Self-reported depression symptoms in haemodialysis patients: Bi-factor structures of two common measures and their association with clinical factors

Copyright © 2018 Elsevier Inc. All rights reserved.Objective: To validate the factor structure of two common self-report depression tools in a large sample of haemodialysis (HD) patients and to examine their demographic and clinical correlates, including urine output, history of depression and transplantation. Methods: Factor structures of the Beck Depression Inventory (BDI-II) and Patient Health Questionnaire (PHQ-9) were evaluated using confirmatory factor analysis (CFA). Data was utilised from the screening phase (n = 709) of a placebo-controlled feasibility randomised control trial (RCT) of sertraline in HD patients with mild to moderate Major Depressive Disorder. Alternative factor models including bi-factor models for the BDI-II and PHQ-9 were evaluated. Coefficient omega and omega-hierarchical were calculated. Results: For both measures, bi-factor measurement models had the overall best fit to the data, with dominant general depression factors. Omega-hierarchical for the general BDI-II and PHQ-9 factors was 0.94 and 0.88 respectively. Both general factors had high reliability (coefficient omega = 0.97 and 0.94 respectively) and explained over 85% of the explained common variance within their respective models. BDI-II and PHQ-9 general depression factors were negatively associated with age and urine output and positively with a history of depression, antidepressant use within the last 3 months and a history of failed transplantation. In adjusted regression models, age, urine output and a history of depression remained significant. Conclusions: These data suggest that both the BDI-II and PHQ-9 are sufficiently unidimensional to warrant the use of a total score. Younger age, lower urine output and a history of depression appear consistent correlates of depression severity among HD patients.Peer reviewedFinal Accepted Versio

Attentional bias towards positive and negative images amongst offenders and non-offenders with intellectual disabilities

Aims: The aim of the study was to examine attentional bias towards positive and negative images amongst men with intellectual disabilities, some of whom had a history of criminal offending. A secondary aim was to explore the relationship between attentional bias, empathy and distorted cognitions. Method: Forty-six men with intellectual disabilities with a history of criminal offending and 51 men with intellectual disabilities without any known history of criminal offending were recruited and invited to complete a dot-probe paradigm using images, as well as measures of distorted cognitions and empathy. Comparisons were made between the two groups. Results: Non-offenders had a significant attentional bias away from negative images, while offenders had a small attentional bias towards negative images. There was a significant positive relationship between distorted cognitions and an attentional bias towards negative images. There was a significant negative relationship between empathy and an attentional bias towards negative images

Sertraline Versus Placebo in Patients with Major Depressive Disorder Undergoing Hemodialysis : A Randomized, Controlled Feasibility Trial

This document is the Accepted Manuscript version of the following article: Karin Friedli, et al, ‘Sertraline Versus Placebo in Patients with Major Depressive Disorder Undergoing Hemodialysis: A Randomized, Controlled Feasibility Trial’, Clinical Journal of the American Society of Nephrology, Vol. 12 (2): 280-286, February 2017. The final, published version is available online at DOI: https://doi.org/10.2215/​CJN.02120216.BACKGROUND AND OBJECTIVES: Depression is common in patients on hemodialysis, but data on the benefits and risks of antidepressants in this setting are limited. We conducted a multicenter, randomized, double-blind, placebo-controlled trial of sertraline over 6 months in patients on hemodialysis with depression to determine study feasibility, safety, and effectiveness. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Patients on hemodialysis at five United Kingdom renal centers completed the Beck Depression Inventory II. Those scoring ≥16 and not already on treatment for depression were invited to undergo diagnostic interview to confirm major depressive disorder. Eligible patients with major depressive disorder were randomized to receive the study medication-either sertraline or placebo. Outcomes included recruitment and dropout rates, change in the Montgomery-Asberg Depression Rating Scale and Beck Depression Inventory II, and qualitative information to guide design of a large-scale trial. RESULTS: In total, 709 patients were screened and enrolled between April of 2013 and October of 2014; 231 (32.6%) had Beck Depression Inventory II scores ≥16, and 68 (29%) of these were already receiving treatment for depression. Sixty-three underwent diagnostic interview, 37 were diagnosed with major depressive disorder, and 30 were randomized; 21 completed the trial: eight of 15 on sertraline and 13 of 15 on placebo (P=0.05). Dropouts due to adverse and serious adverse events were greater in the sertraline group. All occurred in the first 3 months. Over 6 months, depression scores improved in both groups. Beck Depression Inventory II score fell from 29.1±8.4 to 17.3±12.4 (P<0.001), and Montgomery-Asberg Depression Rating Scale score fell from 24.5±4.1 to 10.3±5.8 (P<0.001). There were no differences between sertraline and placebo groups. CONCLUSIONS: Although small, this is the largest randomized trial to date of antidepressant medication in patients on hemodialysis. Our results highlight recruitment issues. No benefit was observed, but trial size and the substantial dropout render consideration of benefit inconclusive. A definitive trial could use shorter follow-up and include depressed patients already taking antidepressants.Peer reviewedFinal Accepted Versio

Depression Symptoms in Haemodialysis Patients Predict All-Cause Mortality but Not Kidney Transplantation: A Cause-Specific Outcome Analysis

Background:Depression is common in haemodialysis (HD) patients and associated with poor outcomes. Purpose:To evaluate whether depression symptoms predict survival and transplantation in a large sample of haemodialysis patients using cause-specific survival models. Methods:Survival data was collected between April 2013 and November 2015, as part of the screening phase of a multicentre randomised placebo-controlled trial of sertraline in HD patients. Depression was measured using the Beck Depression Inventory-II (BDI-II) and the Patient Health Questionnaire-9 (PHQ-9). Demographic and clinical data were collected via a self-report questionnaire and medical records. Competing risk survival analysis involved cause-specific and subdistribution hazard survival models. All models were adjusted for appropriate covariates including co-morbidity and C-reactive protein (CRP) in a subanalysis. Results:Of 707 cases available for analysis, there were 148 deaths. The mean survival time was 787.5 days. Cumulative survival at 12 months was 88.5%. During the study follow-up period, there were 92 transplants. The cumulative transplant event rate at 12 months was 7.8%. In separate adjusted models, depression symptoms predicted mortality (BDI-II HR = 1.03 95% CI 1.01, 1.04; PHQ-9 HR = 1.04 95% CI 1.01, 1.06). With respect to screening cut-off scores, a PHQ-9 ≥ 10 was associated with mortality (HR = 1.51 95% CI 1.01, 2.19) but not a BDI-II ≥ 16. Depression symptoms were not associated with time to transplantation in either cause-specific or subdistribution model. Conclusions:Consistent with past findings in HD patients, depression symptoms predicted survival but were not associated with kidney transplantation. Suitable treatments for depression need further evaluation, and their impact upon quality of life and clinical outcomes determined. Trial Registration Number:(ISRCTN06146268)

Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial.

OBJECTIVE: To investigate the feasibility of a full-scale randomised controlled trial of a picture booklet to improve quality of life for people with epilepsy and learning disabilities. TRIAL DESIGN: A randomised controlled feasibility trial. Randomisation was not blinded and was conducted using a centralised secure database and a blocked 1:1 allocation ratio. SETTING: Epilepsy clinics in 1 English National Health Service (NHS) Trust. PARTICIPANTS: Patients with learning disabilities and epilepsy who had: a seizure within the past 12 months, meaningful communication and a carer with sufficient proficiency in English. INTERVENTION: Participants in the intervention group used a picture booklet with a trained researcher, and a carer present. These participants kept the booklet, and were asked to use it at least twice more over 20 weeks. The control group received treatment as usual, and were provided with a booklet at the end of the study. OUTCOME MEASURES: 7 feasibility criteria were used relating to recruitment, data collection, attrition, potential effect on epilepsy-related quality of life (Epilepsy and Learning Disabilities Quality of Life Scale, ELDQOL) at 4-week, 12-week and 20-week follow-ups, feasibility of methodology, acceptability of the intervention and potential to calculate cost-effectiveness. OUTCOME: The recruitment rate of eligible patients was 34% and the target of 40 participants was reached. There was minimal missing data and attrition. An intention-to-treat analysis was performed; data from the outcome measures suggest a benefit from the intervention on the ELDQOL behaviour and mood subscales at 4 and 20 weeks follow-up. The booklet and study methods were positively received, and no adverse events were reported. There was a positive indication of the potential for a cost-effectiveness analysis. CONCLUSIONS: All feasibility criteria were fully or partially met, therefore confirming feasibility of a definitive trial. TRIAL REGISTRATION NUMBER: ISRCTN80067039.NIHR Research for Patient Benefit Programme (PB-PG-0213-30042).This is the final version of the article. It first appeared from BMJ Publishing Group via https://doi.org/ 10.1136/bmjopen-2016-01299

A study of sertraline in dialysis (ASSertID) : a protocol for a pilot randomised controlled trial of drug treatment for depression in patients undergoing haemodialysis

© 2015 Friedli et al. Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise statedBACKGROUND: The prevalence of depression in people receiving haemodialysis is high with estimates varying between 20 and 40 %. There is little research on the effectiveness of antidepressants in dialysis patients with the few clinical trials suffering significant methodological issues. We plan to carry out a study to evaluate the feasibility of conducting a randomised controlled trial in patients on haemodialysis who have diagnosed Major Depressive Disorder.METHODS/DESIGN: The study has two phases, a screening phase and the randomised controlled trial. Patients will be screened initially with the Beck Depression Inventory to estimate the number of patients who score 16 or above. These patients will be invited to an interview with a psychiatrist who will invite those with a diagnosis of Major Depressive Disorder to take part in the trial. Consenting patients will be randomised to either Sertraline or placebo. Patients will be followed-up for 6 months. Demographic and clinical data will be collected at screening interview, baseline interview and 2 weeks, and every month (up to 6 months) after baseline. The primary outcome is to evaluate the feasibility of conducting a randomised, double blind, placebo pilot trial in haemodialysis patients with depression. Secondary outcomes include estimation of the variability in the outcome measures for the treatment and placebo arms, which will allow for a future adequately powered definitive trial. Analysis will primarily be descriptive, including the number of patients eligible for the trial, drug exposure of Sertraline in haemodialysis patients and the patient experience of participating in this trial.DISCUSSION: There is an urgent need for this research in the dialysis population because of the dearth of good quality and adequately powered studies. Research with renal patients is particularly difficult as they often have complex medical needs. This research will therefore not only assess the outcome of anti-depressants in haemodialysis patients with depression but also the process of running a randomised controlled trial in this population. Hence, the outputs of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the efficacy of anti-depressants in patient on haemodialysis with depression.TRIAL REGISTRATION: ISRCTN registry ISRCTN06146268 and EudraCT reference: 2012-000547-27.Peer reviewedFinal Published versio

Wordless intervention for epilepsy in learning disabilities (WIELD):study protocol for a randomized controlled feasibility trial

Epilepsy is the most common neurological problem that affects people with learning disabilities. The high seizure frequency, resistance to treatments, associated skills deficit and co-morbidities make the management of epilepsy particularly challenging for people with learning disabilities. The Books Beyond Words booklet for epilepsy uses images to help people with learning disabilities manage their condition and improve quality of life. Our aim is to conduct a randomized controlled feasibility trial exploring key methodological, design and acceptability issues, in order to subsequently undertake a large-scale randomized controlled trial of the Books Beyond Words booklet for epilepsy

Counselling patients with emotional problems in general practice: Effects on psychological, social and economic outcomes

Anxiety and depression are common mental disorders found in general practice. There has been an increasing number of counsellors attached to general practice over the past ten years, despite there being little evidence on effectiveness. Many studies have suffered from serious methodological weaknesses. This prospective, randomised controlled trial compares nondirective counselling with routine general practitioner care in assisting people with emotional problems. Fourteen general practices were recruited. Counselling sessions ranged from 1 to 12 sessions over 12 weeks. Most patients suffered from depression due to relationship or family problems. Self-report questionnaires on psychological, social, economic and patient satisfaction outcomes were used at baseline interview and at the three and nine months follow-up interviews. The sample consisted of 136 consenting general practice attenders, mean age 39 years old. Most of the sample were female (81%) and predominately Caucasian (92%). Seventy patients were randomised to the counsellor and 66 patients to the general practitioner. Patients in both groups improved significantly over time, but there were no significant differences on the psychological and social outcome measures between a nondirective counselling intervention and routine general practitioner care. However patients who scored as cases on the Beck Depression Inventory, were younger and from manual classes improved to a greater extent by seeing a counsellor compared to seeing the general practitioner. Patients were also more satisfied and felt less troubled after seeing a counsellor. In terms of cost, counselling was less cost- effective than routine general practitioner care immediately post-treatment, but became cost-effective on direct costs only after nine months. This study indicates that non-directive counselling is as efficacious as routine general practice treatment. The findings on cost effectiveness were equivocal. Patients were more satisfied with seeing a counsellor compared to a doctor. Further research is needed to assess which particular patients could benefit from counselling and whether counselling becomes cost-effective long-term