Harrer 2019.

Study name	Public title: Online‐based self‐help stress management program for distance‐learning students with feedback on demand Scientific title: Online‐based self‐help stress management program for distance‐learning students with feedback on demand ‐ StudiCare
Methods	Study design: RCT Study grouping: parallel group Unit of randomisation: individuals Power (power sample size calculation, level of power achieved): The trialists aim to include 200 participants, allowing for a between‐trial arm group comparison against a statistically relevant effect size threshold of d = 0.40, a power (1 − β) of 80%, and an α of 0.05 (2‐tailed) for the intention‐to‐treat (ITT) analysis. A recent meta‐analytic review for internet‐based stress interventions reported effect sizes of d = 0.64 for perceived stress in guided interventions but considerably smaller effect sizes for unguided programmes (d = 0.34 for depression, d = 0.32 for anxiety). Results for internet‐based interventions addressing psychological distress in tertiary education are mixed, ranging from non‐significant findings to moderate‐sized effects in favour of the respective intervention. Thus, the trialists are aiming for an effect size of d = 0.40. Imputation of missing data: Analyses based on the ITT principle will be conducted, with missing data imputed using a Markov chain Monte Carlo multivariate imputation algorithm with 100 estimations per missing; complete‐case analysis and ITT analysis planned
Participants	Country: Germany, Austria, Switzerland (recruitment) Setting: internet‐based intervention Age: not specified in trial registration or study protocol Sample size (randomised): 200 targeted Sex: not specified Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified Population description: students of a large German distance university with elevated levels of depression (CES‐D score ≥ 16) Inclusion criteria: (see trial registration and study protocol; Harrer 2019): 1) distinct level of perceived study‐related stress: experience elevated levels of depression measured by a score ≥ 16 on the German version of the CES‐D 20‐item version (Allgemeine Depressionsskala (ADS), indicating subthreshold to full‐blown symptoms of depression during the last 2 weeks); 2) enrolled in a bachelor’s or master’s degree programme at a large German distance‐learning tertiary education facility (FernUniversität in Hagen) by the beginning of the intervention; 3) motivation to participate in an online intervention targeting stress reduction; 4) are at least 18 years old; 5) have internet access; 6) willingness to provide a valid e‐mail address and telephone number to the study team; 7) declare willingness to provide self‐report data at all 3 assessment points (online surveys of 45 minutes duration each); 8) give informed consent Exclusion criteria: (see trial registration and study protocol; Harrer 2019): 1) CES‐D score < 16; 2) self‐reported dissociative symptoms or psychosis, currently or in the past; 3) considerable risk for suicide as indicated by a score > 1 on item 9 of the German version of the BDI‐II; “I feel I would be better off dead” or “I would kill myself if I had the chance”; 4) currently undergoing treatment; 5) not enrolled at distance‐learning university; 6) no internet; 7) not willing to sign informed consent Attrition (withdrawals and exclusions): not specified in trial registration or study protocol Reasons for missing data: not specified in trial registration or study protocol
Interventions	Intervention: TAU + StudiCare Fernstudierende (n = 100 planned) delivery: TAU: probably face‐to‐face; individual setting intervention: internet‐based intervention with feedback on demand; IG provided by Minddistrict (company responsible for provision and maintenance of platform); personal diary app; audio files and module summaries; if requested, motivational prompts by short message service (SMS) providers: adherence‐focused guidance concept with personalised feedback on demand guidance in IG by specially trained student in a master’s programme in psychology guidance consists of 3 parts: i) monitoring adherence to the intervention, ii) sending standardised motivational messages after every module, and iii) providing feedback on demand Adherence monitoring involves personal reminders for participants who had not completed a session in the designated time frame (7 days). Standardised motivational messages tailored to each session will be sent when participants completed 1 of the main modules, summarising the content of the previous module and motivating trainees to stay engaged. Feedback on demand will be provided through the internal messaging system of the training platform, which participants may use whenever individualised content feedback is needed. Participants will then receive feedback within 48 hours If requested, participants in the IG will be able to receive automatic messages containing short, motivational prompts via SMS duration of treatment period and timing: 7 modules, each of which can be completed in 1 x 30‐ to 90‐minute session; participants advised to work on 1 or a maximum of 2 modules a week; i.e. IG intended to last 5 ‐ 7 weeks description: TAU: general practitioner visits, counselling services, psychotherapeutic and psychiatric treatment or other forms of primary, secondary, or tertiary care StudiCare Fernstudierende: To tailor the intervention to distance‐learning students’ needs, 1 new student testimonial is introduced and will lead participants through the intervention. The testimonial represents an elder student with children. The testimonial was created to address the specific problems of non‐traditional distant‐learning students, such as limited time for studying, having to take care of children, or facing financial pressure After modules 2 – 7, participants will be offered optional add‐on mini‐modules with information and exercises on student‐specific topics of interest: social support, rumination and worrying, time management, procrastination, test anxiety, sleep, motivation, nutrition and exercise, dealing with writer’s block, and concentration. SESSION 1: introduction: psycho‐education, information about stress and preview of subsequent sessions SESSION 2: problem‐solving: stress management strategies, systematic problem‐solving using a 6‐step problem‐solving heuristic SESSION 3: muscle and breath relaxation: information on basic principles of muscle and breath relaxation, audio exercises for daily usage SESSION 4: mindfulness: coping with self‐criticism, mindfulness exercises SESSION 5: acceptance and tolerance: dealing with unsolvable problems, psycho‐education on and exercises for acceptance and tolerance of unpleasant emotions SESSION 6: self‐compassion: self‐criticism in precarious situations, defusion of self‐worth and performance, exercises for positive self‐support, overcoming dysfunctional perfectionistic thought‐action patterns SESSION 7: my master plan: recognising physiological warning signs, creating a plan for the future SESSION 8: booster session: further information on self‐help and psychotherapy, evaluation of training transfer, recap of all sessions, repetition of previous exercises SESSION 2‐7: 2 – 7 elective mini‐modules: a) social support: communication styles, receiving and providing support; b) rumination and worrying: reflection on positive and negative aspects of worry, coping with uncertainty; c) time management: effective time scheduling, common planning fallacies, learning to prioritise; d) procrastination: identifying situations in which procrastination occurs, strategies to reduce procrastination; e) test anxiety: effective studying techniques, using paradoxical intentions, de‐catastrophising blackouts; f) sleep: sleep restriction; g) motivation: finding reasons for lacking motivation, exercising delay of gratification; h) nutrition and exercise: creating an individual eating and exercise schedule, dealing with relapses; i) dealing with writer’s block: reasons and mechanisms for writer’s block; j) concentration: audio‐based concentration exercises An additional booster session allowing participants to recap and rehearse previously learned strategies will be offered 2 weeks after completion of the main modules Therapeutic content is presented as an illustrative story of a backpacking trip around the world, with each module representing a new continent homework assignments after every module to practice techniques presented during the session To keep track of mood fluctuations and describe experiences in transferring acquired knowledge, a personal diary app is introduced in the first session and can be downloaded afterward. After every module, audio files and module summaries can be accessed, containing exercises to be worked on until the next session compliance: not specified in trial registration or study protocol integrity of delivery: not specified in trial registration or study protocol economic information: not specified in trial registration or study protocol theoretical basis: based on Get.On Stress, an internet‐based stress intervention for employees, which was adapted to a university student context aligns with Lazarus’ transactional model of stress; adheres to a 2‐component structure, incorporating problem‐ and emotion‐focused coping through emotion regulation strategies. (In problem‐focused coping, cognitive behavioural strategies are applied to solve personal problems and to reduce and eliminate stressors. Emotion regulation refers to processes through which individuals monitor, evaluate, and modify emotions to reach relevant goals.) Control: TAU + attention control (n = 100 planned) delivery: TAU: probably face‐to‐face; individual setting attention control: internet‐based; psycho‐educational material provided by Minddistrict (company responsible for provision and maintenance of platform) in contrast to IG: psycho‐education lessons largely text‐based and without interactive components providers: receive guidance parts: i) monitoring adherence to the intervention, and ii) sending standardised motivational messages after every module no feedback on demand compared to IG duration of treatment period and timing: 7 main sessions and 1 booster session; designed to be completed within 5 ‐ 7 weeks description: TAU: general practitioner visits, counselling services, psychotherapeutic and psychiatric treatment or other forms of primary, secondary, or tertiary care attention control: psycho‐education: psycho‐education about cognitive, emotional and physical determinants, symptoms and outcomes of psychosocial stress in general and with respect to distance‐learning students SESSION 1: introduction: prevalence and types of stress; biological response to stress; effects of stress on emotions, thought, somatic symptoms SESSION 2: causes of stress: common stressors among students; Lazarus’ transactional model of stress SESSION 3: Does stress have the same effect on all individuals? Short‐ and long‐term consequences of stress; inter‐individual differences in stress response SESSION 4: What effect does stress have on the body? Physiological response to stressors; evolutionary background of stress reactions; stress and performance SESSION 5: cognitive appraisal: common dysfunctional thoughts contributing to perceived stress; 5 steps for cognitive reappraisal SESSION 6: coping and resources: typical resources and coping mechanisms for stress SESSION 7: health: definition of health and sense of coherence SESSION 8: booster session: recap of previous material compliance: not specified in trial registration or study protocol integrity of delivery: not specified economic information: not specified theoretical basis: not specified For more details, see also study protocol
Outcomes	Outcomes collected and reported: Primary outcome: depression ‐ German version of CES‐D 20: ADS Secondary outcomes: Mental health: anxiety ‐ short version of the Spielberger STAI perceived stress ‐ PSS concerns towards university life, worrying ‐ Academic Worry Questionnaire emotional exhaustion ‐ MBI student version behavioral activation, rumination and functional impairment ‐ BADS Academic outcomes: work impairment, presenteeism ‐ Presenteeism Scale for Students (PSS) subscale for work impairment work impairment, loss of productivity ‐ adaptation of the PSS’ work output scale productivity ‐ visual analog scale college self‐efficacy ‐ College Self‐Efficacy Inventory Risk and protective factors: emotion regulation skills/competencies ‐ German version of the Assessment of Emotion Regulation Skills resilience ‐ CD‐RISC self‐compassion ‐ SCS internal/external locus of control ‐ Multidimensional Locus of Control Scale Form C self‐esteem ‐ RSES personal beliefs about stress (e.g. controllability, harmful and positive nature of stress ‐ Beliefs about Stress Scales’ (BASS) subscales for positive, negative and controllability beliefs Health literacy and help‐seeking intentions: help‐seeking preferences ‐ General Help‐Seeking Questionnaire for personal–emotional problems health literacy ‐ German E‐Health Literacy Scale online counselling experiences and awareness ‐ 2 items extracted from the German Socio‐Economic Panel study‐Innovation Sample module “Internet‐based psychotherapy” reasons for participating in the intervention ‐ self‐developed questionnaire Health economic measures: indirect costs due to presenteeism and absenteeism ‐ productivity loss subscale of Trimbos Institute/institute for Medical Technology Assessment Questionnaire for Costs associated with Psychiatric Illness Additional measures: participant satisfaction ‐ German version of the Client Satisfaction Questionnaire, adapted to the online context; only additional measure assessed at post‐intervention personality ‐ 10‐item Big Five Inventory treatment credibility and expectancies ‐ CEQ According to trial registration also assessed: psychological flexibility ‐ Acceptance and Action Questionnaire‐II Further variables (e.g. suicidal ideation, self‐reported history of psychosis/dissociative symptoms, help‐seeking intentions, internet therapy experience, e‐health literary, reasons for participation, intervention credibility and expectations, sociodemographic characteristics, personality traits) only assessed at baseline (see study protocol, Harrer 2019) Outcomes reported not specified Time points measured and reported: 1) pre‐intervention; 2) post‐intervention (i.e. 7 weeks after randomisation); 3) 5‐week follow‐up (i.e. 3 months after randomisation); time points reported not specified Adverse events: not specified
Starting date	Study start/end date: June 2017 (date of first enrolment); end date not specified
Contact information	Principal investigator: Dr Jennifer Apolinário‐Hagen Address: FernUniversität Hagen, Universitätsstr. 33, 58097 Hagen, Germany Email: jennifer.apolinario‐hagen@fernuni‐hagen.de, stress.hagen@studicare.de Telephone: 02331 987 – 2272
Notes	Contact with authors: We contacted the authors for information on trial status, focus of the intervention on resilience and inclusion of healthcare students (Apolinário‐Hagen 2019 [pers comm]) Funding source: funded through internal research funds of the Fern Universität in Hagen (see study protocol) Declaration of interest: see study protocol. David Ebert is a stakeholder of the Institute for Online Health Trainings, which aims to transfer scientific knowledge related to the present research into routine health care. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest Ethical approval needed/obtained for study: approved by the University of Erlangen‐Nuremberg ethics committee (Erlangen, Germany; 33_17 Bc) Comments by study authors: trial registration number: DRKS00011800 (assigned 27 February 2017) Miscellaneous outcomes by the review authors: according to trial registration, recruitment and follow‐up are both complete (last update in February 2020)