Five-Year Mortality Outcomes for Eating As Treatment (EAT), a Health Behavior Change Intervention to Improve Nutrition in Patients With Head and Neck Cancer: A Stepped-Wedge, Randomized Controlled Trial.

PURPOSE: Malnutrition affects up to 80% of patients with head and neck cancer (HNC) and is associated with higher burden of disease, poorer treatment outcomes, and greater mortality. The Eating As Treatment (EAT) intervention is a behavioral intervention previously demonstrated to be effective in improving nutritional status, depression, and quality of life in patients with HNC. This article examines the effects of the EAT intervention on 5-year mortality among participants. METHODS AND MATERIALS: A multicenter, stepped-wedge, randomized controlled trial was conducted in 5 Australian hospitals. Dietitians were trained to deliver EAT, a combination of motivational interviewing and cognitive behavior therapy strategies, to patients with HNC receiving radiation therapy. Secondary analyses of survival benefit on an intention-to-treat basis were performed. Differences in proportions of 5-year all-cause mortality between the control and EAT intervention arms were analyzed using multivariable logistic regression, and 5-year survival rates were analyzed using Cox proportional hazards regression. Analyses controlled for temporal effects (study duration), hospital site (clustering), and baseline nutritional status differences. RESULTS: Overall, there were 64 deaths in the 5 years after enrollment, 36 (24%) among those assigned to the control condition and 28 (18%) among those assigned to EAT. Logistic regression showed statistically significant reduced odds in favor of EAT (odds ratio, 0.33; 95% CI, 0.11-0.96), with an absolute risk reduction of 17% (95% CI, 0.01-0.33) and a relative risk reduction of 55% (95% CI, 0.22-0.92), resulting in a number needed to treat of 6 (95% CI, 4-13). Survival analysis revealed that risk of death was significantly reduced by the EAT intervention (hazard ratio, 0.39; 0.16-0.96). CONCLUSIONS: Participation in EAT provided a statistically and clinically meaningful survival benefit, likely via improved nutrition during radiation therapy. This survival benefit strengthens the finding of the main trial, showing that a behavioral intervention focused on nutrition could improve HNC outcomes. Replication studies using stepped-wedge designs for implementation into clinical practice may be warranted.

A novel, multidomain, primary care nurse-led and mHealth-assisted intervention for dementia risk reduction in middle-aged adults (HAPPI MIND): study protocol for a cluster randomised controlled trial.

INTRODUCTION: Middle-aged multidomain risk reduction interventions targeting modifiable risk factors for dementia may delay or prevent a third of dementia cases in later life. We describe the protocol of a cluster randomised controlled trial (cRCT), HAPPI MIND (Holistic Approach in Primary care for PreventIng Memory Impairment aNd Dementia). HAPPI MIND will evaluate the efficacy of a multidomain, nurse-led, mHealth supported intervention for assessing dementia risk and reducing associated risk factors in middle-aged adults in the Australian primary care setting. METHODS AND ANALYSIS: General practice clinics (n≥26) across Victoria and New South Wales, Australia, will be recruited and randomised. Practice nurses will be trained to implement the HAPPI MIND intervention or a brief intervention. Patients of participating practices aged 45-65 years with ≥2 potential dementia risk factors will be identified and recruited (approximately 15 patients/clinic). Brief intervention participants receive a personalised report outlining their risk factors for dementia based on Australian National University Alzheimer's Disease Risk Index (ANU-ADRI) scores, education booklet and referral to their general practitioner as appropriate. HAPPI MIND participants receive the brief intervention as well as six individualised dementia risk reduction sessions with a nurse trained in motivational interviewing and principles of behaviour change, a personalised risk reduction action plan and access to the purpose-built HAPPI MIND smartphone app for risk factor self-management. Follow-up data collection will occur at 12, 24 and 36 months. Primary outcome is ANU-ADRI score change at 12 months from baseline. Secondary outcomes include change in cognition, quality of life and individual risk factors of dementia. ETHICS AND DISSEMINATION: Project approved by Monash University Human Research Ethics Committee (ID: 28273). Results will be disseminated in peer-reviewed journals and at healthcare conferences. If effective in reducing dementia risk, the HAPPI MIND intervention could be integrated into primary care, scaled up nationally and sustained over time. TRIAL REGISTRATION NUMBER: ACTRN12621001168842.

Biofeedback Enabled CALM (BeCALM)-the feasibility of biofeedback on procedural anxiety during radiation therapy: study protocol for a pilot randomised controlled trial.

INTRODUCTION: Patients undergoing treatment for cancer who require radiation therapy (RT) report anxiety specifically relating to the RT procedure. Procedural anxiety can be detrimental to treatment delivery, causing disruptions to treatment sessions, or treatment avoidance. Acute procedural anxiety is most commonly managed with anxiolytic medication. There is a need for effective, non-pharmacological interventions for patients not suitable for, or who prefer to avoid, anxiolytic medication. The primary objectives of this pilot trial are to evaluate the: (1) feasibility of conducting the Biofeedback Enabled CALM (BeCALM) intervention during RT treatment sessions; (2) acceptability of the BeCALM intervention among patients; and (3) acceptability of the BeCALM intervention among radiation therapists. The secondary objective of this pilot trial is to examine the potential effectiveness of the BeCALM intervention delivered by radiation therapists to reduce procedural anxiety during RT. METHODS AND ANALYSIS: This is a pilot randomised controlled trial. A researcher will recruit adult patients with cancer (3-month recruitment period) scheduled to undergo RT and meeting eligibility criteria for procedural anxiety at the Calvary Mater Hospital, Newcastle (NSW), Australia. Participants will be randomly assigned to receive treatment as usual or the BeCALM intervention (biofeedback plus brief breathing techniques). The primary outcomes are feasibility (measured by recruitment, retention rates and percentage of treatment sessions in which the intervention was successfully delivered); radiation therapists perceived feasibility and acceptability (survey responses); and patient perceived acceptability (survey responses). Secondary outcome is potential effectiveness of the intervention (as measured by the State Trait Anxiety Inventory-State subscale; the Distress Thermometer; and an analysis of treatment duration). ETHICS AND DISSEMINATION: The study protocol has received approval from Hunter New England Health Human Research Ethics Committee (2021/ETH11356). The results will be disseminated via peer-reviewed publications, as well as presentation at relevant conferences. TRIAL REGISTRATION NUMBER: ACTRN12621001742864.

Is fidelity to a complex behaviour change intervention associated with patient outcomes? Exploring the relationship between dietitian adherence and competence and the nutritional status of intervention patients in a successful stepped-wedge randomised clinical trial of eating as treatment (EAT).

BACKGROUND: Behavioural medicine is characterised by findings for the effectiveness and efficacy of complex behaviour change interventions. Comparatively, scant attention has been paid to key intervention components or mechanisms of action. Evaluating relationships between process variables (fidelity) and intervention effects is central to addressing this imbalance. Accordingly, in the current study, we sought to explore the magnitude and direction of effect between fidelity predictors (dietitian adherence and competence) and intervention effects (patient nutritional status) during the intervention phase of a real-world, stepped-wedge evaluation of 'EAT: Eating As Treatment'. METHODS: The EAT clinical trial was conducted within five major Australian hospitals located in Queensland, Western Australia, Victoria and South Australia between 2013 and 2016. EAT is a dietitian-delivered health behaviour change intervention designed to reduce malnutrition in head and neck cancer (HNC) patients undergoing radiotherapy. Dietitian adherence and competence ratings were derived from a 20% random sample of audio-recorded dietetic consultations (n=194) conducted after dietitians (n=18) were trained in EAT. Sessions were coded by trained, independent, coders using a study checklist, the Behaviour Change Counselling Index (BECCI) and items from the Cognitive Therapy Scale-Revised (CTS-R). Patient nutritional status was measured using the Patient-Generated Subjective Global Assessment (PGSGA). RESULTS: Dietitian adherence to a written nutrition plan (ß=7.62, 95% CI=0.65 to 14.58, p=0.032), dietitian adherence to behaviour change counselling (ß=0.69, 95% CI =0.02 to 1.38, p=0.045) and competence in delivering behaviour change counselling (ß=3.50, 95% CI =0.47 to 6.53, p=0.024) were significant predictors of patient nutritional status. Dietitian adherence and competence ratings were higher during consultations with intervention patients at greater risk of malnutrition. CONCLUSIONS: This study contributes new insights into the relationship between fidelity and treatment outcome by demonstrating that dietitian adherence and competence is greater when working with more challenging patients. This is likely central to the demonstrated success of the EAT intervention in reducing malnutrition and highlights the importance of ensuring that providers are adequately equipped to flexibly integrate intervention elements according to patient need. TRIAL REGISTRATION: This study is a process analysis of a stepped-wedge randomised controlled trial prospectively registered on the Australian New Zealand Clinical Trials Registry ( ACTRN12613000320752 ; Date of registration 21/03/2013).

Differential treatment effects of an integrated motivational interviewing and exercise intervention on depressive symptom profiles and associated factors: A randomised controlled cross-over trial among youth with major depression.

BACKGROUND: Exercise is increasingly recognised as an efficacious intervention for major depressive disorder (MDD) but to our knowledge differential treatment effects on depressive symptom profiles (cognitive, somatic and affective) and associated changes in psychological, physiological and behavioural factors have not been examined among youth with MDD. METHODS: Sixty-eight participants (mean age 20.8) meeting DSM-IV diagnostic criteria for MDD were randomised to an Immediate intervention or Control/delayed condition (n = 34 per group). The integrated intervention comprised an initial session of motivational interviewing (MI) followed by a 12-week, multi-modal exercise program. Changes in depressive symptom profiles were assessed with the Beck Depression Inventory-II (BDI-II) total score and factorial symptom subscales. RESULTS: There were significant differential improvements in BDI-II total scores post-treatment among intervention participants, which were also observed across the cognitive and affective subscales. Individual BDI-II items from the cognitive subscale showing significant differential improvement related to negative self-concept, while those from the affective subscale related to interest/activation; the energy item within the somatic subscale also revealed significant differential improvement. Significant differential improvements were also observed in exercise participation, negative automatic thoughts, behavioural activation and bench press repetitions among intervention participants, which correlated significantly with depression improvements. LIMITATIONS: The exercise intervention was delivered in a supervised, group format and potential social meditators of change cannot be excluded. CONCLUSIONS: Exercise differentially effects depressive symptom profiles with similar antidepressant effects as would be expected from psychological therapies improving negative cognition and emotional health.

Eating As Treatment (EAT): A Stepped-Wedge, Randomized Controlled Trial of a Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition in Patients With Head and Neck Cancer Undergoing Radiation Therapy (TROG 12.03).

PURPOSE: Malnutrition in head and neck cancer (HNC) treatment is common and associated with poorer morbidity and mortality outcomes. This trial aimed to improve nutritional status during radiation therapy (RT) using a novel method of training dietitians to deliver psychological techniques to improve nutritional behaviors in patients with HNC. METHODS AND MATERIALS: This trial used a stepped-wedge, randomized controlled design to assess the efficacy of the Eating As Treatment (EAT) program. Based on motivational interviewing and cognitive behavioral therapy, EAT was designed to be delivered by oncology dietitians and integrated into their clinical practice. During control steps, dietitians provided treatment as usual, before being trained in EAT and moving into the intervention phase. The training was principles based and sought to improve behavior-change skills rather than provide specific scripts. Patients recruited to the trial (151 controls, 156 intervention) were assessed at 4 time points (the first and the final weeks of RT, and 4 and 12 weeks afterward). The primary outcome was nutritional status at the end of RT as measured by the Patient-Generated Subjective Global Assessment. RESULTS: Patients who received the EAT intervention had significantly better scores on the primary outcome of nutritional status at the critical end-of-treatment time point (ß = -1.53 [-2.93 to -.13], P = .03). Intervention patients were also significantly more likely than control patients to be assessed as well-nourished at each time point, lose a smaller percentage of weight, have fewer treatment interruptions, present lower depression scores, and report a higher quality of life. Although results were not statistically significant, patients who received the intervention had fewer and shorter unplanned hospital admissions. CONCLUSIONS: This trial is the first of its kind to demonstrate the effectiveness of a psychological intervention to improve nutrition in patients with HNC who are receiving RT. The intervention provides a means to ameliorate malnutrition and the important related outcomes and consequently should be incorporated into standard care for patients receiving RT for HNC.

The unmet needs of informal carers of stroke survivors: a protocol for a systematic review of quantitative and qualitative studies.

INTRODUCTION: Stroke events deeply affect not only the stroke survivor but also often the quality of life and physical and psychological health of the family and friends who care for them. There is a need for further information about the unmet needs of these informal carers in order to develop support services and interventions. The primary objective of this review is to report and synthesise the research describing the unmet needs of carers of stroke survivors. METHODS AND ANALYSIS: A systematic review of quantitative and qualitative studies that report on the unmet needs of carers will be conducted. The following databases will be searched for relevant articles: MEDLINE, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, EMBASE, Allied and Complementary Medicine Database and Scopus. No publication date constraints will be applied. Studies will be limited to those published in English and conducted among humans. Eligible studies will report on the unmet needs of informal carers of stroke survivors, defined as family members, friends and other unpaid caregivers. Studies which focus on formal, clinical or medical caregivers will be excluded. A narrative synthesis and pooled analysis of the main outcomes will be reported. ETHICS AND DISSEMINATION: This review will be submitted to a peer-reviewed journal. Our findings are expected to provide new insights into the unmet needs of stroke survivors' carers. Knowledge about the unmet needs of carers will inform the development and refinement of interventions and services to address these needs and better support carers of stroke survivors. The findings of this systematic review will be disseminated publicly and in peer-reviewed journals and may be the topic of research presentations. TRIAL REGISTRATION NUMBER: CRD42017067391.

Therapeutic Alliance, Client Need for Approval, and Perfectionism as Differential Moderators of Response to eHealth and Traditionally Delivered Treatments for Comorbid Depression and Substance Use Problems.

PURPOSE: This study sought to undertake an exploratory analysis of the impact of therapeutic alliance and dysfunctional attitudes (perfectionism and need for approval) on outcomes for participants receiving therapist-delivered and eHealth interventions for comorbid depression and alcohol/cannabis use problems. These factors have been shown in previous research to moderate response to psychological treatment for depression and related disorders. METHOD: Participants (N = 274) with concurrent depression and alcohol/cannabis misuse were randomized to 10 sessions of therapist-delivered cognitive behavior therapy/motivational interviewing (CBT/MI), computer-delivered CBT/MI with brief therapist assistance (SHADE CBT/MI), or supportive counseling (PCT). Follow-up occurred at 3, 6, and 12 months post-baseline. Exploratory moderator analyses examined changes in depression, alcohol use, and cannabis use over the 3-12-month follow-up timepoints, adjusting for baseline, as a function of treatment allocation, and the hypothesized moderators of therapeutic alliance, perfectionism, and need for approval. RESULTS: The sample size and number of comparisons in the analysis mean that the results are considered preliminary and need replication in larger trials. The analysis revealed that "client initiative," a subscale of therapeutic alliance, moderated change in depression scores between 3- and 12-month follow-up for the PCT group, with higher scores associated with decreases in depression over time. Higher therapeutic "bond" early in treatment for SHADE CBT/MI participants was associated with reduced cannabis use over time. Participants with higher "perfectionism" scores at baseline who received therapist CBT/MI reported increases in depression over the follow-up period, but reductions in depression if they received SHADE CBT/MI. Therapist CBT/MI participants high on "need for approval" at baseline reported better alcohol use outcomes over time. CONCLUSION: The preliminary nature of these results do not justify firm conclusions. However, the specific variables of perfectionism, need for approval, and client initiative show promise as moderators of treatment efficacy for comorbid depression and alcohol/cannabis use problems. Further research is justified to determine whether these factors can assist in tailoring the modality and strategies offered in the delivery of psychotherapy to this population.

Treatment of cannabis use among people with psychotic disorders: a critical review of randomised controlled trials.

There is growing and converging evidence that cannabis may be a major risk factor in people with psychotic disorders and prodromal psychotic symptoms. The lack of available pharmacological treatments for cannabis use indicates that psychological interventions should be a high priority, especially among people with psychotic disorders. However, there have been few randomised controlled trials (RCTs) of psychological interventions among this group. In the present study we critically overview RCTs of psychological and pharmacologic interventions among people with psychotic disorders, giving particular attention to those studies which report cannabis use outcomes. We then review data regarding treatment preferences among this group. RCTs of interventions within "real world" mental health systems among adults with severe mental disorders suggest that cannabis use is amenable to treatment in real world settings among people with psychotic disorders. RCTs of manual guided interventions among cannabis users indicate that while brief interventions are associated with reductions in cannabis use, longer interventions may be more effective. Additionally, RCTs reviewed suggest treatment with antipsychotic medication is not associated with a worsening of cannabis cravings or use and may be beneficial. The development of cannabinoid agonist medication may be an effective strategy for cannabis dependence and suitable for people with psychotic disorders. The development of cannabis use interventions for people with psychotic disorders should also consider patients' treatment preferences. Initial results indicate face-to-face interventions focussed on cannabis use may be preferred. Further research investigating the treatment preferences of people with psychotic disorders using cannabis is needed.

Clinician-assisted computerised versus therapist-delivered treatment for depressive and addictive disorders: a randomised controlled trial.

OBJECTIVE: To compare computer-delivered and therapist-delivered treatments for people with depression and comorbid addictive disorders. DESIGN: Randomised controlled clinical trial. SETTING AND PARTICIPANTS: Our study was conducted between January 2005 and August 2007 at seven study clinics in rural and urban New South Wales. Participants were 274 people who had a Beck Depression Inventory II (BDI-II) score ≥ 17 and were using alcohol and/or cannabis at harmful levels in the month before baseline. They were self-referred or referred from other sources such as outpatient drug treatment clinics, general practices and non-government support agencies. INTERVENTIONS: Participants were randomly allocated to receive (1) integrated cognitive behaviour therapy and motivational interviewing (CBT/MI) delivered by a therapist; (2) integrated CBT/MI delivered by computer, with brief therapist assistance at the end of each session (clinician-assisted computerised [CAC] treatment), or (3) person-centred therapy (PCT), consisting of supportive counselling given by a therapist (the control group). All three treatments were delivered according to a manual developed specifically for the study. MAIN OUTCOME MEASURES: Changes in depression, alcohol use and cannabis use at 3 months after baseline; significant predictors of change in the primary outcome variables. RESULTS: Compared with computer- or therapist-delivered CBT/MI, PCT was associated with significantly less reduction in depression and alcohol consumption at 3 months. CAC therapy was associated with improvement at least equivalent to that achieved by therapist-delivered treatment, with superior results as far as reducing alcohol consumption. Change in depression was significantly predicted by change in alcohol use (in the same direction) and an ability to determine primacy, irrespective of whether this was for drug use or depression. Change in alcohol use was significantly predicted by changes in cannabis use and depression, and change in cannabis use by change in alcohol use. In the regression model, treatment allocation did not independently predict change, but was associated with significant reduction in depression and alcohol use at 3 months. CONCLUSIONS: Over a 3-month period, CBT/MI was associated with a better treatment response than supportive counselling. CAC therapy was associated with greater reduction in alcohol use than therapist-delivered treatment. TRIAL REGISTRATION NUMBER: ACTRN12610000274077.

Treatment of cannabis use among people with psychotic or depressive disorders: a systematic review.

OBJECTIVE: This article systematically reviews the evidence from randomized controlled trials (RCTs) for pharmacologic and psychological approaches to the treatment of cannabis use among individuals with psychotic or depressive disorders. DATA SOURCES: A systematic literature search was conducted using the PubMed and PsychINFO databases from inception to December 2008. Individual searches in cannabis use (search terms: marijuana, cannabis, marijuana abuse, cannabis abuse, marijuana usage, cannabis usage), mental disorders (search terms: mood disorders, affective disorders, anxiety disorders, anxiety, depressive disorder, depression, psychotic disorders, psychosis, mental disorders), and pharmacotherapy (search terms: medication, drug therapy, pharmacotherapy, psychopharmacology, clinical trials, drug trial, treatment trial) were conducted and limited to humans, adolescents and adults. STUDY SELECTION: A search combining the individual cannabis use, mental disorder and pharmacotherapy searches produced 1,713 articles (PubMed = 1,398; PsychINFO = 315). Combining the cannabis use and mental disorder searches while limiting them to English articles and RCTs produced a total of 286 articles (PubMed = 228; PsychINFO = 58). From this literature, there were 7 RCTs conducted among mental health clients that reported cannabis use outcomes using pharmacologic or psychological interventions. DATA SYNTHESIS: While few RCTs have been conducted, there is evidence that pharmacologic and psychological interventions are effective for reducing cannabis use in the short-term among people with psychotic disorders or depression. CONCLUSIONS: Although it is difficult to make evidence-based treatment recommendations due to the paucity of research in this area, available studies indicate that effectively treating the mental health disorder with standard pharmacotherapy may be associated with a reduction in cannabis use and that longer or more intensive psychological interventions rather than brief interventions may be required, particularly among heavier users of cannabis and those with more chronic mental disorders. Specific recommendations regarding the type and length of specific psychological treatments cannot be made at this time, although motivational interviewing and cognitive-behavioral therapy approaches appear most promising.

Computer-based psychological treatment for comorbid depression and problematic alcohol and/or cannabis use: a randomized controlled trial of clinical efficacy.

AIMS: To evaluate computer- versus therapist-delivered psychological treatment for people with comorbid depression and alcohol/cannabis use problems. DESIGN: Randomized controlled trial. SETTING: Community-based participants in the Hunter Region of New South Wales, Australia. PARTICIPANTS: Ninety-seven people with comorbid major depression and alcohol/cannabis misuse. INTERVENTION: All participants received a brief intervention (BI) for depressive symptoms and substance misuse, followed by random assignment to: no further treatment (BI alone); or nine sessions of motivational interviewing and cognitive behaviour therapy (intensive MI/CBT). Participants allocated to the intensive MI/CBT condition were selected at random to receive their treatment 'live' (i.e. delivered by a psychologist) or via a computer-based program (with brief weekly input from a psychologist). MEASUREMENTS: Depression, alcohol/cannabis use and hazardous substance use index scores measured at baseline, and 3, 6 and 12 months post-baseline assessment. FINDINGS: (i) Depression responded better to intensive MI/CBT compared to BI alone, with 'live' treatment demonstrating a strong short-term beneficial effect which was matched by computer-based treatment at 12-month follow-up; (ii) problematic alcohol use responded well to BI alone and even better to the intensive MI/CBT intervention; (iii) intensive MI/CBT was significantly better than BI alone in reducing cannabis use and hazardous substance use, with computer-based therapy showing the largest treatment effect. CONCLUSIONS: Computer-based treatment, targeting both depression and substance use simultaneously, results in at least equivalent 12-month outcomes relative to a 'live' intervention. For clinicians treating people with comorbid depression and alcohol problems, BIs addressing both issues appear to be an appropriate and efficacious treatment option. Primary care of those with comorbid depression and cannabis use problems could involve computer-based integrated interventions for depression and cannabis use, with brief regular contact with the clinician to check on progress.

The 'co-morbidity roundabout': a framework to guide assessment and intervention strategies and engineer change among people with co-morbid problems.

This paper describes the nature and consequences of co-morbidity, as applied to co-occurring mental health and alcohol/other drug (AOD) use problems. The 'co-morbidity roundabout' is introduced as a useful metaphor for conceptualizing the current experiences of people with co-occurring mental health and AOD use problems. In order to successfully negotiate the 'roundabout', the 'drivers' (people with co-morbid mental health and AOD use problems) must consider a range of internal and external conditions (knowledge about services, support from family, friends, health providers, motivation to change, etc.), account for their vehicle's characteristics (other conditions and demands, including social/legal/financial issues), keep their travel itinerary in mind (plans for change including treatment) and navigate through the many detours and dead-ends that they may confront (eligibility for services, accessibility of treatments, etc.). Co-morbidity is a major contributing factor in 'drivers' failing to successfully negotiate, or even becoming 'stuck' on, the 'roundabout'. A summary of relevant treatment research is also presented, including descriptions of brief interventions and more intensive treatment approaches. Finally, the 'co-morbidity roundabout' metaphor is expanded to assist clinicians to translate the findings from this treatment research into clinical practice. Further suggestions are made for improved navigation through and exit from the 'roundabout', including recommendations for the use of a stepped-care approach to the assessment and treatment of clients with co-morbid mental health and AOD use problems.