The role of mindfulness in promoting wellbeing in patients with Crohn’s disease: An exploratory randomised control trial

Not Applicable

Withdrawn

• Conditions: Crohn's disease; Depression; Stress; Inflammatory and Immune System - Other inflammatory or immune system disorders; Mental Health - Depression

• Registration Number: ACTRN12618002009291
• Lead Sponsor: Deakin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-14
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
depression symptoms as determined by measurements on the Depression Anxiety and Stress Scale (Lovibond & Lovibond 1995)[Immediate post-intervention and six=month follow up]

Secondary Outcome Measures

Name	Time	Method
Homeostatically Protected Mood variability. This will be tested through a series of statistical analyses to participants answers to questions, how happy/content/alert they feel during a tw0-week ecological momentary assessment period. The statistical analyses will include within-person standard deviation, mean successive square differences and multi-level-modelling. [immediately post intervention and at six month follow up];Inflammation levels through levels of C-reactive protein. These will be accessed through blood test results. Blood samples will be collected by the patient’s gastroenterologist as part of usual care. [immediately post-intervention and at six month follow up];stress symptoms as determined by measurements on the Depression Anxiety and Stress Scale (Lovibond & Lovibond 1995)[immediately following intervention and at 6 month follow up]