NCT02647801

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

December 15, 2015

Last Update Submit

March 6, 2017

Conditions

Keywords

Network approachmindfulnessself-controlambulatory assessment

Outcome Measures

Primary Outcomes (2)

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

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

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

  • Three items from the Mindfulness Attention Awareness Scale (MAAS)

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

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

Secondary Outcomes (18)

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

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

  • Attention (state)

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

  • Four items from the Situational Motivation Scale (SIMS)

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

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

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

  • Three items from the Dutch eating behavior questionnaire (DEBQ)

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

  • +13 more secondary outcomes

Other Outcomes (1)

  • Toronto Mindfulness Scale (TMS)

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

Study Arms (2)

Mindfulness intervention

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

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).

Mindfulness intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, Johannes Gutenberg University Mainz

Mainz, Rhineland-Palatinate, 55122, Germany

Location

Related Publications (7)

  • 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.

    PMID: 23593171BACKGROUND
  • 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.

    PMID: 25386148BACKGROUND
  • 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.

    PMID: 20501521BACKGROUND
  • 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.

    PMID: 25844974BACKGROUND
  • 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.

    PMID: 12529060BACKGROUND
  • 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.

MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Mario Wenzel, Dipl. Psych.

    Department of Psychology, Johannes Gutenberg University Mainz

    PRINCIPAL INVESTIGATOR
  • Thomas Kubiak, Prof. Dr.

    Department of Psychology, Johannes Gutenberg University Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dipl. Psych. Mario Wenzel

Study Record Dates

First Submitted

December 15, 2015

First Posted

January 6, 2016

Study Start

September 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 7, 2017

Record last verified: 2017-03

Locations