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Internet-based cognitive behavioral therapy for insomnia (iCBT-I) provides flexibility but requires significant time and includes potentially challenging components such as sleep restriction therapy. This raises questions about its incremental effectiveness compared to less demanding minimal interventions such as sleep hygiene psychoeducation. This study aimed to assess the incremental efficacy of self-guided iCBT-I with optional on-demand feedback for university students with insomnia compared to a single session of digital psychoeducation on sleep hygiene. In a randomized controlled trial, 90 students with insomnia (Insomnia Severity Index ≥10) were randomly allocated to self-help-based iCBT-I (45/90, 50%) or one session of digital sleep hygiene psychoeducation with stimulus control instructions (active control group [aCG]: 45/90, 50%). The self-help-based iCBT-I consisted of 6 sessions on psychoeducation, sleep restriction, and stimulus control, including written feedback on demand from an eCoach. Assessments occurred at baseline (T1), 8 weeks after treatment (T2), and at a 6-month follow-up (T3) via web-based self-assessment and diagnostic telephone interviews. The primary outcome was insomnia severity at T2. Analyses of covariance were conducted in an intention-to-treat sample. Secondary outcomes included diagnoses of insomnia and major depression, sleep quality, sleep efficiency, worrying, recovery experiences, recovery activities, presenteeism, procrastination, cognitive irritation, and recuperation in sleep. There was no difference in insomnia severity at T2 between the iCBT-I group (mean 11.27, SD 5.21) and aCG group (mean 12.36, SD 4.16; F =1.12; P=.29; d=-0.26; 95% CI 0.68 to 0.17). A significant difference emerged at T3 (iCBT-I: mean 9.43, SD 5.36; aCG: mean 12.44, SD 5.39; F =4.72; P=.03), favoring iCBT-I with a medium effect (d=-0.57; 95% CI 1.07 to -0.06). Most secondary outcomes revealed no significant differences between the groups. In total, 51% (23/45) of participants in the iCBT-I group completed all 6 sessions, and 69% (31/45) completed the 4 core sessions. In the short term, students might benefit from low-intensity, easily accessible digital sleep hygiene psychoeducation or iCBT-I. However, it appears that iCBT-I offers superiority over sleep hygiene psychoeducation in the long term. German Clinical Trials Register DRKS00017737; https://drks.de/search/de/trial/DRKS00017737.

Most university students with mental disorders remain untreated. Evaluating the acceptance of intervention targets in mental health treatment, promotion, and prevention, as well as mental health service delivery modes is crucial for reducing potential barriers, increasing healthcare utilization, and efficiently allocating resources in healthcare services. The study aimed to evaluate the acceptance of various intervention targets and delivery modes of mental health care services in German first-year university students. In total, 1,376 first-year students from two German universities from the 2017-2018 multi-center cross-sectional cohort of the StudiCare project, the German arm of the World Mental Health International College Student Survey initiative, completed a web-based survey assessing their mental health. Mental disorder status was based on self-reported data fulfilling the DSM-IV criteria. We report frequencies of accepted delivery modes [categories: group or in-person therapy with on or off campus services, self-help internet- or mobile-based intervention (IMI) with or without coaching, or a combination of a in-person and IMI (blended)]. In a multinomial logistic regression, we estimate correlates of the preference for in-person vs. IMI vs. a combination of both modes (blended) modalities. Additionally, we report frequencies of intervention targets (disorder specific: e.g., social phobia, depressive mood; study-related: test anxiety, procrastination; general well-being: sleep quality, resilience) their association with mental disorders and sex, and optimal combinations of treatment targets for each mental illness. German university students' acceptance is high for in-person (71%-76%), moderate for internet- and mobile-based (45%-55%), and low for group delivery modes (31%-36%). In-person treatment (72%) was preferred over IMI (19%) and blended modalities (9%). Having a mental disorder [odds ratio (OR): 1.56], believing that digital treatments are effective (OR: 3.2), and showing no intention to use services (OR: 2.8) were associated with a preference for IMI compared to in-person modes. Students with prior treatment experience preferred in-person modes (OR: 0.46). In general, treatment targets acceptance was higher among female students and students with mental disorders. However, this was not true for targets with the highest (i.e., procrastination) and the lowest (i.e., substance-use disorder) acceptance. If only two intervention targets were offered, a combination of study-related targets (i.e., procrastination, stress, time management) would reach 85%-88% of the students. In-person services are preferred, yet half of the students consider using IMI, preferably aiming for a combination of at least two study-related intervention targets. Student mental health care services should offer a combination of accepted targets in different delivery modes to maximize service utilization.

IntroductionOnly a minority of people living with mental health problems are getting professional help. As digitalisation moves on, the possibility of providing internet/mobile-based interventions (IMIs) arises. One type of IMIs are fully automated conversational software agents (chatbots). Software agents are computer programs that can hold conversations with a human by mimicking a human conversational style. Software agents could deliver low-threshold and cost-effective interventions aiming at promoting psychological well-being in a large number of individuals. The aim of this trial is to evaluate the clinical effectiveness and acceptance of the brief software agent-based IMI SISU in comparison with a waitlist control group.Methods and analysisWithin a two-group randomised controlled trial, a total of 120 adult participants living with low well-being (Well-being Scale/WHO-5) will be recruited in Germany, Austria and Switzerland. SISU is based on therapeutic writing and acceptance and commitment therapy-based principles. The brief intervention consists of three modules. Participants work through the intervention on 3 consecutive days. Assessment takes place before (t1), during (t2) and after (t3) the interaction with SISU, as well as 4 weeks after randomisation (t4). Primary outcome is psychological well-being (WHO-5). Secondary outcomes are emotional well-being (Flourishing Scale), psychological flexibility (Acceptance and Action Questionnaire-II), quality of life (Assessment of Quality of Life -8D), satisfaction with the intervention (Client Satisfaction Questionnaire-8) and side effects (Inventory for the assessment of negative effectsof psychotherapy). Examined mediators and moderators are sociodemographic variables, personality (Big Five Inventory-10), emotion regulation (Emotion Regulation Questionnaire), alexithymia (Toronto Alexithymia Scale-20), centrality of events (Centrality of Events Scale), treatment expectancies (Credibility Expectancy Questionnaire) and technology alliance (Inventory of Technology Alliance–Online Therapy). Data analysis will be based on intention-to-treat principles. SISU guides participants through a 3-day intervention.Ethics and disseminationThis trial has been approved by the ethics committee of the Ulm University (No. 448/18, 18.02.2019). Results will be submitted for publication in a peer-reviewed journal and presented at conferences.Trial registrationThe trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Trials Register (DRKS): DRKS00016799 (date of registration: 25 April 2019). In case of important protocol modifications, trial registration will be updated. This is protocol version number 1.

Background College is an exciting but also challenging time with an increased risk for mental health issues. Only a minority of the college students concerned get professional help, a problem that might be improvable by internet- and mobile-based interventions (IMIs). However, adherence of IMIs is a concern. While guidance might be a solution, it is resource-intensive, derailing potential implementation on population level. The first aim of this trial is to evaluate the efficacy of the IMI StudiCare Mindfulness (StudiCare-M) for college students with “on demand” and no guidance. The second aim is to examine potential moderators and mediators, contributing to the questions of “how” and “for whom” such interventions work. Methods In this three-armed randomized controlled trial, both an unguided and “guidance on demand” (GoD) condition of StudiCare-M are compared to a waitlist control group. StudiCare-M is based on principles of acceptance and commitment therapy and stress management and consists of 7 modules plus two booster sessions. Participants in the GoD condition may ask their e-coach for support whenever needed. A total of 387 college students with moderate to low mindfulness are recruited at 15+ cooperating universities in Germany, Austria, and Switzerland via circular emails. Assessments take place before as well as 1, 2, and 6 months after randomization. The primary outcome is mindfulness. Secondary outcomes include stress, depression, anxiety, interoception, presenteeism, wellbeing, intervention satisfaction, adherence, and potential side effects. Among examined moderators and mediators are sociodemographic variables, pre-treatment symptomatology, treatment expectancy, self-efficacy, cognitive fusion, emotion regulation, and alexithymia. All data will be analyzed according to intention-to-treat (ITT) principles. Discussion Providing effective interventions to help college students become more resilient can make a valuable contribution to the health and functionality of future society. If effective under the condition of minimal or no guidance, StudiCare-M offers a low-threshold potentially resource-efficient possibility to enhance college student mental health on a population level. Moderation- and mediation analyses will deliver further insights for optimization of target groups and intervention content. Trial registration WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register DRKS00014774 . Registered on 18 May 2018.

BackgroundPrevious studies show that university students experience higher psychological stress than the general population, resulting in increased vulnerability for mental disorders for the student population. Online mindfulness interventions will be delivered to students as a potentially promising and more flexible approach compared to face-to-face interventions with the aim of improving their mental health. This study purposes to investigate the effectiveness of a guided online mindfulness-focused intervention for university students by using both self-reported and psychobiological measures.Methods and analysesIn this multicentre, two-armed randomised controlled trial with a parallel design, a guided version of the online mindfulness-focused intervention ‘StudiCare Mindfulness’ will be compared with a waitlist control group. In total, 120 participants will be recruited at different universities (of Applied Sciences) in (Neu-) Ulm. Data will be assessed prior to randomisation, after eight weeks (post-intervention) and six months after randomisation (follow-up). The primary outcome measure is mindfulness. The secondary outcome measures include depression, anxiety and stress levels, well-being, interoceptive sensibility, emotion regulation and alexithymia. Psychobiological parameters comprise interoceptive accuracy, hair cortisol and FKBP5 genotype. Sociodemographic variables, treatment expectations, side and adverse side effects, as well as intervention satisfaction and adherence will be assessed. All data analyses will be conducted according to the intention-to-treat principle.Ethics and disseminationAll study procedures have been approved by the Ethics Committee of Ulm University (application No. 48/18). The findings will be disseminated widely through peer-reviewed publications and conference presentations.Trial registration numberDRKS00014701.

Background: Physical inactivity is a major contributor to the development and persistence of chronic diseases. Mobile health apps that foster physical activity have the potential to assist in behavior change. However, the quality of the mobile health apps available in app stores is hard to assess for making informed decisions by end users and health care providers. Objective: This study aimed at systematically reviewing and analyzing the content and quality of physical activity apps available in the 2 major app stores (Google Play and App Store) by using the German version of the Mobile App Rating Scale (MARS-G). Moreover, the privacy and security measures were assessed. Methods: A web crawler was used to systematically search for apps promoting physical activity in the Google Play store and App Store. Two independent raters used the MARS-G to assess app quality. Further, app characteristics, content and functions, and privacy and security measures were assessed. The correlation between user star ratings and MARS was calculated. Exploratory regression analysis was conducted to determine relevant predictors for the overall quality of physical activity apps. Results: Of the 2231 identified apps, 312 met the inclusion criteria. The results indicated that the overall quality was moderate (mean 3.60 [SD 0.59], range 1-4.75). The scores of the subscales, that is, information (mean 3.24 [SD 0.56], range 1.17-4.4), engagement (mean 3.19 [SD 0.82], range 1.2-5), aesthetics (mean 3.65 [SD 0.79], range 1-5), and functionality (mean 4.35 [SD 0.58], range 1.88-5) were obtained. An efficacy study could not be identified for any of the included apps. The features of data security and privacy were mainly not applied. Average user ratings showed significant small correlations with the MARS ratings (r=0.22, 95% CI 0.08-0.35; P<.001). The amount of content and number of functions were predictive of the overall quality of these physical activity apps, whereas app store and price were not. Conclusions: Apps for physical activity showed a broad range of quality ratings, with moderate overall quality ratings. Given the present privacy, security, and evidence concerns inherent to most rated apps, their medical use is questionable. There is a need for open-source databases of expert quality ratings to foster informed health care decisions by users and health care providers.

Existing evidence suggests internet- and mobile-based interventions (IMIs) improve depressive symptoms in college students effectively. However, there is far less knowledge about the potential mechanisms of change of mindfulness-based IMIs, which could contribute to optimizing target groups and interventions. Hence, within this secondary analysis of data from a randomized controlled trial (RCT), potential moderators and mediators of the effectiveness of the IMI StudiCare Mindfulness were investigated. Moderation and mediation analyses were based on secondary data from a RCT that examined the effectiveness of the 7-module IMI StudiCare Mindfulness in a sample of college students (intervention group:  = 217; waitlist control group:  = 127). Assessments were collected before (t0; baseline), 4 weeks after (t1; during intervention), and 8 weeks after (t2; post-intervention) randomization. Longitudinal mediation analyses using structural equation modeling were employed, with depressive symptom severity as the dependent variable. For moderation analyses, bilinear interaction models were calculated with depressive symptom severity and mindfulness at t2 as dependent variables. All data-analyses were performed on an intention-to-treat basis. Mediation analyses showed a significant, full mediation of the intervention effect on depressive symptom severity through mindfulness (indirect effect, *  = 0.153,  < 0.01). Only the number of semesters (interaction:  = 0.24,  = 0.035) was found to moderate the intervention's effectiveness on depressive symptom severity at t2, and only baseline mindfulness (interaction:  = -0.20,  = 0.047) and baseline self-efficacy (interaction:  = -0.27,  = 0.012) were found to be significant moderators of the intervention effect on mindfulness at t2. Our results suggest a mediating role of mindfulness. Moderation analyses demonstrated that the intervention improved depressive symptom severity and mindfulness independent of most examined baseline characteristics. Future confirmatory trials will need to support these findings. The trial was registered a priori at the WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register (TRN: DRKS00014774; registration date: 18 May 2018).

Introduction: Deficits in social skills can be an important modulating factor in the development and progress of various mental disorders. However, limited resources in inpatient care often impede effective social skills training. This study investigates the feasibility of a blended group training for social skills (SST) in an inpatient psychiatric setting. Methods and Analysis: For this one-group pretest–posttest trial, inpatients with a diagnosed mental disorder were recruited. Participation in the blended SST lasted four weeks and took place within usual inpatient psychiatric care. The blended intervention comprised four face-to-face group sessions and three complementary online modules within four weeks. Assessments took place before (t1) and after (t2) the training. Feasibility outcomes (use, acceptance, satisfaction, implementability into usual psychiatric inpatient care) and effectiveness outcomes regarding social skills were assessed. Results: N = 15 participants were recruited. Most patients completed all questionnaires (93%) and all modules of the blended SST concept (60%). All participants (100%) would recommend the blended intervention to a friend. Regarding social skills, exploratory analyses revealed a non-significant medium-sized effect (Cohen’s d = 0.5 95%CI 0.3 to 1.25, p = 0.08). Discussion: This trial shows that a blended care SST is feasible for the use in acute psychiatric inpatient care setting. Although the wards were acute, with high turnover and change of inpatients, 60% of participants were treated per protocol over four weeks. Overall, the evidence on blended care concepts in psychiatric care settings is extremely poor to date. Hence, this trial should encourage intensified blended inpatient psychiatric care research.

The college years can be accompanied by mental distress. Internet- and mobile-based interventions (IMIs) have the potential to improve mental health but adherence is problematic. Psychological guidance might promote adherence but is resource intensive. In this three-armed randomized controlled trial, “guidance on demand” (GoD) and unguided (UG) adherence-promoting versions of the seven-module IMI StudiCare Mindfulness were compared with a waitlist control group and each other. The GoD participants could ask for guidance as needed. A total of 387 students with moderate/low mindfulness were recruited. Follow-up assessments took place after 1 (t1), 2 (t2), and 6 (t3) months. Post-intervention (t2), both versions significantly improved the primary outcome of mindfulness (d = 0.91–1.06, 95% CI 0.66–1.32) and most other mental health outcomes (d = 0.25–0.69, 95% CI 0.00–0.94) compared with WL, with effects generally persisting after 6 months. Exploratory comparisons between UG and GoD were mostly non-significant. Adherence was low but significantly higher in GoD (39%) vs. UG (28%) at the 6-month follow-up. Across versions, 15% of participants experienced negative effects, which were mostly mild. Both versions effectively promoted mental health in college students. Overall, GoD was not associated with substantial gains in effectiveness or adherence compared with UG. Future studies should investigate persuasive design to improve adherence.

The proliferation of online eHealth has made it much easier for users to access healthcare services and interventions from the comfort of their own homes. This study looks at how well one such platform—eSano—performs in terms of user experience when delivering mindfulness interventions. In order to assess usability and user experience, several tools such as eye-tracking technology, think-aloud sessions, a system usability scale questionnaire, an application questionnaire, and post-experiment interviews were employed. Participants were evaluated while they accessed the first module of the mindfulness intervention provided by eSano to measure their interaction with the app, and their level of engagement, and to obtain feedback on both the intervention and its overall usability. The results revealed that although users generally rated their experience with the app positively in terms of overall satisfaction, according to data collected through the system usability scale questionnaire, participants rated the first module of the mindfulness intervention as below average. Additionally, eye-tracking data showed that some users skipped long text blocks in favor of answering questions quickly while others spent more than half their time reading them. Henceforth, recommendations were put forward to improve both the usability and persuasiveness of the app—such as incorporating shorter text blocks and more engaging interactive elements—in order to raise adherence rates. Overall findings from this study provide valuable insights into how users interact with the eSano's participant app which can be used as guidelines for the future development of more effective and user-friendly platforms. Moreover, considering these potential improvements will help foster more positive experiences that promote regular engagement with these types of apps; taking into account emotional states and needs that vary across different age groups and abilities.