A randomized controlled trial of a digital cognitive-behavioral therapy program (COMPASS) for managing depression and anxiety related to living with a long-term physical health condition.

BACKGROUND: To evaluate the clinical efficacy of COMPASS, a therapist-supported digital therapeutic for reducing psychological distress (anxiety/depression) in people living with long-term physical health conditions (LTCs). METHODS: A two-armed randomized-controlled trial recruiting from LTC charities. Participants with anxiety and/or depression symptoms related to their LTC(s) were randomized (concealed allocation via independent administrator) to COMPASS (access to 11 tailored modules plus five thirty-minute therapist support sessions) or standard charity support (SCS). Assessments were completed online pre-randomization, at 6- and 12-weeks post-randomization. Primary outcome was Patient Health Questionnaire Anxiety and Depression Scale; PHQ-ADS measured at 12-weeks. Analysis used intention-to-treat principles with adjusted mean differences estimated using linear mixed-effects models. Data-analyst was blinded to group allocation. RESULTS: 194 participants were randomized to COMPASS (N = 94) or SCS (N = 100). At 12-weeks, mean level of psychological distress was 6.82 (95% confidence interval; CI 4.55-9.10) points lower (p < 0.001) in the COMPASS arm compared with SCS (standardized mean difference of 0.71 (95% CI 0.48-0.95)). The COMPASS arm also showed moderate significant treatment effects on secondary outcomes including depression, anxiety and illness-related distress and small significant effects on functioning and quality-of-life. Rates of adverse events were comparable across the arms. Deterioration in distress at 12-weeks was observed in 2.2% of the SCS arm, and no participants in the COMPASS arm. CONCLUSION: Compared with SCS, COMPASS digital therapeutic with minimal therapist input reduces psychological distress at post-treatment (12-weeks). COMPASS offers a potentially scalable implementation model for health services but its translation to these contexts needs further evaluating. TRIAL REGISTRATION: NCT04535778.

The effectiveness of cognitive behavioural therapy and third-wave cognitive behavioural interventions on diabetes-related distress: A systematic review and meta-analysis.

AIM: Diabetes-related distress is common in diabetes and has implications for well-being. Cognitive behavioural therapy (CBT) and third-wave CBT hold promise as treatments for diabetes-related distress, although previous findings are inconclusive. We aimed to conduct a systematic review with meta-analysis to understand the efficacy of these interventions in treating diabetes-related distress, while also assessing the associative benefits of these interventions on depression, anxiety and glycaemic control. We also aimed to conduct a narrative synthesis, and subgroup analyses to identify intervention components most useful in treating diabetes-related distress. METHOD: We searched seven electronic databases from inception to April 2021. Data extraction was independently performed by two reviewers. Methodological quality was assessed. The protocol was registered with the Prospective Register Of Systematic Reviews (PROSPERO): CRD42021240628. RESULTS: We included 22 randomised controlled trials investigating the efficacy of CBT and third-wave CBT interventions on diabetes-related distress. CBT for diabetes-related distress significantly reduced distress (SMD = -0.278, p = 0.010) and depression (SMD = -0.604, p = 0.016). Third-wave CBT for diabetes-related distress significantly reduced anxiety (SMD = -0.451, p = 0.034). No significant effect of either intervention on glycated haemoglobin was observed. CBT interventions that included a digital component, were delivered by a psychological practitioner, and included behavioural activation bolstered the effects on diabetes-related distress. CONCLUSIONS: CBT aiming to target diabetes-related distress is beneficial for distress and depression. Third-wave CBT for diabetes-related distress is beneficial for anxiety. More work is needed to optimise interventions to improve both mental and physical health outcomes in people with diabetes.

Loneliness and type 2 diabetes incidence: findings from the English Longitudinal Study of Ageing.

AIMS/HYPOTHESIS: Loneliness is associated with all-cause mortality and coronary heart disease. However, the prospective relationship between loneliness and type 2 diabetes onset is unclear. METHODS: We conducted a longitudinal observational population study with data on 4112 diabetes-free participants (mean age 65.02 ± 9.05) from the English Longitudinal Study of Ageing. Loneliness was assessed in 2004-2005 using the revised University of California, Los Angeles (UCLA) Loneliness Scale. Incident type 2 diabetes cases were assessed from 2006 to 2017. Associations were modelled using Cox proportional hazards regression, adjusting for potential confounders, which included cardiometabolic comorbidities. RESULTS: A total of 264 (6.42%) participants developed type 2 diabetes over the follow-up period. Loneliness was a significant predictor of incident type 2 diabetes (HR 1.46; 95% CI 1.15, 1.84; p = 0.002) independent of age, sex, ethnicity, wealth, smoking status, physical activity, alcohol consumption, BMI, HbA1c, hypertension and cardiovascular disease. Further analyses detected an association between loneliness and type 2 diabetes onset (HR 1.41; 95% CI 1.04, 1.90; p = 0.027), independent of depressive symptoms, living alone and social isolation. Living alone and social isolation were not significantly associated with type 2 diabetes onset. CONCLUSIONS/INTERPRETATION: Loneliness is a risk factor for type 2 diabetes. The mechanisms underlying this relationship remain to be elucidated. Graphical abstract.

Is successful treatment of depression in dialysis patients an achievable goal?

Depression is undisputedly common among individuals with End-Stage Kidney Failure and associated with adverse outcomes. It is well recognized that effective treatments for depression are needed within routine dialysis care. But, are we any closer to successfully treating depression in dialysis patients? We consider this question here with respect to two common treatments, antidepressant medication and cognitive behavioural therapy (CBT). Currently, there are limited data from randomized placebo-controlled trials regarding the acceptability and efficacy of antidepressants. CBT trials appear to show more consistent treatment effects, albeit the feasibility of routine delivery remains unknown. No studies in dialysis patients has evaluated the combined effects of CBT with antidepressants. There is a need to consider pragmatic depression treatment trials in dialysis patients in order to increase study recruitment in order to have more reliable data from which to evaluate the evidence base. Furthermore, we need to understand why treatments work, and for whom do they work? Lastly, addressing issues surrounding treatment acceptability and implementation as part of regular care remain as key challenges that require attention if we are to improve the mental health of individuals on dialysis.

Approaches to the identification and management of depression in people living with chronic kidney disease: A scoping review of 860 papers.

BACKGROUND: Depression is prevalent across the spectrum of Chronic Kidney Disease and associated with poorer outcomes. There is limited evidence regarding the most effective interventions and care pathways for depression in Chronic Kidney Disease. OBJECTIVES: To investigate how depression is identified and managed in adults with Chronic Kidney Disease. DESIGN: Scoping review. METHODS: Systematic search of eight databases with pre-defined inclusion criteria. Data relevant to the identification and/or management of depression in adults with Chronic Kidney Disease were extracted. RESULTS: Of 2147 articles identified, 860 were included. Depression was most identified using self-report screening tools (n = 716 studies, 85.3%), with versions of the Beck Depression Inventory (n = 283, 33.7%) being the most common. A total of 123 studies included data on the management of depression, with nonpharmacological interventions being more frequently studied (n = 55, 45%). Cognitive Behavioural Therapy (n = 15) was the most common nonpharmacological intervention, which was found to have a significant effect on depressive symptoms compared to controls (n = 10). However, how such approaches could be implemented as part of routine care was not clear. There was limited evidence for antidepressants use in people with Chronic Kidney Disease albeit in a limited number of studies. CONCLUSIONS: Depression is commonly identified using validated screening tools albeit differences exist in reporting practices. Evidence regarding the management of depression is mixed and requires better-quality trials of both pharmacological and nonpharmacological approaches. Understanding which clinical care pathways are used and their evidence, may help facilitate the development of kidney care specific guidelines for the identification and management of depression.

The identification and management of depression in UK Kidney Care: Results from the Mood Maps Study.

BACKGROUND: Depression is common in people with chronic kidney disease, yet little is known about how depression is identified and managed as part of routine kidney care. OBJECTIVES: The primary objective was to survey all UK adult kidney centres to understand how depression is identified and managed. A secondary objective was to broadly describe the variability in psychosocial care. DESIGN: Online survey. METHODS: The survey comprised of three sections: (1) general kidney care, (2) psychological provision and (3) social work provision. RESULTS: 48/68 (71%) of centres responded to the general survey with 20 and 13 responses from psychological and social work module respectively. Only 31.4% reported having both in centre psychological and social work practitioners. Three centres reported no access to psychosocial provision. Of the 25 centres who reported on pathways, 36.0% reported having internal pathways for the identification and management of depression. Within services with psychological provision, screening for depression varied across modality/group (e.g., 7.1% in mild/moderate chronic kidney disease vs. 62.5% in kidney donors). Cognitive Behavioural Therapy and Acceptance and Commitment Therapy were the most common interventions offered. Most psychosocial services were aware of the National Institute for Health and Care Excellence guidelines for managing depression in long-term conditions (n = 18, 94.7%) yet few fully utilised (n = 6, 33.3%). Limited workforce capacity was evident. CONCLUSIONS: There is considerable variability in approaches taken to identify and treat depression across UK kidney services, with few services having specific pathways designed to detect and manage depression. Workforce capacity remains a significant issue.

Clinical efficacy of COMPASS, a digital cognitive-behavioural therapy programme for treating anxiety and depression in patients with long-term physical health conditions: a protocol for randomised controlled trial.

INTRODUCTION: Approximately 30% of people with long-term physical health conditions (LTCs) experience mental health problems, with negative consequences and costs for individuals and healthcare services. Access to psychological treatment is scarce and, when available, often focuses on treating primary mental health problems rather than illness-related anxiety/depression. The aim of this study is to evaluate the clinical efficacy of a newly developed, therapist-supported, digital cognitive-behavioural treatment (COMPASS) for reducing LTC-related psychological distress (anxiety/depression), compared with standard charity support (SCS). METHODS AND ANALYSIS: A two-arm, parallel-group randomised controlled trial (1:1 ratio) with nested qualitative study will be conducted. Two-hundred adults with LTC-related anxiety and depression will be recruited through national LTC charities. They will be randomly allocated to receive COMPASS or SCS only. An independent administrator will use Qualtrics randomiser for treatment allocation, to ensure allocation concealment. Participants will access treatment from home over 10 weeks. The COMPASS group will have access to the digital programme and six therapist contacts: one welcome message and five fortnightly phone calls. Data will be collected online at baseline, 6 weeks and 12 weeks post-randomisation for primary outcome (Patient Health Questionnaire Anxiety and Depression Scale) and secondary outcomes (anxiety, depression, daily functioning, COVID-19-related distress, illness-related distress, quality of life, knowledge and confidence for illness self-management, symptom severity and improvement). Analyses will be conducted following the intention-to-treat principle by a data analyst blinded to treatment allocation. A purposively sampled group of COMPASS participants and therapists will be interviewed. Interviews will be thematically analysed. ETHICS AND DISSEMINATION: The study is approved by King's College London's Psychiatry, Nursing and Midwifery Research Ethics Subcommittee (reference: LRS-19/20-20347). All participants will provide informed consent to take part if eligible. Findings will be published in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER: NCT04535778.

How and for whom does supportive adjustment to multiple sclerosis cognitive-behavioural therapy work? A mediated moderation analysis.

The supportive adjustment for multiple sclerosis (saMS) randomised controlled trial showed cognitive behavioural therapy (CBT) reduced distress at 12-months compared to supportive listening (SL). Larger changes in distress and functional impairment following CBT occurred in participants with clinical distress at baseline. This secondary analysis investigates whether CBT treatment effects occur through pre-defined CBT mechanisms of change in the total cohort and clinically distressed subgroup. 94 participants were randomised to saMS CBT or SL. Primary outcomes were distress and functional impairment (12 months). Mediators included cognitive-behavioural variables at post-treatment (15 weeks). Structural equation mediation and mediated-moderation models adjusting for baseline confounders assessed mediation overall and by distress level. Significant mediation was found but only for those with clinical distress at baseline. Illness acceptance (-0.20, 95% confidence interval -0.01 to -0.46) and reduced embarrassment avoidance behaviours (-0.22, -0.02 to -0.58) mediated CBT's effect on distress. Changes in beliefs about processing emotions (-0.19, -0.001 to -0.46) mediated CBT's effect on functional impairment. saMS CBT had effects on distress and functional impairment via some of the hypothesised mechanisms drawn from a theoretical model of adjustment for MS but only among participants with clinical distress at baseline. Increasing acceptance and emotional expression and decreasing embarrassment avoidance improves MS adjustment.

The role of relapse prevention for depression in collaborative care: A systematic review.

BACKGROUND: Relapse (the re-emergence of depression symptoms before full recovery) is common in depression and relapse prevention strategies are not well researched in primary care settings. Collaborative care is effective for treating acute phase depression but little is known about the use of relapse prevention strategies in collaborative care. We undertook a systematic review to identify and characterise relapse prevention strategies in the context of collaborative care. METHODS: We searched for Randomised Controlled Trials (RCTs) of collaborative care for depression. In addition to published material, we obtained provider and patient manuals from authors to provide more detail on intervention content. We reported the extent to which collaborative care interventions addressed four relapse prevention components. RESULTS: 93 RCTs were identified. 31 included a formal relapse prevention plan; 42 had proactive monitoring and follow-up after the acute phase; 39 reported strategies for optimising sustained medication adherence; and 20 of the trials reported psychological or psycho-educational treatments persisting beyond the acute phase or focussing on long-term health/relapse prevention. 30 (32.3%) did not report relapse prevention approaches. LIMITATIONS: We did not receive trial materials for approximately half of the trials, which limited our ability to identify relevant features of intervention content. CONCLUSION: Relapse is a significant risk amongst people treated for depression and interventions are needed that specifically address and minimise this risk. Given the advantages of collaborative care as a delivery system for depression care, there is scope for more consistency and increased effort to implement and evaluate relapse prevention strategies.

Impact of telephone delivered case-management on the effectiveness of collaborative care for depression and anti-depressant use: A systematic review and meta-regression.

BACKGROUND: The health service delivery framework collaborative care is an effective intervention for depression. However, uncertainties remain about how to optimise its delivery at scale. Structured case management is a core component of collaborative care; its delivery via the telephone may improve access. AIMS: To examine using meta-regression if telephone delivered case management diminishes the clinical effectiveness of collaborative care on depressive symptoms and anti-depressant use relative to face-to-face delivery methods. METHODS: Randomised controlled trials were eligible if they included collaborative care interventions for adults with depression identified using self-report measures or diagnostic interviews and reported depression outcomes. Sociodemographics, intervention characteristics, depressive symptoms, and anti-depressant use were extracted. Random effects univariable and multivariable meta-regression analyses were used to examine the moderating effect of telephone delivered case-management on outcomes. RESULTS: Ninety-four trials were identified comprising of 103 comparisons across 24, 132 participants with depression outcomes and 67 comparisons from 15,367 participants with anti-depressant use outcomes. Telephone delivered case management did not diminish the effects of collaborative care on depressive symptoms (ß = -0.01, 95% CI -0.12 to 0.10; p = 0.86). Telephone delivered case management decreased anti-depressant medication use (relative risk 0.76, 95% CI 0.63 to 0.92; p = 0.005); this effect remained when assessed simultaneously alongside other study-level moderators of collaborative care. CONCLUSION: Using remote platforms such as the telephone to deliver case management may be a feasible way to implement collaborative care with no loss of effectiveness on depressive symptoms. However, adherence to anti-depressant medication may decrease when telephone case management is used.

Screening for psychological distress using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS): Initial validation of structural validity in dialysis patients.

OBJECTIVE: To validate the factor structure of the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)- which is a composite measure of depression and anxiety using the Patient Health Questionnaire-9 and Generalised Anxiety Disorder Scale (GAD-7), in a sample of haemodialysis patients. METHOD: Screening data (n=182) used to select entry into a feasibility study of an online cognitive-behavioural therapy intervention for distress in dialysis patients were analysed here. Structural validity of the PHQ-ADS was evaluated using confirmatory factor analysis (CFA), assessing alternative models including a bi-factor model. In the bi-factor model all items from the PHQ-9 and GAD-7 (16-items in total) were loaded onto a general distress factor. Respective items of the PHQ-9 and GAD-7 were specified as subgroup factors. Omega-hierarchical was calculated to indicate the level of saturation of a multidimensional scale by a general factor. Construct validity was determined against the Brief Illness Perception Questionnaire. RESULTS: A bi-factor PHQ-ADS model had good fit to the data (chi-square=96.1, p=0.26, CFI=0.99; TLI=0.99; RMSEA=0.02). The general distress factor accounted for approximately 84% of the explained variance (omega-h=0.90). Distress scores were significantly higher in females compare with males. There was a significant association between distress and negative illness perceptions (r=0.58, p<0.01). CONCLUSIONS: The PHQ-ADS appears to have good structural validity in haemodialysis patients and is sufficiently unidimensional to warrant the use of a total distress score. A full psychometric analysis of the PHQ-ADS in a larger sample of dialysis patients is warranted.

Biopsychosocial risk factors of persistent fatigue after acute infection: A systematic review to inform interventions.

OBJECTIVES: Fatigue is a prevalent and debilitating symptom, preceded by an acute infectious episode in some patients. This systematic review aimed to identify risk factors for the development of persistent fatigue after an acute infection, to develop an evidence-based working model of post-infectious fatigue. METHODS: Electronic databases (Medline, PsycINFO and EMBASE) were searched, from inception to March 2016, for studies which investigated biopsychosocial risk factors of on-going fatigue after an acute infection. Inclusion criteria were: prospective design; biological, psychological or social risk factors; standardised measure of post-infectious fatigue (self-report scales or clinical diagnosis). Studies were excluded if the sample had a pre-existing medical condition, infection was conceptualised as 'vaccination' or they were intervention trials. A narrative synthesis was performed. RESULTS: Eighty-one full texts were screened, of which seventeen were included in the review. Over half included glandular fever populations. Other infections included dengue fever, 'general'/'viral' and Q-fever. Risk factors were summarised under biological, social, behavioural, cognitive and emotional subthemes. Patients' cognitive and behavioural responses to the acute illness, and pre-infection or baseline distress and fatigue were the most consistent risk factors for post-infectious fatigue. CONCLUSION: An empirical summary model is provided, highlighting the risk factors most consistently associated with persistent fatigue. The components of the model, the possible interaction of risk factors and implications for understanding the fatigue trajectory and informing preventative treatments are discussed.

Examining the efficacy of social-psychological interventions for the management of fatigue in end-stage kidney disease (ESKD): a systematic review with meta-analysis.

Fatigue affects between 42% and 89% of end-stage kidney disease (ESKD) patients, with significant repercussions on quality of life and clinical outcomes. Fatigue management revolves around pharmacotherapy or exercise, which have only modest and short-term improvements. The aim of this systematic review was to investigate whether social-psychological interventions are effective at reducing fatigue in ESKD. Databases were searched to identify randomized controlled trials (RCTs) and quasi-RCTs that determined the effect of social-psychological interventions on fatigue (primary or secondary outcome), in the renal patient population. A meta-analysis was conducted. Sixteen RCTs (N = 1536) were included, predominantly among dialysis patients. Fatigue was a primary outcome in only two studies. The meta-analytic findings showed a significant improvement in fatigue following social-psychological interventions (standardised mean difference, SMD = 0.37, p = .001; 95% CI 0.15 to 0.59, I² = 69.1%, p < .001). There was evidence for greater effectiveness of interventions including stress-management/relaxation techniques, evaluated among fatigued samples meeting diagnostic thresholds, against passive/non-active comparison groups. The studies were generally of poor quality, with high heterogeneity, particularly with the number of sessions ranging from 2 to 96. Development and evaluation of a fatigue-specific social-psychological intervention is warranted in this setting.

Tailored online cognitive behavioural therapy with or without therapist support calls to target psychological distress in adults receiving haemodialysis: A feasibility randomised controlled trial.

BACKGROUND: Psychological distress is prevalent in haemodialysis (HD) patients yet access to psychotherapy remains limited. This study assessed the feasibility and acceptability of online cognitive-behavioural therapy (CBT) tailored for HD patients, with or without therapist support, for managing psychological distress. METHODS: This feasibility randomised controlled trial recruited patients from a UK HD centre. Following psychological distress screens, patients with mild-moderate psychological distress (Patient Health Questionnaire PHQ-9; score: 5-19 and/or Generalised Anxiety Disorder; GAD-7 score: 5-14) who met remaining inclusion criteria were approached for consent. Consenters were individually randomised (1:1) to online-CBT or online-CBT plus three therapist support calls. Outcomes included recruitment, retention, and adherence rates. Exploratory change analyses were performed for: psychological distress, quality of life (QoL), illness perceptions, and costs. The statistician was blinded to allocation. RESULTS: 182 (44%) out of 410 patients approached completed psychological distress screens. 26% found screening unacceptable; a further 30% found it unfeasible. Psychological distress was detected in 101 (55%) patients, 60 of these met remaining inclusion criteria. The primary reason for ineligibility was poor computer literacy (N=17, 53%). Twenty-five patients were randomised to the supported (N=18) or unsupported arm (N=7); 92% were retained at follow-up. No differences in psychological distress or cost-effectiveness were observed. No trial adverse events occurred. CONCLUSION: Online CBT appears feasible but only for computer literate patients who identify with the label psychological distress. A definitive trial using the current methods for psychological distress screening and online care delivery is unfeasible. ClinicalTrials.gov Identifier: NCT02352870.

Improving Distress in Dialysis (iDiD): A tailored CBT self-management treatment for patients undergoing dialysis.

BACKGROUND: There is significant psychological distress in adults with end-stage kidney disease (ESKD). However, psychological treatments tailored to address the unique challenges of kidney failure are absent. We identified psychological correlates of distress in ESKD to develop a cognitive-behavioural therapy (CBT) treatment protocol that integrates the mental health needs of patients alongside their illness self-management demands. METHODS: Studies which examined relationships between distress and psychological factors that apply in the context of ESKD including: health threats, cognitive illness representations and illness management behaviours were narratively reviewed. Review findings were translated into a CBT formulation model to inform the content of a renal-specific seven session CBT treatment protocol, which was commented on and refined by patient representatives. RESULTS: Health threats related to distress were grouped into four themes including: acute ESKD events, loss of role, uncertainty and illness self-management. Having pessimistic illness and treatment perceptions were associated with elevated distress. Non-adherence and avoidance behaviours were related to feelings of distress, whereas cognitive reappraisal, acceptance, social support and assertiveness were associated with less distress. CONCLUSIONS: The dialysis-specific CBT formulation identifies the importance of targeting ESKD-specific correlates of distress to allow the delivery of integrated mental and physical health care. The 'Improving Distress in Dialysis (iDiD)' treatment protocol now requires further evaluation in terms of content, feasibility and potential efficacy.

Does collaborative care improve social functioning in adults with depression? The application of the WHO ICF framework and meta-analysis of outcomes.

BACKGROUND: Collaborative care has proven efficacy in improving symptoms of depression, yet patients value improvements in their social function also. We used the World Health Organisation's International classification of functioning, disability, and health (WHO ICF) to robustly identify measures of social function and explored whether collaborative care interventions improve social functioning using meta-analysis. METHODS: We performed a secondary data analysis on studies identified from our previous Cochrane review of collaborative care interventions for depression and search update (December 2013). The WHO ICF framework was applied to identify studies that included self-report measures of social functioning. Outcomes were extracted at short-term (6 months) and medium-term (≥7 months) and analysed using random-effects meta-analysis. The relationship between improvements in depression outcomes and improvements in social functioning was also explored using bivarable meta-regression. RESULTS: Eighteen trials were identified that measured social functioning and met our remaining inclusion criteria. Collaborative care was associated with small improvements in social functioning in the short (Standardised Mean Difference, SMD=0.23, 95% confidence interval 0.12 to 0.34) and medium term (SMD=0.19, 95% confidence interval 0.09 to 0.29). Improvements in depressive symptoms were associated with moderate improvements in social function (ß=-0.55, 95% confidence interval -0.82 to -0.28) but cross-sectionally only. LIMITATIONS: The small number of studies (N=18) prevented more complex analyses to explore moderators of social functioning outcomes. CONCLUSIONS: Collaborative care improves social functioning but the mechanisms through which this occurs are unknown. Future depression interventions need to consider a person's degree of social function equally alongside their depressive symptoms.

What are the combined effects of negative emotions and illness cognitions on self-care in people with type 2 diabetes? A longitudinal structural equation model.

OBJECTIVE: To explore whether negative emotions mediate the effect of diabetes cognitions on diabetes self-care and conversely whether diabetes cognitions mediate the effect of negative emotions on diabetes self-care. DESIGN: Longitudinal observational study in adults with type 2 diabetes. MAIN OUTCOME MEASURES: Self-reported depression and anxiety (Diabetes Wellbeing Questionnaire), cognitions (Illness Perceptions Questionnaire-Revised; Beliefs about Medicines Questionnaire), and diabetes self-care (Summary of Diabetes Self-Care Activities Scale) were completed at baseline and six months. Analyses used structural equation modelling. RESULTS: Baseline medication concerns were associated with elevated symptoms of depression and anxiety at follow-up, but emotions did not mediate medication concern's effect on diabetes self-care. Baseline depression and anxiety symptoms were associated with specific diabetes cognitions over time, but these cognition domains did not mediate emotion's effect on diabetes self-care. Personal control remained independent of emotions and was associated with diabetes self-care over time. CONCLUSIONS: Negative emotions did not act directly or alongside cognitions to influence diabetes self-care. The reciprocal relationship between diabetes cognitions and emotions suggests cognitive restructuring, in addition to other mood management intervention techniques would likely improve the emotional wellbeing of adults with type 2 diabetes. Likewise, personal control beliefs are likely important intervention targets for improving self-care.

Improving distress in dialysis (iDiD): a feasibility two-arm parallel randomised controlled trial of an online cognitive behavioural therapy intervention with and without therapist-led telephone support for psychological distress in patients undergoing haemodialysis.

INTRODUCTION: Psychological distress is common in end-stage kidney disease (ESKD) and is associated with poorer health outcomes. Cognitive behavioural therapy (CBT) is recommended in UK clinical guidelines for the management of depression in people with long-term conditions. Access to skilled therapists competent in managing the competing mental and physical health demands of ESKD is limited. Online CBT treatments tailored to the needs of the ESKD population offers a pragmatic solution for under-resourced services. This study examines the feasibility and acceptability of implementing a two-arm parallel randomised controlled trial of online CBT with (intervention arm) and without (control arm) therapist support to improve psychological distress in patients undergoing haemodialysis. METHODS: Patients will be screened for depression and anxiety while attending for their haemodialysis treatments. We aim to recruit 60 adult patients undergoing haemodialysis who meet criteria for mild to moderately severe symptoms of depression and/or anxiety. Patients will be randomised individually (using a 1:1 computerised sequence ratio) to either online CBT with therapist telephone support (intervention arm), or online CBT with no therapist (control arm). Outcomes include feasibility and acceptability descriptive data on rates of recruitment, randomisation, retention and treatment adherence. Self-report outcomes include measures of depression (Patient Health Questionnaire-9), anxiety (Generalised Anxiety Disorder-7), quality of life (Euro-QoL), service use (client service receipt inventory) and illness cognitions (brief illness perception questionnaire). A qualitative process evaluation will also be conducted. The statistician will be blinded to treatment allocation. ETHICS AND DISSEMINATION: A National Health Service (NHS) research ethics committee approved the study. Data from this study will provide essential information for the design and testing of further interventions to ameliorate distress in patients undergoing dialysis. Any amendments to the protocol will be submitted to the NHS committee and study sponsor. TRIAL REGISTRATION NUMBER: NCT023528702; Pre-results.

Exploring the relationship between cognitive illness representations and poor emotional health and their combined association with diabetes self-care. A systematic review with meta-analysis.

OBJECTIVE: Depression and anxiety are common in diabetes and are associated with lower diabetes self-care adherence. How this occurs is unclear. Our systematic review explored the relationship between cognitive illness representations and poor emotional health and their combined association with diabetes self-care. METHODS: Medline, Psycinfo, EMBASE, and CINAHL were searched from inception to June 2013. Data on associations between cognitive illness representations, poor emotional health, and diabetes self-care were extracted. Random effects meta-analysis was used to test the relationship between cognitive illness representations and poor emotional health. Their combined effect on diabetes self-care was narratively evaluated. RESULTS: Nine cross-sectional studies were included. Increased timeline cyclical, consequences, and seriousness beliefs were associated with poorer emotional health symptoms. Lower perceived personal control was associated with increased depression and anxiety, but not mixed anxiety and depressive symptoms. Remaining cognitive illness representation domains had mixed statistically significant and non-significant relationships across emotional states or were measured only once. Effect sizes ranged from small to large (r=±0.20 to 0.51). Two studies explored the combined effects of cognitions and emotions on diabetes self-care. Both showed that cognitive illness representations have an independent effect on diabetes self-care, but only one study found that depression has an independent effect also. CONCLUSIONS: Associations between cognitive illness representations and poor emotional health were in the expected direction - negative diabetes perceptions were associated with poorer emotional health. Few studies examined the relative effects of cognitions and emotions on diabetes self-care. Longitudinal studies are needed to clarify directional pathways.