Von der Evaluation zur Implementation: Vier Studien zu internetbasierter Selbsthilfe im Kontext psychischer Gesundheit

In der vorliegenden Dissertation werden vier Artikel vorgestellt, welche nach dem Model of Assessment of Telemedicine applications (MAST)-Konzept kategorisiert wurden. Das MAST-Konzept stellt ein gut fundiertes Modell dar, um die Implementierung von digitalen Behandlungen zu strukturieren und multidisziplinär zu evaluieren. Studie 1 untersucht im primären Versorgungsnetz die Wirksamkeit eines ungeleiteten Selbsthilfe-Programms in Kombination mit Care as Usual (CAU) bei verschiedenen Angststörungen. Studie 2 geht der Frage nach, ob eine internetbasierte, kognitiv-behaviorale Therapie (ICBT) als Ergänzung zu einer regulären Psychotherapie bei klinisch depressiven Personen einen zusätzlichen Nutzen liefert. Studie 3 evaluiert anhand halb-standardisierter Interviews bei depressiven Patienten, welche subjektiven Vor- als auch Nachteile einer kombinierten Therapie (blended treatment), bestehend aus internetbasierter Therapie und Face-to-Face (FtF)-Therapie, im sekundären Versorgungsnetz wahrgenommen werden. Studie 4 erhebt mittels einer Onlinebefragung innerhalb verschiedener europäischer Interessenvertreter den Stand des vorhandenen Wissens, der Empfehlungen und Erwartungen an internetbasierte Therapien sowie an Kombinationsbehandlungen für depressive Patienten. Nach einer Einführung ins Themengebiet werden die einzelnen Artikel zusammenfassend dargestellt und kritisch reflektiert. Auf der Grundlage der Resultate der einzelnen Studien werden Möglichkeiten und Grenzen internetbasierter Interventionen im Gesundheitssystem diskutiert. In ihrer Gesamtheit liefern die Studien einen wichtigen Beitrag zur Frage der Effektivität und der Implementierung von internetbasierten Interventionen im Gesundheitswesen und zeigen auf, dass internetbasierte Ansätze eine vielversprechende Möglichkeit darstellen, die Gesundheitsversorgung zu ergänzen.The present doctoral thesis focuses on four articles, which were categorized on the basis of the Model of Assessment of Telemedicine applications (MAST). The MAST concept points out a profound concept to multidisciplinary evaluation and a structural implementation of digital treatments in mental health. Study 1 investigated whether care as usual (CAU) plus unguided internet-based cognitive behavior therapy (ICBT) is effective for anxiety disorders compared to CAU only, when delivered in primary care. Study 2 examined the question of whether web-based interventions, when used as adjunctive treatment tools to regular psychotherapy, have an additional effect compared to regular psychotherapy for depression. Study 3 evaluates by means of a content analysis the perceived advantages and disadvantages of blended treatments in depression, a combination of ICBT and face-to-face (FtF) treatment, from the patients’ perspective in specialized mental health care in Switzerland. Study 4 evaluated in a survey aimed to exploring stakeholders’ knowledge, acceptance and expectations of digital treatments for depression. After an introduction in the thematic field, the individual articles will be described and critically reflected in more detail. Possibilities and limits of ICBT in mental health care are discussed based on the results of the four presented articles. Taken together, the results of the studies provide an important contribution with regard to the effectiveness and the implementation of ICBT in healthcare and revealed that ICBT is a promising opportunity to complement mental healthcare

An Exploratory Pilot Study

While mental health treatments have proven to be effective for a range of mental health problems, there is comparably little research on its effects on personality disorders or difficulty (PD). New dimensional conceptualizations of PD such as the ICD-11 PD model enable the cost- and time-effective dimensional assessment of severity and style of PD. Furthermore, they constitute a promising tool to investigate PD, not only as a treatment endpoint but also as a predictive or influencing factor for mental health treatments. In this study, we investigated the effects in two different mental health treatment settings [online (N = 38); face-to-face and blended [FTF/blended] (N = 35)] on the reduction of maladaptive personality traits as well as the interaction between maladaptive personality patterns and the response on primary endpoints (i.e., mental distress). Results indicate that both treatment settings have comparable within-group effects on the reduction of distress symptoms, while the treatment in the FTF/blended setting seems to have a stronger impact on the reduction of maladaptive traits. Further, reduction of maladaptive trait expressions was a reliable predictor of treatment response in the FTF/blended setting while explaining less variance in the online setting. Beyond the promising findings on the utility of maladaptive trait change as an outcome measure, we discuss possible applications as an information source for treatment decisions

Attitudes towards digital treatment for depression: A European stakeholder survey

The integration of digital treatments into national mental health services is on the agenda in the European Union. The E-COMPARED consortium conducted a survey aimed at exploring stakeholders' knowledge, acceptance and expectations of digital treatments for depression, and at identifying factors that might influence their opinions when considering the implementation of these approaches. An online survey was conducted in eight European countries: France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland and The United Kingdom. Organisations representing government bodies, care providers, service-users, funding/insurance bodies, technical developers and researchers were invited to participate in the survey. The participating countries and organisations reflect the diversity in health care infrastructures and e-health implementation across Europe. A total of 764 organisations were invited to the survey during the period March–June 2014, with 175 of these organisations participating in our survey. The participating stakeholders reported moderate knowledge of digital treatments and considered cost-effectiveness to be the primary incentive for integration into care services. Low feasibility of delivery within existing care services was considered to be a primary barrier. Digital treatments were regarded more suitable for milder forms of depression. Stakeholders showed greater acceptability towards blended treatment (the integration of face-to-face and internet sessions within the same treatment protocol) compared to standalone internet treatments. Organisations in countries with developed e-health solutions reported greater knowledge and acceptability of digital treatments. Mental health stakeholders in Europe are aware of the potential benefits of digital interventions. However, there are variations between countries and stakeholders in terms of level of knowledge about such interventions and their feasibility within routine care services. The high acceptance of blended treatments is an interesting finding that indicates a gradual integration of technology into clinical practice may fit the attitudes and needs of stakeholders. The potential of the blended treatment approach, in terms of enhancing acceptance of digital treatment while retaining the benefit of cost-effectiveness in delivery, should be further explored. The E-COMPARED project has received funding from the European Union Seventh Framework Programme (FP7/2007–2013) under grant agreement no. 603098

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

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

Examining the Theoretical Framework of Behavioral Activation for Major Depressive Disorder: Smartphone-Based Ecological Momentary Assessment Study.

BACKGROUND: Behavioral activation (BA), either as a stand-alone treatment or as part of cognitive behavioral therapy, has been shown to be effective for treating depression. The theoretical underpinnings of BA derive from Lewinsohn et al's theory of depression. The central premise of BA is that having patients engage in more pleasant activities leads to them experiencing more pleasure and elevates their mood, which, in turn, leads to further (behavioral) activation. However, there is a dearth of empirical evidence about the theoretical framework of BA. OBJECTIVE: This study aims to examine the assumed (temporal) associations of the 3 constructs in the theoretical framework of BA. METHODS: Data were collected as part of the "European Comparative Effectiveness Research on Internet-based Depression Treatment versus treatment-as-usual" trial among patients who were randomly assigned to receive blended cognitive behavioral therapy (bCBT). As part of bCBT, patients completed weekly assessments of their level of engagement in pleasant activities, the pleasure they experienced as a result of these activities, and their mood over the course of the treatment using a smartphone-based ecological momentary assessment (EMA) application. Longitudinal cross-lagged and cross-sectional associations of 240 patients were examined using random intercept cross-lagged panel models. RESULTS: The analyses did not reveal any statistically significant cross-lagged coefficients (all P>.05). Statistically significant cross-sectional positive associations between activities, pleasure, and mood levels were identified. Moreover, the levels of engagement in activities, pleasure, and mood slightly increased over the duration of the treatment. In addition, mood seemed to carry over, over time, while both levels of engagement in activities and pleasurable experiences did not. CONCLUSIONS: The results were partially in accordance with the theoretical framework of BA, insofar as the analyses revealed cross-sectional relationships between levels of engagement in activities, pleasurable experiences deriving from these activities, and enhanced mood. However, given that no statistically significant temporal relationships were revealed, no conclusions could be drawn about potential causality. A shorter measurement interval (eg, daily rather than weekly EMA reports) might be more attuned to detecting potential underlying temporal pathways. Future research should use an EMA methodology to further investigate temporal associations, based on theory and how treatments are presented to patients. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02542891, https://clinicaltrials.gov/ct2/show/NCT02542891; German Clinical Trials Register, DRKS00006866, https://tinyurl.com/ybja3xz7; Netherlands Trials Register, NTR4962, https://www.trialregister.nl/trial/4838; ClinicalTrials.Gov, NCT02389660, https://clinicaltrials.gov/ct2/show/NCT02389660; ClinicalTrials.gov, NCT02361684, https://clinicaltrials.gov/ct2/show/NCT02361684; ClinicalTrials.gov, NCT02449447, https://clinicaltrials.gov/ct2/show/NCT02449447; ClinicalTrials.gov, NCT02410616, https://clinicaltrials.gov/ct2/show/NCT02410616; ISRCTN registry, ISRCTN12388725, https://www.isrctn.com/ISRCTN12388725

Von der Evaluation zur Implementation: Vier Studien zu internetbasierter Selbsthilfe im Kontext psychischer Gesundheit

In der vorliegenden Dissertation werden vier Artikel vorgestellt, welche nach dem Model of Assessment of Telemedicine applications (MAST)-Konzept kategorisiert wurden. Das MAST-Konzept stellt ein gut fundiertes Modell dar, um die Implementierung von digitalen Behandlungen zu strukturieren und multidisziplinär zu evaluieren. Studie 1 untersucht im primären Versorgungsnetz die Wirksamkeit eines ungeleiteten Selbsthilfe-Programms in Kombination mit Care as Usual (CAU) bei verschiedenen Angststörungen. Studie 2 geht der Frage nach, ob eine internetbasierte, kognitiv-behaviorale Therapie (ICBT) als Ergänzung zu einer regulären Psychotherapie bei klinisch depressiven Personen einen zusätzlichen Nutzen liefert. Studie 3 evaluiert anhand halb-standardisierter Interviews bei depressiven Patienten, welche subjektiven Vor- als auch Nachteile einer kombinierten Therapie (blended treatment), bestehend aus internetbasierter Therapie und Face-to-Face (FtF)-Therapie, im sekundären Versorgungsnetz wahrgenommen werden. Studie 4 erhebt mittels einer Onlinebefragung innerhalb verschiedener europäischer Interessenvertreter den Stand des vorhandenen Wissens, der Empfehlungen und Erwartungen an internetbasierte Therapien sowie an Kombinationsbehandlungen für depressive Patienten. Nach einer Einführung ins Themengebiet werden die einzelnen Artikel zusammenfassend dargestellt und kritisch reflektiert. Auf der Grundlage der Resultate der einzelnen Studien werden Möglichkeiten und Grenzen internetbasierter Interventionen im Gesundheitssystem diskutiert. In ihrer Gesamtheit liefern die Studien einen wichtigen Beitrag zur Frage der Effektivität und der Implementierung von internetbasierten Interventionen im Gesundheitswesen und zeigen auf, dass internetbasierte Ansätze eine vielversprechende Möglichkeit darstellen, die Gesundheitsversorgung zu ergänzen.The present doctoral thesis focuses on four articles, which were categorized on the basis of the Model of Assessment of Telemedicine applications (MAST). The MAST concept points out a profound concept to multidisciplinary evaluation and a structural implementation of digital treatments in mental health. Study 1 investigated whether care as usual (CAU) plus unguided internet-based cognitive behavior therapy (ICBT) is effective for anxiety disorders compared to CAU only, when delivered in primary care. Study 2 examined the question of whether web-based interventions, when used as adjunctive treatment tools to regular psychotherapy, have an additional effect compared to regular psychotherapy for depression. Study 3 evaluates by means of a content analysis the perceived advantages and disadvantages of blended treatments in depression, a combination of ICBT and face-to-face (FtF) treatment, from the patients’ perspective in specialized mental health care in Switzerland. Study 4 evaluated in a survey aimed to exploring stakeholders’ knowledge, acceptance and expectations of digital treatments for depression. After an introduction in the thematic field, the individual articles will be described and critically reflected in more detail. Possibilities and limits of ICBT in mental health care are discussed based on the results of the four presented articles. Taken together, the results of the studies provide an important contribution with regard to the effectiveness and the implementation of ICBT in healthcare and revealed that ICBT is a promising opportunity to complement mental healthcare

An Integrative Neuro-Psychotherapy Treatment to Foster the Adjustment in Acquired Brain Injury Patients—A Randomized Controlled Study

Adjustment disorders (AjD) with depressive symptoms following an acquired brain injury (ABI) is a common phenomenon. Although brain injuries are increasing more and more, research on psychological therapies is comparably scarce. The present study compared, by means of a randomized controlled trial (RCT), a newly developed integrative treatment (Standard PLUS) to a standard neuropsychological treatment (Standard). Primary outcomes were depressive symptoms assessed with the Beck Depression Inventory (BDI-II) at post-treatment and 6-month follow-up assessment. In total, 25 patients (80% after a stroke) were randomized to one of the two conditions. Intention-to-treat analyses showed that the two groups did not significantly differ either at post-treatment nor at follow-up assessment regarding depressive symptoms. Both treatments showed large within-group effect sizes on depressive symptoms. Regarding secondary outcomes, patients in the Standard PLUS condition reported more emotion regulation skills at post-assessment than in the control condition. However, this difference was not present anymore at follow-up assessment. Both treatments showed medium to large within-group effects sizes on most measures for patients suffering from an AjD after ABI. More research with larger samples is needed to investigate who profits from which intervention

Virtual reality-based attention bias modification training for social anxiety: A feasibility and proof of concept study

Attention bias modification (ABM) programs have been considered as a promising new approach for the treatment of various disorders, including social anxiety disorder (SAD). However, previous studies yielded ambiguous results regarding the efficacy of ABM in SAD. The present proof-of-concept study investigates the feasibility of a newly developed virtual reality (VR)-based dot-probe training paradigm. It was designed to facilitate attentional disengagement from threatening stimuli in socially anxious individuals (N = 15). The following outcomes were examined: (a) self-reports of enjoyment, motivation, flow, and presence; (b) attentional bias for social stimuli; and (c) social anxiety symptoms. Results showed that ABM training is associated with high scores in enjoyment, motivation, flow, and presence. Furthermore, significant improvements in terms of attention bias and social anxiety symptoms were observed from pre- to follow-up assessment. The study suggests that VR is a feasible and presumably a promising new medium for ABM trainings. Controlled studies will need to be carried out

Evaluating an e-mental health program (“deprexis”) as adjunctive treatment tool in psychotherapy for depression: design of a pragmatic randomized controlled trial

Background Major depressive disorder (MDD) places a significant disease burden on individuals as well as on societies. Several web-based interventions for MDD have shown to be effective in reducing depressive symptoms. However, it is not known whether web-based interventions, when used as adjunctive treatment tools to regular psychotherapy, have an additional effect compared to regular psychotherapy for depression. Methods/design This study is a currently recruiting pragmatic randomized controlled trial (RCT) that compares regular psychotherapy plus a web-based depression program (¿deprexis¿) with a control condition exclusively receiving regular psychotherapy. Adults with a depressive disorder (N?=?800) will be recruited in routine secondary care from therapists over the course of their initial sessions and will then be randomized within therapists to one of the two conditions. The primary outcome is depressive symptoms measured with the Beck Depression Inventory (BDI-II) at three months post randomization. Secondary outcomes include changes on various indicators such as anxiety, somatic symptoms and quality of life. All outcomes are again assessed at the secondary endpoint six months post randomization. In addition, the working alliance and feasibility/acceptability of the treatment condition will be explored. Discussion This is the first randomized controlled trial to examine the feasibility/acceptability and the effectiveness of a combination of traditional face-to-face psychotherapy and web-based depression program compared to regular psychotherapeutic treatment in depressed outpatients in routine care