Psychoeducation versus treatment as usual in diabetic patients with subthreshold depression: preliminary results of a randomized controlled trial

BACKGROUND ----- Research on the effects of treating sub-threshold depression in persons with diabetes is scarce in spite of the findings indicating that this condition is highly prevalent in the diabetic population and may increase the risk of developing a subsequent major depression. This study was aimed at exploring the effects of a psycho-educational intervention on depression- and diabetes-related outcomes in patients with mild to moderate depressive symptoms. METHODS ----- A randomized controlled study design with a one-year follow-up was used. Fifty patients with mild to moderate depressive symptoms (74% female, aged 57 +/- 9 yrs, diabetes duration of 10 +/- 8 yrs, BMI 31 +/- 6 kg/m2, HbA1C 7.7% +/- 1.4, 53% insulin treated) were randomly assigned to either an intervention or a control group. The intervention group underwent four psycho-educational sessions aimed at enabling self-management of depressive symptoms. The control group was informed about the screening results and depression treatment options while continuing diabetes treatment as usual. Both groups were contacted by phone in 2-3-month intervals, and re-assessed for depression after 6 and 12 months. Changes in depressive symptoms and glycaemic control were considered primary outcomes. Mann-Whitney U test and Friedman ANOVA were used to compare between- and within-group indicators at 6- and 12-month follow-ups. RESULTS ----- Both the intervention and the control group reported a significant decrease in depressive symptoms as measured by the CES-D scale (Friedman ANOVA chi2 = 10.8 p = .004 and chi2 = 7.3 p = 0.03, respectively). The 6-month and 1-year indicators of glycaemic control as compared to baseline HbA1C values were also improved in both groups (chi2 = 11.6 p = 0.003 and chi2 = 17.1 p = 0.0002, respectively). Between-group differences in depressive symptoms and HbA1C values were not statistically significant either at 6- or at 12-month follow-up (all p > 0.05).CONCLUSION ----- Psycho-educational treatment appears to be beneficial in diabetic patients with mild to moderate depressive symptoms, but its effects are comparable with the non-specific support given to the subjects in the control group. TRIAL REGISTRATION ----- Current Controlled Trials ISRCTN58745372

Does treatment of subsyndromal depression improve depression and diabetes related outcomes: protocol for a randomised controlled comparison of psycho-education, physical exercise and treatment as usual

<p>Abstract</p> <p>Background</p> <p>The prevalence of mood difficulties in persons with diabetes is approximately twice that in the general population, affecting the health outcomes and patients' quality of life in an undesirable way. Although subsyndromal depression is an important predictor of a more serious clinical depression, it is often overlooked. This study aims to compare the effects of two non-pharmacological interventions for subsyndromal depression, psychoeducation and physical exercise, with diabetes treatment as usual on mood- and diabetes-related outcomes.</p> <p>Methods and Design</p> <p>Type 2 diabetic patients aged 18-65 yrs. who report mood difficulties and the related need for help in a mail survey will be potential participants. After giving informed consent, they will be randomly assigned to one of the three groups (psychoeducation, physical activity, treatment as usual). Depressive symptoms, diabetes distress, health-related quality of life and diabetes self-care activities will be assessed at baseline, at 6 weeks, 6 months and 12 months. A structured clinical interview for DSM-IV Axis I Disorders (SCID-I) will be performed at baseline and at one-year follow-up in order to determine the clinical significance of the patients' depressive symptoms. Disease-related data will be collected from patients' files and from additional physical examinations and laboratory tests.</p> <p>The two interventions will be comparable in terms of format (small group work), duration (six sessions) and approach (interactive learning; supporting the participants' active roles). The group treated as usual will be informed about their screening results and about the importance of treating depression. They will be provided with brief re-education on diabetes and written self-help instructions to cope with mood difficulties.</p> <p>Primary outcomes will be depressive symptoms. Secondary outcomes will be glycaemic control, diabetes-related distress, self-management of diabetes and health-related quality of life. Tertiary outcomes will be biochemical markers reflecting common pathophysiological processes of insulin resistance, inflammation and oxidative damage that are assumed to be intertwined in both diabetes and depression. The mixed-effect linear model will be used to compare the outcome variables.</p> <p>Power analysis has indicated that the two intervention groups and the control group should comprise 59 patients to enable detection of clinically meaningful differences in depressive symptoms with a power of 80% and alpha = 0.05. Outcomes will be analysed on an intention-to-treat basis.</p> <p>Trial Registration</p> <p>ISRCTN: <a href="http://www.controlled-trials.com/ISRCTN05673017">ISRCTN05673017</a></p

Patient-reported outcomes in a trial of exenatide and insulin glargine for the treatment of type 2 diabetes

BACKGROUND: Patient-reported measures can be used to examine whether drug differences other than clinical efficacy have an impact on outcomes that may be important to patients. Although exenatide and insulin glargine appear to have similar efficacy for treatment of type 2 diabetes, there are several differences between the two treatments that could influence outcomes from the patient's perspective. The purpose of the current study was to examine whether the two drugs were comparable as assessed by patient-reported outcomes using data from a clinical trial in which these injectable medications were added to pre-existing oral treatment regimens. METHODS: Patients were randomized to either twice daily exenatide or once daily insulin glargine during a 26-week international trial. At baseline and endpoint, five patient-reported outcome measures were administered: the Vitality Scale of the SF-36, The Diabetes Symptom Checklist – Revised (DSC-R), the EuroQol EQ-5D, the Treatment Flexibility Scale (TFS), and the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Change from baseline to endpoint was analyzed within each treatment group. Group differences were examined with General linear models (GLMs), controlling for country and baseline scores. RESULTS: A total of 549 patients with type 2 diabetes were enrolled in the trial, and current analyses were conducted with data from the 455 per protocol patients (228 exenatide and 227 insulin glargine). The sample was primarily Caucasian (79.6%), with slightly more men (55.2%) than women, and with a mean age of 58.5 years. Paired t-tests found that both treatment groups demonstrated statistically significant baseline to endpoint change on several of the health outcomes instruments including the DSC-R, DTSQ, and the SF-36 Vitality subscale. GLMs found no statistically significant differences between groups in change on the health outcomes instruments. CONCLUSION: This analysis found that both exenatide and insulin glargine were associated with significant improvements in patient-reported outcomes when added to oral medications among patients with type 2 diabetes. Despite an additional daily injection and a higher rate of gastrointestinal adverse events, treatment satisfaction in the exenatide group was comparable to that of the glargine group, possibly because of weight reduction observed in patients treated with exenatide

Self management interventions for type 2 diabetes in adult people with severe mental illness

Background: People with severe mental illness are twice as likely to develop type 2 diabetes asthose without severe mental illness. Treatment guidelines for type 2 diabetes recommend that structured education should be integrated into routine care and should be offered to all.However, for people with severe mental illness, physical health may be a low priority, and motivation to change may be limited. These additional challenges mean that the findings reported in previous systematic reviews of diabetes self management interventions may not be generalised to those with severe mental illness, and that tailored approaches to effective diabetes education may be required for this population. Objectives: To assess the effects of diabetes self management interventions specifically tailored for people with type 2 diabetes and severe mental illness. Search methods: We searched the Cochrane Library, MEDLINE, EMBASE, PsycINFO, the Cumulative Index to Nursing and Allied Health Literature(CINAHL), the International Clinical Trials Registry Platform (ICTRP) Search Portal, ClinicalTrials.gov and grey literature. The date of the last search of all databases was 07 March 2016. Selection criteria Randomised controlled trials of diabetes self management interventions for people with type 2 diabetes and severe mental illness. Data collection and analysis: Two review authors independently screened abstracts and full-text articles, extracted data and conducted the risk of bias assessment. We used a taxonomy of behaviour change techniques and the framework for behaviour change theory to describe the theoretical basis of the interventions and active ingredients. We used the GRADE method (Grades of Recommendation, Assessment, Development and Evaluation Working Group) to assess trials for overall quality of evidence. Main results: We included one randomised controlled trial involving 64 participants with schizophrenia or schizoaffective disorder. The average age of participants was 54 years; participants had been living with type 2 diabetes for on average nine years, and with their psychiatric diagnosis since they were on average 28 years of age. Investigators evaluated the 24-week Diabetes Awareness and Rehabilitation Training(DART) programme in comparison with usual care plus information (UCI). Follow-up after trial completion was six months. Risk of bias was mostly unclear but was high for selective reporting. Trial authors did not report on diabetes-related complications, all-cause mortality, adverse events, health-related quality of life nor socioeconomic effects. Twelve months of data on self care behaviours as measured by total energy expenditure showed a mean of 2148 kcal for DART and 1496 kcal for UCI (52 participants; very low-quality evidence), indicating no substantial improvement. The intervention did not have a substantial effect on glycosylated haemoglobin A1c (HbA1c) at 6 or 12 months of follow-up (12-month HbA1c data 7.9% for DART vs 6.9% for UCI; 52 participants; very low-quality evidence). Researchers noted small improvements in body mass index immediately after the intervention was provided and at six months, along with improved weight post intervention. Diabetes knowledge and self efficacy improved immediately following receipt of the intervention, and knowledge also at six months. The intervention did not improve blood pressure. Authors’ conclusions: Evidence is insufficient to show whether type 2 diabetes self management interventions for people with severe mental illness are effective in improving outcomes. Researchers must conduct additional trials to establish efficacy, and to identify the active ingredients in these interventions and the people most likely to benefit from them