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)
Control: TAU + attention control (n = 100 planned)
For more details, see also study protocol |
Outcomes |
Outcomes collected and reported: Primary outcome:
Secondary outcomes: Mental health:
Academic outcomes:
Risk and protective factors:
Health literacy and help‐seeking intentions:
Health economic measures:
Additional measures:
According to trial registration also assessed:
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) |