None listed
Conditions
Brief summary
The study aims to contribute to understanding of the relationship between stress and inflammation. It is thought that, during period of high psychological stress and inflammation, an individual's inner homeostatic system that controls mood and emotional regulation is challenged such that homeostasis is no longer functional. The study will explore whether a mindfulness intervention can aid in the restoration of homeostasis, and, if so, whether this restoration is also associated with a reduction in inflammation, perceived stress levels and symptoms of depression.
Interventions
An eight week training in Mindfulness Based Stress Reduction consisting of 2.5 hours of instruction per week and 45 minutes per day of home practice. The course will utilize the materials from palousemindfulness.com (permission has been sought and received from the site owner), which include video and written materials. Mindfulness practices include mindful eating, body scans, focused breathing and gentle yoga poses. These are conducted during the sessions and in home practice tasks. The palouse
An eight week training in Mindfulness Based Stress Reduction consisting of 2.5 hours of instruction per week and 45 minutes per day of home practice. The course will utilize the materials from palousemindfulness.com (permission has been sought and received from the site owner), which include video and written materials. Mindfulness practices include mindful eating, body scans, focused breathing and gentle yoga poses. These are conducted during the sessions and in home practice tasks. The palousemindfulness course is designed to be self-directed; however in this case the participants will meet as a group with a university student (doctoral student in clinical psychology) acting as facilitator. Maximum group numbers will be 10 per group. The group will be conducted in a meeting room at the rooms of the gastroenterologist (Dr Lauren Beswick) associated with the study. Each week participants will be given homework sheets to record their home practice; these will be collected and the times recorded as part of the data collection. The intervention is in addition to the standard care each patient will receive as part of their ongoing treatment with the gastroenterologist.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) A clinically established diagnosis of Crohn’s disease (per usual clinical practice in a tertiary care centre) 2) Sufficient knowledge of English to understand the study instructions, answer the questionnaires and participate in the Mindfulness Based Stress Reduction group (MBSR). Note; as this is an exploratory study and involves a group intervention, it will not be possible to conduct the MBSR intervention in any language other than English. 3) 18 years of age or older 4) Competence to consent 5) Access to the internet by a smart phone and the willingness to download the Instant Survey app. 6) A willingness to commit to 2.5 hours of MBSR at the identified times for a period of 8 consecutive or near-consecutive weeks, and engage with the homework sheets in the intervening period. 7) Scores of depression at mild or moderate levels of the DASS scale
Exclusion criteria
1) Alcohol/substance dependence, as identified by the gastroenterology team 2) Severe mental illness (e.g. psychosis, schizophrenia), as identified by the gastroenterology team 3) Severe anxiety or depressive symptoms as indicated by a scores >21 on the depression scale or > 15 on the anxiety scale of the DASS measure 4) Significant cognitive impairment 5) Inability to read or write 6) Inability to speak or understand English (see note above) 7) A regular (weekly or more often) mindfulness practice.
Outcome results
None listed