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Objective: To investigate the effectiveness of a guided, internet- and smartphone-based gratitude intervention on the transdiagnostic risk-factor ‘repetitive negative thinking’. The multicomponent intervention integrates a variety of gratitude exercises, targeting the cognitive, emotional and behavioural facets of gratitude. Method: Two hundred adults with pronounced repetitive negative thinking were recruited from the general population. Participants were randomly assigned to either a four-session guided gratitude intervention (n = 100) or waiting list (n = 100). The primary outcome was repetitive negative thinking three months after randomization, with exploratory assessments at six weeks and six months, the latter just for participants in the intervention group. Results: Following the intention-to-treat principle, by analyses of covariance (ANCOVA), the gratitude intervention group exhibited significantly lower levels of repetitive negative thinking than controls at three months, with d = 0.66, 95 % CI [0.37, 0.94] maintained at six-month follow-up. Significant and meaningful beneficial effects were observed in symptoms of depression (d = 0.42) and generalized anxiety (d = 0.38). These effects were notably stronger in intervention completers who finished at least three sessions. Conclusions: Results suggest that a multicomponent gratitude intervention is effective at reducing repetitive negative thinking. Multicomponent interventions may be a next step needed to fully realize the potential of gratitude interventions. Such interventions could expand the repertoire of transdiagnostic interventions, especially for repetitive negative thinking. Furthermore, due to its positive connotations, gratitude is a candidate for an indirect intervention aimed at reducing the burden of depression in the general population. Trial registration: The study is registered in the German Clinical Trial Register (approved primary register of the WHO) as DRKS00006825. The trial protocol can be assessed at: https://www.drks.de/

Background: Depression is highly prevalent among individuals with chronic back pain. Internet-based interventions can be effective in treating and preventing depression in this patient group, but it is unclear who benefits most from this intervention format. Method: In an analysis of two randomized trials (N = 504), we explored ways to predict heterogeneous treatment effects of an Internet-based depression intervention for patients with chronic back pain. Univariate treatment-moderator interactions were explored in a first step. Multilevel model-based recursive partitioning was then applied to develop a decision tree model predicting individualized treatment benefits. Results: The average effect on depressive symptoms was d = −0.43 (95 % CI: −0.68 to –0.17; 9 weeks; PHQ-9). Using univariate models, only back pain medication intake was detected as an effect moderator, predicting higher effects. More complex interactions were found using recursive partitioning, resulting in a final decision tree with six terminal nodes. The model explained a large amount of variation (bootstrap-bias-corrected R2 = 45 %), with predicted subgroup-conditional effects ranging from di = 0.24 to −1.31. External validation in a pilot trial among patients on sick leave (N = 76; R2 = 33 %) pointed to the transportability of the model. Conclusions: The studied intervention is effective in reducing depressive symptoms, but not among all chronic back pain patients. Predictions of the multivariate tree learning model suggest a pattern in which patients with moderate depression and relatively low pain self-efficacy benefit most, while no benefits arise when patients' self-efficacy is already high. If corroborated in further studies, the developed tree algorithm could serve as a practical decision-making tool.

Introduction: Farmers, forest workers and gardeners have a higher risk of developing depression compared to other occupational populations. As part of the German pilot project “With us in balance”, the potential of six guided internet- and mobile-based interventions (IMIs) to prevent depression among their insurants is examined. The IMI program is tailored to various risk factors of depression, individual symptoms, and needs. Although IMIs have been shown to be effective in reducing depressive symptoms, there is little qualitative research about the acceptance of digital preventive IMIs. The aim of this qualitative study is to gain insights into participants' experiences with the guided IMIs by focusing on determinants for acceptance and satisfaction. Methods: Semi-structured interviews were conducted with 22/171 (13 %) intervention group (IG) participants of a randomized controlled trial. The interview guide was developed based on theoretical models of user acceptance (Unified Theory of Acceptance and Use of Technology) and patient satisfaction (evaluation model, discrepancy theory). The interviews were evaluated independently by two coders performing a deductive-inductive content analysis and attaining a substantial level of agreement (K = 0.73). Results: The qualitative analysis revealed 71 determinants for acceptance and satisfaction across ten dimensions: performance expectancy, organisation, e-coach, usability, training content and structure, training usage, training outcome, financing, social influence, and behavioural intention. The most frequently identified drivers for the IMI use include “location independence”, “positive relationship to the e-coach” (each n = 19, 86 %), “personal e-coach guidance”, “expertise of the e-coach”, “target group specific adaptation” (each n = 18, 82 %), “flexibility”, “high willingness for renewed participation” (each n = 17, 77 %), “fast and easy availability”, “training of health enhancing attitudes and behaviours” and “content with figurative expressions” (each n = 16, 73 %). Discussion: The qualitative findings predominantly suggest the acceptance of and satisfaction with the IMI program for the prevention of depression in famers and related lines of work. Many identified positive drivers are related to the e-coach guidance, which emphasizes its importance in the preventive setting from the perspective of the participants. Nevertheless, some negative aspects have been identified which help to understand potential weaknesses of the IMI program. Participants indicated different needs in terms of IMI content and usage, which points towards the potential benefit of individualisation. The possibility of being able to use IMIs anonymously, flexibly and independently of location might be highly relevant for this specific target group.

Objective: Evidence of long-term stability for positive mental health effects of internet-based interventions (IBIs) for depression prevention is still scarce. We evaluate long-term effectiveness of a depression prevention program in green professions (i.e. agriculture, horticulture, forestry). Methods: This pragmatic RCT (n = 360) compares a tailored IBI program to enhanced treatment as usual (TAU+) in green professions with at least subthreshold depression (PHQ ≥ 5). Intervention group (IG) received one of six IBIs shown previously to efficaciously reduce depressive symptoms. We report 6- and 12-month follow-up measures for depression, mental health and intervention-related outcomes. Intention-to-treat and per-protocol regression analyses were conducted for each measurement point and complemented by latent growth modeling. Results: After 6 months, depression severity (β = −0.30, 95%-CI: −0.52; −0.07), insomnia (β = −0.22, 95%-CI: −0.41; −0.02), pain-associated disability (β = −0.26, 95%-CI: −0.48; −0.04) and quality of life (β = 0.29, 95%-CI: 0.13; 0.45) in IG were superior to TAU+. Onset of possible depression was not reduced. After 12 months, no intervention effects were found. Longitudinal modeling confirmed group effects attenuating over 12 months for most outcomes. After 12 months, 55.56% of IG had completed at least 80% of their IBI. Conclusions: Stability of intervention effects along with intervention adherence was restricted. Measures enhancing long-term effectiveness of IBIs for depression health promotion are indicated in green professions. Trial registration: German Clinical Trial Registration: DRKS00014000. Registered: 09 April 2018.

Internet- and mobile-based interventions (IMI) offer an effective way to complement health care. Acceptance of IMI, a key facilitator of their implementation in routine care, is often low. Based on the Unified Theory of Acceptance and Use of Technology (UTAUT), this study validates and adapts the UTAUT to digital health care.Following a systematic literature search, 10 UTAUT-grounded original studies (N = 1588) assessing patients' and health professionals' acceptance of IMI for different somatic and mental health conditions were included. All included studies assessed Performance Expectancy, Effort Expectancy, Social Influence, Facilitating Conditions and acceptance as well as age, gender, internet experience, and internet anxiety via self-report questionnaires. For the model validation primary data was obtained and analyzed using structural equation modeling.The best fitting model (RMSEA = 0.035, SRMR = 0.029) replicated the basic structure of UTAUT's core predictors of acceptance. Performance Expectancy was the strongest predictor (γ = 0.68, p

Introduction: While the general uptake of e-mental health interventions remained low over the past years, physical distancing and lockdown measures relating to the COVID-19 pandemic created a need and demand for online consultations in only a matter of weeks. Objective: This study investigates the uptake of online consultations provided by mental health professionals during lockdown measures in the first wave of the COVID-19 pandemic in the participating countries, with a specific focus on professionals' motivations and perceived barriers regarding online consultations. Methods: An online survey on the use of online consultations was set up in March 2020. The Unified Theory of Acceptance and Use of Technology (UTAUT) guided the deductive qualitative analysis of the results. Results: In total, 2082 mental health professionals from Austria, Belgium, Cyprus, France, Germany, Italy, Lebanon, Lithuania, the Netherlands, Norway, Portugal, Spain, and Sweden were included. The results showed a high uptake of online consultations during the COVID-19 pandemic but limited previous training on this topic undergone by mental health professionals. Most professionals reported positive experiences with online consultations, but concerns about the performance of online consultations in a mental health context (e.g., in terms of relational aspects) and practical considerations (e.g., relating to privacy and security of software) appear to be major barriers that hinder implementation. Conclusions: This study provides an overview of the mental health professionals' actual needs and concerns regarding the use of online consultations in order to highlight areas of possible intervention and allow the implementation of necessary governmental, educational, and instrumental support so that online consultations can become a feasible and stable option in mental healthcare.

Background: It is well known that web-based interventions can be effective treatments for various conditions. Less is known about predictors, moderators, and mediators of outcome and especially interrelations between participant and interventions characteristics, process variables and outcomes in online interventions. Clinical trials often lack statistical power to detect variables that affect intervention effects and their interrelations. Within ICare, we can investigate the interrelation of potential predictor and process variables in a large sample. Method: The ICare consortium postulated a model of interrelations between participant and intervention characteristics, process variables and outcomes in online interventions. We will assess general and disorder-specific interrelations between characteristics of the intervention, characteristics of the participants, adherence, working alliance, early response, and intervention outcomes in a sample of over 7500 participants from seven clinical trials evaluating 15 online interventions addressing a range of mental health conditions and disorders, using an individual participant data meta-analyses approach. Discussion/conclusion: Existing research tends to support the efficacy of online mental health interventions, but the knowledge base regarding factors that affect intervention effects needs to be expanded. The overarching analyses using data from the ICare intervention trials will add considerably to the evidence. Keywords: Internet-based interventions, Mental health, Adherence, Early response, Working alliance, Predictors

Background: Mental health problems are common and place a burden on the individual as well as on societal resources. Despite the existence of evidence-based treatments, access to treatment is often prevented or delayed due to insufficient health care resources. Effective internet-based self-help interventions have the potential to reduce the risk for mental health problems, to successfully bridge waiting time for face-to-face treatment and to address inequities in access. However, little is known about the cost-effectiveness of such interventions. This paper describes the study protocol for the economic evaluation of the studies that form the ICare programme of internet-based interventions for the prevention and treatment of a range of mental health problems. Methods: An overarching work package within the ICare programme was developed to assess the cost-effectiveness of the internet-based interventions alongside the clinical trials. There are two underlying tasks in the ICare economic evaluation. First, to develop schedules that generate equivalent and comparable information on use of services and supports across seven countries taking part in clinical trials of different interventions and second, to estimate unit costs for each service and support used. From these data the cost per person will be estimated by multiplying each participant's use of each service by the unit cost for that service. Additionally, productivity losses will be estimated. This individual level of cost data matches the level of outcome data used in the clinical trials. Following the analyses of service use and costs data, joint analysis of costs and outcomes will be undertaken to provide findings on the relative cost-effectiveness of the interventions, taking both a public sector and a societal perspective. These analyses use a well-established framework, the Production of Welfare approach, and standard methods and techniques underpinned by economic theory. Discussion/conclusion: Existing research tends to support the effectiveness of internet-based interventions, but there is little information on their cost-effectiveness compared to ‘treatment as usual’. The economic evaluation of ICare interventions will add considerably to this evidence base. Keywords: Cost-effectiveness, Cost-utility, Service use, Economic evaluation, Internet-based interventions, Mental health

Background: Mental disorders and their symptoms are highly prevalent in the university student population, and the transition from secondary to tertiary education is associated with a rise in mental health problems. Existing web-based interventions for the prevention of common mental disorders in student populations often focus on just one disorder and have not been designed specifically for students. There is thus a need for transdiagnostic, student-specific preventative interventions that can be widely disseminated. This two-arm, parallel group randomised controlled trial aims to evaluate the effectiveness and cost-effectiveness of a web-based transdiagnostic mental health problem prevention programme (PLUS) across several universities in four countries. Method: Students (N = 5550) will be recruited through a variety of channels and asked to complete a personality assessment to determine whether they are at high risk for developing common mental disorders. Students at high risk will be randomly allocated to either PLUS or a control intervention, which provides practical support around issues commonly experienced at university. Students at low risk will be allocated to the control intervention. Both intervention groups will be assessed at baseline, 4 weeks, 3 months, 6 months and 12 months after randomisation. Depression and generalised anxiety, assessed using the Patient Health Questionnaire and the Generalised Anxiety Disorder scales, will form the primary outcomes in this study. Secondary outcome measures include alcohol and drug use, eating behaviour, self-esteem, and quality of life. The cost-effectiveness of the intervention will also be evaluated. Conclusions: This study will contribute to understanding the role of transdiagnostic indicated web-based interventions for the prevention of common mental disorders in university students. It will also be one of the first studies to investigate the cost-effectiveness of such interventions. Trial Registration: This trial was registered in the ISRCTN register (ISRCTN15570935) on 12th February 2016. Keywords: Students, Internet, Mental health, Depression, Anxiety, Prevention, CBT

Background: Despite the high prevalence of comorbid depression in people living with coronary artery disease (CAD), uptake of psychological treatment is generally low. This study was designed to investigate the feasibility of an internet-based cognitive-behavioral (iCBT) depression intervention for people with CAD and depressive symptoms. Methods: People with CAD and depressive symptoms (PHQ-9 ≥ 5) were randomly assigned to the eight modules comprising iCBT (N = 18), or waitlist-control (N = 16). Measures were taken at baseline (t1) and at post-treatment (eight weeks after randomization, t2). Feasibility-related outcomes were recruitment strategy, study attrition, intervention dropout, satisfaction, negative effects as well as the potential of the intervention to affect likely outcomes in a future full-scale trial (depression, anxiety, quality of life, fear of progression). Data analyses were based on intention-to-treat principles. Linear regression models were used to detect between group differences. Linear Mixed Models were used to model potential changes over time. Results: This trial was terminated prior to a-priori defined sample size has been reached given low recruitment success as well as high intervention dropout (88%) and study attrition (23%). On average, participants in the intervention group completed M = 2.78 (SD = 3.23) modules. Participants in the waitlist control group barely started one module (M = 0.82, SD = 1.81). The satisfaction with the intervention was low (M = 20.6, SD = 0.88). Participants reported no negative effects attributed to the iCBT. Differences between groups with regard to depression, anxiety, fear of progression and quality of life remained non-significant (p > 0.05). Conclusion: This trial failed to recruit a sufficient number of participants. Future work should explore potential pitfalls with regards to the reach and persuasiveness of internet interventions for people living with CAD. The study gives important indications for future studies with regard to the need for new ideas to reach and treat people with CAD and depression.

Depression is highly prevalent among university students. Internet-based interventions have been found to be effective in addressing depressive symptoms, but it is open if this also applies to interventions directed at academic stress. It is also largely unclear if the techniques employed in such programs provide significant additional benefits when controlling for non-specific intervention effects.A sample of N = 200 students with elevated levels of depression (CES-D ≥ 16) of a large distance-learning university were randomly assigned to either an Internet- and App-based stress intervention group (IG; n = 100) or an active control group (CG; n = 100) receiving an Internet-based psychoeducational program of equal length. Self-report data was assessed at baseline, post-treatment (7 weeks) and three-month follow-up. The primary outcome was depression (CES-D) post-treatment. Secondary outcomes included mental health outcomes, modifiable risk factors, and academic outcomes.We found significant between-group effects on depressive symptom severity (d = 0.36; 95% CI: 0.08–0.64), as well as behavioral activation (d = 0.61; 95% CI: 0.30–0.91), perceived stress (d = 0.45; 95% CI: 0.18–0.73), anxiety (d = 0.35; 95% CI: 0.03–0.67) and other secondary outcomes post-treatment. Effects on depression were sustained at three-month follow-up. Response rates for depressive symptoms were significantly higher in the IG (26%) than the CG (14%) at post-test (χ2=4.5, p = 0.04), but not at three-month follow-up (p = 0.454). We also found significant effects on relevant academic outcomes, including work impairment (follow-up; d = 0.36), work output (post-treatment; d = 0.27) and work cutback (follow-up; d = 0.36).The intervention was more effective for depressive symptoms compared to the CG, and so controlling for unspecific intervention effects. This suggests that specific techniques of the intervention may provide significant additional benefits on depressive symptoms.Trial registration: German Clinical Trial Registration (DRKS): DRKS00011800 (https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00011800).

Background: Panic disorder with and without agoraphobia (PD) is a common psychological disorder. Internet-based interventions have the potential to offer highly scalable low-threshold evidence-based care to people suffering from PD. GET.ON Panic is a newly developed internet-based intervention addressing symptoms of PD. In order to transfer the training into the daily life of the individuals, we integrated mobile components in the training and created a so-called hybrid online training. The development and beta-testing of such a training requires a novel interdisciplinary approach between IT specialists and psychologists. From this point of view, we would like to share our experiences in this exploratory paper. Methods: This initial feasibility study (N = 10) offers, on the one hand, a brief overview of the interdisciplinary development phase of the mobile application and on the other hand, provides first insights into the usage, usability and acceptance of this mobile application using qualitative interview data as well quantitative measures of 8 completing participants. For these reasons, we used a pre-posttest design without a control group. Furthermore, we present initial clinical outcomes of the intervention on e.g. panic symptom severity, depressive symptoms as well additional anxiety measures. Finally, we end with implications for further research in the relatively new field of mobile mental health. Results: Overall, usability, user satisfaction, motivational value and technology acceptance of the app were perceived as high. The usage of app components was diverse: The use of interoceptive exposure exercises and daily summaries on anxiety and mood was highest while using in-vivo exposure exercises and monitoring panic symptoms was perceived as difficult. Furthermore, participants showed after the training less clinical symptoms as at baseline-assessment. Discussion: The current feasibility study contributes to an in-depth understanding of the potential of mobile technology in e-mental health. Overall, the GET.ON Panic app appears to be an acceptable and motivational part of a CBT-based hybrid online training for PD that has the potential to promote training success. After some suggested adjustments have been made, the efficacy should be investigated in a randomized controlled trial. Keywords: M-mental health, Panic disorder, Agoraphobia, Feasibility study, Thematic analyses, Cognitive behavior therapy

Introduction: Blended therapies (BT) combine face-to-face (f2f) sessions with internet- and mobile-based interventions (IMIs). However, the use of blended interventions in routine care is still rare and depends on the acceptance of key health care professionals such as the therapists. Little is yet known about the therapists' perspective on and experiences with blended approaches. The aim of this pilot study was to identify barriers and facilitators, as perceived by psychotherapists, for implementing a blended therapy for depression. Methods: Semi-structured expert interviews were conducted with five therapists, who were part of the German study arm of the FP7-project E-Compared (www.e-compared.eu). All patients (N = 173) were treated in the context of a registered RCT (DRKS00006866) in which the clinical and cost-effectiveness of BT for depression, consisting of ten internet- and mobile-based cognitive behavioral therapy modules and six f2f sessions, was compared to the treatment usually provided by general practitioners. To identify barriers and facilitators an interview guide based on the theoretical domains framework (TDF) was developed. The interviews were audio-recorded, transcribed verbatim and analyzed using a qualitative content analysis by two independent coders. Results: The results revealed 29 barriers and 33 facilitators, which are hindering or enabling factors on the levels of ‘implementation in the health care system’, ‘therapy’, ‘therapists’ and ‘patients’. Key barriers stated by all therapists were ‘Limited customizability and autonomy of decisions concerning blending the therapy’ (number of statements, k = 44); ‘Disease-related contraindications for BT’ (k = 25); ‘Negative affect was caused by burden through technical problems’ (k = 18); ‘Limited number of f2f sessions hindered the therapy process’; and ‘Establishment of therapeutic alliance was burdened by technical issues’ (each k = 15). Key facilitators stated by all therapists were: ‘Patients’ interest, willingness and motivation to participate’ (k = 22); ‘Patients' access to online content between f2f sessions and after therapy end’ (k = 20); ‘Preset structure of IMI-part guided the treatment course of BT’ (k = 18); and ‘Effective help with BT in a short time frame’ (k = 15), as well as ‘Reduction of the treatment gap’ (k = 13). Discussion: Therapists supported the implementation of BT for depression. Results indicated the consideration of a wide range of determinants: among others, the possibility of individualizing the treatment; the autonomy of decision making in respect to the ratio and number of online and f2f sessions; the necessity of providing training; the need to develop a concept of embedding BT in the health care system and funding the additional effort; and the use of sophisticated technical solutions. Keywords: Barriers, Facilitators, Blended therapy, Depression, Qualitative study, Therapists' view

Introduction: Internet-based guided self-help and face-to-face CBT have shown to be effective in the treatment of depression, but both approaches might not be an available treatment option for all patients. A treatment which blends internet-based guided self-help with video-based psychotherapy might reduce potential disadvantages of both approaches, while maintaining major advantages such as being location-independent. Additionally, it could provide a stronger focus on patient empowerment and lower resource use compared to traditional face-to-face treatment. Aim: The aim of this study is to evaluate patient's experiences with blended internet- and video-based CBT (blended iCBT) treatment and to derive suggestions for the improvement of such services. Methods: Semi-structured interviews were conducted with 15 participants of the blended iCBT treatment as part of the European MasterMind trial. Participants included adults suffering from Major Depressive Disorder. The interview guide assessed patient's experiences regarding the four treatment components program, 1. face-to-face diagnostic interviews, 2. video-based synchronous therapy sessions (VTS), 3. online self-help treatment modules (OTM) as well as 4. behaviour diaries and symptom monitoring. Interviews were analyzed using the framework method and outcomes regarding connections within and between participants and categories were generated by counting the statements within relevant themes. Results: Overall, patients indicated to have been satisfied with all components of the treatment, highlighting the option to independently work from home in their own pace. While the OTMs allowed for a deeper reflection of the content, the VTS with the therapist were mentioned to provide the personal character of the service. The working alliance with the therapist was experienced as fostering the individual fit of the treatment. Patients reported a high self-perceived treatment effectiveness. Negative effects included that some patients felt overwhelmed by the service, e.g. by working with the content of the OTM as they forced them to address their problems. Within the combination of OTM and VTS, both components were rated as equally important and patients felt that the combination depicted a treatment at least equal to regular face-to-face treatment regarding the perceived effectiveness. Other identified themes included patient's individual factors, reactions in their social environment and suggestions for improvement of the service. Discussion: Predominantly, patients reported positive experiences with the blended iCBT service and rate the treatment as adequate and effective to treat their condition. The importance of the VTS is highlighted. Following this approach might be an option to make affordable and effective evidence-based CBT available independent from regional barriers. Keywords: Blended therapy, Patient's experience, Depression, Routine care, Video-based psychotherapy, Internet-based self-help

Background: 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. Method: 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. Results: 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. Conclusion: 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. Funding: The E-COMPARED project has received funding from the European Union Seventh Framework Programme (FP7/2007–2013) under grant agreement no. 603098.

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. Keywords: Procrastination, Internet-based intervention, Online intervention, Cognitive behavior therapy, Randomized controlled trial, College students

Internet-based problem-solving training (IPST) effectively reduces depressive symptoms in employees. Yet, it is unknown which employees benefit most from this particular treatment. The study aimed to identify predictors and moderators of treatment outcome in IPST offered to employees with depressive symptoms. Within a randomized controlled trial (N = 150), designed to test the effectiveness of IPST, variables that predict and moderate the effects of IPST when compared with a waitlist control group (WLC) were explored. The outcome was change in depression severity, assessed using the Center for Epidemiological Studies Depression Scale (CES-D). Both depression severity and other psychopathological symptoms and potential predictors/moderators were assessed as self-reports at baseline (t1) and in follow-up assessments after seven weeks (t2), three months (t3) and six months (t4). Higher depression severity at baseline predicted improvement in depressive symptomology in follow-up assessments after seven weeks, and three- and six months. Depression severity moderated the effectiveness of IPST assessed at six-month follow-up. Simple slope analyses revealed that the long-term effectiveness of the intervention was more pronounced among participants with high (CES-D range: 33–44, M = 37.0, SD = 3.2) and moderate (CES-D range: 14–32, M = 23.1, SD = 5.6) depression baseline scores, compared to participants displaying low depression baseline scores (CES-D range: 5–13, M = 9.0, SD = 2.2). No indication was found that participants presenting low depression severity at baseline significantly benefitted from IPST in the long-term. IPST might be appropriate for employees with a wide range of different characteristics. While there appears to be no reason to exclude employees with severe depression from Internet-based occupational mental health interventions, for employees low in depression severity, watchful waiting or potentially no intervention should be considered. These findings may not apply to other low-intensity interventions and/or target groups.

Background: Acceptance and Commitment Therapy (ACT) is an effective intervention for the treatment of chronic pain. Internet-based pain interventions might be an effective and cost-effective way to overcome treatment barriers of traditional face-to-face pain interventions such as the lack of availability and accessibility. However, little is known about the general (cost-)effectiveness of internet-based pain interventions and the specific (cost-) effectiveness of guided and unguided pain interventions. Therefore, the aim of this study is to investigate the effectiveness and cost-effectiveness of a guided and unguided ACT-based online intervention for persons with chronic pain (ACTonPain). Methods: ACTonPain is a pragmatic three-armed randomised controlled trial comparing ACTonPain with or without therapist guidance against a waitlist control group. Both active conditions differ only with regard to guidance provided by an eCoach, who sends feedback after each module. This study aims to include 300 participants. Randomisation and allocation will be performed using permuted block randomisation with variable block sizes. The intervention contains seven ACT-based modules with interactive exercises, and audio and video clips. Furthermore, the participants have the opportunity to receive daily text messages. Online self-assessments will take place at pre- and post-treatment, as well as at 6 month follow-up. The primary outcome is pain interference. Secondary outcomes include physical and emotional functioning, pain intensity, ACT-related variables as well as health-related quality of life. Moreover, a cost-effectiveness analysis will be conducted from a societal perspective. Demographic and medical variables will be assessed on the basis of self-reports in order to detect potential moderators or mediators of the effects. The data will be analysed on an intention-to-treat basis and also using per-protocol analyses. Discussion: This study will contribute to the evidence base of internet-based pain interventions and provide valuable information about the treatment success and cost-effectiveness regarding the intervention's level of guidance (self-help only vs. guided self-help). If ACTonPain is shown to be effective, investigations in different healthcare settings should follow, to examine possible ways of implementing ACTonPain into existing healthcare systems. The implementation of ACTonPain could help to shorten waiting times, expand access to pain treatment and, potentially, also reduce treatment costs.

Internet interventions have great potential for alleviating emotional distress, promoting mental health, and enhancing well-being. Numerous clinical trials have demonstrated their efficacy for a number of psychiatric conditions, and interventions delivered via the Internet will likely become a common alternative to face-to-face treatment. Meanwhile, research has paid little attention to the negative effects associated with treatment, warranting further investigation of the possibility that some patients might deteriorate or encounter adverse events despite receiving best available care. Evidence from research of face-to-face treatment suggests that negative effects afflict 5–10% of all patients undergoing treatment in terms of deterioration. However, there is currently a lack of consensus on how to define and measure negative effects in psychotherapy research in general, leaving researchers without practical guidelines for monitoring and reporting negative effects in clinical trials. The current paper therefore seeks to provide recommendations that could promote the study of negative effects in Internet interventions with the aim of increasing the knowledge of its occurrence and characteristics. Ten leading experts in the field of Internet interventions were invited to participate and share their perspective on how to explore negative effects, using the Delphi technique to facilitate a dialog and reach an agreement. The authors discuss the importance of conducting research on negative effects in order to further the understanding of its incidence and different features. Suggestions on how to classify and measure negative effects in Internet interventions are proposed, involving methods from both quantitative and qualitative research. Potential mechanisms underlying negative effects are also discussed, differentiating common factors shared with face-to-face treatments from those unique to treatments delivered via the Internet. The authors conclude that negative effects are to be expected and need to be acknowledged to a greater extent, advising researchers to systematically probe for negative effects whenever conducting clinical trials involving Internet interventions, as well as to share their findings in scientific journals.