Cochrane Library. Search terms were "Emotional Reasoning", "ex-consequentia reasoning", "Affect-as-information"; and "emotional disorders", "anxiety", "depression", "depressive". Nine articles were included. An association was demonstrated between ER and a greater degree of anxious symptomatological severity. In depressive symptomatology, no significant differences were found. One study reported the effect of Cognitive Behavioural Therapy on ER bias, finding no changes after the intervention. Finally, another study evaluated the efficacy of computerised experiential training in reducing ER bias, showing significant differences. There are few studies on ER and its evolution in research has not been uniform over time. Encouragingly, though, research to date suggests that ER is a transdiagnostic process involved in several anxiety disorders. More investigation is needed to dilucidate whether ER also underlies the onset and maintenance of depressive disorders.

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.

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.

Spanish-Speaking Therapists Increasingly Switch to Telepsychology During COVID-19: Networked Virtual Reality May Be Next.

Background: Social distancing restrictions imposed due to the Novel Coronavirus 2019 (COVID-19) pandemic resulted in a rapid shift in the delivery of psychological interventions from in-person to telehealth. Much of the research on this transition has been conducted with English-speaking mental health providers, leaving a gap in understanding related to how this shift has impacted Spanish-speaking treatment providers. Methods: Fifty non-U.S. Spanish-speaking therapists completed a survey related to their use of telecommunication modalities; client population characteristics; professional, ethical, and legal/regulatory issues; and telehealth training and practice. Participants completed the survey at one time point and retrospectively described their use of telehealth both pre-pandemic and during the pandemic. Results: Most of the 50 Spanish-speaking therapists surveyed reported using telepsychology 58% before COVID-19 versus 84% during the COVID-19 pandemic (χ2 = 5.76, p < 0.05). Compared with pre-pandemic, the number of hours therapists spent using telepsychology per week increased significantly for early adopter therapists (those who began using telehealth before the pandemic began) (Z = -3.18, p = 0.001) and also for late adopter therapists who only began using telehealth during the pandemic (Z = -3.74, p < 0.001). Many therapists reported equity issues. Most participants also reported ethical and regulatory concerns regarding security/confidentiality or Health Insurance Porability and Accountability Act. Conclusions: The rapid adoption of technology to deliver therapy during COVID-19 has spurred growing pains for Spanish-speaking therapists and their underserved clients, and more research is needed to better understand and improve the therapists' adoption of these technologies with diverse patient populations.

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.

Confirmatory factor analysis and psychometric properties of the Emotion Regulation Questionnaire in participants with personality disorders.

Emotional dysregulation is a key symptom in participants with personality disorders. The Emotional Regulation Questionnaire (ERQ) has been studied with nonclinical samples; however, it is necessary to confirm the factorial structure of the ERQ in participants with personality disorders. The aims of the present study were to confirm the factorial structure of the Spanish version of the ERQ and analyse its psychometric properties as well as the association between the ERQ and the Borderline Symptoms List (BSL-23) and the Difficulties in Emotion Regulation Scale (DERS). The overall sample was composed of 250 patients with personality disorders, of whom 195 met the criteria for borderline personality disorder. Confirmatory factor analysis was conducted. The two-factor model showed an acceptable fit, similar to the original structure, in the participants with personality disorders and with borderline personality disorder. Cognitive reappraisal was negatively correlated with the DERS and BSL-23, and expressive suppression was positively correlated with the BSL-23. The ERQ is a reliable and valid instrument to evaluate emotional dysregulation in participants with personality disorders and participants with borderline personality disorder.

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 "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.

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.

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.

Technology-based parenting interventions for children's physical and psychological health: a systematic review and meta-analysis.

BACKGROUND: Parenting interventions have important consequences for the wellbeing and emotional competences of parents and their children. Technology provides an opportunity with advantages for psychological intervention. The aim of this systematic review and meta-analysis is to analyze the characteristics and effectiveness of technology-based interventions for parents to promote children's physical health or psychological issues. METHODS: We conducted a systematic review and meta-analysis for articles about parenting skills for prevention or treatment of children's physical or psychological concerns using technology. We explore the aim of the intervention with parents, kind of problem with children, intervention model, instruments, methodological quality, and risk of bias. A random-effects meta-analysis was conducted. RESULTS: Twenty-four studies were included in the systematic review and a meta-analysis of 22 studies was performed to find out the effects of intervention depending on the kind of problem, intervention model, follow-up, type of intervention, type of control condition, and type of outcome data. Results show the usefulness of technology-based therapy for parenting interventions with moderate effect sizes for intervention groups with statistically significant differences from control groups. CONCLUSIONS: Technology-based parenting programs have positive effects on parenting and emotional wellbeing of parents and children. Attendance and participation level in technology-based treatment increase compared with traditional parenting intervention.

Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies.

BACKGROUND: There are evidence-based interventions for depression that include different components. However, the efficacy of their therapeutic components is unknown. Another important issue related to depression interventions is that, up to now, their therapeutic components have only focused on reducing negative symptoms rather than on improving positive affect and well-being. Because the low levels of positive affect are more strongly linked to depression than to other emotional disorders, it is important to include this variable as an important treatment target. Positive psychotherapeutic strategies (PPs) could help in this issue. The results obtained so far are consistent and promising, showing that Internet-based interventions are effective in treating depression. However, most of them are also multi-component, and it is important to make progress in investigating what each component contributes to the intervention. METHODS: The current study will be a three-armed, simple-blinded, randomized controlled clinical trial with a dismantling design. 192 participants will be randomly assigned to: a) an Internet-based Global Protocol condition, which includes traditional therapeutic components of evidence-based treatments for depression (Motivation for change, Psychoeducation, Cognitive Therapy, Behavioral Activation (BA), Relapse Prevention) and PPs component, offering strategies to enhance positive mood and promote psychological strengths; b) an Internet-based BA Protocol condition (without the PPs component), and c) an Internet-based PPs Protocol condition (without the BA component). Primary outcome measures will be the BDI-II and PANAS. Secondary outcomes will include other variables such as depression, anxiety and stress, quality of life, resilience, and wellbeing related measures. Treatment acceptance and usability will also be measured. Participants will be assessed at pre-, post-treatment, 3-, 6- and 12- month follow- ups. The data will be analyzed based on the Intention-to-treat principle. Per protocol analyses will also be performed. DISCUSSION: To the best of our knowledge, this is the first randomized dismantling intervention study for depression with the aim of exploring the contribution of a PPs component and the BA component in an Internet-based intervention. The three protocols are online interventions, helping to reach many people who need psychological treatments and otherwise would not have access to them. TRIAL REGISTRATION: Clinicalstrials.gov as NCT03159715 . Registered 19 May 2017.

Efficacy of a blended low-intensity internet-delivered psychological programme in patients with multimorbidity in primary care: study protocol for a randomized controlled trial.

BACKGROUND: The World Health Organization (WHO) has included comorbidity between depression and a chronic disease among the 10 leading global health priorities. Although there is a high prevalence of multimorbidity, health care systems are mainly designed for the management of individual diseases. Given the difficulty in delivering face-to-face psychological treatments, alternative models of treatment delivery have been proposed, emphasizing the role of technologies such as the Internet. The aim of this study is to assess the efficacy in Primary Care (PC) of a blended low-intensity psychological intervention applied using information and communication technologies (ICTs) for the treatment of multimorbidity in PC (depression and type 2 diabetes/low back pain) by means of a randomized controlled trial (RCT). Our main hypothesis is that improved usual care combined with psychological therapy applied using ICTs will be more efficacious for improvement in the symptomatology of multimorbidity, compared to a group with only improved treatment as usual six months after the end of treatment. METHODS: A protocol has been designed combining a face-to-face intervention with a supporting online programme that will be tested by an RCT conducted in three different regions (Andalusia, Aragon and the Balearic Islands). The RCT will evaluate three hundred participants diagnosed with depression and type 2 diabetes/low back pain. Four highly experienced research groups specializing in clinical psychology are involved in this trial, and there will be ample possibilities for translation and transfer to usual clinical practice. DISCUSSION: This clinical trial will lead to improvement in financial sustainability, maximizing the use of resources and responding to principles of efficiency and effectiveness. Furthermore, based on the evaluation of the feasibility of implementing this intervention in primary care facilities, we expect to be able to suggest the intervention for incorporation into public policy. In conclusion, positive results of this study could have a significant impact on one of the most important health-related problems, multimorbidity. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03426709 . Registered retrospectively on 08 February 2018.