Comparative effectiveness of guided Internet-based stress management training versus established in-person group training in employees – a pragmatic, randomized, non-inferiority trial

Comparative effectiveness of guided Internet-based stress management training versus established in-person group training in employees – a pragmatic, randomized, non-inferiority trial - PragmatiKK_Stress

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024892

Enrollment

448

Registered

2021-04-09

Start date

2022-07-04

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

work-related stress Z73

Interventions

Group 1: Guided Internet-based self-help stressmanagement: participants get access to an Internet-based training, consisting of 7 sessions. Participants will need approximately 60-90 minutes to comple

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: a) be employed, b) have access to the Internet to complete online training sessions weekly, c) be able to visit group sessions in their local area, d) give their informed consent to participate, e) complete the baseline assessment (T1)

Exclusion criteria

Exclusion criteria: suicide ideations, assessed by scoring > 1 on the suicide ideations item of the Beck Inventory for Depression II (Beck et al., 1996)

Design outcomes

Primary

Measure	Time frame
Perceived stress, assessed by the Perceived Stress Scale (PSS-10; Cohen et al. 1983) at 3 months after randomization (T3). The non-inferiority margin will be 2 points on the PSS-10, corresponding to an between-group effect size of Cohen's d=0.29.	—

Secondary

Measure	Time frame
Perceived Stress Scale (PSS-10; Cohen et al., 1983; Klein et al., 2016; Reis et al., 2017) (T1, T2, T3, T4) Center for Epidemiological Studies on Depression Scale (CES-D; Radloff, 1977; Hautzinger et al. 2012) (T1, T3) Brief Resilience Scale (BRS; Smith et al., 2008; Chmitorz et al., 2018) (T1, T3) Effort-Reward-Imbalance Questionnaire (ERI; Siegrist et al., 2009) (T1, T3) Job Crafting Scale (JCS; Tims et al., 2012; Lichtenthaler et al., 2016) - adapted (T1, T3) Treatment Inventory of Costs in Psychiatric Patients (TIC-P; Bouwmans et al., 2013), subscale for productivity loss (T1, T4) Health and Labor Questionnaire (HLQ; Van Roijen et al., 1996) (T1, T4) Assessment of Quality of Life (AQoL-6D; Richardson et al., 2012) (T1, T4) Client Satisfaction Questionnaire (CSQ/CSQ-I; Attkisson & Zwick, 1982; Boß et al. 2016) (T3) Adherence to the intervention - self-developed (T3) Potential moderator variables: Patient Questionnaire on Therapy Expectation and Evaluation (PATHEV; Schulte, 2005) – adapted (T1) Technology Readiness Index (TRI 2.0; Parasuraman et al., 2015) (T1) Preferences for online and group stress management - self-developed (T1, T3) --- T1 = Baseline Assessment T2 = Pre-Intervention Assessment prior to intervention beginning T3 = Post-Intervention-Assessment, 3 months after allocation to study arms T4= Post-Intervention-Assessment, 6 months after allocation to study arms	—

Measure

Time frame

Perceived Stress Scale (PSS-10; Cohen et al., 1983; Klein et al., 2016; Reis et al., 2017) (T1, T2, T3, T4) Center for Epidemiological Studies on Depression Scale (CES-D; Radloff, 1977; Hautzinger et al. 2012) (T1, T3) Brief Resilience Scale (BRS; Smith et al., 2008; Chmitorz et al., 2018) (T1, T3) Effort-Reward-Imbalance Questionnaire (ERI; Siegrist et al., 2009) (T1, T3) Job Crafting Scale (JCS; Tims et al., 2012; Lichtenthaler et al., 2016) - adapted (T1, T3) Treatment Inventory of Costs in Psychiatric Patients (TIC-P; Bouwmans et al., 2013), subscale for productivity loss (T1, T4) Health and Labor Questionnaire (HLQ; Van Roijen et al., 1996) (T1, T4) Assessment of Quality of Life (AQoL-6D; Richardson et al., 2012) (T1, T4) Client Satisfaction Questionnaire (CSQ/CSQ-I; Attkisson & Zwick, 1982; Boß et al. 2016) (T3) Adherence to the intervention - self-developed (T3) Potential moderator variables: Patient Questionnaire on Therapy Expectation and Evaluation (PATHEV; Schulte, 2005) – adapted (T1) Technology Readiness Index (TRI 2.0; Parasuraman et al., 2015) (T1) Preferences for online and group stress management - self-developed (T1, T3) --- T1 = Baseline Assessment T2 = Pre-Intervention Assessment prior to intervention beginning T3 = Post-Intervention-Assessment, 3 months after allocation to study arms T4= Post-Intervention-Assessment, 6 months after allocation to study arms

—

Countries

Germany

Contacts

Public ContactLeif Boß

Leuphana Universität Lüneburg, Institut für Psychologie, Abteilung Gesundheitspsychologie und Angewandte Biologische Psychologie

boss@leuphana.de+4941316771710

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 14, 2026