Self RegulationSMASHNCT02647801
Self-control and Mindfulness Within Ambulatorily Assessed Network Systems Across Health Related Domains
A study testing Mindfulness intervention in people with Self Regulation, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Self Regulation
- What is being tested?
- Mindfulness intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- understanding and speaking German
- aged between 18 and 65 years
- knowledge about how to use a mobile phone
Who cannot join
- psychological disease
- mental or somatic disability that could impair the usage of a mobile phone
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychology, Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, 55122
About this study
Official title: The SMASH Study: Self-control and Mindfulness Within Ambulatorily Assessed Network Systems Across Health Related Domains
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.
- Conditions
- Self Regulation
- Being tested
- Mindfulness intervention
- Keywords
- Network approach, mindfulness, self-control, ambulatory assessment
- Medical subject headings
- Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness interventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three items from the State Self-control Capacity Scale (SSCCS)
German version of the SSCCS. Self-report on current self-control capacity of participants.
Measured: 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.
Measured: 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)
Eight items which Kuppens and colleagues used for an experience sampling study (Kuppens, Allen, \& Sheeber, 2010). Self-report on momentary affect of participants.
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre- and Post measurement (at day 0 and 42)
Breath counting task (Levinson et al., 2014)
Behavioral measure of mindfulness.
Measured: 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.
Measured: 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.
Measured: Pre- and Post measurement (at day 0 and 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Self RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Wenzel, Johannes Gutenberg University Mainz
- Investigators
- Mario Wenzel, Dipl. Psych., Principal investigator, Department of Psychology, Johannes Gutenberg University MainzThomas Kubiak, Prof. Dr., Principal investigator, Department of Psychology, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647801
- Sponsor's protocol ID
- 2015-JGU-psychEK-011
- Acronym
- SMASH
- Status last verified
- Mar 2017
- First submitted
- 15 Dec 2015
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23593171Levinson 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 25386148Kuppens 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 20501521Koval 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 25844974Russell 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 12529060Rowland 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 30570315Rowland 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SMASH Study: Self-control and Mindfulness Within Ambulatorily Assessed Network Systems Across Health Related Domains
- ClinicalTrials.gov ID
- NCT02647801
- Acronym / sponsor ID
- SMASH / 2015-JGU-psychEK-011
- Conditions
- Self Regulation
- Keywords
- Network approach, mindfulness, self-control, ambulatory assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness intervention | Experimental | Behavioral: Mindfulness interventionThe experimental group comes to weekly laboratory meetings and practices mindfulness. Participants also fill out self-report questionnaires which assess self-control and mindfulness. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- understanding and speaking German
- aged between 18 and 65 years
- knowledge about how to use a mobile phone
Key exclusion criteria (2 listed)
- psychological disease
- mental or somatic disability that could impair the usage of a mobile phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness interventionMindfulness 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). | Behavioural | Mindfulness intervention |
Primary outcome
Three items from the State Self-control Capacity Scale (SSCCS)
Time frame: From day 1 till day 40, six times a day between 10 am and 8 pm
German version of the SSCCS. Self-report on current self-control capacity of participants.
Three items from the Mindfulness Attention Awareness Scale (MAAS)
Time frame: From day 1 till day 40, six times a day between 10 am and 8 pm
Items from the German version of the MAAS. Self-report on current mindfulness of participants.
18 secondary outcomes
Eight affect items based on the affective circumplex (Russel, 2003)
Time frame: From day 1 till day 40, six times a day between 10 am and 8 pm and at weekly laboratory meetings
Attention (state)
Time frame: From day 1 till day 40, six times a day between 10 am and 8 pm
Four items from the Situational Motivation Scale (SIMS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: From day 1 till day 40, six times a day between 10 am and 8 pm
Three items from the Recovery Experience Questionnaire
Time frame: From day 1 till day 40, six times a day between 10 am and 8 pm
Self-Control Scale (SCS-KD)
Time frame: at seven weekly laboratory meetings (day 0, 7, 14, 21, 28, 35 and 42)
WHO-Five Well-Being Index
Time frame: Pre- and post measurement (at day 0 and 42)
Emotion Regulation Questionnaire (ERQ)
Time frame: Pre- and post measurement (at day 0 and 42)
Adult Attachment Scale (AAS)
Time frame: Pre- and post measurement (at day 0 and 42)
Dutch eating behavior questionnaire (DEBQ)
Time frame: Pre- and post measurement (at day 0 and 42)
Mindful Attention and Awareness Scale (MAAS)
Time frame: At weekly laboratory meetings (day 0, 7, 14, 21, 28, 35 and 42)
Big Five Inventory (BFI-44)
Time frame: Pre- and Post measurement (at day 0 and 42)
Breath counting task (Levinson et al., 2014)
Time frame: Pre- and Post measurement (at day 0 and 42)
Brief Symptom Inventory (BSI-18)
Time frame: Pre- and Post measurement (at day 0 and 42)
Kentucky Inventory of Mindfulness Skills (KIMS)
Time frame: Pre- and Post measurement (at day 0 and 42)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Background: PubMed 23593171Bringmann 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.
- Background: PubMed 25386148Levinson 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.
- Background: PubMed 20501521Kuppens 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.
- Background: PubMed 25844974Koval 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.
- Background: PubMed 12529060Russell 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.
- Derived from this study: PubMed 30570315Rowland 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.
- Derived from this study: PubMed 27906104Rowland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness intervention in people with Self Regulation, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three items from the State Self-control Capacity Scale (SSCCS) (time frame: From day 1 till day 40, six times a day between 10 am and 8 pm). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02647801, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.