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Randomized controlled feasibility trial to examine efficacy on different psychophysiological variables of an internet-based intervention for enhancing mindfulness in college students (StudiCare Mindfulness)

Randomized controlled feasibility trial to examine efficacy on different psychophysiological variables of an internet-based intervention for enhancing mindfulness in college students (StudiCare Mindfulness) - StudiCare_Mindfulness

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00014701
Enrollment
120
Registered
2018-05-07
Start date
2018-05-10
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Healthy volunteers

Interventions

Group 1: intervention group with immediate access to a e-coach guided internet-based mindfulness intervention developed according to the principles of Acceptance and Commitment therapy (e. g. dealing
consisting of seven modules that are supposed to be worked through every week Group 2: waitlist control group
access to same internet-based training as intervention group after waiting period of 24 weeks

Sponsors

Universität Ulm; Institut für Psychologie und Pädagogik; Abt. Klinische und Gesundheitspsychologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: At least 18 years old; enrolled as a college/university student at Ulm University; internet access; moderate to low mindfulness (Freiburg Mindfulness Inventory of 37 or lower)

Exclusion criteria

Exclusion criteria: Not currently in psychotherapy or participate in other mindfulness intervention

Design outcomes

Primary

MeasureTime frame
Mindfulness according to the Freiburg Mindfulness Inventory; data collection before randomization and also 8/9 weeks thereafter as well as 24 weeks after randomization

Secondary

MeasureTime frame
Questionnaires: Anxiety (GAD-7), stress (PSQ, hair cortisol, DHEA, FKBP5), depression (PHQ-9), quality of life (SF-12), intervention satisfaction (ZUF-8), -acceptance (CEQ) and adherence (number of completed modules), emotion regulation (ERQ), interoceptive sensibility (BPQ), alexithymia (TAS-20); acceptance (qualitative data) Psychophysiological data: Interoceptive accuracy (heartbeat perception), hair cortisol, DHEA, FKBP5 Procedure: Data will be collected before randomization and after the intervention (8/9 weeks), followed by a follow-up measurement 24 weeks later. Gene FKBP5 will only be assessed before randomization.

Countries

Germany

Contacts

Public ContactDana Schultchen

Universität Ulm; Institut für Psychologie und Pädagogik; Abt. Klinische und Gesundheitspsychologie

dana.schultchen@uni-ulm.de+49-(0)731/50 3174

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026