IBDmindfulness-mindfulness for youth with Inflammatory Bowel Disease (IBD) and depression trial

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2017
INTERVENTION: The intervention delivered in the study will be Mindfulness‐Based Cognitive Therapy (MBCT), a group psychological intervention, delivered face‐to‐face to groups of 10‐12 participants in 2‐hours long weekly sessions, over a period of eight weeks. MBCT will be delivered by an experienced mindfulness teacher, trained in MBCT and MBSR up to a teacher level and with four years post teacher training experience as well as experience running several previous mindfulness group courses for people with chronic illness. MBCT is designed to help people who suffer repeated bouts of depression by cultivating mindfulness and learning about habitual thinking patterns that make us vulnerable to depression.. It uses a combination of psycho‐education, mindfulness practices of focused attention without judgement and cognitive techniques including meta‐cognitive processes to assist with disengaging from maladaptive ways of coping and thinking. .It's proven to be effective in both preventing and treating depression. Participants will be recruited via the IBD outpatient services at Mater Young Adult Health Centre Brisbane. The MBCT will be conducted at Mater Young Adult Health Centre, an urban tertiary hospital specializing in treatment of young adults aged 16‐25 with chronic illness. . A subset of participants will receive the fMRI scans, and these will be performed at The Centre for Advanced Imaging (CAI) on the St Lucia campus of the University of Queensland. At all other times, participants will be treated as per standard care at Mater South Brisbane. Following recruitment, participants will be randomly allocated to either treatment as usual (TAU‐control group) or an intervention group (INT group) who will receive the MBCT. Participants in the intervention group will attend two hours of weekly group mindfulness‐based cognitive therapy, and a subset of this group will be asked to undergo MRI scans (16 from the intervention group and 16 from the control group). All participants will be asked to complete questionnaires, and this will be collated with routinely collected clinical data. CONDITION: Depression Inflammatory Bowel Disease PRIMARY OUTCOME: The primary outcome measure for the study will be the depression subscale score from the Depression, Anxiety and Stress Scale (DASS). SECONDARY OUTCOME: Coping with illness (COPE) IBD disease activity questionnaires: a simple clinical colitis activity index (SCAI) for ulcerative colitis and Harvey‐Bradshaw Index (HBI) for Crohn's disease activity. IBD related quality of life (SIBDQ,10), Illness knowledge (CCKNOW) Illness perception (IPQ) Inflammatory IBD markers (CRP, ESR, IL‐6, faecal calprotectin), ; Faecal calprotectin is assessed on stool samples as part of usual care using an ELISA based assay through Mater pathology. ; CRP and ESR are assessed on serum samples as part of usual care using Mater Pathology. ; IL‐6 will be measured in house on serum collected as part of usual care using an commercial ELISA kit. Medication adherence (MAQ). Microbiome analysis. ; Microbiome analysis will be performed on stool collected on patients as part of usual care through the Australian center for Ecogenomics at the university of Queensland using metagenomic sequencing. Mindfulness on Five Facets of Mindfulness Questionnaire (FFMQ). Neural Connectivity changes on functional Magnetic resonance imaging scans (fMRIs). ; Participants will be scanned on the 3T MRI scanner at the Centre for Advanced Imaging (CAI), UQ St Lucia Campus with the following protocols: ; 1. T1‐MPRAGE for high resolution structure. ; 2. T2‐FLAIR for detecting brain lesion and small vessel disease ; 3. resting‐state fMRI for functional connectivity ; 5. diffusion tensor imaging for structural connectivity MBCT intervention will be adapted to suit the young age of participants and also their IBD symptoms which could necessitate shorter practices due to pain and other GI symptoms (e.g. urgency to go to the toilet, fatigue etc)... In particular, mindfulness practices will be shortened (e.g. 20 minutes instead of 30 minutes body scan or mindfulness of the breath) while trying to maintain the recommended "daily dose" of mindfulness practices through introducing additional shorter practices and making practices more youth friendly (e.g. youth relevant poetry, use of language and themes)..Psycho‐educational component of the course will be expanded to include a module on IBD and its interaction with stress and mood.Intervention adherence or fidelity will be assessed,by participants having a weekly log of mindfulness practice including type of practice,amount of time practiced and any reflections barriers to practice. All weekly group sessions will be video recorded and later assessed by an external, experienced MBCT teacher to ensure adherence to MBCT session conducting guidelines. ; The total scan time would be 25 min. ; ; Sixteen participants from each group (intervention group and control group) will undergo fMRIs. The allocation of participants to fMRIs will be random (as specified in the sampling plan with each of the 64 participants already pre‐allocated to 8 cells by stratification).As we are planning to use age, gender and depression level (all dichotomous) we’ll end up with 8 cells after stratification (2x2x2). ; The participants for fMRIs will be selecting randomly from each of the eight cells created after stratification. ; ; ; Post traumatic growth inventory (PTGI). Self‐efficacy for appropriate medication use scale (SEAMS). Small intestinal ultrasound. ; Small bowel ultrasound is routinely performed during clinical assessments at the Mater Hospital and wall thickness of colonic segments and terminal ileum measured. These wall thickness values will be recorded for the trial. ; INCLUSION CRITERIA: Young adult (aged 16‐29); • Able to verbally communicate and write in English • Able to give informed consent (for youth aged 16‐18 both the participant and their parent/guardian will provide consent) • Confirmed diagnosis of Crohn’s disease or ulcerative colitis • Confirmed clinical diagnosis of depression corresponding to DASS depression subscale scores between 10‐27 • Attending the IBD outpatient clinic at the Mater Young Adult Health Centre Brisbane; • Have access to internet‐enabled computer • Able to do light exercise because this program involves a mindful movement component • Able to commit to attend the eight weekly sessions of two hours’ duration • Able to commit to do home practice of up to 45 minutes per day over the 8 weeks of the study as this is a requirement of the program • No change in antidepressant medication (dose or type) within three months of trial onset
Epistemonikos ID: 2e795a5a09ebc5855e94a477d2e875920737bb68
First added on: Aug 23, 2024