None listed
Conditions
Brief summary
Inflammatory Bowel Disease is an auto-inflammatory disease characterised by chronic inflammation of the gastrointestinal tract and a chronic, relapsing and remitting course. Individuals with IBD are significantly more likely to suffer from depressive and other emotional health symptoms than age matched individuals in general population as well as people suffering from other chronic illnesses. Research has shown that individuals with IBD have triple the rate of mental disorders than that of general population. In particular, youth with IBD had higher rates of depressive disorders than youth with other chronic conditions, lower parent- and youth-reported QOL, and lower youth-reported social functioning compared to healthy youth.Research to date identifies that psychological interventions involving IBD cohorts are effective in reducing psychological distress (e.g., anxiety and/or depression), with cognitive behaviour therapy having the most evidential support. More recently, mindfulness based interventions have been found to reduce anxiety and depression and enhance quality of life]. The aim of this study is to conduct a randomised controlled trial (RCT) exploring the potential benefit of a group, IBD-focused, mindfulness-based cognitive therapy (MBCT) for youth living with IBD and comorbid depression. This randomised trial will also explore the potential benefit of the mindfulness intervention on immune markers associated with IBD and functional neuroimaging changes in response to the mindfulness intervention to provide insight in the mechanisms of action of this intervention. HYPOTHESES 1. MBCT (intervention group) will improve depression scores (pre-post); 2. Intervention will increase quality of life, mindfulness, medication adherence, perceived health care empowerment, coping and perceived illness perceptions and it will reduce anxiety symptoms (pre-post); 3. Intervention will change the structural and functional connectivity in default mode and executive control networks; 4. Intervention will be associated with decreased inflammatory burden, and improved microbiome. 5. MBCT intervention will be feasible and acceptable as indicated by sessions attendance, completion of home practices, recruitment and attrition rates, and participants’ MBCT group experiences assessed through focus groups and post MBCT evaluation questionnaire. OBJECTIVES Using 64 volunteer individuals (aged 16-29) with IBD and depression, the aim of this study is to conduct an RCT exploring the benefits of IBD-focused MBCT on depressive symptoms in youth living with IBD and comorbid depression. Secondary aims of this study are to explore the potential benefits of the MBCT on: • QoL, post-traumatic growth, medication adherence, health care empowerment, coping patterns, illness perceptions, and anxiety; • Biological markers of IBD, • Brain neuroconnectivity • Specific aim related to the pilot nature of the study is to determine the feasibility of the program
Interventions
The intervention delivered in the study will be Mindfulness-Based Cognitive Therapy (MBCT), a group psychological intervention, delivered face-to-face to groups of 8-10 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 chro
The intervention delivered in the study will be Mindfulness-Based Cognitive Therapy (MBCT), a group psychological intervention, delivered face-to-face to groups of 8-10 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. 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. All participants who completed the MBCT program will be offered optional participation in focus groups assessing their MBCT experiences.
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to 29 Years
Healthy volunteers
No
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 IBD • Confirmed clinical diagnosis of depression and DASS depression subscale scores of 10 and above • 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
Exclusion criteria
• Individuals not meeting inclusion criteria will be excluded from the study • Individuals who do not have conversational or written English; • Individuals who may have limited or no capacity to self-care; and • Individuals who have no depression or have extremely severe levels of depression or anxiety • Individuals with major mental illness other than depression as its treatment as well as symptoms could interfere with their ability to participate in program (e.g. current psychotic symptoms, current PTSD, OCD etc.) • Individuals with a history of alcohol or drug dependency • Individuals with current alcohol or drug dependency as substance dependence that would impact on program participation • Individuals scheduled for major surgery in the next 3 months as this would impact on their ability to attend the program for its entire duration • Individuals who have been started on antidepressants or changed their antidepressant dose within three months of the study onset • Individuals enrolled or participating in another psychological therapy study or pharmacological study within the last six months or intending to participate during this study duration • Exacerbation of IBD symptoms (flare) as this will make it difficult for participants to attend weekly sessions and complete home practice
Outcome results
None listed