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Mental Health and General Well-beingNCT03079154

The Influence of Mindfulness on the Link Between Consumer Culture Values and Well-being

A study testing Teacher-led MBCT course and Self-guided MBCT course in people with Mental Health and General Well-being, run by University of Sussex.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is a three-arm intervention, where students are randomly assigned to one of three conditions: Teacher-led group-based MBCT, Self-guided MBCT using an audio book, or 'wait list' control. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Health and General Well-being
What is being tested?
Teacher-led MBCT course and Self-guided MBCT course
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
No sites listed yet
Study dates
30 Sep 2016to 28 Sep 2017
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Student at the University of Sussex

Who cannot join

  • Having experienced a significant life event (e.g., bereavement) in the six months proceeding the study Suffering from a mental health condition at clinical levels Having prior time commitments that prevent the respondents from taking parts in all phases of the study

About this study

Official title: A Pilot RCT Intervention to Test the Impact of High and Low-intensity Mindfulness-based Cognitive Therapy (MBCT) on Self, Values, and Well-being

The study is a three-arm intervention, where students are randomly assigned to one of three conditions: Teacher-led group-based MBCT, Self-guided MBCT using an audio book, or 'wait list' control. Pre-intervention, respondents complete a questionnaire assessing self, values, psychological processes related to self, and well-being. Post-intervention, respondents complete the same questionnaire, and then take part in a laboratory-based study which assesses behaviours related to the variables measured in the questionnaires. We are aiming for a sample size of 180 students at Sussex, 60 in each intervention arm.

Read the detailed description

Substantive evidence shows that mindfulness training improves mental health and general well-being (see meta-analyses by Cavanagh, Strauss, and colleagues). A significant factor that reduces well-being is the internalisation of two core consumer culture values: a materialistic value orientation (MVO) and body perfect ideals (see meta-analyses by Dittmar and colleagues for MVO, and Grabe et al, Barlett et al. for idealised media models). Thus, mindfulness may act as a buffer against the negative impact of consumer culture ideals, consistent with value circumplex models which place materialistic and appearance-focused values at the self-enhancement end, opposite to self-transcendence values, such as caring for self and others and community engagement.

Self-transcendence values lead to psychological need satisfaction, whereas consumer culture values undermine such satisfaction (Self-Determination Theory).

Three novel questions are examined: (1) Is change in self-related values and psychological processes significant for the beneficial consequences of mindfulness for well-being? (2) Does mindfulness training reduce consumer culture values and associated harmful behaviours, such as disordered eating and excessive buying? (3) Do high and low intensity mindfulness interventions differ in impact?

The project involves collaboration with Kate Cavanagh in Psychology and the Co-Directors of the Sussex Centre for Mindfulness Clara Strauss and Robert Marx. It consists of: 1. qualitative interviews with experienced mindfulness teachers, 2. a multi-phase student intervention study, and 3. an exposure experiment with the same student sample.

Study 1: INTERVIEWS WITH MINDFULNESS TEACHERS (n=12) Semi-structured interviews with teachers (recruited through the UK Network of Mindfulness Teacher Training Organisations) will examine their views on the psychological processes significant in individuals' mental health improvement, focusing on processes related to values and self. Interviews will be audio-taped.

Study 2: INTERVENTION WITH STUDENTS (n=165-180) Phase 1: Online survey to collect baseline measures on all variables of interest, using established scales Trait mindfulness (Gu et al, 2016); Consumer Culture Values (Easterbrook et al., 2014); Core Self Beliefs (Fowler et al, 2006); Self-Discrepancies (Dittmar et al., 1996; Self-compassion (Neff, 2016); Self-esteem (Robins et al., 2001; Self-objectification (Lindner \& Tantleff-Dunn, in press); Self-worth (Crocker et al., 2003); Self-concept clarity (Campbell et al., 2003); Self-construal (individualist vs. relational) (Aron et al., 1992); Social comparison tendency (Gibbons \& Buunk, 1999); Consumer self-confidence, author, date); Mental health assessment (DASS-21); Subjective well-being (Dittmar \& Kapur, 2001); Body esteem (Mendelson et al., 2001); Material esteem (Dittmar et al., 2016); Eating Behaviour (Van Strien et al., 1986, shortened); Excessive Buying (Dittmar et al., 2007); Emotion regulation (Bjureberg, 2016); Consumption-based coping (Wright et al., 2016)

Phase 2: Intervention (randomised control trial)

  • 8-week mindfulness-based cognitive group therapy course guided by (non-NHS) mindfulness teachers (high intensity)
  • Self-guided MBCT training using a published audio book and CDs (low intensity)
  • 'Waiting list' (control; respondents are offered the book after the study)

Phase 3: On-line survey (same as Phase 1) Study 3: IMPACT OF EXPOSURE TO CONSUMER CULTURE STIMULI (n=165-180) Using a 3 (mindfulness intervention condition) x 4 (CC stimuli: materialistic, appearance, combination, control) design, respondents view a film excerpt that contains an ad break (containing CC stimuli, approved in ER/HMC28/2), and then complete measures of actual eating (respondents will be offered food as a reward) and buying behaviour (approved in ER/RLJ/1), as well as selected measures used in Phases 1 and 3.

Studies 2 and 3 include 3 ug and 3 masters research projects.

Being tested
Teacher-led MBCT course, Self-guided MBCT course
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Teacher-led MBCT courseOther

    Also called Mindfulness-based cognitive therapy (high intensity)

    9 x 2 hour group sessions following national guidelines for mindfulness-based cognitive therapy

  • Self-guided MBCT courseOther

    Also called Mindfulness-based cognitive therapy (low intensity)

    9 weeks of self-guided mindfulness-based cognitive therapy, following an audiobook covering the same material and exercises as the teacher-led intervention

Study groups in NCT03079154
Study groupRoleWhat they receive
Teacher-led MBCT courseExperimentalEight-session mindfulness-based cognitive therapy course, including an initial orientation session, led by a qualified mindfulness teacher working with the Sussex Mindfulness Centre, a part of the NHS Sussex Partnership Mental Health Trust.
Receives: Other: Teacher-led MBCT course
Self-guided MBCT courseActive comparatorMindfulness-based cognitive therapy course, after an initial information session, which is self-guided using the audiobook Mindfulness: A practical guide to finding peace in a frantic world by Mark Williams and Danny Penman (2011). It consists of eight substantive chapters that map on to the eight-session MBCT course taught by teachers to groups of students. Students will be asked to work through one chapter a week, thus matching the pace of the teacher-led intervention.
Receives: Other: Self-guided MBCT course
Wait list controlNo interventionStudents in the wait list (control) arm do not receive any intervention for the same length of time as the experimental and active comparator arms of the intervention are taking place. Students are invited to complete the self-guided MBCT course after the end of the research project.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Indicators of psychological well-being: Change in Mental health

    We are using a mental health assessment (DASS-21) widely used in clinical and non-clinical populations which assess symptoms of depression, anxiety, and stress

    Measured: The change in this self-report measure will be be measured by being collected five-six weeks before the intervention, and immediately after the intervention

  2. Indicators of psychological well-being: Change in Subjective well-being

    This measure consists of an assessment of life satisfaction, and a brief measure of the frequency of positive and negative affective experiences as used in (Dittmar and Kapur, 2011)

    Measured: The change in this self-report measure will be be measured by being collected five-six weeks before the intervention, and immediately after the intervention

  3. Indicators of psychological well-being: Change in consumption-based coping

    This is a newly developed scale which measures the extent to which individuals use buying material goods as a strategy to cope with stress (Wright et. al, 2016)

    Measured: The change in this self-report measure will be be measured by beingcollected five-six weeks before the intervention, and immediately after the intervention

  4. Indicators of psychological well-being: Change in body esteem

    We are using a well-established scale of body esteem (Mendelson et al., 2001), which assesses general appearance evaluation, evaluation of one's weight, and perceived evaluation by others

    Measured: The change in this self-report measure will be be measured by being collected five-six weeks before the intervention, and immediately after the intervention

  5. Indicators of psychological well-being: Change in material esteem

    This is a newly developed scale that assesses individuals' esteem in terms of the material goods they own (Dittmar et al., 2016)

    Measured: The change in this self-report measure will be be measured by being collected five-six weeks before the intervention, and immediately after the intervention

  6. Indicators of psychological well-being: Change in eating behaviour

    We will use a shortened form of the Dutch Eating Behaviour Scale (Van Strien et al., 1986) which measures restraint, emotional, and external eating

    Measured: The change in this self-report measure will be be measured by being collected five-six weeks before the intervention, and immediately after the intervention

  7. Indicators of psychological well-being: Change in excessive buying

    This scale measures compulsive buying tendencies, such as having urges to buy or feeling out of control of one's shopping behaviour (Dittmar et al., 2007)

    Measured: The change in this self-report measure will be be measured by being collected five-six weeks before the intervention, and immediately after the intervention

  8. Indicators of psychological well-being: Change in emotional regulation

    This scale, developed by Bjureberg (2016), assessing difficulties that people experience in dealing with, and regulating strong emotions

    Measured: The change in this self-report measure will be be measured by being collected five-six weeks before the intervention, and immediately after the intervention

Secondary outcomes (3)
  1. Consumer culture values (materialistic and appearance-focused personal values)

    This questionnaire measures motives and internalisation with respect to materialistic and appearance-focused values (Easterbrook et al., 2014)

    Measured: This self-report measure will be collected five-six weeks before the intervention, immediately after the intervention, and immediately after exposure to consumer culture stimuli in phase 4 of the research

  2. Behavioural measure related to consumer culture: eating

    Research participants will be offered a plate of snack foods and told they are can eat as many of them as they would like

    Measured: This behavioural measure will be collected immediately after exposure to consumer culture stimuli in phase 4 of the research

  3. Behavioural measure related to consumer culture: buying consumer goods online

    Respondents will be invited to use an online retail website for discounted goods to make purchases if they so wish

    Measured: This behavioural measure will be collected immediately after exposure to consumer culture stimuli in phase 4 of the research

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2017
  2. Study start30 Sep 2016
  3. Primary completion28 Sep 2017
  4. Study completion28 Sep 2017

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03079154
Sponsor's protocol ID
ER/HELGAD/10
Status last verified
Jun 2019
First submitted
2 Mar 2017
Last updated
12 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gu J, Strauss C, Crane C, Barnhofer T, Karl A, Cavanagh K, Kuyken W. Examining the factor structure of the 39-item and 15-item versions of the Five Facet Mindfulness Questionnaire before and after mindfulness-based cognitive therapy for people with recurrent depression. Psychol Assess. 2016 Jul;28(7):791-802. doi: 10.1037/pas0000263. Epub 2016 Apr 14.

    PubMed 27078186
  • Easterbrook, M. J., Wright, M. L., Dittmar, H., & Banerjee, R. (2014). Consumer culture ideals, extrinsic motivations, and well-being in children. European Journal of Social Psychology, 44(4), 349-359. doi:10.1002/ejsp.2020

  • Fowler D, Freeman D, Smith B, Kuipers E, Bebbington P, Bashforth H, Coker S, Hodgekins J, Gracie A, Dunn G, Garety P. The Brief Core Schema Scales (BCSS): psychometric properties and associations with paranoia and grandiosity in non-clinical and psychosis samples. Psychol Med. 2006 Jun;36(6):749-59. doi: 10.1017/S0033291706007355. Epub 2006 Mar 27.

    PubMed 16563204
  • Dittmar H, Beattie J, Friese S. Objects, decision considerations and self-image in men's and women's impulse purchases. Acta Psychol (Amst). 1996 Sep;93(1-3):187-206. doi: 10.1016/0001-6918(96)00019-4.

    PubMed 8826795
  • Crocker J, Luhtanen RK, Cooper ML, Bouvrette A. Contingencies of self-worth in college students: theory and measurement. J Pers Soc Psychol. 2003 Nov;85(5):894-908. doi: 10.1037/0022-3514.85.5.894.

    PubMed 14599252
  • Gibbons FX, Buunk BP. Individual differences in social comparison: development of a scale of social comparison orientation. J Pers Soc Psychol. 1999 Jan;76(1):129-42. doi: 10.1037//0022-3514.76.1.129.

    PubMed 9972558
  • Mendelson BK, Mendelson MJ, White DR. Body-esteem scale for adolescents and adults. J Pers Assess. 2001 Feb;76(1):90-106. doi: 10.1207/S15327752JPA7601_6.

    PubMed 11206302
  • Bjureberg J, Ljotsson B, Tull MT, Hedman E, Sahlin H, Lundh LG, Bjarehed J, DiLillo D, Messman-Moore T, Gumpert CH, Gratz KL. Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16. J Psychopathol Behav Assess. 2016 Jun;38(2):284-296. doi: 10.1007/s10862-015-9514-x. Epub 2015 Sep 14.

    PubMed 27239096

Questions about this trial

What is this clinical trial studying?

A study testing Teacher-led MBCT course and Self-guided MBCT course in people with Mental Health and General Well-being, run by University of Sussex.

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 1 inclusion and 1 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 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Indicators of psychological well-being: Change in Mental health (time frame: The change in this self-report measure will be be measured by being collected five-six weeks before the intervention, and immediately after the intervention). The study lists 8 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 NCT03079154, which also lists 8 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 12 Jun 2019.

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