StudiCare Mindfulness - Randomized controlled trial to evaluate an unguided as well as a guidance on demand version of an internet-based mindfulness intervention for students

Not Applicable

• Conditions: no health condition, preventive; low to moderate mindfulness

• Registration Number: DRKS00014774
• Lead Sponsor: niversität Ulm; Institut für Psychologie und Pädagogik; Abt. Klinische Psychologie und Psychotherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-18
• Study Completion: 2020-11-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 387

Inclusion Criteria

moderate to low mindfulness (Freiburg Mindfulness inventory 37 or lower); at least 18 Jears old; enrolled as a college/university student

Exclusion Criteria

no current psychotherapy or other mindfulness intervention

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mindfulness according to the Freiburg Mindfulness Inventory; data collection before (t0), 8 weeks after (t1) and 6 months after (Follow-Up, FU) randomisation; additional intermediate assessment for mediation analysis after 4 weeks

Secondary Outcome Measures

Name	Time	Method
Depression (PHQ-9), anxiety (GAD-7),, stress (PSS-4), wellbeing (WHO-5), self-efficacy (SWE), presenteeism (SPS), cognitive fusion (CFQ-D), intervention satisfaction (CSQ-8), adherence (number of completed modules) and acceptance (self-developed questionnaire), credebility/expectancy (CEQ), risks and side effects (modifed version of INEP); data collection before (t0), 8 weeks after (t1) and 6 months after (Follow-Up, FU) randomisation; additional intermediate assessment of anxiety, stress, depression, self-efficacy and cognitive fusion for mediation analysis after 4 weeks