RESUMEN

Depressive disorders are an enormous societal burden given their high prevalence and impact on all facets of being human (e.g., relationships, emotions, motivation). There is a variety of evidence-based psychological treatments, with cognitive behavioral therapy (CBT) being the gold standard for major depression. Research has shown that mindfulness-based interventions (MBIs) such as mindfulness-based cognitive therapy (MBCT) are an effective relapse prevention and treatment for depression and that MBIs can be integrated in individual therapy. Furthermore, various delivery modes (e.g., digital-delivered therapy) and settings are offered to best meet different needs and improve accessibility: Evidence suggests that therapist-guided digital CBT, blended therapy, and, to some degree, digitalized MBIs may be an efficacious supplement to traditional face-to-face therapy. This chapter provides an overview of the principles and evidence base for CBT and MBCT as well as different delivery modes for depressive disorders in adults. Finally, chances and challenges of integration are discussed as implications for practice, as well as recommendations and ideas for future research.

Asunto(s)

RESUMEN

INTRODUCTION: Mental health problems are steadily increasing worldwide. In Austria, the overall supply of mental health services is low, especially in rural areas. Mobile technology and a blended care approach have the potential to overcome problems with service provision. The aim of this study was to map the attitudes of practitioners and people living in Austria towards blended therapy. METHOD: Two individual online questionnaires (including the Unified Theory of Acceptance and Use of Technology, advantages and disadvantages, useful features) were distributed to practitioners and the general population in Austria. RESULTS: The questionnaires were answered by 152 members of the general public and 129 practitioners. The general population and practitioners seem to be cautious, but slightly positive about blended therapy. Previous experience of practitioners with blended therapy was low. Practitioners are most worried about the therapeutic process and their work-life balance, while the general population is worried about being overwhelmed by the concept, mainly due to the time investment. Tracking, recording and reminding functions (e.g., for mood, homework) were seen as especially valuable features and accessibility was deemed the biggest advantage by both samples. CONCLUSION: Practitioners' attitudes are important for implementation of blended therapy. More awareness might help against the cautiousness as well as implementing digital health applications in Austrian health policies.

RESUMEN

BACKGROUND: Early weight loss is an established predictor for treatment outcomes in weight management interventions for people with obesity. However, there is a paucity of additional, reliable, and clinically actionable early predictors in weight management interventions. Novel blended-care weight management interventions combine coach and app support and afford new means of structured, continuous data collection, informing research on treatment adherence and outcome prediction. OBJECTIVE: Against this backdrop, this study analyzes app engagement as a predictor for weight loss in large-scale, real-world, blended-care interventions. We hypothesize that patients who engage more frequently in app usage in blended-care treatment (eg, higher logging activity) lose more weight than patients who engage comparably less frequently at 3 and 6 months of intervention. METHODS: Real-world data from 19,211 patients in obesity treatment were analyzed retrospectively. Patients were treated with 3 different blended-care weight management interventions, offered in Switzerland, the United Kingdom, and Germany by a digital behavior change provider. The principal component analysis identified an overarching metric for app engagement based on app usage. A median split informed a distinction in higher and lower engagers among the patients. Both groups were matched through optimal propensity score matching for relevant characteristics (eg, gender, age, and start weight). A linear regression model, combining patient characteristics and app-derived data, was applied to identify predictors for weight loss outcomes. RESULTS: For the entire sample (N=19,211), mean weight loss was -3.24% (SD 4.58%) at 3 months and -5.22% (SD 6.29%) at 6 months. Across countries, higher app engagement yielded more weight loss than lower engagement after 3 but not after 6 months of intervention (P3 months<.001 and P6 months=.59). Early app engagement within the first 3 months predicted percentage weight loss in Switzerland and Germany, but not in the United Kingdom (PSwitzerland<.001, PUnited Kingdom=.12, and PGermany=.005). Higher age was associated with stronger weight loss in the 3-month period (PSwitzerland=.001, PUnited Kingdom=.002, and PGermany<.001) and, for Germany, also in the 6-month period (PSwitzerland=.09, PUnited Kingdom=.46, and PGermany=.03). In Switzerland, higher numbers of patients' messages to coaches were associated with higher weight loss (P3 months<.001 and P6 months<.001). Messages from coaches were not significantly associated with weight loss (all P>.05). CONCLUSIONS: Early app engagement is a predictor of weight loss, with higher engagement yielding more weight loss than lower engagement in this analysis. This new predictor lends itself to automated monitoring and as a digital indicator for needed or adapted clinical action. Further research needs to establish the reliability of early app engagement as a predictor for treatment adherence and outcomes. In general, the obtained results testify to the potential of app-derived data to inform clinical monitoring practices and intervention design.

Asunto(s)

RESUMEN

Blended-care, a psychosocial intervention combining traditional, face-to-face therapy with digital mental health tools, has shown potential for improving therapeutic processes, fostering patient engagement, and augmenting clinical outcomes. This systematic review aimed to evaluate the development and effectiveness of blended-care interventions tailored for adults diagnosed with schizophrenia-spectrum disorders or other conditions with psychotic features. Our search strategy spanned three electronic databases (PsycINFO, Web of Science, and PubMed) in accordance with the reporting guidelines outlined by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. We identified 11 papers, each examining the use of one of eight distinct blended-care interventions. Significantly, the majority of these papers (10/11, 91 %) examined these interventions exclusively within controlled research environments, demonstrating both acceptability and favourable impacts on symptomatology and recovery (e.g., 0.22 ≤ Cohen's ds ≤ 1.00). Only one intervention was examined in research settings and real-world conditions, and the shift resulted in low real-world uptake (e.g., only 50 % of practitioners were able to engage at least one of their clients with the intervention) and an inability to reproduce positive changes in clinical outcomes. Additional research is needed to determine the viability of successfully developing and implementing blended-care interventions for psychosis in real-world conditions. An exploration of the developmental processes that could facilitate the transition from research settings to routine clinical practice is vital.

Asunto(s)

RESUMEN

BACKGROUND: Integrating innovative digital mental health interventions within specialist services is a promising strategy to address the shortcomings of both face-to-face and web-based mental health services. However, despite young people's preferences and calls for integration of these services, current mental health services rarely offer blended models of care. OBJECTIVE: This pilot study tested an integrated digital and face-to-face transdiagnostic intervention (eOrygen) as a blended model of care for youth psychosis and borderline personality disorder. The primary aim was to evaluate the feasibility, acceptability, and safety of eOrygen. The secondary aim was to assess pre-post changes in key clinical and psychosocial outcomes. An exploratory aim was to explore the barriers and facilitators identified by young people and clinicians in implementing a blended model of care into practice. METHODS: A total of 33 young people (aged 15-25 years) and 18 clinicians were recruited over 4 months from two youth mental health services in Melbourne, Victoria, Australia: (1) the Early Psychosis Prevention and Intervention Centre, an early intervention service for first-episode psychosis; and (2) the Helping Young People Early Clinic, an early intervention service for borderline personality disorder. The feasibility, acceptability, and safety of eOrygen were evaluated via an uncontrolled single-group study. Repeated measures 2-tailed t tests assessed changes in clinical and psychosocial outcomes between before and after the intervention (3 months). Eight semistructured qualitative interviews were conducted with the young people, and 3 focus groups, attended by 15 (83%) of the 18 clinicians, were conducted after the intervention. RESULTS: eOrygen was found to be feasible, acceptable, and safe. Feasibility was established owing to a low refusal rate of 25% (15/59) and by exceeding our goal of young people recruited to the study per clinician. Acceptability was established because 93% (22/24) of the young people reported that they would recommend eOrygen to others, and safety was established because no adverse events or unlawful entries were recorded and there were no worsening of clinical and social outcome measures. Interviews with the young people identified facilitators to engagement such as peer support and personalized therapy content, as well as barriers such as low motivation, social anxiety, and privacy concerns. The clinician focus groups identified evidence-based content as an implementation facilitator, whereas a lack of familiarity with the platform was identified as a barrier owing to clinicians' competing priorities, such as concerns related to risk and handling acute presentations, as well as the challenge of being understaffed. CONCLUSIONS: eOrygen as a blended transdiagnostic intervention has the potential to increase therapeutic continuity, engagement, alliance, and intensity. Future research will need to establish the effectiveness of blended models of care for young people with complex mental health conditions and determine how to optimize the implementation of such models into specialized services.

Asunto(s)

RESUMEN

Background: Internet-based interventions offer a way to meet the high demand for psychological support. However, this setting also has disadvantages, such as the lack of personal contact and the limited ability to respond to crises. Blended care combines Internet-based interventions with face-to-face psychotherapy and merges the benefits of both settings. To ensure the uptake of blended care in routine care, Internet-based interventions need to be suitable for different therapeutic approaches and mental disorders. Objective: This paper describes the participatory development process of the Internet-based intervention "TONI" using a common therapeutic language and content on various transdiagnostic topics to be integrated into routine outpatient psychotherapy. Methods: To develop this intervention in a participatory manner, we followed the Integrate, Design, Assess, and Share (IDEAS) framework. In a multilevel development process, we used a combination of interviews, focus groups, and proofreading to optimally tailor online modules to routine outpatient psychotherapy. Building on well-established cognitive-behavioral online content, we included expert interviews with psychodynamic (n = 20) and systemic psychotherapists (n = 9) as well as focus groups with psychotherapists of different approaches (n = 10) and persons with lived experience of mental illness (PWLE; n = 10). Results: We describe the development process of TONI step-by-step, outlining the specific requirements that therapists from different therapeutic approaches as well as PWLE have and how we implemented them in our intervention. This includes the content and specific exercises in the online modules, aspects of data protection, language, design, and usability. Conclusion: Internet-based interventions that use a common therapeutic language and address therapeutic principles across different approaches have the potential to advance digitalization in psychotherapy. Involving psychotherapists and PWLE in intervention development may positively impact acceptance and usage in practice. This study shows how participatory intervention development involving both psychotherapists and PWLE can be carried out.

RESUMEN

BACKGROUND: The majority of stroke survivors experience long-term impairments. Regular physical activity and other lifestyle modifications play an important role in rehabilitation. Outpatient rehabilitation using telemedicine might be suitable to improve functional ability and long-term secondary prevention. The Strokecoach Intervention Program (SIP, Strokecoach GmbH, Cologne, Germany) comprises training, coaching and monitoring with the aim of improving or at least maintaining functional independence and preventing further stroke through more targeted physical activity. The SIP is provided as blended care, which refers to the integrated and coordinated delivery of healthcare services that combines traditional in-person interactions with technology-mediated interventions, optimizing the use of both face-to-face and virtual modalities to enhance patient outcomes. OBJECTIVE: The aim of this study was to evaluate the acceptance of the SIP by the participants and its practical application, as well as to obtain initial indications of effects of the SIP on the basis of patient-related outcome measures, blood pressure measurements and recording of physical activity in parallel with the intervention. METHODS: Data from individuals with stroke participating in the SIP were analyzed retrospectively. Within the SIP, participants received an application-based training program, were instructed to measure their blood pressure daily and to wear an activity tracker (pedometer). During the intervention period of either 6 or 12 weeks, the participants were supported and motivated by a personal coach via a messenger application. The primary outcomes of the analysis were recruitment, acceptance of and satisfaction with the SIP. Secondary outcomes included functional measures, mobility and health-related quality of life. RESULTS: A total of 122 individuals with stroke could be recruited for the SIP. A total of 96 out of 122 were able to start the program (54% female, mean age 54.8 (SD = 13.1), 6.1 (SD = 6.6) years after stroke onset) and 88 completed the SIP. Participants wore the activity tracker on 66% and tracked their blood pressure on 72% of their intervention days. A further analyzed subgroup of 38 participants showed small improvements in patient-reported outcomes such as health-related quality of life (SF-36) with an increase of 12 points in the subdomain mental health, vitality (12.6) and physical functioning (9.1). However, no statistically significant improvements were found in other performance-based measures (Timed Up and Go test, gait speed). CONCLUSIONS: This study showed that a blended therapy approach for stroke survivors with mild to moderate impairments in the chronic phase is feasible and was highly accepted by participants, who benefitted from the additional coaching.

RESUMEN

OBJECTIVE: Few evidence-based interventions addressing high levels of fear of cancer recurrence (FCR) have been implemented. Understanding how these might be implemented is crucial to bridge the research-practice gap. This study investigated the feasibility of implementing the blended Survivors' Worries of Recurrent Disease (SWORD) intervention in real-world psycho-oncology practice. METHODS: SWORD was offered for 15 months (2021-2022) as the standard care for clinical FCR in a university hospital, a general hospital, and psycho-oncological center. We evaluated using a mixed-methods design six feasibility outcomes based on Bowen's framework: demand, limited effectiveness, degree of execution, acceptability, practicality, and integration. Anonymous data were collected for all oncology patients on referral. Study participants completed questionnaires before and after treatment, including the Cancer Worry Scale (CWS-6) as the primary measure of effectiveness. Qualitative data included interviews with patients and psychologists, and field notes. RESULTS: Regarding demand, 81 of 644 patients referred (13%) were eligible for SWORD. The uptake of SWORD was 79% (n = 63/80) and the completion rate 73% (n = 46/63). SWORD was effective in reducing FCR (p < 0.001, ηp2  = 0.694). Regarding execution, a variability in the length, planning and number of treatment sessions was found between different settings. Adherence to the treatment manual's content was high (89%). Regarding acceptability, most patients were satisfied with SWORD (average 8.2/10) and psychologists valued the blended format. Psychologists reported SWORD was practical to deliver given their knowledge and skills. Although differences between settings were found, SWORD integrated well into practice. Referral for FCR and a reluctance to contract new eHealth providers were barriers for implementation. CONCLUSIONS: Despite differences between healthcare settings, the implementation of SWORD was evaluated well. The feasibility of SWORD in different settings should inform a national implementation strategy.

Asunto(s)

RESUMEN

BACKGROUND: Refugees are at high risk for developing mental illnesses. Due to language and cultural barriers, there is need for specifically adapted therapeutic procedures for refugees in inpatient mental health care settings. Internet-based applications in refugee mother tongues have the potential to improve the outcomes of mental health care for this vulnerable population. The key research question of the present implementation study is whether the newly developed "blended ALMAMAR" app for Arabic and Farsi speaking refugees in Germany is used and accepted by patients and professionals in routine inpatient mental health care (blended care). METHODS: We present the design of an observational, prospective multicenter implementation study in eight psychiatric hospitals. We plan to recruit 100 Farsi or Arabic speaking refugees receiving in-patient treatment due to depression, anxiety disorder, posttraumatic stress disorder or substance use disorders. These patients will get access to the "blended ALMAMAR" app during their inpatient stay in a blended-care approach. We will assess the usage (e.g., duration and frequency of use of the app) as well as subjective acceptability and usability of the intervention. To identify sociodemographic and clinical factors associated with "blended ALMAMAR" usage, we will also perform clinical and questionnaire assessments. DISCUSSION: The newly developed "blended ALMAMAR" app may help to close communication gaps for the hard-to reach and vulnerable group of refugees in inpatient mental health care. It is the first blended-care intervention that addresses severely mentally ill refugees in an inpatient psychiatric setting in Germany. TRIAL REGISTRATION: The trial was registered in the German Clinical Trials Register on November 11, 2021 (DRKS00025972) and adapted on November 14, 2023.

Asunto(s)

RESUMEN

In this paper, we present m-Path (www.m-Path.io), an online platform that provides an easy-to-use and highly tailorable framework for implementing smartphone-based ecological momentary assessment (EMA) and intervention (EMI) in both research and clinical practice in the context of blended care. Because real-time monitoring and intervention in people's everyday lives have unparalleled benefits compared to traditional data collection techniques (e.g., retrospective surveys or lab-based experiments), EMA and EMI have become popular in recent years. Although a surge in the use of these methods has led to a myriad of EMA and EMI applications, many existing platforms only focus on a single aspect of daily life data collection (e.g., assessment vs. intervention, active self-report vs. passive mobile sensing, research-dedicated vs. clinically-oriented tools). With m-Path, we aim to integrate all of these facets into a single platform, as it is exactly this all-in-one approach that fosters the clinical utility of accumulated scientific knowledge. To this end, we offer a comprehensive platform to set up complex and highly adjustable EMA and EMI designs with advanced functionalities, using an intuitive point-and click web interface that is accessible for researchers and clinicians with limited programming skills. We discuss the strengths of daily life data collection and intervention in general and m-Path in particular. We describe the regular workflow to set up an EMA or EMI design within the m-Path framework, and summarize both the basic functionalities and more advanced features of our software.

RESUMEN

BACKGROUND: Nonspecific low back pain (LBP) is a leading contributor to disability worldwide, and its socioeconomic burden is substantial. Self-management support is an important recommendation in clinical guidelines for the physiotherapy treatment of patients with LBP and may support cost-effective management. However, providing adequate individually tailored self-management support is difficult. The integration of web-based applications into face-to-face care (ie, blended care) seems promising to optimize tailored treatment and enhance patients' self-management and, consequently, may reduce LBP-related costs. OBJECTIVE: We aimed to evaluate the long-term effectiveness and cost-effectiveness of stratified blended physiotherapy (e-Exercise LBP) compared with face-to-face physiotherapy in patients with nonspecific LBP. METHODS: An economic evaluation was conducted alongside a prospective, multicenter, cluster randomized controlled trial in primary care physiotherapy. Patients with nonspecific LBP were treated with either stratified blended physiotherapy (e-Exercise LBP) (n=104) or face-to-face physiotherapy (n=104). The content of both interventions was based on the Dutch physiotherapy guidelines for nonspecific LBP. Blended physiotherapy was stratified according to the patients' risk of developing persistent LBP using the STarT Back Screening Tool. The primary clinical outcome was physical functioning (Oswestry Disability Index version 2.1a). For the economic evaluation, quality-adjusted life years (QALYs; EQ-5D-5L) and physical functioning were the primary outcomes. Secondary clinical outcomes included fear avoidance beliefs and self-reported adherence. Costs were measured from societal and health care perspectives using self-report questionnaires. Effectiveness was estimated using linear mixed models. Seemingly unrelated regression analyses were conducted to estimate total cost and effect differences for the economic evaluation. RESULTS: Neither clinically relevant nor statistically substantial differences were found between stratified blended physiotherapy and face-to-face physiotherapy regarding physical functioning (mean difference [MD] -1.1, 95% CI -3.9 to 1.7) and QALYs (MD 0.026, 95% CI -0.020 to 0.072) over 12 months. Regarding the secondary outcomes, fear avoidance beliefs showed a statistically significant improvement in favor of stratified blended physiotherapy (MD -4.3, 95% CI -7.3 to -1.3). Societal and health care costs were higher for stratified blended physiotherapy than for face-to-face physiotherapy, but the differences were not statistically significant (societal: €972 [US $1027], 95% CI -€1090 to €3264 [US -$1151 to $3448]; health care: €73 [US $77], 95% CI -€59 to €225 [US -$62 to $238]). Among the disaggregated cost categories, only unpaid productivity costs were significantly higher for stratified blended physiotherapy. From both perspectives, a considerable amount of money must be paid per additional QALY or 1-point improvement in physical functioning to reach a relatively low to moderate probability (ie, 0.23-0.81) of stratified blended physiotherapy being cost-effective compared with face-to-face physiotherapy. CONCLUSIONS: The stratified blended physiotherapy intervention e-Exercise LBP is neither more effective for improving physical functioning nor more cost-effective from societal or health care perspectives compared with face-to-face physiotherapy for patients with nonspecific LBP. TRIAL REGISTRATION: ISRCTN 94074203; https://www.isrctn.com/ISRCTN94074203. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12891-020-3174-z.

Asunto(s)

RESUMEN

BACKGROUND: Common challenges in the youth mental health system include low access, poor uptake, poor adherence, and limited overall effectiveness. Digital technologies offer promise, yet challenges in real-world integration and uptake persist. Moderated Online Social Therapy (MOST) aims to overcome these problems by integrating a comprehensive digital platform into existing youth mental health services. Theory of change (ToC) frameworks can help articulate how and why complex interventions work and what conditions are required for success. OBJECTIVE: The objective of this study is to create a ToC for MOST to explain how it works, why it works, who benefits and how, and what conditions are required for its success. METHODS: We used a multimethod approach to construct a ToC for MOST. The synthesis aimed to assess the real-world impact of MOST, a digital platform designed to enhance face-to-face youth mental health services, and to guide its iterative refinement. Data were gathered from 2 completed and 4 ongoing randomized controlled trials, 11 pilot studies, and over 1000 co-design sessions using MOST. Additionally, published qualitative findings from diverse clinical contexts and a review of related digital mental health literature were included. The study culminated in an updated ToC framework informed by expert feedback. The final ToC was produced in both narrative and table form and captured components common in program logic and ToC frameworks. RESULTS: The MOST ToC captured several assumptions about digital mental health adoption, including factors such as the readiness of young people and service providers to embrace digital platforms. External considerations included high service demand and a potential lack of infrastructure to support integration. Young people and service providers face several challenges and pain points MOST seeks to address, such as limited accessibility, high demand, poor engagement, and a lack of personalized support. Self-determination theory, transdiagnostic psychological treatment approaches, and evidence-based implementation theories and their associated mechanisms are drawn upon to frame the intervention components that make up the platform. Platform usage data are captured and linked to short-, medium-, and long-term intended outcomes, such as reductions in mental health symptoms, improvements in functioning and quality of life, reductions in hospital visits, and reduced overall mental health care costs. CONCLUSIONS: The MOST ToC serves as a strategic framework for refining MOST over time. The creation of the ToC helped guide the development of therapeutic content personalization, user engagement enhancement, and clinician adoption through specialized implementation frameworks. While powerful, the ToC approach has its limitations, such as a lack of standardized methodology and the amount of resourcing required for its development. Nonetheless, it provides an invaluable roadmap for iterative development, evaluation, and scaling of MOST and offers a replicable model for other digital health interventions aiming for targeted, evidence-based impact.

RESUMEN

BACKGROUND: Despite preventive measures, the number of people with type 2 diabetes and obesity is increasing. Obesity increases morbidity and mortality in people with type 2 diabetes, making weight loss a cornerstone of treatment. We previously developed a very low energy diet (VLED) intervention that effectively reduced weight in people with type 2 diabetes in the long term. However, this intervention requires considerable time and manpower, which reduces the number of people who can benefit from it. eHealth offers more efficient solutions but has proven to be less effective than face-to-face interventions. Therefore, we want to investigate whether a blended version of our VLED intervention (in which face-to-face contact is partly replaced by an eHealth (mobile) application (E-VLED)) would be more cost-effective than the current face-to-face intervention. METHODS: We will conduct a randomised, controlled trial with non-inferiority design in patients with type 2 diabetes and obesity (BMI > 30 kg/m2), aged 18-75 years. The control group will receive the usual care VLED intervention, while the intervention group will receive the E-VLED intervention for 1 year, where face-to-face contact will be partly replaced by an eHealth (mobile) application. The main study endpoint is the difference in weight (% change) between the control and intervention group after 1 year, plus the difference between the total costs (euro) of the treatment in the control and intervention groups. The secondary aims are to investigate the effectiveness of the E-VLED diet intervention regarding cardiovascular risk factors, quality of life, patient satisfaction, compliance, and to study whether there is a difference in effectiveness in pre-specified subgroups. General linear models for repeated measurements will be applied for the statistical analysis of the data. DISCUSSION: We hypothesise that the E-VLED intervention will be equally effective compared to the usual care VLED but lower in costs due to less time invested by the dietician. This will enable to help more people with type 2 diabetes and obesity to effectively lose weight and improve their health-related quality of life. TRIAL REGISTRATION: Netherlands Trial Register, NL7832, registered on 26 June 2019.

Asunto(s)

RESUMEN

BACKGROUND: Despite the availability of a wide variety of evidence-based treatments for major depressive disorder (MDD), many patients still experience impairments in their lives after remission. Programs are needed that effectively support patients in coping with these impairments. The program Storytelling and Training to Advance Individual Recovery Skills (STAIRS) was developed to address this need and combines the use of peer contact, expert-by-experience guidance, family support and professional blended care. The aim of the planned study is (1) to assess the efficacy of the STAIRS program in patients with remitted MDD, (2) to investigate patients' subjective experiences with STAIRS, and (3) to evaluate the program's cost-effectiveness. METHODS: A concurrent mixed-methods randomized controlled trial design will be used. Patients aged between 18 and 65 years with remitted MDD (N = 140) will be randomized to either a group receiving care as usual (CAU) + the STAIRS-program or a control group receiving CAU + some basic psychoeducation. Quantitative efficacy data on functional and personal recovery and associated aspects will be collected using self-report questionnaires at the start of the intervention, immediately following the intervention, and at the six-month follow-up. Insights into patients' experiences on perceived effects and the way in which different program elements contribute to this effect, as well as the usability and acceptability of the program, will be gained by conducting qualitative interviews with patients from the experimental group, who are selected using maximum variation sampling. Finally, data on healthcare resource use, productivity loss and quality of life will be collected and analysed to assess the cost-effectiveness and cost-utility of the STAIRS-program. DISCUSSION: Well-designed recovery-oriented programs for patients suffering from MDD are scarce. If efficacy and cost-effectiveness are demonstrated with this study and patients experience the STAIRS program as usable and acceptable, this program can be a valuable addition to CAU. The qualitative interviews may give insights into what works for whom, which can be used to promote implementation. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov on 1 July 2021, registration number NCT05440812.

Asunto(s)

RESUMEN

BACKGROUND: Digital formats have the potential to enhance accessibility to care for individuals with suicidal ideation. However, digital self-help interventions have faced limitations, including small effect sizes in reducing suicidal ideation, low adherence, and safety concerns. OBJECTIVE: Therefore, we aimed to develop a remote blended cognitive behavioral therapy intervention that specifically targets suicidal ideation by blending video therapy with web-based self-help modules. The objective of this paper is to describe the collaborative development process and the resulting intervention and treatment rationale. METHODS: First, we compiled intervention components from established treatment manuals designed for people with suicidal ideation or behavior, resulting in the development of 11 drafts of web-based modules. Second, we conducted a qualitative study, involving 5 licensed psychotherapists and 3 lay counselors specialized in individuals with suicidal ideation who reviewed these module drafts. Data were collected using the think-aloud method and semistructured interviews, and a qualitative content analysis was performed. The 4 a priori main categories of interest were blended care for individuals with suicidal ideation, contents of web-based modules, usability of modules, and layout. Subcategories emerged inductively from the interview transcripts. Finally, informed by previous treatment manuals and qualitative findings, we developed the remote blended treatment program. RESULTS: The participants suggested that therapists should thoroughly prepare the web-based therapy with patients to tailor the therapy to each individual's needs. Participants emphasized that the web-based modules should explain concepts in a simple manner, convey empathy and validation, and include reminders for the safety plan. In addition, participants highlighted the need for a simple navigation and layout. Taking these recommendations into account, we developed a fully remote blended cognitive behavioral therapy intervention comprising 12 video therapy sessions and up to 31 web-based modules. The treatment involves collaboratively developing a personalized treatment plan to address individual suicidal drivers. CONCLUSIONS: This remote treatment takes advantage of the high accessibility of digital formats while incorporating full sessions with a therapist. In a subsequent pilot trial, we will seek input from individuals with lived experience and therapists to test the feasibility of the treatment.

RESUMEN

Compassion-focused interventions represent a promising transdiagnostic approach, but the mechanisms involved in hybrid delivery combining face-to-face sessions and an ecological momentary intervention remain unexplored. The current study aimed at exploring associations of putative mechanisms with clinical outcomes at post-intervention/follow-up and mediation of outcome at follow-up by preceding pre-to post-intervention changes in putative mechanisms. The compassion-focused EMIcompass intervention was applied in an exploratory randomized controlled trial (treatment as usual (TAU) vs. TAU + EMIcompass) with youth with early mental health problems. Data was collected before randomization, at post-intervention and at four-week follow-up. We recruited N = 92 participants, N = 46 were allocated to the experimental condition. After control for baseline levels of the target outcomes, baseline-to post-intervention improvement in adaptive emotion regulation was associated with lower levels of clinical outcomes (e.g. psychological distress b = -1.15; 95%CI = -1.92 to -0.39) across time points. We could not detect indirect effects, but we observed associations of change in self-compassion and adaptive emotion regulation with outcomes at follow-up in the mediation analysis (e.g., ß = -0.35, 95%CI = -0.52 to -0.16). If successfully targeted by interventions, self-compassion and emotion regulation may be promising putative therapeutic mechanisms of change.

Asunto(s)

RESUMEN

BACKGROUND: Informal caregivers of people with dementia are crucial in dementia care. However, they are insufficiently supported and report caregiver burdens, which urges the need for cost-effective interventions aimed at supporting caregivers. This paper presents the design of a study evaluating the effectiveness, cost-effectiveness, and cost-utility of a blended self-management program for early-stage dementia caregivers. METHODS/DESIGN: A pragmatic, cluster randomized controlled trial with a shared control group will be conducted. Participants will be informal caregivers of people with early-stage dementia and will be recruited by local care professionals. Randomization will be carried out at the level of the care professional level in a ratio of 35% to 65% (control arm vs. intervention arm). Participants in the control arm will receive care as usual and the intervention arm will receive the blended care self-management program "Partner in Balance" within a usual care setting in the Netherlands. Data will be collected at baseline and at 3-, 6-, 12-, and 24-month follow-ups. The primary outcome for effectiveness (part 1) is care management self-efficacy. For the health-economic evaluation (part 2) total care costs and the quality of life for individuals with dementia (cost-effectiveness) and quality-adjusted life years (cost-utility) will be the base case analysis. Secondary outcomes (parts 1 and 2) will include depression, anxiety, perceived informal caregiving stress, service-use self-efficacy, quality of life, caregivers' gain, and perseverance time. A process evaluation (part 3) will investigate the internal and external validity of the intervention. DISCUSSION: In this trial, we plan to evaluate the effectiveness, cost-effectiveness, and cost-utility of "Partner in Balance" among informal caregivers of people with dementia. We expect to find a significant increase in care management self-efficacy, and the program to be cost-effective, and provide valuable insights to stakeholders of "Partner in Balance." TRIAL REGISTRATION: ClinicalTrials.gov, NCT05450146. Registered on 4 November 2022.

Asunto(s)

RESUMEN

INTRODUCTION: Appropriate treatment for people with an increased risk for developing chronic Persistent Somatic Symptoms (PSS) is of great importance at an early stage to improve quality of life and prevent high costs for society. OBJECTIVE: To evaluate the cost-effectiveness of an integrated blended care intervention compared to usual care for QALYs, subjective symptom impact and physical and mental health status in patients with moderate PSS. METHODS: This economic evaluation was conducted alongside a 12-month prospective, multicenter cluster randomized controlled trial in Dutch primary care. 80 participants received the intervention and 80 participants received usual care. Seemingly unrelated regression analyzes were performed to estimate cost and effect differences. Missing data were imputed using multiple imputation. Bootstrapping techniques were used to estimate uncertainty. RESULTS: We found no significant difference in total societal costs. Intervention, primary and secondary healthcare and absenteeism costs were higher for the intervention group. The ICER for QALYs demonstrated the intervention was on average less costly and less effective compared to usual care. For the subjective symptom impact and physical health, the ICER indicated that the intervention group was on average less costly and more effective. For mental health, the intervention was on average more costly and less effective. CONCLUSION: We didn't find an integrated blended primary care intervention to be cost-effective compared to usual care. However, when looking on relevant, but specific outcome measures (subjective symptom impact and physical health) for this population, average costs are found to be lower and the effectiveness found to be higher.

Asunto(s)

RESUMEN

BACKGROUND: Antisocial behavior during adolescence can have long-lasting negative effects and leads to high societal costs. Forensic Outpatient Systemic Therapy (Forensische Ambulante Systeem Therapie; FAST) is a promising treatment for juveniles aged 12-21 showing severe antisocial behavior. The intensity, content and duration of FAST can be adjusted to the needs of the juvenile and their caregiver(s), which is considered crucial for effective treatment. Next to the regular version of FAST (FASTr), a blended version (FASTb) in which face-to-face contacts are replaced by minimally 50% online contacts over the duration of intervention was developed during the Covid-19 pandemic. The current study will investigate whether FASTb is equally effective as FASTr, and through which mechanisms of change, for whom, and under which conditions FASTr and FASTb work. METHODS: A randomized controlled trial (RCT) will be carried out. Participants (N = 200) will be randomly assigned to FASTb (n = 100) or FASTr (n = 100). Data collection will consist of self-report questionnaires and case file analysis, and include a pre-test at the start of the intervention, a post-test immediately after the intervention, and a six month follow-up. Mechanisms of change will be investigated using monthly questionnaires of key variables during treatment. Official recidivism data will be collected at two-year follow-up. DISCUSSION: This study aims to improve the effectiveness and quality of forensic mental health care for juveniles with antisocial behavior by studying the effectiveness of blended care, which has not been studied before in treatment of externalizing behavior. If found to be at least as effective as face-to-face treatment, blended treatment can help meet the urgent need for more flexible and efficient interventions in this field. In addition, the proposed study aims to unravel what works for whom, knowledge urgently needed in mental health care for juveniles with severe antisocial behavior. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov on 07/11/2022, registration number NCT05606978.

Asunto(s)

RESUMEN

OBJECTIVE: Integrating digital technologies with clinical practice promises to improve access and enhance care in the context of high service demand and constrained capacity. METHOD: We outline the emerging research in the integration of digital tools in clinical care, known as blended care, and provide case examples of mental health technology platforms currently in use, summarise findings regarding novel technologies such as virtual reality, and outline real-world implementation challenges and potential solutions. RESULTS: Recent evidence shows that blended care approaches are clinically effective and improve service efficiency. Youth-specific technologies such as moderated online social therapy (MOST) are achieving a range of positive clinical and functional outcomes, while emerging technologies like virtual reality have strong evidence in anxiety disorder, and accumulating evidence in psychotic conditions. Implementation science frameworks show promise in helping overcome the common challenges faced in real-world adoption and ongoing use. CONCLUSION: The integrated, blended use of digital mental health technologies with face-to-face clinical care has the potential to improve care quality for young people while helping overcome the growing challenges faced by youth mental health service providers.

Asunto(s)