A smartphone-based serious game for depressive symptoms: Protocol for a pilot randomized controlled trial.

Background: Depression is the most prevalent mental disorder, with detrimental effects on the patient's well-being, high disability, and a huge associated societal and economic cost. There are evidence-based treatments, but it is difficult to reach all people in need. Internet-based interventions, and more recently smartphone-based interventions, were explored to overcome barriers to access. Evidence shows them to be effective alternatives to traditional treatments. This paper presents the protocol of a pilot study whose primary aim is to investigate the efficacy of a smartphone-based serious game intervention for patients with mild to moderate depressive symptoms. Methods: This randomized controlled pilot trial protocol foresees two arms design: 1/ smartphone- based serious game intervention (based on Cognitive Behavior Therapy with particular emphasis on Behavioral Activation and Physical Activity), 2/ waiting list control group. The study is expected to recruit 40 participants (18+), which will be randomly assigned to one of the experimental conditions. The duration of the intervention is two months. The primary outcome measure will be depressive symptomatology. Secondary outcomes will include other variables such as physical activity, resilience, anxiety, depression impairment, and positive and negative affect. Treatment expectation, satisfaction, usability, and game playability will also be measured. The data will be analyzed based on the intention-to-treat and per protocol analyses. Discussion: The study aims to establish initial evidence for the efficacy of a smartphone-based serious game intervention, to serve as input for a larger-scale randomized control trial. The intervention exploits advanced smartphone capabilities, such as the use of a serious game as delivery mode, with the potential benefit of engagement and treatment adherence, and motion sensors to monitor and stimulate physical activity. As a secondary objective, the study aims to gather initial evidence on the user's expectations, satisfaction, usability and playability of the serious game as a treatment.

Client's Experiences Using a Location-Based Technology ICT System during Gambling Treatments' Crucial Components: A Qualitative Study.

Cognitive Behavioral Therapy is the treatment of choice for Gambling Disorder (GD), with stimulus control (SC) and exposure with response prevention (ERP) being its two core components. Despite their efficacy, SC and ERP are not easy to deliver, so it is important to explore new ways to enhance patient compliance regarding SC and ERP. The aim of this study is to describe and assess the opinion of two patients diagnosed with problem gambling and GD that used the Symptoms app, a location-based ICT system, during SC and ERP. A consensual qualitative research study was conducted. We used a semi-structured interview, developed ad-hoc based on the Expectation and Satisfaction Scale and System Usability Scale. A total of 20 categories were identified within six domains: usefulness, improvements, recommendation to other people, safety, usability, and opinion regarding the use of the app after completing the intervention. The patients considered the app to be useful during the SC and ERP components and emphasized that feeling observed and supported at any given time helped them avoid lapses. This work can offer a starting point that opens up new research paths regarding psychological interventions for gambling disorder, such as assessing whether location-based ICT tools enhance commitment rates.

Efficacy of an internet-based psychological intervention for problem gambling and gambling disorder: Study protocol for a randomized controlled trial.

Gambling Disorder is a prevalent non-substance use disorder, which contrasts with the low number of people requesting treatment. Information and Communication Technologies (ICT) could help to enhance the dissemination of evidence-based treatments and considerably reduce the costs. The current study seeks to assess the efficacy of an online psychological intervention for people suffering from gambling problems in Spain. The proposed study will be a two-arm, parallel-group, randomized controlled trial. A total of 134 participants (problem and pathological gamblers) will be randomly allocated to a waiting list control group (N = 67) or an intervention group (N = 67). The intervention program includes 8 modules, and it is based on motivational interviewing, cognitive-behavioral therapy (CBT), and extensions and innovations of CBT. It includes several complementary tools that are present throughout the entire intervention. Therapeutic support will be provided once a week through a phone call with a maximum length of 10 min. The primary outcome measure will be gambling severity and gambling-related cognitions, and secondary outcome measures will be readiness to change, and gambling self-efficacy. Other variables that will be considered are depression and anxiety symptoms, positive and negative affect, difficulties in emotion regulation strategies, impulsivity, and quality of life. Individuals will be assessed at baseline, post-treatment, and 3-, 6-, and 12-month follow-ups. During the treatment, participants will also respond to a daily Ecological Momentary Intervention (EMI) in order to evaluate urges to gamble, self-efficacy to cope with gambling urges, gambling urge frequency, and whether gambling behaviour occurs. The EMI includes immediate automatic feedback depending on the participant's responses. Treatment acceptance and satisfaction will also be assessed. The data will be analysed both per protocol and by Intention-to-treat. As far as we know, this is the first randomized controlled trial of an online psychological intervention for gambling disorder in Spain. It will expand our knowledge about treatments delivered via the Internet and contribute to improving treatment dissemination, reaching people suffering from this problem who otherwise would not receive help. TRIAL REGISTRATION: Clinicaltrials.gov as NCT04074681. Registered 22 July 2019.

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.

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.

Internet-Based Cognitive Behavioral Therapy for Depression: A Systematic Review and Individual Patient Data Network Meta-analysis.

Importance: Personalized treatment choices would increase the effectiveness of internet-based cognitive behavioral therapy (iCBT) for depression to the extent that patients differ in interventions that better suit them. Objective: To provide personalized estimates of short-term and long-term relative efficacy of guided and unguided iCBT for depression using patient-level information. Data Sources: We searched PubMed, Embase, PsycInfo, and Cochrane Library to identify randomized clinical trials (RCTs) published up to January 1, 2019. Study Selection: Eligible RCTs were those comparing guided or unguided iCBT against each other or against any control intervention in individuals with depression. Available individual patient data (IPD) was collected from all eligible studies. Depression symptom severity was assessed after treatment, 6 months, and 12 months after randomization. Data Extraction and Synthesis: We conducted a systematic review and IPD network meta-analysis and estimated relative treatment effect sizes across different patient characteristics through IPD network meta-regression. Main Outcomes and Measures: Patient Health Questionnaire-9 (PHQ-9) scores. Results: Of 42 eligible RCTs, 39 studies comprising 9751 participants with depression contributed IPD to the IPD network meta-analysis, of which 8107 IPD were synthesized. Overall, both guided and unguided iCBT were associated with more effectiveness as measured by PHQ-9 scores than control treatments over the short term and the long term. Guided iCBT was associated with more effectiveness than unguided iCBT (mean difference [MD] in posttreatment PHQ-9 scores, -0.8; 95% CI, -1.4 to -0.2), but we found no evidence of a difference at 6 or 12 months following randomization. Baseline depression was found to be the most important modifier of the relative association for efficacy of guided vs unguided iCBT. Differences between unguided and guided iCBT in people with baseline symptoms of subthreshold depression (PHQ-9 scores 5-9) were small, while guided iCBT was associated with overall better outcomes in patients with baseline PHQ-9 greater than 9. Conclusions and Relevance: In this network meta-analysis with IPD, guided iCBT was associated with more effectiveness than unguided iCBT for individuals with depression, benefits were more substantial in individuals with moderate to severe depression. Unguided iCBT was associated with similar effectiveness among individuals with symptoms of mild/subthreshold depression. Personalized treatment selection is entirely possible and necessary to ensure the best allocation of treatment resources for depression.

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.

Cultural adaptation of the Smiling is Fun program for the treatment of depression in the Ecuadorian public health care system: A study protocol for a randomized controlled trial.

BACKGROUND: Depression is one of the world's major health problems. Due to its high prevalence, it constitutes the first cause of disability among the Americas, where only a very low percentage of the population receives the adequate evidence-based psychological treatment. Internet-Based Interventions (IBIs) are a great alternative to reduce the treatment gap for mental disorders. Although there are several studies in low-and middle-income countries proving IBIs' feasibility and acceptability, there is still little evidence of the effectiveness in diverse social and cultural contexts such as Latin America. METHODS: Two studies will be described: Study 1 is focused on the cultural adaptation of a cognitive-behavioral IBI Smiling is Fun (Botella et al. 2012, 2015) for Ecuadorian population with depression based on the procedure by Salamanca-Sanabria et al. (2018). Study 2 describes the design of a randomized controlled trial to test the preliminary efficacy of the culturally adapted intervention in a Public Health Care setting. A total of 153 patients with mild to moderate degree of depression as assessed with the Mini-International Neuropsychiatric Interview (M.I.N.I.) and the Patient Health Questionnaire-9 (PHQ-9) will be randomly assigned to either an IBI group using only automated support by the system; an IBI group including also minimal human support; or a waiting list group. The primary outcome (depression) and secondary outcomes (e.g., anxiety, affect, quality of life) will be collected at baseline, 3, 6 and 12 months. Mixed-model analyses with no ad hoc imputations will be conducted. DISCUSSION: This paper is pioneering in exploring the role of an Internet-based culturally adapted intervention for depression in a public care context in Ecuador. Results obtained will offer new insights into the viability and effectiveness of digital technologies for the psychological treatment of mental illnesses in developing countries.

A Low-Intensity Internet-Based Intervention Focused on the Promotion of Positive Affect for the Treatment of Depression in Spanish Primary Care: Secondary Analysis of a Randomized Controlled Trial.

Background: A large number of low-intensity Internet-based interventions (IBIs) for the treatment of depression have emerged in Primary Care; most of them focused on decreasing negative emotions. However, recent studies have highlighted the importance of addressing positive affect (PA) as well. This study is a secondary analysis of a randomized control trial. We examine the role of an IBI focused on promoting PA in patients with depression in Primary Care (PC). The specific objectives were to explore the profile of the patients who benefit the most and to analyze the change mechanisms that predict a significantly greater improvement in positive functioning measures. Methods: 56 patients were included. Measures of depression, affect, well-being, health-related quality of life, and health status were administered. Results: Participants who benefited the most were those who had lower incomes and education levels and worse mental health scores and well-being at baseline (7.9%-39.5% of explained variance). Improvements in depression severity and PA were significant predictors of long-term change in well-being, F (3,55) = 17.78, p < 0.001, R2 = 47.8%. Conclusions: This study highlights the importance of implementing IBIs in PC and the relevance of PA as a key target in Major Depressive Disorder treatment.

Smartphone Apps for the Treatment of Mental Disorders: Systematic Review.

BACKGROUND: Smartphone apps are an increasingly popular means for delivering psychological interventions to patients suffering from a mental disorder. In line with this popularity, there is a need to analyze and summarize the state of the art, both from a psychological and technical perspective. OBJECTIVE: This study aimed to systematically review the literature on the use of smartphones for psychological interventions. Our systematic review has the following objectives: (1) analyze the coverage of mental disorders in research articles per year; (2) study the types of assessment in research articles per mental disorder per year; (3) map the use of advanced technical features, such as sensors, and novel software features, such as personalization and social media, per mental disorder; (4) provide an overview of smartphone apps per mental disorder; and (5) provide an overview of the key characteristics of empirical assessments with rigorous designs (ie, randomized controlled trials [RCTs]). METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for systematic reviews were followed. We performed searches in Scopus, Web of Science, American Psychological Association PsycNET, and Medical Literature Analysis and Retrieval System Online, covering a period of 6 years (2013-2018). We included papers that described the use of smartphone apps to deliver psychological interventions for known mental disorders. We formed multidisciplinary teams, comprising experts in psychology and computer science, to select and classify articles based on psychological and technical features. RESULTS: We found 158 articles that met the inclusion criteria. We observed an increasing interest in smartphone-based interventions over time. Most research targeted disorders with high prevalence, that is, depressive (31/158,19.6%) and anxiety disorders (18/158, 11.4%). Of the total, 72.7% (115/158) of the papers focused on six mental disorders: depression, anxiety, trauma and stressor-related, substance-related and addiction, schizophrenia spectrum, and other psychotic disorders, or a combination of disorders. More than half of known mental disorders were not or very scarcely (<3%) represented. An increasing number of studies were dedicated to assessing clinical effects, but RCTs were still a minority (25/158, 15.8%). From a technical viewpoint, interventions were leveraging the improved modalities (screen and sound) and interactivity of smartphones but only sparingly leveraged their truly novel capabilities, such as sensors, alternative delivery paradigms, and analytical methods. CONCLUSIONS: There is a need for designing interventions for the full breadth of mental disorders, rather than primarily focusing on most prevalent disorders. We further contend that an increasingly systematic focus, that is, involving RCTs, is needed to improve the robustness and trustworthiness of assessments. Regarding technical aspects, we argue that further exploration and innovative use of the novel capabilities of smartphones are needed to fully realize their potential for the treatment of mental health disorders.

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.

Exploring the Relationship Between the Acceptability of an Internet-Based Intervention for Depression in Primary Care and Clinical Outcomes: Secondary Analysis of a Randomized Controlled Trial.

Background: Depression is one of the most prevalent psychological disorders worldwide. Although psychotherapy for depression is effective, there are barriers to its implementation in primary care in Spain. The use of the Internet has been shown to be a feasible solution. However, the acceptability of Internet-based interventions has not been studied sufficiently. Objective: To assess the acceptability of an Internet-based intervention (IBI) for depression in primary care, and explore the relationship between expectations and satisfaction and the improvement in the clinical variables in primary care patients receiving this intervention. Furthermore, it offers data about the effects of some sociodemographic characteristics on these acceptability variables and analyzes whether the expectations are related to finalizing the intervention. Methods: Data were based on depressive patients who were participants in a randomized controlled trial. In the present study, we present the data from all the participants in the Internet intervention groups (N = 198). All the participants filled out the expectation and satisfaction scales (six-item scales regarding treatment logic, satisfaction, recommending, usefulness for other disorders, usefulness for the patient, and unpleasantness), the Beck Depression Inventory-II, and the secondary outcome measures: depression and anxiety impairment, and positive and negative affect. Results: Results showed that participants' expectations and satisfaction with the program were both high and differences in expectations and satisfaction depended on some sociodemographic variables (age: older people have higher expectations; sex: women have greater satisfaction). A positive relationship between these variables and intervention efficacy was found: expectations related to "usefulness for the patient" were a statistically related predictor to the results on the BDI-II (Beta = 0.364), and the perception of how logical the treatment is (Beta = 0.528) was associated with change in the clinical variable. Furthermore, the higher the expectations, the higher the improvements exhibited by the patients in all measures evaluated during the ten intervention modules. High expectations were also directly related to finalizing the intervention. Conclusions: This is the first study in Spain to address this issue in the field of IBIs for depression in primary care. The IBI showed high acceptance related to the intervention's efficacy and completion. Research on IBI acceptability could help to implement the treatment offered. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT01611818.

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.

Capturing the Severity and Impairment Associated With Depression: The Overall Depression Severity and Impairment Scale (ODSIS) Validation in a Spanish Clinical Sample.

Background: The Overall Depression Severity and Impairment Scale (ODSIS) is a self-report scale designed to evaluate the severity and functional impairment associated with depression. Objective: This study evaluated the psychometric properties of the online version of the ODSIS in Spanish outpatients with depression and anxiety disorders. Method: Patients with a main diagnosis of a depressive (n = 283) or anxiety disorder (n = 191) and a mean age of 38.15 (SD = 12.06) were evaluated with a clinical diagnostic interview and measures assessing depression, anxiety, positive and negative affect, and quality of life. Factorial structure, internal consistency, convergent, and discriminant validity and cutoff scores were analyzed. Results: Consistent with previous validations of the instrument, Confirmatory Factor Analysis showed a unidimensional factor structure. Furthermore, the results obtained supported the internal consistency and construct validity of the ODSIS scores. A score of 5 was found to meet the criteria used in this study for the optimal cutoff score. Conclusion: The results obtained in this study show that the Spanish version of the ODSIS delivered online is an adequate tool to assess the depression-related severity and impairment in a brief and easy fashion.

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.

An Internet based intervention for improving resilience and coping strategies in university students: Study protocol for a randomized controlled trial.

BACKGROUND: The literature shows a high prevalence of depression and anxiety in young people. The university represents a change in the lives of students, and is considered a stress factor. Therefore, it is particularly relevant to develop interventions specifically addressed to students and foster supportive environments and resilient communities. As students are "digital natives", online interventions offer several potential advantages in doing this. This study aims to develop and evaluate the efficacy of an Internet-based intervention (CORE: Cultivating our Resilience), based on the Ryff model of well-being, to promote resilience and coping skills, decrease symptoms of depression and anxiety, and increase overall wellbeing in young people confronting a crucial life event (the university). This paper summarizes the study protocol. METHOD: The design of the planned study is a randomized controlled trial. A minimum of 464 participants will be randomly assigned to two conditions: 1) an unguided Internet-based intervention to enhance resilience (N = 232); 2) a care-as-usual condition (CAU) (N = 232). The primary outcome will be the Connor-Davidson resilience scale. Secondary outcomes will - among others - include other relevant clinical measures, such as anxiety and depressive symptoms, quality of life, and social support. Outcomes will be assessed 4 and 8 weeks, and 6 and 12-months follow-ups. Intention-to-treat and per-protocol analyses will be performed. DISCUSSION: The results of this study will contribute to the growing research on Internet-delivered interventions. The expected results may have a major impact on the prevention of mental disorders and possible negative consequences in at-risk populations, such as college students.

Exploring the Incorporation of a Positive Psychology Component in a Cognitive Behavioral Internet-Based Program for Depressive Symptoms. Results Throughout the Intervention Process.

Traditionally, evidence-based treatments for depression have focused on negative symptoms. Different authors describe the need to include positive affect as a major target of treatment. Positive psychology aims to fill this gap. Reaching everyone in need is also important, and Internet-based interventions can help in this task. The present study is a secondary analysis derived from a randomized controlled trial aimed to test the efficacy of an Internet-based intervention for patients with depressive symptoms. This intervention consisted of an 8-module Internet-based program that combined four modules based on cognitive-behavioral therapy strategies and four modules based on positive psychology strategies. The main goal of this secondary analysis is to report the data collected after each module from the participants who completed the intervention, explore the changes throughout the intervention process, and examine the changes observed in the different variables before versus after the introduction of the positive psychology component. A total of 103 patients completed the intervention. At pre-, post-intervention, and post-module evaluations, they completed positive and negative affect, depression, and anxiety measures. Negative affect and anxiety decreased significantly during the implementation of the cognitive-behavioral therapy and positive psychology modules. However, depression and positive affect improved only after the introduction of the positive psychology modules. This is the first study to explore, throughout the intervention process (module by module), the incorporation of a positive psychology component in an Internet-based program. Results suggest that positive psychology techniques might have an impact on clinical symptomatology, and they emphasize the need to include these techniques to achieve a more profound change in positive functioning measures. Clinical Trial Registration: NCT02148354 (http://ClinicalTrials.gov/ct2/show/NCT02148354).

Effectiveness and treatment moderators of internet interventions for adult problem drinking: An individual patient data meta-analysis of 19 randomised controlled trials.

BACKGROUND: Face-to-face brief interventions for problem drinking are effective, but they have found limited implementation in routine care and the community. Internet-based interventions could overcome this treatment gap. We investigated effectiveness and moderators of treatment outcomes in internet-based interventions for adult problem drinking (iAIs). METHODS AND FINDINGS: Systematic searches were performed in medical and psychological databases to 31 December 2016. A one-stage individual patient data meta-analysis (IPDMA) was conducted with a linear mixed model complete-case approach, using baseline and first follow-up data. The primary outcome measure was mean weekly alcohol consumption in standard units (SUs, 10 grams of ethanol). Secondary outcome was treatment response (TR), defined as less than 14/21 SUs for women/men weekly. Putative participant, intervention, and study moderators were included. Robustness was verified in three sensitivity analyses: a two-stage IPDMA, a one-stage IPDMA using multiple imputation, and a missing-not-at-random (MNAR) analysis. We obtained baseline data for 14,198 adult participants (19 randomised controlled trials [RCTs], mean age 40.7 [SD = 13.2], 47.6% women). Their baseline mean weekly alcohol consumption was 38.1 SUs (SD = 26.9). Most were regular problem drinkers (80.1%, SUs 44.7, SD = 26.4) and 19.9% (SUs 11.9, SD = 4.1) were binge-only drinkers. About one third were heavy drinkers, meaning that women/men consumed, respectively, more than 35/50 SUs of alcohol at baseline (34.2%, SUs 65.9, SD = 27.1). Post-intervention data were available for 8,095 participants. Compared with controls, iAI participants showed a greater mean weekly decrease at follow-up of 5.02 SUs (95% CI -7.57 to -2.48, p < 0.001) and a higher rate of TR (odds ratio [OR] 2.20, 95% CI 1.63-2.95, p < 0.001, number needed to treat [NNT] = 4.15, 95% CI 3.06-6.62). Persons above age 55 showed higher TR than their younger counterparts (OR = 1.66, 95% CI 1.21-2.27, p = 0.002). Drinking profiles were not significantly associated with treatment outcomes. Human-supported interventions were superior to fully automated ones on both outcome measures (comparative reduction: -6.78 SUs, 95% CI -12.11 to -1.45, p = 0.013; TR: OR = 2.23, 95% CI 1.22-4.08, p = 0.009). Participants treated in iAIs based on personalised normative feedback (PNF) alone were significantly less likely to sustain low-risk drinking at follow-up than those in iAIs based on integrated therapeutic principles (OR = 0.52, 95% CI 0.29-0.93, p = 0.029). The use of waitlist control in RCTs was associated with significantly better treatment outcomes than the use of other types of control (comparative reduction: -9.27 SUs, 95% CI -13.97 to -4.57, p < 0.001; TR: OR = 3.74, 95% CI 2.13-6.53, p < 0.001). The overall quality of the RCTs was high; a major limitation included high study dropout (43%). Sensitivity analyses confirmed the robustness of our primary analyses. CONCLUSION: To our knowledge, this is the first IPDMA on internet-based interventions that has shown them to be effective in curbing various patterns of adult problem drinking in both community and healthcare settings. Waitlist control may be conducive to inflation of treatment outcomes.

A brief online transdiagnostic measure: Psychometric properties of the Overall Anxiety Severity and Impairment Scale (OASIS) among Spanish patients with emotional disorders.

The Overall Anxiety Severity and Impairment Scale (OASIS) is a self-report questionnaire designed to evaluate the severity and functional impairment associated with anxiety. Given its transdiagnostic nature, it can be used indistinctly across anxiety and depressive disorders. In this study, the psychometric properties of the online version of the OASIS were evaluated in a Spanish clinical sample with emotional disorders. Patients (n = 583) with anxiety (n = 250) and depression (n = 333) with a mean age of 37.21 (SD = 12.22), underwent a diagnostic interview and questionnaires assessing anxiety, depression, positive and negative affect, and quality of life. Factorial structure, internal consistency, convergent and discriminant validity, cutoff scores, and sensitivity to change were analyzed. Confirmatory Factor Analysis yielded a unidimensional factor structure, consistent with previous validations of the instrument. The analyses showed good internal consistency and adequate convergent and discriminant validity, as well as sensitivity to change. A cutoff score of 7.5 was found to meet the criteria used in this study to select the optimal cutoff point. Overall, in this study, the psychometric properties of the online version of the OASIS were found to be appropriate. The brevity and ease of use of the OASIS support its adequacy as a valid measure of anxiety severity and impairment in Spanish clinical samples with anxiety and depression.

An internet-based intervention for adjustment disorder (TAO): study protocol for a randomized controlled trial.

BACKGROUND: Adjustment Disorder (AjD) is a common and disabling mental health problem. The lack of research on this disorder has led to the absence of evidence-based interventions for its treatment. Moreover, because the available data indicate that a high percentage of people with mental illness are not treated, it is necessary to develop new ways to provide psychological assistance. The present study describes a Randomized Controlled Trial (RCT) aimed at assessing the effectiveness and acceptance of a linear internet-delivered cognitive-behavioral therapy (ICBT) intervention for AjD. METHODS: A two-armed RCT was designed to compare an intervention group to a waiting list control group. Participants from the intervention group will receive TAO, an internet-based program for AjD composed of seven modules. TAO combines CBT and Positive Psychology strategies in order to provide patients with complete support, reducing their clinical symptoms and enhancing their capacity to overcome everyday adversity. Participants will also receive short weekly telephone support. Participants in the control group will be assessed before and after a seven-week waiting period, and then they will be offered the same intervention. Participants will be randomly assigned to one of the 2 groups. Measurements will be taken at five different moments: baseline, post-intervention, and three follow-up periods (3-, 6- and 12-month). BDI-II and BAI will be used as primary outcome measures. Secondary outcomes will be symptoms of AjD, posttraumatic growth, positive and negative affect, and quality of life. DISCUSSION: The development of ICBT programs like TAO responds to a need for evidence-based interventions that can reach most of the people who need them, reducing the burden and cost of mental disorders. More specifically, TAO targets AjD and will entail a step forward in the treatment of this prevalent but under-researched disorder. Finally, it should be noted that this is the first RCT focusing on an internet-based intervention for AjD in the Spanish population. TRIAL REGISTRATION: ClinicalTrial.gov: NCT02758418 . Trial registration date 2 May 2016.