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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00014774 |
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Date of registration:
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18/05/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 - StudiCare-M-II
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Date of first enrolment:
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21/05/2018 |
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Target sample size:
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387 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00014774 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active//No treatment / Standard of care; Assignment: parallel; Study design purpose: prevention
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Phase:
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N/A
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Countries of recruitment
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Austria
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Germany
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Switzerland
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Contacts
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Name:
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Ann-Marie
Küchler |
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Address:
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Albert-Einstein-Allee 47
89081
Ulm
Germany |
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Telephone:
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+49-(0)731/50 32812 |
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Email:
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ann-marie.kuechler at uni-ulm.de |
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Affiliation:
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Universität Ulm; Institut für Psychologie und Pädagogik; Abt. Klinische Psychologie und Psychotherapie |
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Name:
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Ann-Marie
Küchler |
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Address:
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Albert-Einstein-Alle 47
89081
Ulm
Germany |
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Telephone:
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+49-(0)731/50 32812 |
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Email:
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achtsamkeit@studicare.com; ann-marie.kuechler@uni-ulm.de |
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Affiliation:
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Universität Ulm;Institut für Psychologie und Pädagogik; Abt. Klinische Psychologie und Psychotherapie |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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no health condition, preventive; low to moderate mindfulness
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Intervention(s)
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Group 1: unguided intervention group with immediate access to an internet-based mindfulness intervention developed according to the principles of Acceptance and Commitment Therapy as well as stress management (e. g. interoception, dealing with stressful thoughts, values and goals); consisting of seven modules that are supposed to be worked through on a weekly basis as well as two booster sessions 4 and 12 weeks after completion of the last (seventh) module; additionally the possibility to book a SMS coach with tips and reminders for the time of the intervention
Group 2: "guidance on demand" intervention group that also receives immediate access to the same intervention as the unguided intervention group; additionally, participants of this group have the possibility to contact their e-coach in case of questions or for feedback concerning their finished modules at any time
Group 3: waitlist control group; access to same internet-based training as unguided intervention group after waiting period of 6 months
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Barmer GEK
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Ethics review
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Status: Approved
Approval date: 07/03/2018
Contact:
ethik-kommission@uni-ulm.de
Ethikkommission der Universität Ulm
+49-731-50022050
ethik-kommission@uni-ulm.de
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