Title: Prevalence and depression risk factors in patients with diabetes mellitus
Investigators: Mirjana Pibernik-Okanovic, PhD, Silvija Szabo, PhD, Drazen Begic, MD PhD, Kristijan Peros, MD, Maja Radman, MD MSc, Zeljko Metelko, MD, PhD.
Funding Agency:
Ministry of Science and Technology of the Republic of CroatiaAbstract:
Aims and research questions: The aim of the investigation is to contribute to the understanding of depression in patients with diabetes in Croatia and compare the obtained data with those from other European countries. The following questions will be answered: 1. How high is the average prevalence of depression, based on diagnostic criteria for depression (DSM-IV) in Croatian patients with diabetes? 2.In what way is the level of depression associated with sociodemographic, psychological and clinical characteristics of diabetic patients? and 3. Which tendencies in the studied patients with respect to depression level, degree of self-care, quality of life and glycemic control will be observed during 6-month and 12-month follow-up periods?
Patients and methods: The study is planned to be carried out on 1000 randomly selected patients attending their scheduled check-ups at the Outpatient clinic of the Vuk Vrhovac Institute. A level of depression, emotional burden of diabetes, diabetes self-care activities, subjective health and quality of life will be determined using psychological questionnaires (Center for Epidemiologic Studies-Depression, Radloff 1977; Problem Areas in Diabetes, Welch et al. 1997; Diabetes Self-care Activities, Toobert et al 2000; Health Survey SF-12, Ware et al; and the World Health Organisation Quality of Life Questionnaire WHO-5). Semi-structured psychological interview will encompass demographic data, history of psychiatric morbidity/ treatment, major stressful events over the previous 12 months, experienced social support, smoking, psychotropic medication and possible drug abuse. The SCID will be used to confirm a clinical diagnosis of depression.
The patients with CES-D scores of 16 and higher will be informed about their hypothetical risk to develop depression, and about possible treatments. These patients will be retested after six months in order to check their help-seeking behaviour and the present state of depression. The patients scoring below the level indicative of depressive disorders will be retested after 12 months in order to check whether they are still symptom-free or whether their status has changed.
The prevalence rates of depression will be determined on the basis of the CES-D score indicative of depression, and DSM-IV diagnostic criteria for depressive disorders. Associations of depression with demographic, clinical and psychological variables will be determined by correlational methods. Differences between depressed and non-depressed subjects with respect to their quality of life, subjective health, diabetes-related emotional problems and health care activities will be determined by means of t-test for independent groups. Regression analysis will be used in order to identify depression predictors in patients with diabetes mellitus.
Application of the research: It is expected that the collected data will enable making recommendations for the promotion of early detection and treatment of depression in patients with diabetes mellitus.
Title: Depression Screening in Diabetes Outpatient Clinics. Point-prevalence of major depression and the impact of case-finding on the course of depression and glycemic control.
Investigators: Dr F. Pouwer, Prof dr R. J. Heine, Dr. A.J. Beekman, Dr F.J. Snoek, Dr H.J. Adèr
Funding Agency:
Diabetes Fonds NederlandAbstract:
International studies have reported depression to be at least twice as prevalent among people with diabetes (and more persistent) than in the general population, negatively impacting both patients’ quality of life and glycemic control. Depression is to be regarded a serious psychological complication in diabetes, impeding on self-management. To date, research on the prevalence of depression in Dutch diabetes patients is scarce. Major depression can in most cases be treated effectively (psychotherapy/pharmacotherapy), with beneficial effects of depression treatment on glycemic control. However, depression is often underdiagnosed by physicians. The use of case-finding instruments has been advocated to improve recognition rates of depression in clinical practice. This multi-centre study aims to determine the point-prevalence of major depression in a random sampe of 2000 Dutch diabetes outpatients (type 1 and type 2) drawn from four clinics spread around the Netherlands, using a case-finding instrument (CES-D) and diagnostic interview (CIDI). An additional 1000 persons with diabetes from the Dutch Diabetic Association (DVN) will fill out the CES-D serving as reference group. Demographic, medical and psychological correlates of depression in the outpatient sample are examined cross-sectionally. Patients newly diagnosed with depression and not yet under treatment for their mood disorder are informed of the diagnosis and stimulated to seek treatment for their depression. The effects of the screening procedure on the patients’ help-seeking behaviour, course of the depression, self-care and glycemic control are evaluated after 6 months.
Title: Web-based cognitive behavioural therapy (W-CBT) for diabetes patients with co-morbid depression: Design of a randomised controlled trial
Investigators: Kim MP van Bastelaar, Frans Pouwer, Pim Cuijpers, Jos WR Twisk, and Frank J Snoek
Funding Agency:
Diabetes Fonds NederlandBackground: Depression is common among people with diabetes, negatively affecting quality of life, treatment adherence and diabetes outcomes. In routine clinical care, diabetes patients have limited access to mental health services and depression therefore often remains untreated. Web-based therapy could potentially be an effective way to improve the reach of psychological care for diabetes patients, at relatively low costs. This study seeks to test the effectiveness of a web-based self-help depression programme for people with diabetes and co-morbid depression.
Methods/Design: The effectiveness of a web-based self-help course for adults with diabetes with co-morbid depression will be tested in a randomised trial, using a wait-list controlled design. The intervention consists of an 8-week, moderated self-help course that is tailored to the needs of persons living with diabetes and is offered on an individual basis. Participants receive feedback on their homework assignments by e-mail from their coach. We aim to include 286 patients (143/143), as power analyses showed that this number is needed to detect an effect size of 0.35, with measurements at baseline, directly after completing the web-based intervention and at 1, 3, 4 and 6 months follow-up. Patients in the control condition are placed on a waiting list, and follow the course 12 weeks after randomisation.
Primary outcomes are depressive symptoms and diabetes-specific emotional distress. Secondary outcomes are satisfaction with the course, perceived health status, self-care behaviours, glycaemic control, and days in bed/absence from work. Questionnaires are administered via the Internet.
Discussion: The intervention being trialled is expected to help improve mood and reduce diabetes-specific emotional distress in diabetes patients with depression, with subsequent beneficial effects on diabetes self-care and glycaemic outcomes. When proven efficacious, the intervention could be disseminated to reach large groups of patients with diabetes and concurrent depressive symptoms.
Trial registration
Current Controlled Trials ISRCTN24874457
Title: The DiaDDZOB Study: Longitudinal associations between depression, Type D personality and diabetes outcomes in primary care patients with type 2 diabetes
Investigators: Giesje Nefs, Victor Pop, Johan Denollet, François Pouwer
Funding Agency:
CoRPSObjective: The aim of the DiaDDZOB-project is to examine the associations between psychosocial variables, lifestyle factors, diabetes outcomes and health care consumption. Of special interest is the association between baseline depressive symptoms / Type D personality and the onset / progression of micro- and macrovascular complications of diabetes.
Study design: The DiaDDZOB-project is an observational cohort study with a prospective longitudinal design. Assessments will take place annually during a three-year period.
Study population: The study population consists of a cohort of approximately 10,000 adult patients with type 2 diabetes from the “Kempen” region, who are being treated for their diabetes by their primary care physician within the framework of PoZoB, a large shared care organisation in the Southeastern region of The Netherlands. Patients will be invited to complete a questionnaire on a yearly basis, in addition to regular care procedures. Patients are excluded if they are diagnosed with a condition that causes hyperglycemia other than type 2 diabetes, are physically or mentally incapable of completing a questionnaire, do not have sufficient mastery of the Dutch language and do not consent that the general practitioner is notified of deviant scores on the questionnaire.
Main study outcomes: The main study variables of interest are depressive symptomatology and Type D personality (as assessed by means of validated questionnaires) and the following study outcomes: 1) disease-related outcomes (glycemic control, micro- and macrovascular complications, insulin initiation, mortality); 2) quality of life and health status; 3) health care utilisation. Of further interest is the course of depression and the possibly mediating role of lifestyle-related factors (self-care) in the association between depressive symptomatology / Type D personality and the outcome parameters.
Title: Eicosapentaenoic acid as an add-on to antidepressants for co-morbid major depression in patients with diabetes mellitus: a randomized, double-blind placebo-controlled study.
Investigators: Mariska Bot, François Pouwer, Johanna Assies, Eugène H.J.M. Jansen, Michaela Diamant, Frank J. Snoek, Aartjan T.F. Beekman, Peter de Jonge.
Funding Agency:
Diabetes Fonds NederlandOBJECTIVE: Depression is common in individuals with diabetes. The present study is the first randomized controlled trial to test the efficacy of -3 ethyl-eicosapentaenoic acid (E-EPA) as adjuvant to antidepressants in the treatment of depression in adults with diabetes mellitus.
METHOD: We conducted a 12-week, placebo-controlled, double-blind, parallel-group intervention study of E-EPA (1 gram/day) versus placebo in 25 diabetes patients meeting DSM-IV criteria for major depressive disorder, who were already using antidepressant medication. The primary outcome was severity of depressive symptoms, assessed by the Montgomery Åsberg Depression Rating Scale (MADRS) at baseline and 12-week follow-up at two-weekly intervals. Blood samples were collected at baseline and at 12-week follow-up to determine EPA levels in the erythrocyte membranes. Data were analyzed with ANOVA for repeated measures.
RESULTS: Thirteen participants were randomly assigned to E-EPA; 12 subjects were given placebo. At 12-week follow-up, erythrocyte membranes from patients receiving E-EPA contained tripled levels of EPA, while no changes were noted in subjects receiving placebo. In both groups, depressive symptoms significantly decreased over time (F=21.14, p<0.001), yet no significant differences were found between those treated with E-EPA versus placebo (F=1.63, p=0.17).
CONCLUSIONS: In this study, no evidence was found for the efficacy of adding E-EPA to antidepressants in reducing depressive symptoms in diabetic patients with co-morbid depression.
Treatment of co-morbid emotional problems in patients with type 2 diabetes: development and evaluation of a mindfulness-based cognitive therapy.
Investigators: Jenny van Son (PhD student), Ivan Nyklicek (PhD), Victor Pop (MD, PhD), Frans Pouwer (PhD).
Funding Agency:
Diabetes Fonds NederlandFunding Agency:
CoRPSObjective: Emotional problems such as depression, anxiety and diabetes-specific emotional distress are common in individuals with diabetes. The present study involves the development of a diabetes-specific, mindfulness based cognitive behavioural therapy. The efficacy of this new intervention trial in the treatment of emotional distress in adults with type 2 diabetes mellitus will be tested with a randomized controlled trial (2009-2013).
Title: Symptoms of depression and diabetes-specific emotional distress are associated with a negative appraisal of insulin therapy in insulin-naïve patients with type 2 diabetes mellitus. A study from the European Depression in Diabetes [EDID] Research Consortium.
Investigators: C. Makine, Ç. Karşıdağ, P Kadıoğlu, H. Ilkova, K. Karşıdağ, S.E. Skovlund, F.J. Snoek, F. Pouwer
Funding Agency:
Novo Nordisk Turkey and Novo Nordisk DenmarkObjective: A meta-analysis concluded that depression is associated with poor glycemic control in type 2 diabetes (DM2). In DM2 patients with deteriorating glycemic control, the initiation of insulin therapy is often postponed. The aim of the present study is to determine whether symptoms of depression and diabetes-specific emotional distress are associated with more negative appraisals of insulin therapy.
Methods: We collected cross-sectional data in two outpatient university clinics in Istanbul, Turkey. The study sample consisted of 154 insulin-naïve patients with DM2. A self-report questionnaire was used to obtain demographic and clinical data. Main instruments were the Centre for Epidemiologic Studies Depression Scale, the Problem Areas in Diabetes survey, a measure of diabetes-distress and the Insulin Treatment Appraisal Scale (ITAS).
Results: Analysis of variance revealed that patients with a high depression score rated insulin therapy significantly more negatively then patients with lower depression scores. Moreover, 47% of patients with a high depression score had a negative appraisal of insulin therapy on 7 or more of the 20 ITAS-items, compared to 25 to 29% of those with low-moderate depression. Multiple regression analyses showed that a negative appraisal of insulin therapy was significantly associated with higher depression and diabetes-distress scores and low education, but not with sex, age or duration of diabetes.
Conclusions: Higher levels of depression and diabetes-distress tended to be associated with more negative beliefs about insulin therapy in insulin-naïve diabetes patients. Longitudinal research is needed to test whether insulin therapy is indeed more frequently postponed in depressed and distressed patients with DM2.
Title: Screening for Depression in Diabetes Outpatient Clinics. Point prevalence of major depression and the impact of case-finding on the course of depression and glycemic control
Investigators: Dr. Arie Nouwen, Dr. Andrej Maruši
Funding Agency:
The British Council Title: Short-term psychotherapy in diabetics with comorbid depression and poor glucose control
Investigators: Johannes Kruse, Norbert Schmitz, Achim Grinschgl, Lutz Altenhoven
Funding Agency:
NovoNordisk Abstract:
Several studies have shown that there is an association between depression and poor glucose control. Unfortunately, only a few studies evaluated the effect of psychotherapy on depression and blood glucose levels in this patient group.
The aim of the study is to investigate the effect of a short-term psychodynamic intervention on blood glucose level, depression and quality of life.
We will include 100 diabetic patients in this randomised controlled trail. Inclusion criteria are poor glycaemic control (2 x HbA1c >8% in the last 6 months) and signs of a depressive symptomatology (HADS-D >10). All diabetic patients are treated in a standardised treatment programme in a specialised diabetes facility. 50 patients will be randomised to receive a structured, short-term psychotherapeutic intervention (8-10 sessions). The remaining 50 patients will receive medical care in a specialised practice only.