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.

Psychosocial and Clinical Associations of Fatigue Severity and Fatigue-Related Impairment in Kidney Transplant Recipients.

Debilitating fatigue is common in people living with kidney disease and often persists after a kidney transplant. Current understanding of fatigue is centered around pathophysiological processes. Little is known about the role of cognitive and behavioral factors. The aim of this study was to evaluate the contribution of these factors to fatigue among kidney transplant recipients (KTRs). A cross-sectional study of 174 adult KTRs who completed online measures of fatigue, distress, illness perceptions, and cognitive and behavioral responses to fatigue. Sociodemographic and illness-related information was also collected. 63.2% of KTRs experienced clinically significant fatigue. Sociodemographic and clinical factors explained 16.1% and 31.2% of the variance in the fatigue severity and fatigue impairment, respectively, increasing by 28% and 26.8% after adding distress. In adjusted models, all the cognitive and behavioral factors except for illness perceptions were positively associated with increased fatigue-related impairment, but not severity. Embarrassment avoidance emerged as a key cognition. In conclusion, fatigue is common following kidney transplantation and associated with distress and cognitive and behavioral responses to symptoms, particularly embarrassment avoidance. Given the commonality and impact of fatigue in KTRs, treatment is a clinical need. Psychological interventions targeting distress and specific beliefs and behaviors related to fatigue may be beneficial.

Feasibility and acceptability of a personalised script-elicitation method for improving evening sleep hygiene habits.

Background: Attempts to improve evening sleep hygiene have overlooked that sleep preparation behaviours are often undertaken automatically with little awareness; that is, habitually. This mixed-methods study assessed aspects of the feasibility and acceptability of a novel behavioural intervention procedure ('script elicitation'), which encourages reflection on and reorganisation of the content and sequencing of habitual evening pre-sleep routines. Methods: The study was advertised via social media, and circular lists at a UK university. Twenty-four UK-based adults, reporting <6 h/night sleep, were recruited. At baseline, they completed sleep hygiene and quality measures, then participated in an online, one-to-one script elicitation interview. This involved the interviewer working with the participant to generate a fine-grained description of the content, organisation and variability of their typical pre-sleep routine, and plan a more sleep-conducive alternative routine to follow over the next week. One week later, participants completed sleep quality and hygiene measures, and a semi-structured interview about the intervention. Feasibility was assessed using quantitative data on response rates and attrition, and acceptability via sleep hygiene and quality scores, and qualitative data on intervention experiences. Results: All criteria were met. The target response rate was exceeded, none of the 24 participants dropped out, and sleep hygiene and quality scores either improved or remained stable. In interviews, all participants reported finding script elicitation useful. Script elicitation raised participants' awareness of habitual sleep hygiene routines, which gave many a newfound sense of autonomy over changing their sleep hygiene habits. While the habitual nature of existing routines obstructed change for some participants, most reported successfully changing aspects of their routine, and achieving behaviour, sleep and wellbeing improvements. Discussion: Script elicitation is a promising and acceptable method for tackling poor evening sleep hygiene habits. A more rigorous trial is warranted.

The Cognitive and Behavioural Responses to Symptoms Questionnaire (CBRQ): Development, reliability and validity across several long-term conditions.

OBJECTIVES: Cognitive and behavioural responses to symptoms can worsen or maintain the severity of symptoms across long-term conditions (LTCs). Although the Cognitive and Behavioural Responses Questionnaire (CBRQ) has been used in research, its original development and psychometric properties as a transdiagnostic measure have not been reported. Our aim was to evaluate the psychometric properties of the CBRQ and a recently proposed short version, across different LTCs. DESIGN: Psychometric validation study. METHODS: Confirmatory factor analysis (CFA) tested the factor structure of the CBRQ in two datasets from the CBRQ's original development; (chronic fatigue syndrome, N = 230; and multiple sclerosis, N = 221) and in additional groups: haemodialysis (N = 174), inflammatory bowel disease (N = 182) and chronic dizziness (N = 185). Scale reliability and construct validity were assessed. The factor structure of the shortened CBRQ (CBRQ-SF) was also assessed. RESULTS: CFA revealed that a 7-or 8-factor structure had generally appropriate fit supporting the originally proposed 7 factors (Fear avoidance, Damage beliefs, Catastrophising, Embarrassment avoidance, Symptom focusing, All-or-nothing behaviour and Avoidance/Resting behaviour). Omega coefficients indicated satisfactory internal reliability. Correlations with related constructs suggested construct validity. The scale appeared sensitive to change. The CBRQ-SF also displayed good psychometric quality, with a better model fit than the CBRQ. CONCLUSIONS: The CBRQ and the shortened version were shown to be reliable and valid at assessing a range of cognitive and behavioural responses to symptoms, highlighting the multi-symptom, transdiagnostic properties of this questionnaire. Further research is necessary to determine the test-retest reliability and sensitivity to change of the CBRQ and CBRQ-SF and a thorough evaluation of the content validity of the items.

Experiences of a cognitive behavioural therapy (CBT) intervention for fatigue in patients receiving haemodialysis.

BACKGROUND: A feasibility randomised-controlled trial found that a cognitive-behavioural therapy intervention for renal fatigue has the potential to reduce fatigue in patients receiving haemodialysis, but uptake was low. OBJECTIVES: Nested in the randomised-controlled trial (RC) qualitative interviews were undertaken to understand the acceptability of renal fatigue, the facilitators of, and barriers to, engagement, and the psychosocial processes of change. DESIGN: The trial included 24 participants at baseline. Semi-structured interviews were conducted with nine participants from the intervention arm (n = 12). Approach Interviews were carried out immediately following treatment (3 months post-randomisation). Data were analysed using inductive thematic analysis. FINDINGS: Five main themes were formulated. The overarching theme was a sense of coherence (whether the illness, symptoms and treatment made sense to individuals), which appeared to be central to acceptability and engagement. Two themes captured the key barriers and facilitators to engagement, cognitive and illness/treatment burdens and collaboration with the therapist. Participants described changes related to their activity, thoughts and social identity/interactions, which shaped perceptions of change in fatigue. Lastly, participants discussed the optimal delivery of the intervention. CONCLUSIONS: This study revealed the importance of patients' understanding of fatigue and acceptance of the treatment model for the acceptability of and engagement with a cognitive-behavioural therapy-based intervention for fatigue. Overall, there was an indication that such an intervention is acceptable to patients and the mechanisms of change align with the proposed biopsychosocial model of fatigue. However, it needs to be delivered in a way that is appealing and practical to patients, acknowledging the illness and treatment burdens.

Self-reported symptom burden in postural orthostatic tachycardia syndrome (POTS): A narrative review of observational and interventional studies.

BACKGROUND AND OBJECTIVE: Postural Orthostatic Tachycardia Syndrome (POTS) is a chronic health condition affecting mostly women of childbearing age, and significantly impacting their health and quality of life. It is currently poorly understood with no approved licensed treatments. The aim of this systematic review was to contextualize the symptom burden of POTS, and review factors associated with this burden that may guide future treatments. The specific questions were (1) How does symptom burden in POTS compare to the burden in other long term conditions (LTCs), (2) Which factors are associated with POTS symptom burden, and (3) Which interventions show promise in reducing symptom burden in POTS. DATABASES AND DATA TREATMENT: Electronic databases (CENTRAL, MEDLINE, EMBASE, CINAHL, PsycINFO, Web of Science, APA PsycArticles, OpenGrey) were searched from inception to January 2022 for observational studies reporting on the association between any biological, psychological or social factors and symptom burden, and randomized controlled trials reporting on interventions for symptom burden in adults with POTS. Two reviewers independently conducted eligibility screening, data extraction and quality assessment. A narrative synthesis was undertaken. RESULTS/CONCLUSION: 5159 entries were screened for eligibility. Twenty-nine studies were included (1372 participants with POTS of a total sample size of 2314, 17 High-, 12 Medium-quality), seventeen were observational and twelve were randomized controlled experimental and intervention trials. Overall methodological quality of the evidence was medium-high but heterogeneity was high and sample sizes modest, allowing moderately robust conclusions. Orthostatic symptom burden was higher in POTS than other LTCs. Serum activity against adrenergic α1 receptors, physical functioning, depression, catastrophizing, prolonged cognitive stress testing and anxiety were significantly associated with symptom burden in medium-high quality studies. Preliminary medium-high quality evidence from predominantly proof-of-concept (n = 11) studies and one 3-month 2 × 2 factorial design trial suggest that compression garments, propranolol, pyridostigmine, desmopressin, and bisoprolol may hold promise in reducing symptom burden. Directions for future research include investigating associated factors over time, the development of complex interventions which address both biological and psychosocial factors associated with symptom burden, and effectiveness trials of these interventions. SIGNIFICANCE: POTS symptom burden is high, particularly in relation to orthostatic intolerance when compared to other long-term conditions (LTCs). Despite this burden, there are no effectiveness randomized controlled trials of treatment to reduce symptoms in POTS. This review provides a starting point to understanding researched biological and psychosocial factors associated with this burden. There was however inconsistency in the measurement of symptom burden, lowering the confidence of cross-study inferences. A coherent definition of POTS symptom range, severity and impact along with a validated and reliable POTS-specific instrument is currently lacking. A standardized questionnaire to assess POTS symptom burden as a core outcome measure will help clarify future research and clinical practice.

'I don't know which is the chicken and which is the egg': A qualitative study of weight loss-related beliefs and behaviours among adults with psoriasis and comorbid obesity.

OBJECTIVES: Obesity is a common (30%-40%) comorbidity of psoriasis. Weight loss is shown to improve the severity of psoriasis; however, little is known about the factors that may influence successful weight loss in the context of obesity and psoriasis. The current qualitative study aimed to explore the obesity-associated beliefs, perceptions, and behaviours related to weight loss in psoriasis. Preferences for a weight loss intervention were also explored. DESIGN: Qualitative in-depth semi-structured interviews were conducted with 24 adults (62.5% male) with moderate-to-severe psoriasis and obesity (mean body mass index = 35.2 kg/m2 , SD = 4.1), recruited through a patient organization website in the UK. Data were analysed using inductive thematic analysis. RESULTS: Most participants viewed psoriasis as unrelated to obesity. A well-controlled psoriasis and improvements in psoriasis symptoms were considered as major motivators for engaging in a weight loss program by individuals who viewed psoriasis and obesity as related conditions. Comfort eating was perceived as an escape strategy from the psoriasis-induced negative emotions. Participants shared their dissatisfaction with current weight loss recommendations which were too generic. They suggested that a desirable weight loss program would require both emotional and behavioural support, with an emphasis on psoriasis' burden. CONCLUSION: The findings accentuate the importance of (1) clinicians discussing the link between obesity and psoriasis with patients, (2) weight loss advice to include both behavioural and emotional support, and (3) a weight loss advice to consider the psoriasis burden and the perceived barriers which may potentially lead to improved outcomes to obesity management in psoriasis.

The importance of illness severity and multimorbidity in the association between mental health and body weight in psoriasis: Cross-sectional and longitudinal analysis.

Background: High body weight is common in psoriasis and is associated with depression and anxiety. Past studies are mostly cross-sectional and may underestimate the role of demographic and illness-related factors in the association between mental health and body weight in psoriasis. Objectives: This study explored the association between depression and anxiety with waist circumference and body mass index (BMI) cross-sectionally and at 12 months follow-up, adjusting for demographic and illness-related factors in people with psoriasis. Method: Routine psoriasis care data were combined with data on depression and anxiety from a large specialist psoriasis centre. The analytical samples consisted of patients with complete data on either waist circumference (N = 326 at time 1; N = 191 at follow-up) or BMI (N = 399 at time 1; N = 233 at follow-up) and corresponding mental health, demographic, and illness-related information. Associations between weight-related outcomes and mental health variables were assessed at time one and at 12 months follow-up, after adjusting for demographic and illness-related factors. Results: We found no evidence of associations between mental health and waist circumference or BMI, after adjusting for age, gender and illness-related factors. Higher age, male gender and illness-related factors, specifically multimorbidity and psoriasis severity, were positively associated with waist circumference and BMI at both time points. Conclusion: This study revealed the important role of factors related to illness severity in body weight in psoriasis. The contribution of depression and anxiety to weight was not observed here likely due to the sample and methodology used. Future work should explore other psychosocial factors such as weight-related attitudes and emotional eating in the context of weight in psoriasis, to help inform the development of successful weight-management treatments.

Defining routine fatigue care in Multiple Sclerosis in the United Kingdom: What treatments are offered and who gets them?

BACKGROUND: Fatigue is common and disabling in Multiple Sclerosis (MS). A recent meta-analytic systematic review reported 113 trials of exercise and behavioural interventions for fatigue, yet patients consistently describe fatigue being under-treated. The extent of the research-to-practice gap is yet to be documented. OBJECTIVE: To describe what fatigue treatments people with MS (pwMS) in the United Kingdom (UK) have been offered. METHODS: A cross-sectional survey of pwMS on the UK MS Register (UKMSR). Data on fatigue treatments offered were collected using an online questionnaire developed with patient input and summarised using descriptive statistics. Sociodemographic, MS-related, and psychological factors associated with treatment offered were evaluated using a logistic regression model. RESULTS: 4,367 respondents completed the survey, 90.3% reported experiencing fatigue. Of these, 30.8% reported having been offered at least one type of pharmacological/non-pharmacological treatment for fatigue. Pharmacological treatments were more commonly offered (22.4%) compared to non-pharmacological treatments (12.6%; 2.9% exercise and 5.9% behavioural therapy). In the logistic regression model, older age, working, shorter time since MS diagnosis, and lower fatigue were associated with lower odds of having been offered treatment for fatigue. CONCLUSION: This study accentuates the extent of the unmet need for fatigue treatment in MS in the UK.

Validity of the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) in Patients With Dizziness.

HYPOTHESIS: The Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) will be a valid and reliable combined measure of depression and anxiety in people with vertigo and dizziness. BACKGROUND: Co-occurrence of depressive, anxiety, and somatic symptoms are common. The Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Scale-7 (GAD-7) measure symptoms of depression and anxiety respectively, although measuring them separately may be suboptimal in people who have illness-related distress. There is some evidence that these scales can be combined in long-term conditions resulting in the PHQ-ADS, but validity is yet to be determined in people with vertigo and dizziness. METHODS: Two separate datasets from a tertiary vestibular clinic were analyzed where the PHQ-ADS was completed at initial clinical assessment (n = 624) and while on a waiting list (n = 185). A cross-sectional design was used to examine the factor structure (confirmatory factor analysis), internal consistency (omega index), and construct validity (Pearson correlation coefficient) of the PHQ-ADS. Construct validity was determined against the dizziness handicap inventory (DHI). RESULTS: A bi-factor PHQ-ADS model had good fit to the data (χ2 = 397.163, 249.763; comparative fit index [CFI] = 0.954, 0.919; Tucker-Lewis index [TLI] = 0.938, 0.892; root mean squared error of approximation [RMSEA] = 0.076, 0.098). The general distress factor explained 81 to 85% of the common variance between items. There were moderate to large significant positive correlations between the PHQ-ADS and DHI. CONCLUSION: The PHQ-ADS appears to have good structural validity in patients with vertigo and dizziness. Clinicians and researchers can use this scale where a composite psychological measure is desired.

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.

Which exercise and behavioural interventions show most promise for treating fatigue in multiple sclerosis? A network meta-analysis.

BACKGROUND: Fatigue is a common, debilitating symptom of multiple sclerosis (MS) without a current standardised treatment. OBJECTIVE: The aim of this systematic review with network meta-analyses was to estimate the relative effectiveness of both fatigue-targeted and non-targeted exercise, behavioural and combined (behavioural and exercise) interventions. METHODS: Nine electronic databases up to August 2018 were searched, and 113 trials (n = 6909) were included: 34 were fatigue-targeted and 79 non-fatigue-targeted trials. Intervention characteristics were extracted using the Template for Intervention Description and Replication guidelines. Certainty of evidence was assessed using GRADE. RESULTS: Pairwise meta-analyses showed that exercise interventions demonstrated moderate to large effects across subtypes regardless of treatment target, with the largest effect for balance exercise (SMD = 0.84). Cognitive behavioural therapies (CBTs) showed moderate to large effects (SMD = 0.60), with fatigue-targeted treatments showing larger effects than those targeting distress. Network meta-analysis showed that balance exercise performed significantly better compared to other exercise and behavioural intervention subtypes, except CBT. CBT was estimated to be superior to energy conservation and other behavioural interventions. Combined exercise also had a moderate to large effect. CONCLUSION: Treatment recommendations for balance and combined exercise are tentative as the certainty of the evidence was moderate. The certainty of the evidence for CBT was high.

Which behavioural and exercise interventions targeting fatigue show the most promise in multiple sclerosis? A systematic review with narrative synthesis and meta-analysis.

Fatigue is a common and highly debilitating symptom of multiple sclerosis (MS). This meta-analytic systematic review with detailed narrative synthesis examined randomised-controlled (RCTs) and controlled trials of behavioural and exercise interventions targeting fatigue in adults with MS to assess which treatments offer the most promise in reducing fatigue severity/impact. Medline, EMBASE and PsycInfo electronic databases, amongst others, were searched through to August 2018. Thirty-four trials (12 exercise, 16 behavioural and 6 combined; n = 2,434 participants) met inclusion criteria. Data from 31 studies (n = 1,991 participants) contributed to the meta-analysis. Risk of bias (using the Cochrane tool) and study quality (GRADE) were assessed. The pooled (SMD) end-of-treatment effects on self-reported fatigue were: exercise interventions (n = 13) -.84 (95% CI -1.20 to -.47); behavioural interventions (n = 16) -.37 (95% CI -.53 to -.22); combined interventions (n = 5) -.16 (95% CI: -.36 to .04). Heterogeneity was high overall. Study quality was very low for exercise interventions and moderate for behavioural and combined interventions. Considering health care professional time, subgroup results suggest web-based cognitive behavioural therapy for fatigue, balance and/or multicomponent exercise interventions may be the cost-efficient therapies. These need testing in large RCTs with long-term follow-up to help define an implementable fatigue management pathway in MS.

Feasibility Trial of Cognitive Behavioral Therapy for Fatigue in Hemodialysis (BReF Intervention).

CONTEXT: Fatigue affects at least half of patients who are on hemodialysis (HD) with considerable repercussions on their functioning, quality of life, and clinical outcomes. OBJECTIVES: This study assessed the feasibility, acceptability, and potential benefits of a cognitive behavioral therapy intervention for renal fatigue (BReF intervention). METHODS: This was a feasibility randomized controlled trial of the BReF intervention vs. waiting-list control. Outcomes included recruitment, retention, and adherence rates. Exploratory estimates of treatment effect were computed. The statistician was blinded to allocation. RESULTS: Twenty-four prevalent HD patients experiencing clinical levels of fatigue were individually randomized (1:1) to BReF (N = 12) or waiting-list control arms (N = 12). Fifty-three (16.6%; 95% CI = 12.7-21.1) of 320 patients approached consented and completed the screening questionnaire. It was necessary to approach 13 patients for screening for every one patient randomized. The rate of retention at follow-up was 75% (95% CI = 53.29-90.23). Moderate to large treatment effects were observed in favor of BReF on fatigue severity, fatigue-related functional impairment, depression, and anxiety (standardized mean difference [SMD]g = 0.81; SMDg = 0.93; SMDg = 0.38; SMDg = 0.42, respectively) but not sleep quality (SMDg = -0.31). No trial adverse events occurred. CONCLUSION: There was promising evidence in support of the need and benefits of a cognitive behavioral therapy-based intervention for fatigue in HD. However, uptake was low, possibly as a result of an already high treatment burden in this setting. Considerations on the context of delivery are necessary before pursuing a definitive trial.

A prospective study of fatigue trajectories among in-centre haemodialysis patients.

OBJECTIVES: Fatigue is common and debilitating among dialysis patients. The aim of this study was to understand the longitudinal trajectory of fatigue and consider sociodemographic, clinical, and psychological factors that are related to variation in fatigue levels over time. DESIGN: A prospective study of fatigue with yearly assessments over 3 years among prevalent in-centre haemodialysis (HD) patients. METHODS: Fatigue severity was measured using the Chalder Fatigue Questionnaire and fatigue-related functional impairment using the Work and Social Adjustment Scale. The trajectories of fatigue outcomes were examined using piecewise growth models, using length of time on dialysis as time. Sociodemographic, clinical, and psychological predictors of fatigue were assessed using linear growth models, using follow-up time. RESULTS: One hundred and seventy-four prevalent HD patients completed baseline measures, 118 at 12 months, 84 at 24 months, and 66 at 36 months. Fatigue severity scores decreased by 0.15 each year. Fatigue-related functional impairment increased by 1.17 each year. In adjusted linear growth models, non-white ethnicity was a significant predictor of lower initial fatigue severity (B = -2.95, 95% CI -5.51 to -0.40) and a greater reduction in fatigue severity of 1.60 each year (95% CI 0.35-2.36). A one-point increase in damage beliefs was associated with a 0.36 increase in fatigue-related functional impairment each year (95% CI -0.61 to -0.01). CONCLUSION: Damage beliefs predicted an increase in fatigue-related functional impairment over time. However, the data strongly suggested that fatigue outcomes vary by length of time on dialysis. Statement of contribution What is already known on this subject? At least 1 in 2 haemodialysis (HD) patients are clinically fatigued. Growing evidence is available on the important role of psychological factors in fatigue across chronic conditions. The contribution of psychological factors, beyond distress, to fatigue in HD has not been examined to date. What does this study add? Ethnicity played a role in the initial level of fatigue severity and over time. Damage beliefs predicted an increase in fatigue-related impairment over time. Data strongly suggested that fatigue outcomes vary by length of time on dialysis.

Challenges and solutions for N-of-1 design studies in health psychology.

Theories of behaviour change and health behaviour change interventions are most often evaluated in between-person designs. However, behaviour change theories apply to individuals not groups and behavioural interventions ultimately aim to achieve within-person rather than between-group change. Within-person methodology, such as N-of-1 (also known as single case design), can circumvent this issue, though has multiple design-specific challenges. This paper provides a conceptual review of the challenges and potential solutions for undertaking N-of-1 studies in health psychology. Key challenges identified include participant adherence to within-person protocols, carry-over and slow onset effects, suitability of behaviour change techniques for evaluation in N-of-1 experimental studies, optimal allocation sequencing and blinding, calculating power/sample size, and choosing the most suitable analysis approach. Key solutions include involving users in study design, employing recent technologies for unobtrusive data collection and problem solving by design. Within-person designs share common methodological requirements with conventional between-person designs but require specific methodological considerations. N-of-1 evaluation designs are appropriate for many though not all types of interventions. A greater understanding of patterns of behaviours and factors influencing behaviour change at the within-person level is required to progress health psychology into a precision science. Video abstract: Supplementary Material 1.

Fatigue in Prevalent Haemodialysis Patients Predicts All-cause Mortality and Kidney Transplantation.

BACKGROUND: Fatigue affects between 49% and 92% of dialysis patients with considerable repercussions on their functioning and quality of life. PURPOSE: To evaluate whether fatigue severity and its impact on functioning predict survival (all-cause mortality) and time to transplantation among in-centre haemodialysis patients. METHODS: As part of a prospective study of fatigue among in-centre haemodialysis patients, survival data were collected between April 2014 and August 2017. Fatigue severity was measured using the Chalder Fatigue Questionnaire (CFQ) and fatigue-related functional impairment using the Work and Social Adjustment Scale (WSAS). Sociodemographic, clinical, and psychological data were collected. The association between fatigue and outcomes was assessed using proportional hazard survival models, allowing for competing risks, and discrete-time survival models. All models were adjusted for relevant risk factors. RESULTS: The sample consisted of 174 haemodialysis patients. There were 37 deaths and 31 transplantations over 3 years. At 1,095 days (36 months), cumulative survival was 70.5% and the cumulative transplantation rate was 22.2%. In unadjusted models, fatigue was significantly associated with an increased risk of death (CFQ-continuous SHR = 1.06, 95% CI: 1.02 to 1.11; CFQ-dichotomous SHR = 2.18, 95% CI: 1.11 to 4.31; WSAS SHR = 1.03, 95% CI: 1.01 to 1.05) and decreased likelihood of transplantation (CFQ-continuous SHR = 0.92, 95% CI: 0.87 to 0.98; CFQ-dichotomous SHR = 0.33, 95% CI: 0.15 to 0.75; WSAS SHR = 0.96, 95% CI: 0.93 to 0.99). However, these associations ceased to be significant after controlling for covariates. CONCLUSIONS: Fatigue was predictive of an increased risk of death and decreased likelihood of transplantation among patients, possibly through distress, impaired functioning, and its consequences, rather than clinical and inflammatory markers.