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

Self Regulation Clinical Trial

— SMASH  

Official title:

The SMASH Study: Self-control and Mindfulness Within Ambulatorily Assessed Network Systems Across Health Related Domains

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647801
• Other study ID #: 2015-JGU-psychEK-011
• Status: Completed
• Phase: N/A
• First received: December 15, 2015
• Last updated: March 6, 2017
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Self Regulation

Intervention

Behavioral:
• Mindfulness 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).

Locations

Country	Name	City	State
Germany	Department of Psychology, Johannes Gutenberg University Mainz	Mainz	Rhineland-Palatinate

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. Erratum in: PLoS One. 2014;9(4):e96588. — View 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. — View Citation

Kuppens P, Allen NB, Sheeber LB. Emotional inertia and psychological maladjustment. Psychol Sci. 2010 Jul;21(7):984-91. doi: 10.1177/0956797610372634. — View 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. — View Citation

Russell JA. Core affect and the psychological construction of emotion. Psychol Rev. 2003 Jan;110(1):145-72. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Toronto Mindfulness Scale (TMS)	Self-report on meditation experiences after breathing meditation.	At weekly laboratory meetings (day 7, 14, 21, 28, 35)
Primary	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
Primary	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	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.	From day 1 till day 40, six times a day between 10 am and 8 pm and at weekly laboratory meetings
Secondary	Attention (state)	A single self-report item assessing momentary attention: "For the last 30 minutes I have had problems concentrating."	From day 1 till day 40, six times a day between 10 am and 8 pm
Secondary	Four items from the Situational Motivation Scale (SIMS)	Self-report of participants on momentary intrinsic motivation, identified regulation, external regulation, and amotivation.	From day 1 till day 40, six times a day between 10 am and 8 pm
Secondary	Five emotion regulation strategies (Koval, Brose, Pe et al., 2015)	Self-report on momentary emotion regulation strategies of participants.	From day 1 till day 40, six times a day between 10 am and 8 pm
Secondary	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.	From day 1 till day 40, six times a day between 10 am and 8 pm
Secondary	Three items from the Work related Flow Inventory (WOLF)	Self-report on momentary work flow experience of participants.	From day 1 till day 40, six times a day between 10 am and 8 pm
Secondary	Three items from the State Adult Attachment Measure (SAAM)	Self-report on current attachment style of participants.	From day 1 till day 40, six times a day between 10 am and 8 pm
Secondary	Three items from the Recovery Experience Questionnaire	Self-report on recovery from work in leisure time of participants.	From day 1 till day 40, six times a day between 10 am and 8 pm
Secondary	Self-Control Scale (SCS-KD)	German adaptation of the SCS. Self-report on dispositional self-control of participants.	at seven weekly laboratory meetings (day 0, 7, 14, 21, 28, 35 and 42)
Secondary	WHO-Five Well-Being Index	German version of the WHO-5 Well-being index. Self-report on well-being of participants.	Pre- and post measurement (at day 0 and 42)
Secondary	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.	Pre- and post measurement (at day 0 and 42)
Secondary	Adult Attachment Scale (AAS)	German adaptation of the AAS. Self-report on attachment related attitudes of participants.	Pre- and post measurement (at day 0 and 42)
Secondary	Dutch eating behavior questionnaire (DEBQ)	German version of the DEBQ. Self-report on restrictive, emotional and external eating behaviors of participants.	Pre- and post measurement (at day 0 and 42)
Secondary	Mindful Attention and Awareness Scale (MAAS)	German version of the MAAS. Self-report on dispositional mindfulness of participants.	At weekly laboratory meetings (day 0, 7, 14, 21, 28, 35 and 42)
Secondary	Big Five Inventory (BFI-44)	German adaptation of the BFI-44. Self-report on personality traits of participants.	Pre- and Post measurement (at day 0 and 42)
Secondary	Breath counting task (Levinson et al., 2014)	Behavioral measure of mindfulness.	Pre- and Post measurement (at day 0 and 42)
Secondary	Brief Symptom Inventory (BSI-18)	German version of the BSI-18. Self-report on symptoms of somatisation, depression and anxiety of participants.	Pre- and Post measurement (at day 0 and 42)
Secondary	Kentucky Inventory of Mindfulness Skills (KIMS)	German version of the KIMS. Self-report on mindfulness skills of participants.	Pre- and Post measurement (at day 0 and 42)