Clinical trial NCT02647801: Self-control and Mindfulness Within Ambulatorily Assessed Network Systems Across Health Related Domains
Official title: The SMASH Study: Self-control and Mindfulness Within Ambulatorily Assessed Network Systems Across Health Related Domains
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Regulation
Keywords: Network approach
mindfulness
self-control
ambulatory assessment
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Three items from the State Self-control Capacity Scale (SSCCS)
timeFrame: From day 1 till day 40, six times a day between 10 am and 8 pm
measure: Three items from the Mindfulness Attention Awareness Scale (MAAS)
timeFrame: From day 1 till day 40, six times a day between 10 am and 8 pm
Secondary outcomes:
measure: Eight affect items based on the affective circumplex (Russel, 2003)
timeFrame: From day 1 till day 40, six times a day between 10 am and 8 pm and at weekly laboratory meetings
measure: Attention (state)
timeFrame: From day 1 till day 40, six times a day between 10 am and 8 pm
measure: Four items from the Situational Motivation Scale (SIMS)
timeFrame: From day 1 till day 40, six times a day between 10 am and 8 pm
measure: Five emotion regulation strategies (Koval, Brose, Pe et al., 2015)
timeFrame: From day 1 till day 40, six times a day between 10 am and 8 pm
measure: Three items from the Dutch eating behavior questionnaire (DEBQ)
timeFrame: From day 1 till day 40, six times a day between 10 am and 8 pm
measure: Three items from the Work related Flow Inventory (WOLF)
timeFrame: From day 1 till day 40, six times a day between 10 am and 8 pm
measure: Three items from the State Adult Attachment Measure (SAAM)
timeFrame: From day 1 till day 40, six times a day between 10 am and 8 pm
measure: Three items from the Recovery Experience Questionnaire
timeFrame: From day 1 till day 40, six times a day between 10 am and 8 pm
measure: Self-Control Scale (SCS-KD)
timeFrame: at seven weekly laboratory meetings (day 0, 7, 14, 21, 28, 35 and 42)
measure: WHO-Five Well-Being Index
timeFrame: Pre- and post measurement (at day 0 and 42)
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: Pre- and post measurement (at day 0 and 42)
measure: Adult Attachment Scale (AAS)
timeFrame: Pre- and post measurement (at day 0 and 42)
measure: Dutch eating behavior questionnaire (DEBQ)
timeFrame: Pre- and post measurement (at day 0 and 42)
measure: Mindful Attention and Awareness Scale (MAAS)
timeFrame: At weekly laboratory meetings (day 0, 7, 14, 21, 28, 35 and 42)
measure: Big Five Inventory (BFI-44)
timeFrame: Pre- and Post measurement (at day 0 and 42)
measure: Breath counting task (Levinson et al., 2014)
timeFrame: Pre- and Post measurement (at day 0 and 42)
measure: Brief Symptom Inventory (BSI-18)
timeFrame: Pre- and Post measurement (at day 0 and 42)
measure: Kentucky Inventory of Mindfulness Skills (KIMS)
timeFrame: Pre- and Post measurement (at day 0 and 42)
Other outcomes:
measure: Toronto Mindfulness Scale (TMS)
timeFrame: At weekly laboratory meetings (day 7, 14, 21, 28, 35)
Locations:
city: Mainz
country: Germany
facility: Department of Psychology, Johannes Gutenberg University Mainz
state: Rhineland-Palatinate
Study officials:
affiliation: Department of Psychology, Johannes Gutenberg University Mainz
name: Mario Wenzel, Dipl. Psych.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology, Johannes Gutenberg University Mainz
name: Thomas Kubiak, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.