- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02647801
Self-control and Mindfulness Within Ambulatorily Assessed Network Systems Across Health Related Domains (SMASH)
The SMASH Study: Self-control and Mindfulness Within Ambulatorily Assessed Network Systems Across Health Related Domains
The aim of this trial is to test a novel network approach (Bringmann et al., 2013), which enables to investigate the complex, interdependent network of self-control and its influences in everyday life. By adding an intervention to the network, such as mindfulness training, it is also possible to explore the way mindfulness changes connection strengths between network variables.
For six weeks, an ambulatory assessment and additional seven weekly laboratory sessions are conducted with 120 students from the Johannes Gutenberg University Mainz who are randomized to a control (n=60) or intervention condition (n=60). Pre and post measurement sessions take place to assess self-reported trait self-control and mindfulness and a behavioral measure of mindfulness (Levinson, Stoll, Kindy, Merry & Davidson 2014). Participants of both the experimental and control condition come to five weekly lab meetings in which they fill out questionnaires to assess changes in self-reported self-control and mindfulness. But only participants of the experimental condition take part in weekly computer based mindfulness trainings. During the ambulatory assessment, participants complete questionnaires six times a day via mobile phones that are randomly prompted and answer questions about state self-control, motivation, affect, and current situation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rhineland-Palatinate
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Mainz, Rhineland-Palatinate, Germany, 55122
- Department of Psychology, Johannes Gutenberg University Mainz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- understanding and speaking German
- aged between 18 and 65 years
- knowledge about how to use a mobile phone
Exclusion Criteria:
- psychological disease
- mental or somatic disability that could impair the usage of a mobile phone
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Mindfulness intervention
The experimental group comes to weekly laboratory meetings and practices mindfulness.
Participants also fill out self-report questionnaires which assess self-control and mindfulness.
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Mindfulness is practiced with a weekly computer based guided breathing meditation in which one's own breath has to be counted repetitively from 1 to 9. Participants have to press a specific button for breaths 1 to 8 and then press another button for breath 9 on a keyboard.
During this practice they put on headphones and listen to a voice that guides them through breathing meditation.
A "click" sound will occur if breath is miscounted (Levinson et al., 2014).
After each computer based breathing meditation the experimenter and participants exchange meditation experiences and views.
After the first mindfulness training participants in the experimental group are also able to practice mindfulness at home by listening to audio files on the mobile phone (bodyscan or breathing meditation).
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No Intervention: Control group
The control group comes to weekly laboratory meetings and fills out self-report questionnaires which assess self-control and mindfulness.
No mindfulness training is carried out.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Three items from the State Self-control Capacity Scale (SSCCS)
Time Frame: From day 1 till day 40, six times a day between 10 am and 8 pm
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German version of the SSCCS.
Self-report on current self-control capacity of participants.
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From day 1 till day 40, six times a day between 10 am and 8 pm
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Three items from the Mindfulness Attention Awareness Scale (MAAS)
Time Frame: From day 1 till day 40, six times a day between 10 am and 8 pm
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Items from the German version of the MAAS.
Self-report on current mindfulness of participants.
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From day 1 till day 40, six times a day between 10 am and 8 pm
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eight affect items based on the affective circumplex (Russel, 2003)
Time Frame: From day 1 till day 40, six times a day between 10 am and 8 pm and at weekly laboratory meetings
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Eight items which Kuppens and colleagues used for an experience sampling study (Kuppens, Allen, & Sheeber, 2010).
Self-report on momentary affect of participants.
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From day 1 till day 40, six times a day between 10 am and 8 pm and at weekly laboratory meetings
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Attention (state)
Time Frame: From day 1 till day 40, six times a day between 10 am and 8 pm
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A single self-report item assessing momentary attention: "For the last 30 minutes I have had problems concentrating."
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From day 1 till day 40, six times a day between 10 am and 8 pm
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Four items from the Situational Motivation Scale (SIMS)
Time Frame: From day 1 till day 40, six times a day between 10 am and 8 pm
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Self-report of participants on momentary intrinsic motivation, identified regulation, external regulation, and amotivation.
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From day 1 till day 40, six times a day between 10 am and 8 pm
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Five emotion regulation strategies (Koval, Brose, Pe et al., 2015)
Time Frame: From day 1 till day 40, six times a day between 10 am and 8 pm
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Self-report on momentary emotion regulation strategies of participants.
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From day 1 till day 40, six times a day between 10 am and 8 pm
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Three items from the Dutch eating behavior questionnaire (DEBQ)
Time Frame: From day 1 till day 40, six times a day between 10 am and 8 pm
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German version of the DEBQ.
Self-report on momentary restrictive, emotional and external eating behaviors of participants.
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From day 1 till day 40, six times a day between 10 am and 8 pm
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Three items from the Work related Flow Inventory (WOLF)
Time Frame: From day 1 till day 40, six times a day between 10 am and 8 pm
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Self-report on momentary work flow experience of participants.
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From day 1 till day 40, six times a day between 10 am and 8 pm
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Three items from the State Adult Attachment Measure (SAAM)
Time Frame: From day 1 till day 40, six times a day between 10 am and 8 pm
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Self-report on current attachment style of participants.
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From day 1 till day 40, six times a day between 10 am and 8 pm
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Three items from the Recovery Experience Questionnaire
Time Frame: From day 1 till day 40, six times a day between 10 am and 8 pm
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Self-report on recovery from work in leisure time of participants.
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From day 1 till day 40, six times a day between 10 am and 8 pm
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Self-Control Scale (SCS-KD)
Time Frame: at seven weekly laboratory meetings (day 0, 7, 14, 21, 28, 35 and 42)
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German adaptation of the SCS.
Self-report on dispositional self-control of participants.
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at seven weekly laboratory meetings (day 0, 7, 14, 21, 28, 35 and 42)
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WHO-Five Well-Being Index
Time Frame: Pre- and post measurement (at day 0 and 42)
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German version of the WHO-5 Well-being index.
Self-report on well-being of participants.
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Pre- and post measurement (at day 0 and 42)
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Emotion Regulation Questionnaire (ERQ)
Time Frame: Pre- and post measurement (at day 0 and 42)
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German adaptation of the ERQ.
Self-report on habitual use of emotion regulation strategies (cognitive reappraisal and expressive suppression) of participants.
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Pre- and post measurement (at day 0 and 42)
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Adult Attachment Scale (AAS)
Time Frame: Pre- and post measurement (at day 0 and 42)
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German adaptation of the AAS.
Self-report on attachment related attitudes of participants.
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Pre- and post measurement (at day 0 and 42)
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Dutch eating behavior questionnaire (DEBQ)
Time Frame: Pre- and post measurement (at day 0 and 42)
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German version of the DEBQ.
Self-report on restrictive, emotional and external eating behaviors of participants.
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Pre- and post measurement (at day 0 and 42)
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Mindful Attention and Awareness Scale (MAAS)
Time Frame: At weekly laboratory meetings (day 0, 7, 14, 21, 28, 35 and 42)
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German version of the MAAS.
Self-report on dispositional mindfulness of participants.
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At weekly laboratory meetings (day 0, 7, 14, 21, 28, 35 and 42)
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Big Five Inventory (BFI-44)
Time Frame: Pre- and Post measurement (at day 0 and 42)
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German adaptation of the BFI-44.
Self-report on personality traits of participants.
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Pre- and Post measurement (at day 0 and 42)
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Breath counting task (Levinson et al., 2014)
Time Frame: Pre- and Post measurement (at day 0 and 42)
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Behavioral measure of mindfulness.
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Pre- and Post measurement (at day 0 and 42)
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Brief Symptom Inventory (BSI-18)
Time Frame: Pre- and Post measurement (at day 0 and 42)
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German version of the BSI-18.
Self-report on symptoms of somatisation, depression and anxiety of participants.
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Pre- and Post measurement (at day 0 and 42)
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Kentucky Inventory of Mindfulness Skills (KIMS)
Time Frame: Pre- and Post measurement (at day 0 and 42)
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German version of the KIMS.
Self-report on mindfulness skills of participants.
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Pre- and Post measurement (at day 0 and 42)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toronto Mindfulness Scale (TMS)
Time Frame: At weekly laboratory meetings (day 7, 14, 21, 28, 35)
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Self-report on meditation experiences after breathing meditation.
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At weekly laboratory meetings (day 7, 14, 21, 28, 35)
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Collaborators and Investigators
Investigators
- Principal Investigator: Mario Wenzel, Dipl. Psych., Department of Psychology, Johannes Gutenberg University Mainz
- Principal Investigator: Thomas Kubiak, Prof. Dr., Department of Psychology, Johannes Gutenberg University Mainz
Publications and helpful links
General Publications
- Levinson DB, Stoll EL, Kindy SD, Merry HL, Davidson RJ. A mind you can count on: validating breath counting as a behavioral measure of mindfulness. Front Psychol. 2014 Oct 24;5:1202. doi: 10.3389/fpsyg.2014.01202. eCollection 2014.
- Bringmann LF, Vissers N, Wichers M, Geschwind N, Kuppens P, Peeters F, Borsboom D, Tuerlinckx F. A network approach to psychopathology: new insights into clinical longitudinal data. PLoS One. 2013 Apr 4;8(4):e60188. doi: 10.1371/journal.pone.0060188. Print 2013. Erratum In: PLoS One. 2014;9(4):e96588.
- Kuppens P, Allen NB, Sheeber LB. Emotional inertia and psychological maladjustment. Psychol Sci. 2010 Jul;21(7):984-91. doi: 10.1177/0956797610372634. Epub 2010 May 25.
- Koval P, Brose A, Pe ML, Houben M, Erbas Y, Champagne D, Kuppens P. Emotional inertia and external events: The roles of exposure, reactivity, and recovery. Emotion. 2015 Oct;15(5):625-36. doi: 10.1037/emo0000059. Epub 2015 Apr 6.
- Russell JA. Core affect and the psychological construction of emotion. Psychol Rev. 2003 Jan;110(1):145-72. doi: 10.1037/0033-295x.110.1.145.
- Rowland Z, Wenzel M, Kubiak T. A mind full of happiness: How mindfulness shapes affect dynamics in daily life. Emotion. 2020 Apr;20(3):436-451. doi: 10.1037/emo0000562. Epub 2018 Dec 20.
- Rowland Z, Wenzel M, Kubiak T. The effects of computer-based mindfulness training on Self-control and Mindfulness within Ambulatorily assessed network Systems across Health-related domains in a healthy student population (SMASH): study protocol for a randomized controlled trial. Trials. 2016 Dec 1;17(1):570. doi: 10.1186/s13063-016-1707-4.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2015-JGU-psychEK-011
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