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

Study Overview
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Brief Summary
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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.

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

Conditions
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Self Regulation

Intervention / Treatment
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* Behavioral: Mindfulness intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness intervention<br>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<br>* 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).<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| Breath counting task (Levinson et al., 2014) | Behavioral measure of mindfulness. | Pre- and Post measurement (at day 0 and 42) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Network approach, mindfulness, self-control, ambulatory assessment