Cognitive-behavioural therapy for inflammatory bowel disease: 24-month data from a randomised controlled trial

PURPOSE: There is ongoing controversy on the effectiveness of psychotherapy in inflammatory bowel disease (IBD). In the few small studies, cognitive-behavioural therapy (CBT) has been shown to alleviate symptoms of anxiety or depression. However, there is little research on the impact of CBT on physical outcomes in IBD and no studies on long-term effectiveness of CBT.

METHODS: The present two-arm pragmatic randomised controlled trial aimed to establish the impact of CBT on disease course after 24 months of observation. The study compared standard care plus CBT (+CBT) with standard care alone (SC). CBT was delivered over 10 weeks, face-to-face (F2F) or online (cCBT). The data were analysed using linear mixed-effects models.

RESULTS: CBT did not significantly influence disease activity as measured by disease activity indices at 24 months (Crohn's Disease Activity Index (CDAI), p = 0.92; Simple Clinical Colitis Activity Index (SCCAI), p = 0.88) or blood parameters (C-reactive protein (CRP), p < 0.62; haemoglobin (Hb), p = 0.77; platelet, p = 0.64; white cell count (WCC), p = 0.59) nor did CBT significantly affect mental health, coping or quality of life (all p > 0.05).

CONCLUSIONS: Therefore, we conclude that CBT does not influence the course of IBD over 24 months. Given the high rate of attrition, particularly in the CBT group, future trials should consider a personalised approach to psychotherapy, perhaps combining online and one-to-one therapist time.

Cognitive-behavioural therapy has no effect on disease activity but improves quality of life in subgroups of patients with inflammatory bowel disease: a pilot randomised controlled trial.

BACKGROUND: Studies have demonstrated usefulness of cognitive-behavioural therapy (CBT) in managing distress in inflammatory bowel disease (IBD); however, few have focused on IBD course. The present trial aimed to investigate whether adding CBT to standard treatment prolongs remission in IBD in comparison to standard therapy alone. METHODS: A 2-arm parallel pragmatic randomised controlled trial (+CBT - standard care plus either face-to-face (F2F) or online CBT over 10 weeks versus standard care alone (SC)) was conducted with adult patients in remission. IBD remission at 12 months since baseline was the primary outcome measure while the secondary outcome measures were mental health status and quality of life (QoL). Linear mixed-effect models were used to compare groups on outcome variables while controlling for baseline. RESULTS: Participants were 174 patients with IBD (90 +CBT, 84 SC). There was no difference in remission rates between groups, with similar numbers flaring at 12 months. Groups did not differ in anxiety, depression or coping at 6 or 12 months (p >0.05). When only participants classified as 'in need' (young, high baseline IBD activity, recently diagnosed; poor mental health) were examined in the post-hoc analysis (n = 74, 34 CBT and 40 controls), CBT significantly improved mental QoL (p = .034, d = .56) at 6 months. Online CBT group had a higher score on Precontemplation than the F2F group, which is consistent with less developed coping with IBD in the cCBT group (p = .045). CONCLUSIONS: Future studies should direct psychological interventions to patients 'in need' and attempt to recruit larger samples to compensate for significant attrition when using online CBT. TRIAL REGISTRATION: The protocol was registered on 21/10/2009 with the Australian New Zealand Clinical Trials Registry (ID: ACTRN12609000913279).

Randomised controlled trial of a digitally assisted low intensity intervention to promote personal recovery in persisting psychosis: SMART-Therapy study protocol

BACKGROUND: Psychosocial interventions have an important role in promoting recovery in people with persisting psychotic disorders such as schizophrenia. Readily available, digital technology provides a means of developing therapeutic resources for use together by practitioners and mental health service users. As part of the Self-Management and Recovery Technology (SMART) research program, we have developed an online resource providing materials on illness self-management and personal recovery based on the Connectedness-Hope-Identity-Meaning-Empowerment (CHIME) framework. Content is communicated using videos featuring persons with lived experience of psychosis discussing how they have navigated issues in their own recovery. This was developed to be suitable for use on a tablet computer during sessions with a mental health worker to promote discussion about recovery.

METHODS/DESIGN: This is a rater-blinded randomised controlled trial comparing a low intensity recovery intervention of eight one-to-one face-to-face sessions with a mental health worker using the SMART website alongside routine care, versus an eight-session comparison condition, befriending. The recruitment target is 148 participants with a schizophrenia-related disorder or mood disorder with a history of psychosis, recruited from mental health services in Victoria, Australia. Following baseline assessment, participants are randomised to intervention, and complete follow up assessments at 3, 6 and 9 months post-baseline. The primary outcome is personal recovery measured using the Process of Recovery Questionnaire (QPR). Secondary outcomes include positive and negative symptoms assessed with the Positive and Negative Syndrome Scale, subjective experiences of psychosis, emotional symptoms, quality of life and resource use. Mechanisms of change via effects on self-stigma and self-efficacy will be examined.

DISCUSSION: This protocol describes a novel intervention which tests new therapeutic methods including in-session tablet computer use and video-based peer modelling. It also informs a possible low intensity intervention model potentially viable for delivery across the mental health workforce.

A family-based intervention to increase fruit and vegetable consumption in adolescents : a pilot study

Objective: To evaluate the feasibility and effectiveness of a pilot family-based newsletter intervention to increase fruit and vegetable (FV) consumption among adolescents.
Design: Family-based, two-group randomised control trial with baseline, postintervention and follow-up measures. The intervention group received two FV newsletter packs over a 1 month period by postal mail. Social cognitive and behavioural choice theories provide the theoretical framework for the design and development of intervention materials. Control families were provided with all intervention materials at the end of the study. Adolescent FV consumption was assessed by an FFQ. Adolescent-reported barriers to eating FV, FV habits and preferences were the secondary outcomes, along with parent FV consumption, and parents reported knowledge, encouragement, home availability and accessibility of FV. Repeated-measures ANOVA was used to detect differences in behavioural and psychosocial outcomes between groups, time and group-by-time.
Setting: East Midlands, UK.
Subjects: Forty-nine parents and adolescents aged 12–14 years.
Results: Process evaluation indicated high reach, dose acceptability and fidelity of the intervention. At post-intervention and 6 weeks later at follow-up, adolescents in the intervention group had significantly higher fruit: (P0<·01) and vegetable (P<0·05) consumption and higher preferences for vegetables (P<0·01), compared with the control group. At post-intervention and follow-up, parents in the intervention group had significantly higher fruit (P<0·001) and vegetable (P<0·01) consumption and reported higher accessibility of fruit and vegetables (P<0·001), compared with those in the control group.
Conclusions: Family-based, newsletter interventions promoting FV consumption to adolescents appear to be feasible and effective at increasing FV consumption.

Nutrition screening by nurses in dialysis

Aims and objectives : To determine whether a nurse-completed dialysis nutritional screening tool improves referral rates for nutritional support and compare nutrition sensitive biochemical indices, mortality rates and patient-centred quality of life outcomes between referred and non-referred dialysis patients.

Background : People with chronic kidney disease requiring dialysis are nutritionally at risk. Nutrition screening has been shown to identify dialysis patients who are nutritionally at risk to refer to dietitian expertise.

Design : Prospective cluster-randomised control trial.

Methods : Monthly nurse-completed nutrition screening was completed for six consecutive months using a validated four-item instrument measuring weight change, serum phosphate, serum potassium and appetite. Participants (n = 81) were haemodialysis patients from four satellite haemodialysis centres in one Australian metropolitan health service. Primary outcome measure was rate of referral to dietetic services for nutrition support for intervention vs. control groups at six months. Secondary outcome measures were blood pressure, biochemical indices and mortality for referred vs. non-referred patients at six and nine months, and generic and dialysis-specific quality of life for referred vs. non-referred at nine months was examined.

Results : There were three times as many dietetic referrals in the intervention group than in the control group (26·3 vs. 9·3%). Serum phosphate increased significantly more in the referred patients than the non-referred patients. There were no clinically significant changes between groups in quality of life, blood pressure, mortality rates or other biochemical indices at either six or nine months.

Conclusion : Nurse-completed nutritional screening can lead to appropriate dietetic referrals for nutritional support by nutritional expert clinicians.

Relevance to clinical practice : This study is the first to demonstrate that monthly systematic nurse-completed nutritional screening can facilitate appropriate dietetic referrals that may lead to increased nutritional care for people in satellite dialysis centres.

A study protocol to investigate the management of depression and challenging behaviors associated with dementia in aged care settings

Background: 

Quality care outcomes following transitional care interventions for older people from hospital to home: a systematic review

 Background
Provision of high quality transitional care is a challenge for health care providers in many western countries. This systematic review was conducted to (1) identify and synthesise research, using randomised control trial designs, on the quality of transitional care interventions compared with standard hospital discharge for older people with chronic illnesses, and (2) make recommendations for research and practice.

Methods
Eight databases were searched; CINAHL, Psychinfo, Medline, Proquest, Academic Search Complete, Masterfile Premier, SocIndex, Humanities and Social Sciences Collection, in addition to the Cochrane Collaboration, Joanna Briggs Institute and Google Scholar. Results were screened to identify peer reviewed journal articles reporting analysis of quality indicator outcomes in relation to a transitional care intervention involving discharge care in hospital and follow-up support in the home. Studies were limited to those published between January 1990 and May 2013. Study participants included people 60 years of age or older living in their own homes who were undergoing care transitions from hospital to home. Data relating to study characteristics and research findings were extracted from the included articles. Two reviewers independently assessed studies for risk of bias.

Results
Twelve articles met the inclusion criteria. Transitional care interventions reported in most studies reduced re-hospitalizations, with the exception of general practitioner and primary care nurse models. All 12 studies included outcome measures of re-hospitalization and length of stay indicating a quality focus on effectiveness, efficiency, and safety/risk. Patient satisfaction was assessed in six of the 12 studies and was mostly found to be high. Other outcomes reflecting person and family centred care were limited including those pertaining to the patient and carer experience, carer burden and support, and emotional support for older people and their carers. Limited outcome measures were reported reflecting timeliness, equity, efficiencies for community providers, and symptom management.

Conclusions
Gaps in the evidence base were apparent in the quality domains of timeliness, equity, efficiencies for community providers, effectiveness/symptom management, and domains of person and family centred care. Further research that involves the person and their family/caregiver in transitional care interventions is needed.

Empirical evidence of recall bias for primary health care visits

BACKGROUND: While it is common for an economic evaluation of health care to rely on trial participants for self-reported health service utilisation, there is variability in the accuracy of this data due to potential recall bias. The aim of this study was to quantify the level of recall bias in self-reported primary health care general practitioner (GP) visits following inpatient rehabilitation over a 12 month period.

METHODS: This report is a secondary analysis from a larger randomised control trial of an economic evaluation of additional Saturday inpatient rehabilitation. Participants were adults who had been discharged into the community following admission to an acute general rehabilitation hospital. Participants were asked to recall primary health care visits, including community GP visits, via a telephone questionnaire which was administered at 6 and 12 months following discharge from inpatient rehabilitation. Participants were asked to recall health service utilisation over each preceding 6 month period. The self-reported data were compared to equivalent claims data from the national insurer, over the same period.

RESULTS: 751 participants (75% of the full trial) with a mean age of 74 years (SD 13) were included in this analysis. Over the 12 month period following discharge from rehabilitation there was an under-reporting of 14% in self-reported health service utilisation for GP visits compared to national insurer claims data over the same period. From 0 to 6 months following discharge from rehabilitation, there was an over-reporting of self-reported GP visits of 35% and from 7 to 12 months there was an under-reporting of self-reported GP visits of 36%, compared to national insurer claims data over the same period. 46% of patients reported the same or one number difference in self-reported GP visits between the 0 to 6 and the 7 to 12 month periods.

CONCLUSION: Based on these findings we recommend that an economic evaluation alongside a clinical trial for an elderly adult rehabilitation population include a sensitivity analysis that inflates self-reported GP visits by 16% over 12 months. However caution is required when utilising self-reported GP visits as the data may contain periods of both over and under reporting. Where general practitioner visits are expected to vary significantly between intervention and control groups we recommend that administrative data be included in the trial to accurately capture resources for an economic evaluation.

Does sleep education change sleep parameters? Comparing sleep education trials for middle school students in Australia and New Zealand

Background: Adolescents suffer daytime consequences from sleep loss. Sleep education programs have been developed in an attempt to increase sleep knowledge and/or duration. This paper presents data from three trials of the Aus-tralian Centre for Education in Sleep (ACES) program for adolescents.

Methods: The ACES program was delivered to 69 Australian adolescents in a pre-post cross-sectional design (mean age 15.2) and 29 New Zealand adolescents in a randomised control trial (mean age 14.8 years). Assessments in sleep parame-ters were undertaken at baseline and post intervention.

Results: Where sleep knowledge was evaluated (Australian trials), significant improvements were shown in all trials (All p <0.05). Where sleep duration was assessed (New Zealand trial) significant improvements were found in week and weekend sleep duration [F(1, 27)=4.26, p=0.04). Both, students and teachers found the program feasible, interesting, and educational.

Conclusions: ACES sleep education programmes can improve both sleep knowledge and sleep duration in adolescents. Improving the programme so sleep knowledge attained equates to actual sleep behaviour change are areas for future direc-tion. Collectively these findings provide encouraging signs that adolescents can improve their sleep knowledge and behav-iour with sleep education which bodes well for sleep-related health and psycho-social issues.

The population cost-effectiveness of delivering universal and indicated school-based interventions to prevent the onset of major depression among youth in Australia

AIMS: School-based psychological interventions encompass: universal interventions targeting youth in the general population; and indicated interventions targeting youth with subthreshold depression. This study aimed to: (1) examine the population cost-effectiveness of delivering universal and indicated prevention interventions to youth in the population aged 11-17 years via primary and secondary schools in Australia; and (2) compare the comparative cost-effectiveness of delivering these interventions using face-to-face and internet-based delivery mechanisms. METHODS: We reviewed literature on the prevention of depression to identify all interventions targeting youth that would be suitable for implementation in Australia and had evidence of efficacy to support analysis. From this, we found evidence of effectiveness for the following intervention types: universal prevention involving group-based psychological interventions delivered to all participating school students; and indicated prevention involving group-based psychological interventions delivered to students with subthreshold depression. We constructed a Markov model to assess the cost-effectiveness of delivering universal and indicated interventions in the population relative to a 'no intervention' comparator over a 10-year time horizon. A disease model was used to simulate epidemiological transitions between three health states (i.e., healthy, diseased and dead). Intervention effect sizes were based on meta-analyses of randomised control trial data identified in the aforementioned review; while health benefits were measured as Disability-adjusted Life Years (DALYs) averted attributable to reductions in depression incidence. Net costs of delivering interventions were calculated using relevant Australian data. Uncertainty and sensitivity analyses were conducted to test model assumptions. Incremental cost-effectiveness ratios (ICERs) were measured in 2013 Australian dollars per DALY averted; with costs and benefits discounted at 3%. RESULTS: Universal and indicated psychological interventions delivered through face-to-face modalities had ICERs below a threshold of $50 000 per DALY averted. That is, $7350 per DALY averted (95% uncertainty interval (UI): dominates - 23 070) for universal prevention, and $19 550 per DALY averted (95% UI: 3081-56 713) for indicated prevention. Baseline ICERs were generally robust to changes in model assumptions. We conducted a sensitivity analysis which found that internet-delivered prevention interventions were highly cost-effective when assuming intervention effect sizes of 100 and 50% relative to effect sizes observed for face-to-face delivered interventions. These results should, however, be interpreted with caution due to the paucity of data. CONCLUSIONS: School-based psychological interventions appear to be cost-effective. However, realising efficiency gains in the population is ultimately dependent on ensuring successful system-level implementation.

A cluster randomised trial of a telephone-based intervention for parents to increase fruit and vegetable consumption in their 3-to 5-year-old children : study protocol

Background: Inadequate fruit and vegetable consumption in childhood increases the risk of developing chronic disease. Despite this, a substantial proportion of children in developed nations, including Australia, do not consume sufficient quantities of fruits and vegetables. Parents are influential in the development of dietary habits of young children but often lack the necessary knowledge and skills to promote healthy eating in their children. The aim of this study is to assess the efficacy of a telephone-based intervention for parents to increase the fruit and vegetable consumption of their 3- to 5-year-old children.
Methods/Design: The study, conducted in the Hunter region of New South Wales, Australia, employs a cluster randomised controlled trial design. Two hundred parents from 15 randomly selected preschools will be randomised to receive the intervention, which consists of print resources and four weekly 30-minute telephone support calls delivered by trained telephone interviewers. The calls will assist parents to increase the availability and accessibility of fruit and vegetables in the home, create supportive family eating routines and role-model fruit and vegetable consumption. A further two hundred parents will be randomly allocated to the control group and will receive printed nutrition information only. The primary outcome of the trial will be the change in the child's consumption of fruit and vegetables as measured by the fruit and vegetable subscale of the Children's Dietary Questionnaire. Pre-intervention and post-intervention parent surveys will be administered over the telephone. Baseline surveys will occur one to two
weeks prior to intervention delivery, with follow-up data collection calls occurring two, six, 12 and 18 months following baseline data collection.
Discussion: If effective, this telephone-based intervention may represent a promising public health strategy to increase fruit and vegetable consumption in childhood and reduce the risk of subsequent chronic disease.
Trial registration: Australian Clinical Trials Registry ACTRN12609000820202

The TrueBlue model of collaborative care using practice nurses as case managers for depression alongside diabetes or heart disease: a randomised trial

Objectives:
To determine the effectiveness of collaborative care in reducing depression in primary care patients with diabetes or heart disease using practice nurses as case managers.

Predictors of primary care referrals to a vascular disease prevention lifestyle program among participants in a cluster randomised trial

Background

Cardiovascular disease accounts for a large burden of disease, but is amenable to prevention through lifestyle modification. This paper examines patient and practice predictors of referral to a lifestyle modification program (LMP) offered as part of a cluster randomised controlled trial (RCT) of prevention of vascular disease in primary care.

Methods

Data from the intervention arm of a cluster RCT which recruited 36 practices through two rural and three urban primary care organisations were used. In each practice, 160 eligible high risk patients were invited to participate. Practices were randomly allocated to intervention or control groups. Intervention practice staff were trained in screening, motivational interviewing and counselling and encouraged to refer high risk patients to a LMP involving individual and group sessions. Data include patient surveys; clinical audit; practice survey on capacity for preventive care; referral records from the LMP. Predictors of referral were examined using multi-level logistic regression modelling after adjustment for confounding factors.

Results

Of 301 eligible patients, 190 (63.1%) were referred to the LMP. Independent predictors of referral were baseline BMI ≥ 25 (OR 2.87 95%CI:1.10, 7.47), physical inactivity (OR 2.90 95%CI:1.36,6.14), contemplation/preparation/action stage of change for physical activity (OR 2.75 95%CI:1.07, 7.03), rural location (OR 12.50 95%CI:1.43, 109.7) and smaller practice size (1–3 GPs) (OR 16.05 95%CI:2.74, 94.24).

Conclusions

Providing a well-structured evidence-based lifestyle intervention, free of charge to patients, with coordination and support for referral processes resulted in over 60% of participating high risk patients being referred for disease prevention. Contrary to expectations, referrals were more frequent from rural and smaller practices suggesting that these practices may be more ready to engage with these programs.

Evaluation of a decision aid for prenatal testing of fetal abnormalities : a cluster randomised trial [ISRCTN22532458]

Background: By providing information on the relative merits and potential harms of the options available and a framework to clarify preferences, decision aids can improve knowledge and realistic expectations and decrease decisional conflict in individuals facing decisions between alternative forms of action. Decision-making about prenatal testing for fetal abnormalities is often confusing and difficult for women and the effectiveness of decision aids in this field has not been established. This study aims to test whether a decision aid for prenatal testing of fetal abnormalities, when compared to a pamphlet, improves women's informed decision-making and decreases decisional conflict.

Methods/design: A cluster designed randomised controlled trial is being conducted in Victoria, Australia. Fifty General Practitioners (GPs) have been randomised to one of two arms: providing women with either a decision aid or a pamphlet. The two primary outcomes will be measured by comparing the difference in percentages of women identified as making an informed choice and the difference in mean decisional conflict scores between the two groups. Data will be collected from women using questionnaires at 14 weeks and 24 weeks gestation.

The sample size of 159 women in both arms of the trial has been calculated to detect a difference of 18% (50 to 68%) in informed choice between the two groups. The required numbers have been adjusted to accommodate the cluster design, miscarriage and participant lost – to – follow up.

Baseline characteristics of women will be summarised for both arms of the trial. Similarly, characteristics of GPs will be compared between arms.

Differences in the primary outcomes will be analysed using 'intention-to-treat' principles. Appropriate regression techniques will adjust for the effects of clustering and include covariates to adjust for the stratifying variable and major potential confounding factors.

Discussion: The findings from this trial will make a significant contribution to improving women's experience of prenatal testing and will have application to a variety of maternity care settings. The evaluation of a tailored decision aid will also have implications for pregnancy care providers by identifying whether or not such a resource will support their role in providing prenatal testing information.