A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care
Summary
The study involves a 32-week randomized controlled trial in primary care of a comprehensive diabetic and depression intervention in patients with type 2 diabetes and comorbid MDD, compared to a group treated with usual care for MDD plus disease self-management and measurement-based care for diabetes.
Description
The overarching goal of the study is to translate research-based treatment procedures that have been shown to improve outcomes for both DM and MDD for use in primary care. More specifically, the aims are: 1) to evaluate the benefits of CDDI in improving diabetic outcomes compared to usual care for MDD plus disease self-management for diabetes; 2) to evaluate the benefits of CDDI in improving depression outcomes compared to the UC for MDD treatment protocol; and 3) to evaluate the benefits of CDDI in terms of improved (1) cardiovascular risk factors (blood pressure, body mass index, lipids, and abdominal fat), (2) levels of exercise and better diet, (3) clinician and patient satisfaction with care, (4) fidelity to treatment guidelines, and (5) cognitive function.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Type 2 Diabetes
Intervention
Diabetes and depression intervention, Diabetes intervention
Location
Methodist Family Health Center Cedar Hill Clinic
Cedar Hill
Texas
United States
75104
Status
Not yet recruiting
Source
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00939250
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Prediabetic State
The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).
Diabetes Mellitus, Type 2
A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.
Polyuria
Urination of a large volume of urine with an increase in urinary frequency, commonly seen in diabetes (DIABETES MELLITUS; DIABETES INSIPIDUS).
Pregnancy In Diabetics
The state of PREGNANCY in women with DIABETES MELLITUS. This does not include either symptomatic diabetes or GLUCOSE INTOLERANCE induced by pregnancy (DIABETES, GESTATIONAL) which resolves at the end of pregnancy.
Diabetes, Gestational
Diabetes mellitus induced by PREGNANCY but resolved at the end of pregnancy. It does not include previously diagnosed diabetics who become pregnant (PREGNANCY IN DIABETICS). Gestational diabetes usually develops in late pregnancy when insulin antagonistic hormones peaks leading to INSULIN RESISTANCE; GLUCOSE INTOLERANCE; and HYPERGLYCEMIA.
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PubMed Articles
In diabetes patients, depression is correlated with diabetes-specific emotional distress, and observational studies have suggested that diabetes distress may have a greater impact on diabetes outcomes...
Affective symptoms and change in diabetes self-efficacy and glycaemic control.
AIMS: To examine the role of baseline depression, anxiety and stress symptoms on post-intervention diabetes self-efficacy and glycaemic control (HbA(1c) ). METHODS: The current study analysed data fro...
A Psychoeducational Intervention (SWEEP) for Depressed Women with Diabetes.
BACKGROUND: Clinically significant depression is present in 25 % of individuals with type 2 diabetes, its risk being doubled in women. PURPOSE: To examine the effectiveness of the Study of Women's Em...
Treatment Response in Type 2 Diabetes Patients with Major Depression.
AIMS: Major depression is more prevalent in patients with type 2 diabetes mellitus (T2DM) than in general population. Comparing psychotherapeutic and pharmacological treatment responses could help to...
