Mental health services for German university students: acceptance of intervention targets and preference for delivery modes.

Introduction: 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. Aim: 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. Methods: 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. Results: 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. Conclusion: 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.

An Online Mindfulness Intervention for International Students: A Randomized Controlled Feasibility Trial.

Background: Student mobility across borders poses challenges to health systems at the university and country levels. International students suffer from stress more than their local peers, however, do not seek help or underutilize existing help offers. Some barriers to help-seeking among international students are insufficient information regarding the health offers, stigma, and language, which might be overcome via culturally adapted internet and mobile-based interventions (IMI). Method: A randomized controlled feasibility trial with a parallel design assessed the feasibility and potential efficacy of an online mindfulness intervention adapted for international university students. Participants were randomized into either an adapted online mindfulness intervention (StudiCareM-E) (IG, n = 20) or a waitlist control group (WL, n = 20). Participants were assessed at baseline (t0) and eight-week post-randomization (t1). The feasibility of StudiCareM-E was evaluated regarding intervention adherence, client satisfaction, and potential negative effects. The potential efficacy of StudiCareM-E was measured by means of the level of mindfulness, perceived stress, depression, anxiety, presenteeism, and wellbeing. Efficacy outcomes were evaluated with regression models on the intention-to-treat (ITT) sample (n = 40), adjusting for the baseline values. Results: Participants' formative feedback suggested improvements in the content of the IMI. There were no crucial negative effects compared to WL. Assessment dropout was 35% (IG: 50%: WL: 20%), and intervention dropout was 60%. StudiCareM-E yielded significant improvements in mindfulness (ß = .34), well-being (ß = .37), and anxiety (ß = -.42) compared to WL. Conclusion: StudiCareM-E might be used among culturally diverse international student populations to improve their well-being. Future studies might carefully inspect the extent of the adaptation needs of their target group and design their interventions accordingly.

Internet-Based Treatment of Body Dysmorphic Disorder: Feasibility, Evaluation, and Self-Report Data.

ABSTRACT: Initial findings indicate the effectiveness of internet-based interventions for body dysmorphic disorder (BDD). In order to substantiate these findings, a seven-module guided internet-based intervention was created and examined. We report the mixed data of participants with clinical and subclinical BDD of the treatment group (n = 18). We investigated the feasibility, the quality of the program content, the design and usability, and its effects on symptom severity and related psychopathology. Adherence to the intervention was low and dropout rate high (55.6%). The program content, perceived website usability, and visual aesthetic were rated high. Credibility and expectancy were on a medium level. Satisfaction with appearance improved significantly in the intention-to-treat analysis (d = 0.58). In sum, symptom-related outcomes and program evaluation showed a positive trend albeit the study conduction was difficult. Future programs should investigate the role of additional motivation strategies and more flexible support addressing the known treatment barriers.

Moderators and mediators of change of an internet-based mindfulness intervention for college students: secondary analysis from a randomized controlled trial.

Background: 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. Methods: 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: n = 217; waitlist control group: n = 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. Results: Mediation analyses showed a significant, full mediation of the intervention effect on depressive symptom severity through mindfulness (indirect effect, a*b = 0.153, p < 0.01). Only the number of semesters (interaction: ß = 0.24, p = 0.035) was found to moderate the intervention's effectiveness on depressive symptom severity at t2, and only baseline mindfulness (interaction: ß = -0.20, p = 0.047) and baseline self-efficacy (interaction: ß = -0.27, p = 0.012) were found to be significant moderators of the intervention effect on mindfulness at t2. Conclusion: 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. Clinical Trial Registration: 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).

Exploring the usability of an internet-based intervention and its providing eHealth platform in an eye-tracking study.

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. Supplementary Information: The online version contains supplementary material available at 10.1007/s12652-023-04635-4.

A Three-Armed Randomized Controlled Trial to Evaluate the Effectiveness, Acceptance, and Negative Effects of StudiCare Mindfulness, an Internet- and Mobile-Based Intervention for College Students with No and "On Demand" Guidance.

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.

Is Therapist Support Needed? Comparing Therapist- and Self-Guided Internet-Based CBT for Somatic Symptom Distress (iSOMA) in Emerging Adults.

Persistent somatic symptoms of varying etiology are very common in emerging adults and can lead to distress and impairment. Internet-delivered interventions could help to prevent the burden and chronicity of persistent somatic symptoms. This study investigated the impact of therapist guidance on the effectiveness of a cognitive-behavioral Internet intervention for somatic symptom distress (iSOMA) in emerging adults, as a secondary analysis of a two-armed randomized controlled trial. We included 149 university students (83.2% female, 24.60 yrs) with varying degrees of somatic symptom distress who were either allocated to the 8-week intervention with regular, written therapeutic guidance (iSOMA guided) or to the control group (waitlist), which was afterwards crossed over to receive iSOMA with guidance-on-demand (iSOMA-GoD). Primary outcomes were somatic symptom distress (assessed by the PHQ-15) and psychobehavioral symptoms of the somatic symptom disorder (assessed by the SSD-12) at pre- and post-treatment. Secondary outcomes included depression, anxiety, and disability. Both treatments showed statistically significant pre-post improvements in primary (iSOMA-guided: d = 0.86-0.92, iSOMA-GoD: d = 0.55-0.63) and secondary outcomes. However, intention-to-treat analysis revealed non-significant between-group effects for all outcomes (ps ≥ .335), after controlling for confounding variables, and effect sizes were marginal (d = -0.06 to 0.12). Overall, our findings indicate that Internet-delivered cognitive behavioral therapy with regular guidance is not unequivocally superior to guidance-on-demand in alleviating somatic symptom distress and associated psychopathology in emerging adults. As a next step, non-inferiority studies are needed to test the robustness of these findings and their impact on clinical populations.

Comparative effectiveness of three versions of a stepped care model for insomnia differing in the amount of therapist support in internet-delivered treatment: study protocol for a pragmatic cluster randomised controlled trial (GET Sleep).

INTRODUCTION: It is unclear how internet-delivered cognitive-behavioural therapy for insomnia (CBT-I) can be integrated into healthcare systems, and little is known about the optimal level of therapist guidance. The aim of this study is to investigate three different versions of a stepped care model for insomnia (IG1, IG2, IG3) versus treatment as usual (TAU). IG1, IG2 and IG3 rely on treatment by general practitioners (GPs) in the entry level and differ in the amount of guidance by e-coaches in internet-delivered CBT-I. METHODS AND ANALYSIS: In this randomised controlled trial, 4268 patients meeting International Classification of Diseases, Tenth Revision (ICD-10) criteria for insomnia will be recruited. The study will use cluster randomisation of GPs with an allocation ratio of 3:3:3:1 (IG1, IG2, IG3, TAU). In step 1 of the stepped care model, GPs will deliver psychoeducational treatment; in step 2, an internet-delivered CBT-I programme will be used; in step 3, GPs will refer patients to specialised treatment. Outcomes will be collected at baseline, and 4 weeks, 12 weeks and 6 months after baseline assessment. The primary outcome is insomnia severity at 6 months. An economic evaluation will be conducted and qualitative interviews will be used to explore barriers and facilitators of the stepped care model. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Medical Centre-University of Freiburg. The results of the study will be published irrespective of the outcome. TRIAL REGISTRATION NUMBER: DRKS00021503.

Internet-based CBT for somatic symptom distress (iSOMA) in emerging adults: A randomized controlled trial.

OBJECTIVE: Persistent somatic symptom distress is common in emerging adults and is associated with adverse health outcomes and impairment. Internet-based interventions could help to prevent burden and chronicity. This randomized controlled trial tested the efficacy of a guided, cognitive-behavioral internet intervention for somatic symptom distress (iSOMA) in emerging adults at risk for somatic symptom disorder compared to a waitlist control condition. METHOD: 158 participants (N = 156 analyzed; 24.53 years, 83.3% female) with multiple somatic symptoms were recruited among German-speaking universities and randomly allocated to either receive the 8-week iSOMA intervention with psychologist support or the waitlist, both with access to treatment as usual. Primary outcomes were somatic symptom distress Patient Health Questionnaire, somatic symptom scale (PHQ-15) and psychobehavioral features of somatic symptom disorder-12 (SSD-12), assessed at baseline and 8-weeks postrandomization. Secondary outcomes included depression, anxiety, illness worries, functional impairment, and attitudes toward psychological treatment. RESULTS: Participants in the iSOMA group showed significantly greater improvements (ps < .001) in primary outcomes (PHQ-15: d = 0.70 [0.36, 1.05], SSD-12: d = 0.65 [0.30, 0.99], and secondary outcomes (ps < .05; d = 0.41-0.52) compared to the waitlist, except for attitudes toward psychological treatment (p = .944). Satisfaction with iSOMA was high (91.0%), most participants (72.8%) completed at least 4 of 7 modules and negative treatment effects were infrequent (14.9%). CONCLUSIONS: Our intervention had a substantial positive impact on somatic symptom distress across a broad range of persistent physical symptoms in a vulnerable target group, opening up promising possibilities for indicative prevention and blended care for somatic symptom disorders. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Blended Care in In-Patient Acute Psychiatric Care. The Example of a Group Training for Social Competences in Adults-A Pretest-Posttest Feasibility Study.

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.

Quality of Physical Activity Apps: Systematic Search in App Stores and Content Analysis.

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.

Study protocol of a randomised controlled trial on SISU, a software agent providing a brief self-help intervention for adults with low psychological well-being.

INTRODUCTION: Only 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 ANALYSIS: Within 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 DISSEMINATION: This 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 REGISTRATION: The 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.

StudiCare mindfulness-study protocol of a randomized controlled trial evaluating an internet- and mobile-based intervention for college students with no and "on demand" guidance.

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.

Digital interventions in adult mental healthcare settings: recent evidence and future directions.

PURPOSE OF REVIEW: Internet and mobile-based interventions (IMI) can be used as online delivered forms of psychotherapeutic mental health treatments. These interventions can be an effective as well as time and cost-efficient treatment with the potential to scale up mental healthcare. In this review, we map implementation possibilities into routine mental healthcare settings and provide the most recent evidence. RECENT FINDINGS: Fourteen articles on digital mental healthcare approaches published in the last 18 months were included. Despite the limited number, the studies provide evidence for the effectiveness of IMI in treating inpatients and outpatients with various disorders in different mental healthcare settings. IMI were investigated as stand-alone interventions, in combination with other treatment forms (blended-care), or as aftercare. SUMMARY: Although there is encouraging evidence for the effectiveness of IMI in mental healthcare settings, several limitations have to be considered. The small number of studies conducted within the healthcare system, especially with inpatient samples, calls for more collaboration between researchers and clinical practitioners to unravel barriers and develop efficient protocols for the integration into routine care. Nonetheless, IMI are a promising tool for the endeavour of closing the treatment gap and should, therefore, be further explored in varying settings.

Effectiveness of a guided online mindfulness-focused intervention in a student population: Study protocol for a randomised control trial.

BACKGROUND: Previous 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 ANALYSES: In 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 DISSEMINATION: All 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 NUMBER: DRKS00014701.

Effectiveness of an internet-based intervention for procrastination in college students (StudiCare Procrastination): Study protocol of a randomized controlled trial.

BACKGROUND: Procrastination, defined as irrational and voluntary delaying of necessary tasks, is widespread and clinically relevant. Its high prevalence among college students comes with serious consequences for mental health and well-being of those affected. Research for proper treatment is still relatively scarce and treatment of choice seems to be cognitive behavior therapy (CBT). The aim of this study is to evaluate the effectiveness and acceptability of an internet- and mobile-based intervention (IMI) for procrastination based on CBT for college students. METHODS: A two-armed randomized controlled trial with a calculated sample size of N = 120 participants with problematic procrastination behavior will be conducted. Students will be recruited in Germany, Austria and Switzerland via circular emails at 15+ cooperating universities in the framework of StudiCare, a well-established project that provides IMIs to college students for different health related issues. The intervention group will receive the e-coach guided 5-week IMI StudiCare Procrastination. A waitlist-control group will get access to the unguided IMI 12 weeks after randomization. Assessments will take place before as well as 6 and 12 weeks after randomization. Primary outcome is procrastination, measured by the Irrational Procrastination Scale (IPS). Secondary outcomes include susceptibility to temptation, depression, anxiety, wellbeing and self-efficacy as well as acceptability aspects such as intervention satisfaction, adherence and potential side effects. Additionally, several potential moderators as well as the potential mediators self-efficacy and susceptibility to temptation will be examined exploratorily. Data-analysis will be performed on intention-to-treat basis. DISCUSSION: This study will contribute to the evidence concerning effectiveness and acceptability of an intervention for procrastination delivered via the internet. If it shows to be effective, StudiCare Procrastination could provide a low-threshold, cost-efficient way to help the multitude of students suffering from problems caused by procrastination.Trial registration: The trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register (DRKS): DRKS00014321 (date of registration: 06.04.2018). In case of important protocol modifications, trial registration will be updated.Trial status: This is protocol version number 1, 11th December 2019. Recruitment started 9th of April 2018 and was completed 30th of November 2018. Assessment and intervention are still ongoing and will be completed by April 2019.

Increasing intentions to use mental health services among university students. Results of a pilot randomized controlled trial within the World Health Organization's World Mental Health International College Student Initiative.

BACKGROUND: The majority of university students with mental health problems are untreated. Only a small empirical literature exists on strategies to increase mental health service use. AIMS: To investigate the effects and moderators of a brief acceptance-facilitating intervention on intention to use mental health services among university students. METHOD: Within the German site of the World Health Organization's World Mental Health International College Student (WMH-ICS) initiative, 1,374 university students were randomized to an intervention condition (IC; n = 664) or a control condition (CC; n = 710) that was implemented in the survey itself. Both conditions received the questions assessing mental disorders and suicidality that were included in other WMH-ICS surveys. The IC group then additionally received: Internet-based personalized feedback based on subject symptom severity in the domains of depression, anxiety, substance use, suicidal thoughts and behaviors, and nonsuicidal self-injury; psychoeducation tailored to the personal symptom profile; and information about available university and community mental health services. The primary outcome was reported intention to use psychological interventions in the next semester, which was the last question in the survey. A broad range of potential moderating factors was explored. RESULTS: There was a significant main effect of the intervention with students randomized to IC, reporting significantly higher intentions to seek help in the next semester than students in the CC condition (d = 0.12, 95% CI: 0.02 to 0.23). Moderator analyses indicated that the intervention was more effective among students that fulfilled the criteria for lifetime (d = 0.34; 95% CI: -0.08 to 0.7) and 12-month panic-disorder (d = 0.32; 95% CI: -0.10 to 0.74) compared with those without lifetime (d = 0.11; 95% CI: 0.00 to 0.22) or 12-month panic disorder (d = 0.11; 95% CI: 0.00 to 0.22), students with lower (d = 0.37; 95% CI: -0.77 to 1.51) than higher (d = -0.01; 95% CI: -0.36 to 0.34) self-reported physical health, and students with nonheterosexual (d = 0.38; 95% CI: 0.08 to 0.67) compared with heterosexual (d = 0.06; 95% CI: -0.06 to 0.17) sexual orientation. The intervention had no effects among students who reported that they recognized that they had an emotional problem and "are already working actively to change it" (Stage 4 "stages of change"). CONCLUSIONS: A simple acceptance-facilitating intervention can increase intention to use mental health services, although effects, are on average, small. Future studies should investigate more personalized approaches with interventions tailored to barriers and clinical characteristics of students. In order to optimize intervention effects, the development and evaluation should be realized in designs that are powered to allow incremental value of different intervention components and tailoring strategies to be evaluated, such as in multiphase optimization designs.