Mental Health and General Well-being Clinical Trial
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
| Verified date | June 2019 |
| Source | University of Sussex |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 180 |
| Est. completion date | September 28, 2017 |
| Est. primary completion date | September 28, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: Student at the University of Sussex Exclusion Criteria: 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Sussex | Sussex Mindfulness Centre |
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Self and self-related processes: Change in core self beliefs | Core self beliefs (Fowler et al, 2006) measure the habitual negative and positive beliefs people hold about their self | 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 | |
| Other | Self and self-related processes: Change in self-discrepancies | Self-discrepancies (Dittmar et al., 1998) refer to perceived gaps between how a person would ideally like to be and how they actually are | 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 | |
| Other | Self and self-related processes: Change in self-compassion | Self-compassion (Neff, 2016 short form) refers to having a kind and empathic approach to oneself | 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 | |
| Other | Self and self-related processes: Change in self-concept clarity | Self-concept clarity (Campbell et al., 2003) means that people have a clear and confident view of who and what they are like | 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 | |
| Other | Self and self-related processes: Change in self-construal | Self-construal (Aron et al., 1992) assesses the extent to which a person sees themselves as an individual entity that is separate for others or connected with others | 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 | |
| Other | Self and self-related processes: Change in social comparison tendency | Social comparison tendency (Gibbons & Buunk, 1999) | 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 | |
| Primary | 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 | 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 | |
| Primary | 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) | 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 | |
| Primary | 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) | The change in this self-report measure will be be measured by beingcollected five-six weeks before the intervention, and immediately after the intervention | |
| Primary | 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 | 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 | |
| Primary | 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) | 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 | |
| Primary | 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 | 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 | |
| Primary | 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) | 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 | |
| Primary | 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 | 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 | 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) | 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 | |
| Secondary | 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 | This behavioural measure will be collected immediately after exposure to consumer culture stimuli in phase 4 of the research | |
| Secondary | 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 | This behavioural measure will be collected immediately after exposure to consumer culture stimuli in phase 4 of the research |