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

BACKGROUND: 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.

Evidence that self-affirmation improves phosphate control in hemodialysis patients: a pilot cluster randomized controlled trial.

BACKGROUND: Hemodialysis patients are at risk of serious health complications, yet treatment non-adherence remains high. PURPOSE: Warnings about health risks associated with non-adherence may trigger defensive reactions. We studied whether an intervention based on self-affirmation theory (Steele 1988) reduced patients' resistance to health-risk information and improved adherence. METHODS: One hundred twelve patients either self-affirmed or completed a matched control task before reading about the risks associated with a lack of phosphate control. Serum phosphate was collected from baseline up to 12 months. RESULTS: Self-affirmed patients had significantly reduced serum phosphate levels at 1 and 12 months. However, contrary to the predictions derived from self-affirmation theory, self-affirmed participants and controls did not differ in their evaluation of the health-risk information, behavioural intention or self-efficacy. CONCLUSIONS: A low-cost, high-reach health intervention based on self-affirmation theory was shown to reduce serum phosphate over a 12 month period. Further work is required to identify mediators of the observed effects.