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CompletedNCT02647801SMASHUpdated Mar 7, 2017

Self-control and Mindfulness Within Ambulatorily Assessed Network Systems Across Health Related Domains

An interventional study of Mindfulness intervention in Self Regulation, sponsored by Johannes Gutenberg University Mainz. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-07.

Sponsored by Johannes Gutenberg University Mainz · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
137
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Self Regulation

Keywords

  • Network approach
  • mindfulness
  • self-control
  • ambulatory assessment
03

In context

Lead sponsor

Johannes Gutenberg University Mainz is the lead sponsor of 153 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • understanding and speaking German
  • aged between 18 and 65 years
  • knowledge about how to use a mobile phone

Exclusion criteria

Exclusion Criteria:

  • psychological disease
  • mental or somatic disability that could impair the usage of a mobile phone
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
137 participants (actual)

Study arms

  • 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.

    Behavioral: Mindfulness intervention

  • 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.

Interventions

  • BehavioralMindfulness intervention

    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).

06

What researchers measure

Primary outcomes

  1. Three items from the State Self-control Capacity Scale (SSCCS)

    German version of the SSCCS. Self-report on current self-control capacity of participants.

    Time frame: From day 1 till day 40, six times a day between 10 am and 8 pm

  2. Three items from the Mindfulness Attention Awareness Scale (MAAS)

    Items from the German version of the MAAS. Self-report on current mindfulness of participants.

    Time frame: From day 1 till day 40, six times a day between 10 am and 8 pm

Secondary outcomes

  1. Eight affect items based on the affective circumplex (Russel, 2003)

    Eight items which Kuppens and colleagues used for an experience sampling study (Kuppens, Allen, \& Sheeber, 2010). Self-report on momentary affect of participants.

    Time frame: From day 1 till day 40, six times a day between 10 am and 8 pm and at weekly laboratory meetings

  2. Attention (state)

    A single self-report item assessing momentary attention: "For the last 30 minutes I have had problems concentrating."

    Time frame: From day 1 till day 40, six times a day between 10 am and 8 pm

  3. Four items from the Situational Motivation Scale (SIMS)

    Self-report of participants on momentary intrinsic motivation, identified regulation, external regulation, and amotivation.

    Time frame: From day 1 till day 40, six times a day between 10 am and 8 pm

  4. Five emotion regulation strategies (Koval, Brose, Pe et al., 2015)

    Self-report on momentary emotion regulation strategies of participants.

    Time frame: From day 1 till day 40, six times a day between 10 am and 8 pm

  5. Three items from the Dutch eating behavior questionnaire (DEBQ)

    German version of the DEBQ. Self-report on momentary restrictive, emotional and external eating behaviors of participants.

    Time frame: From day 1 till day 40, six times a day between 10 am and 8 pm

  6. Three items from the Work related Flow Inventory (WOLF)

    Self-report on momentary work flow experience of participants.

    Time frame: From day 1 till day 40, six times a day between 10 am and 8 pm

  7. Three items from the State Adult Attachment Measure (SAAM)

    Self-report on current attachment style of participants.

    Time frame: From day 1 till day 40, six times a day between 10 am and 8 pm

  8. Three items from the Recovery Experience Questionnaire

    Self-report on recovery from work in leisure time of participants.

    Time frame: From day 1 till day 40, six times a day between 10 am and 8 pm

  9. Self-Control Scale (SCS-KD)

    German adaptation of the SCS. Self-report on dispositional self-control of participants.

    Time frame: at seven weekly laboratory meetings (day 0, 7, 14, 21, 28, 35 and 42)

  10. WHO-Five Well-Being Index

    German version of the WHO-5 Well-being index. Self-report on well-being of participants.

    Time frame: Pre- and post measurement (at day 0 and 42)

  11. Emotion Regulation Questionnaire (ERQ)

    German adaptation of the ERQ. Self-report on habitual use of emotion regulation strategies (cognitive reappraisal and expressive suppression) of participants.

    Time frame: Pre- and post measurement (at day 0 and 42)

  12. Adult Attachment Scale (AAS)

    German adaptation of the AAS. Self-report on attachment related attitudes of participants.

    Time frame: Pre- and post measurement (at day 0 and 42)

  13. Dutch eating behavior questionnaire (DEBQ)

    German version of the DEBQ. Self-report on restrictive, emotional and external eating behaviors of participants.

    Time frame: Pre- and post measurement (at day 0 and 42)

  14. Mindful Attention and Awareness Scale (MAAS)

    German version of the MAAS. Self-report on dispositional mindfulness of participants.

    Time frame: At weekly laboratory meetings (day 0, 7, 14, 21, 28, 35 and 42)

  15. Big Five Inventory (BFI-44)

    German adaptation of the BFI-44. Self-report on personality traits of participants.

    Time frame: Pre- and Post measurement (at day 0 and 42)

  16. Breath counting task (Levinson et al., 2014)

    Behavioral measure of mindfulness.

    Time frame: Pre- and Post measurement (at day 0 and 42)

  17. Brief Symptom Inventory (BSI-18)

    German version of the BSI-18. Self-report on symptoms of somatisation, depression and anxiety of participants.

    Time frame: Pre- and Post measurement (at day 0 and 42)

  18. Kentucky Inventory of Mindfulness Skills (KIMS)

    German version of the KIMS. Self-report on mindfulness skills of participants.

    Time frame: Pre- and Post measurement (at day 0 and 42)

Other outcomes

  1. Toronto Mindfulness Scale (TMS)

    Self-report on meditation experiences after breathing meditation.

    Time frame: At weekly laboratory meetings (day 7, 14, 21, 28, 35)

07

Study locations

1 site
  • Department of Psychology, Johannes Gutenberg University Mainz
    Mainz, Rhineland-Palatinate 55122, Germany
08

References and documents

Publications

  • 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. PubMed 23593171 ↗
  • 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. PubMed 25386148 ↗
  • 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. PubMed 20501521 ↗
  • 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. PubMed 25844974 ↗
  • 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. PubMed 12529060 ↗
  • 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. PubMed 30570315 ↗
  • 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. PubMed 27906104 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02647801
Lead sponsor
Johannes Gutenberg University Mainz
Responsible party
Mario Wenzel (Dipl. Psych. Mario Wenzel, Johannes Gutenberg University Mainz) — Principal investigator
First posted
Jan 6, 2016
Start date
Sep 2015
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Mar 7, 2017

Study contacts

Mario Wenzel, Dipl. Psych.
principal investigator · Department of Psychology, Johannes Gutenberg University Mainz
Thomas Kubiak, Prof. Dr.
principal investigator · Department of Psychology, Johannes Gutenberg University Mainz

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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