Effectiveness and cost-effectiveness of an electronic mindfulness-based intervention to improve maternal mental health in the peripartum: study protocol for a randomised controlled trial.

BACKGROUND: Perinatal women are highly vulnerable to developing mental health issues and particularly susceptible to a recurrence of psychiatric illness. Poor mental health during the perinatal period can have long-term impacts on the physical and psychiatric health of both mother and child. A potentially useful strategy to improve women's mental health is through a mobile application teaching mindfulness, an evidence-based technique helping individuals focus on the present moment. METHODS: A mixed method, prospective randomised controlled trial. The study group comprise women aged 18 years and over, who are attending the public and private maternity clinics at Mater Mothers' Hospital. A sample of 360 prenatal women will be randomised into the intervention group (with the use of the mindfulness app) or usual care. Participants will remain in the study for 11 months and will be assessed at four timepoints for changes in postnatal depression, mother-infant bonding, and quality of life. A cost-effectiveness evaluation will also be conducted using quality-adjusted life year (QALY) calculations. A random selection of intervention participants will be invited to attend focus groups to give feedback on the mindfulness app. DISCUSSION: Previous studies have found mindfulness interventions can reduce stress, anxiety, depression, and sleep disturbances in a prenatal population. The risks of the intervention are low, but could be of significant benefit for women who are unable to attend face-to-face appointments due to geographical, financial, or time barriers; during endemic or pandemic scenarios; or due to health or mobility issues. TRIAL REGISTRATION: This study was approved by the Mater Misericordiae Human Research Ethics Committee (83,589). Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12622001581752 ( https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385107&isReview=true ). Registered on 22 Dec. 2022.

Protocol for a Single-Arm Feasibility Study of Photobiomodulation for Fatigue, Depression, and Pain in Inflammatory Bowel Disease.

BACKGROUND: There are limited treatment options for mental health comorbidities associated with Inflammatory Bowel Disease (IBD), although they have been shown to negatively affect the course of IBD and multiple important areas of functioning. Photobiomodulation (PBM) is a new therapeutic intervention using laser-generated low-powered light therapy that has shown early promise in alleviating fatigue, depression, and pain in chronic illness. METHODS: This prospective, single-arm pilot study aims to assess the feasibility and efficacy of PBM in the treatment of fatigue, depression, and pain in youth with IBD. We will recruit 28 young adults with IBD who will receive PBM in addition to treatment as usual. The primary outcome will be fatigue, while secondary outcomes will include depression, pain, quality of life, inflammatory markers, alterations in microbiome composition, physical activity, and functioning. Outcome measures will be assessed at baseline, after a 10-week control period (pre-PBM), at 20 weeks (post-PBM), and at 30 weeks. Feasibility will be assessed by attendance, recruitment rates, and participants' views of PBM. Mixed-effects linear regression modelling will be used to assess the PBM effect on continuous outcomes (fatigue, depression, anxiety and stress scores, and inflammation levels). RESULTS: The study will provide preliminary indicators of PBM feasibility and efficacy in IBD.

A Holistic Perspective on How Photobiomodulation May Influence Fatigue, Pain, and Depression in Inflammatory Bowel Disease: Beyond Molecular Mechanisms.

BACKGROUND: Numerous mechanisms, mostly molecular, have been tested and proposed for photobiomodulation. Photobiomodulation is finding a niche in the treatment of conditions that have no gold-standard treatment or only partially effective pharmacological treatment. Many chronic conditions are characterised by symptoms for which there is no cure or control and for which pharmaceuticals may add to the disease burden through side effects. To add quality to life, alternate methods of symptom management need to be identified. OBJECTIVE: To demonstrate how photobiomodulation, through its numerous mechanisms, may offer an adjunctive therapy in inflammatory bowel disease. Rather than considering only molecular mechanisms, we take an overarching biopsychosocial approach to propose how existing evidence gleaned from other studies may underpin a treatment strategy of potential benefit to people with Crohn's disease and ulcerative colitis. MAIN FINDINGS: In this paper, the authors have proposed the perspective that photobiomodulation, through an integrated effect on the neuroimmune and microbiome-gut-brain axis, has the potential to be effective in managing the fatigue, pain, and depressive symptoms of people with inflammatory bowel disease.

The Australian evidence-based clinical practice guideline for attention deficit hyperactivity disorder.

OBJECTIVE: The objective of this article was to provide an overview of the development and recommendations from the Australian evidence-based clinical practice guideline for attention deficit hyperactivity disorder (ADHD). The guideline aims to promote accurate and timely identification and diagnosis, and optimal and consistent treatment of ADHD. METHODS: Development integrated the best available evidence with multidisciplinary clinical expertise and the preferences of those with lived experience, underpinned by the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework. The 23 guideline development group members included psychiatrists, paediatricians, general practitioners, psychologists, speech pathologists, occupational therapists, educators, Indigenous psychologists, and people with a lived experience; with two independent chairs and a methodologist. Where appropriate, evidence reviews from the National Institute for Health and Care Excellence (NICE) 2018 'Attention Deficit Hyperactivity Disorder: Diagnosis and Management' guideline were updated. Fifty prioritised clinical questions were addressed in 14 systematic reviews (new and updated from NICE 2018) and 28 narrative reviews. RESULTS: The 113 clinical recommendations apply to young children (5 years and under), children, adolescents and adults. They provide guidance for clinicians on identification, screening, diagnosis, multimodal treatment and support, including pharmacological and non-pharmacological interventions. The guideline and supporting information are available online: https://adhdguideline.aadpa.com.au/. CONCLUSIONS: The guideline was approved by the National Health and Medical Research Council (NHMRC) of Australia and relevant medical and allied health professional associations. It is anticipated that successful implementation and uptake of the guideline by organisations, health care providers and other professionals will increase delivery of evidence-based treatment and improve health outcomes for the more than 800,000 Australians with ADHD.

Schwartz Rounds for Staff in an Australian Tertiary Hospital: Protocol for a Pilot Uncontrolled Trial.

BACKGROUND: Schwartz Rounds are a unique, organization-wide interdisciplinary intervention aimed at enhancing staff well-being, compassionate care, teamwork, and organizational culture in health care settings. They provide a safe space wherein both clinical and nonclinical health staff can connect and share their experiences about the social and emotional aspects of health care. OBJECTIVE: Although Schwartz Rounds have been assessed and widely implemented in the United States and United Kingdom, they are yet to be formally evaluated in Australian health care settings. The purpose of this study is to evaluate the feasibility and impact of Schwartz Rounds on staff well-being, compassionate care, and organizational culture, in a tertiary metropolitan hospital in Brisbane, Australia. METHODS: This mixed methods repeated measures pilot study will recruit 24 participants in 2 groups from 2 departments, the intensive care unit and the gastroenterology department. Participants from each group will take part in 3 unit-based Schwartz Rounds. Primary outcomes will include the study and intervention feasibility measures, while secondary outcomes will include scores on the Maslach Burnout Inventory-Human Services Survey, the Schwartz Centre Compassionate Care Scale, and the Culture of Care Barometer. Primary and secondary outcomes will be collected at baseline, after the Rounds, and 3-month follow-up. Two focus groups will be held approximately 2 months after completion of the Schwartz Rounds. Descriptive statistics, paired t tests, chi-square tests, and analysis of variance will be used to compare quantitative data across time points and groups. Qualitative data from focus groups and free-text survey questions will be analyzed using an inductive thematic analysis approach. RESULTS: The study was approved by the Mater Hospital Human Research Ethics Committee (reference number: HREC/MML/71868) and recruitment commenced in July 2021; study completion is anticipated by May 2022. CONCLUSIONS: The study will contribute to the assessment of feasibility and preliminary efficacy of the Schwartz Rounds in a tertiary Australian hospital during the COVID-19 pandemic. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12621001473853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382769&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35083.

Psychosocial burden of inflammatory bowel disease in adolescents and young adults.

BACKGROUND: This study examined the psychosocial burden of inflammatory bowel disease (IBD) in young people aged 15-25 years attending a tertiary specialist health centre for adolescents and young adults in Brisbane. AIMS: To describe the impact of IBD on psychosocial well-being in young people and to compare well-being in the IBD cohort to well-being among young people with other chronic conditions, with a view to identifying characteristics and challenges unique to those with IBD. METHODS: Young people with IBD provided demographic information and psychosocial data through a cross-sectional self-report survey. Psychosocial data included the Kessler Psychological Distress Scale, Perceived Stress Scale, Brief Illness Perception Questionnaire, World Health Organisation Well-being Index, Paediatric Quality of Life Inventory, Short Quality of Life Questionnaire for IBD, Multidimensional Scale of Perceived Social Support, Connor Davidson Resilience Scale 2 and the Multidimensional Health Locus of Control Scale. RESULTS: Surveys were collected from 51 young people with IBD and compared with surveys from 210 young people with juvenile rheumatic disease (n = 31), phenylketonuria (n = 21), cystic fibrosis (n = 33), renal transplants (n = 14) and craniomaxillofacial conditions (n = 111). On the psychosocial domains, 41% of young people with IBD had poor well-being and 37% were at risk of depression. When assessed against the comparison group, young people with IBD reported higher depressive symptoms (P = 0.04), worse illness perceptions (P < 0.01) and lower internal locus of control (P < 0.01). CONCLUSIONS: Early recognition and treatment of depression and other psychosocial comorbidities within integrated pathways of care is crucial in adolescents and young adults with IBD and likely to improve the course of IBD and their overall health and well-being. Interventions aimed at enhancing self-efficacy and increasing public awareness are also likely to be helpful.

Development and implementation of guidelines for the management of depression: a systematic review.

OBJECTIVE: To evaluate the development and implementation of clinical practice guidelines for the management of depression globally. METHODS: We conducted a systematic review of existing guidelines for the management of depression in adults with major depressive or bipolar disorder. For each identified guideline, we assessed compliance with measures of guideline development quality (such as transparency in guideline development processes and funding, multidisciplinary author group composition, systematic review of comparative efficacy research) and implementation (such as quality indicators). We compared guidelines from low- and middle-income countries with those from high-income countries. FINDINGS: We identified 82 national and 13 international clinical practice guidelines from 83 countries in 27 languages. Guideline development processes and funding sources were explicitly specified in a smaller proportion of guidelines from low- and middle-income countries (8/29; 28%) relative to high-income countries (35/58; 60%). Fewer guidelines (2/29; 7%) from low- and middle-income countries, relative to high-income countries (22/58; 38%), were authored by a multidisciplinary development group. A systematic review of comparative effectiveness was conducted in 31% (9/29) of low- and middle-income country guidelines versus 71% (41/58) of high-income country guidelines. Only 10% (3/29) of low- and middle-income country and 19% (11/58) of high-income country guidelines described plans to assess quality indicators or recommendation adherence. CONCLUSION: Globally, guideline implementation is inadequately planned, reported and measured. Narrowing disparities in the development and implementation of guidelines in low- and middle-income countries is a priority. Future guidelines should present strategies to implement recommendations and measure feasibility, cost-effectiveness and impact on health outcomes.

Mindfulness-based cognitive therapy experiences in youth with inflammatory bowel disease and depression: findings from a mixed methods qualitative study.

OBJECTIVES: Mindfulness-based cognitive therapy (MBCT) is effective in treating psychosocial comorbidities in inflammatory bowel disease (IBD); however, there have been no qualitative studies of MBCT experiences among youth with IBD. We aimed to examine the experiences of youth with IBD and depression who completed an adapted MBCT group programme, and the impact of common psychotherapy and group factors. DESIGN: This mixed method qualitative study, nested within a randomised controlled trial (RCT) of MBCT for youth with IBD, employed thematic analysis of qualitative data from three focus groups and open-ended survey questions. SETTING: The study was conducted in the outpatient department of a tertiary hospital for young adults in Brisbane, Australia. PARTICIPANTS: Out of sixty-four adolescents and young adults recruited to the RCT of MBCT for youth with IBD and depression, 29 completed the MBCT evaluation survey and 19 attended the focus groups. RESULTS: Four key themes emerged: 'connectedness and shared understanding', 'growing in wisdom', 'therapeutic alliance' and 'barriers to mindfulness practice'. Participants described MBCT experiences as healing and transformative with the themes of connectedness, growing in wisdom and therapeutic alliance laying the foundation for therapeutic change. Main barriers included fatigue, depression, time and travel constraints. CONCLUSIONS: The study identified key themes facilitating the process of therapeutic change within the MBCT programme for youth with IBD and elucidated common and group psychotherapy factors underlying the key themes. Participants perceived connecting with peers as essential for learning mindfulness skills which in turn strengthened the connection. Study findings will facilitate interpretation of the results of the RCT of MBCT in youth with IBD and inform the design of future studies of MBCT in this cohort. TRIAL REGISTRATION NUMBER: ACTRN12617000876392; Results.

Mindfulness-Based Cognitive Therapy Experiences in Youth With Inflammatory Bowel Disease and Depression: Protocol for a Mixed Methods Qualitative Study.

BACKGROUND: Mindfulness-based programs are increasingly used as a part of integrated treatment for inflammatory bowel disease (IBD). However, the majority of research has been quantitative with limited qualitative exploration of patients' experiences of mindfulness programs and no studies among adolescents and young adults with IBD. Furthermore, there has been a paucity of research exploring the role of common psychotherapy and group factors within mindfulness programs. OBJECTIVE: This study aims to explore the experiences of adolescents and young adults with IBD and depression who completed a mindfulness-based cognitive therapy (MBCT) group program, as well as the role of therapeutic alliance, group affiliation, and other common psychotherapy and group factors. METHODS: This mixed methods qualitative study, nested within a randomized controlled trial (RCT) of MBCT for adolescents and young adults with IBD, will obtain qualitative data from focus groups and open-ended survey questions. The study aims to conduct three to four focus groups with 6-8 participants in each group. It will employ data and investigator triangulation as well as thematic analysis of the qualitative data. RESULTS: The study was approved by the Mater Hospital Human Research Ethics Committee and recruitment commenced in May 2019; study completion is anticipated by early 2020. CONCLUSIONS: The study will contribute to the assessment of acceptability and feasibility of the MBCT program for adolescents and young adults with IBD. It will also elucidate the role of previously unexplored common psychotherapy and group factors within mindfulness training and help inform the design of a future large-scale RCT of MBCT in this cohort. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12617000876392; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373115. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/14432.

Protocol for a pilot randomised controlled trial of mindfulness-based cognitive therapy in youth with inflammatory bowel disease and depression.

INTRODUCTION: Inflammatory bowel disease (IBD) is a chronic autoinflammatory disease of the gastrointestinal tract with peak age of onset during adolescence and young adulthood. Adolescents and young adults (AYAs) with IBD experience higher depression rates compared with peers who are well or have other chronic conditions. Mindfulness-based interventions are of particular interest because of their potential to improve both the course of IBD and depression. METHODS AND ANALYSIS: This study is a parallel design, single-blind, pilot randomised controlled trial (RCT) of mindfulness-based cognitive therapy (MBCT) in AYAs with IBD and depression. The trial aims to recruit 64 participants who will be randomly allocated to MBCT or treatment as usual. The primary outcome measure is the depression subscale score from the Depression, Anxiety and Stress Scale. Secondary outcomes include anxiety, stress, post-traumatic growth, IBD-related quality of life, illness knowledge, medication adherence, mindfulness, IBD activity, inflammatory markers, microbiome and brain neuroconnectivity changes. All outcomes other than neuroimaging will be collected at three time points: at baseline, at therapy completion and at 20 weeks. Neuroimaging will be conducted at baseline and at therapy completion. Mixed-effects linear and logistic regression modelling will be used to analyse continuous and dichotomous outcomes, respectively. Participants' experiences will be explored through focus groups, and thematic analysis will be used to generate relevant themes. ETHICS AND DISSEMINATION: The protocol has been approved by the Mater Hospital Human Research Ethics Committee (HREC) and University of Queensland HREC. Trial findings will be published in peer-reviewed journals and will be presented at scientific conferences. TRIAL REGISTRATION NUMBER: ACTRN12617000876392, U1111-1197-7370; Pre-results.

A systematic review and meta-analysis of mindfulness based interventions and yoga in inflammatory bowel disease.

BACKGROUND: Mindfulness interventions are increasingly used as a part of integrated treatment in inflammatory bowel disease (IBD) but there are limited data and a lack of consensus regarding effectiveness. OBJECTIVES: We explored the efficacy of mindfulness interventions compared to treatment as usual (TAU), or other psychotherapeutic interventions, in treating physical and psychosocial symptoms associated with IBD. METHODS: We conducted a systematic review and meta-analysis of relevant randomized controlled trials (RCTs). We included a broad range of mindfulness interventions including mindfulness-based interventions and yoga, with no restrictions on date of publication, participants' age, language or publication type. We searched the following electronic databases: MEDLINE, EMBASE, PsycINFO, CINAHL and WHO ICTRP database. We adhered to the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines in conducting the review. RESULTS: We included eight studies in the meta-analysis. Mindfulness interventions showed a statistically significant effect on stress in both the short(SMD = -0.48; 95%CI:-0.97, 0.00; P = .05), and long term(SMD = -0.55; 95%CI:-0.78, -0.32; P < .00001), significant long term effects on depression (SMD = -0.36; 95%CI:-0.66, -0.07; P = .02) and quality of life (SMD = 0.38; 95%CI:0.08, 0.68; P = .01),and small but not statistically significant improvements in anxiety (SMD = -0.27; 95%CI:-0.65, 0.11; P = .16).Effects on physical outcomes were equivocal and not statistically significant. CONCLUSIONS: Mindfulness interventions are effective in reducing stress and depression and improving quality of life and anxiety, but do not lead to significant improvements in the physical symptoms of IBD. Further research involving IBD-tailored interventions and more rigorously designed trials is warranted.

Psychosocial screening and management of young people aged 18-25 years with diabetes.

BACKGROUND: Routine psychosocial screening and management of people with diabetes is recommended. AIMS: To profile demographic, medical and psychosocial characteristics of young people with diabetes, and to develop a screening tool and care pathway for routine use. METHODS: Indices of diabetes control and recorded diabetes complications were complimented by psychosocial screening tools assessing psychological, diabetes specific and perceived stress (Kessler 10, Problem Area in Diabetes, Perceived Stress Scale), well-being (World Health Organization Well Being Index-5), disordered eating (Eating Disorder Risk Inventory-3 Risk Composite), compensatory behaviour questionnaire, social support (Multidimensional Scale of Perceived Social Support), resilience (Connor Davidson Resilience Scale - 2 item) and financial concerns. Service provision and demographic data were also collected. Diabetes and mental health clinicians then identified a subset of measures to use for routine screening along with care pathways. RESULTS: Psychosocial screening was well accepted. Participants (151) had suboptimal glycaemic control (glycated haemoglobin 8.0 interquartile range 1.8%/64 interquartile range 22 mmol/mol). Severe diabetes-related distress (Problem Area in Diabetes ≥40) was found in 19.4% and 26.0% reported difficulties managing healthcare costs. A mental health disorder was likely in 9.7%, whilst 23.4% had high Kessler 10 scores. Low World Health Organization Well Being Index-5 scores (≤13) were seen in 29.0%. Risk for an eating disorder (Eating Disorder Risk Inventory-3 Risk Composite) was 12.7%, whereas approximately 36.0% had disturbed eating behaviours. CONCLUSION: Psychosocial screening of young adults with diabetes identified complex needs. A brief psychosocial screening tool and associated care pathways were developed for routine use in a young adult tertiary referral diabetes clinic. The tool assesses constructs, such as diabetes distress, depression, anxiety, well-being, hypoglycaemia-unawareness, fear of hypoglycaemia, social support, weight, shape and eating concerns and financial concerns. This will provide a longitudinal data source for further research to inform clinical practice.