A Tailored Cognitive-Behavioural Intervention Produces Comparable Reductions in Regimen-Related Distress in Adults With Type 2 Diabetes Regardless of Insulin Use: 12-Month Outcomes From the COMRADE Trial.

OBJECTIVES: Our aim in this study was to determine whether a cognitive-behavioural therapy plus small changes lifestyle intervention can produce comparable improvements in insulin users vs patients not using insulin with uncontrolled type 2 diabetes (T2D) and comorbid depressive or regimen-related distress (RRD) symptoms. METHODS: This study is a secondary analysis of Collaborative Care Management for Distress and Depression in Rural Diabetes Study, a randomized, controlled trial of a 16-session, severity-tailored cognitive-behavioural therapy plus small changes lifestyle intervention compared with usual care. Outcomes included glycated hemoglobin (A1C), regimen-related distress, depression, medication adherence and diabetes self-care. Our investigation provides 2 sets of contrasts: 1) insulin users in the intervention group compared with insulin users in the usual-care group and 2) insulin users compared with noninsulin users in the intervention group only. RESULTS: Of the 139 participants, 72 (52%) were using insulin at baseline and had significantly higher levels of A1C (10.2±2.1% vs 8.9±1.6%) and RRD (3.3±1.4 vs 2.8±1.1), and significantly poorer medication adherence (5.2±2.1 days/wk vs 5.5±1.7 days/wk). Intervention patients using insulin exhibited significantly greater reductions in RRD and marginally significant improvements in medication adherence and A1C compared with insulin users in usual care. Within the intervention group, changes in RRD, medication adherence and A1C did not differ significantly by insulin use. CONCLUSIONS: Tailored cognitive-behavioural therapy with a small-changes lifestyle intervention improved elevated RRD and A1C outcomes at least as effectively in insulin users as non‒insulin users. Future powered studies need to address the role of insulin use in uptake and treatment outcomes.

Randomized Trial of a Tailored Cognitive Behavioral Intervention in Type 2 Diabetes With Comorbid Depressive and/or Regimen-Related Distress Symptoms: 12-Month Outcomes From COMRADE.

OBJECTIVE: This study evaluated the effect of cognitive behavioral therapy (CBT) plus lifestyle counseling in primary care on hemoglobin A1c (HbA1c) in rural adult patients with type 2 diabetes (T2D) and comorbid depressive or regimen-related distress (RRD) symptoms. RESEARCH DESIGN AND METHODS: This study was a randomized controlled trial of a 16-session severity-tailored CBT plus lifestyle counseling intervention compared with usual care. Outcomes included changes in HbA1c, RRD, depressive symptoms, self-care behaviors, and medication adherence across 12 months. RESULTS: Patients included 139 diverse, rural adults (mean age 52.6 ± 9.5 years; 72% black; BMI 37.0 ± 9.0 kg/m2) with T2D (mean HbA1c 9.6% [81 mmol/mol] ± 2.0%) and comorbid depressive or distress symptoms. Using intent-to-treat analyses, patients in the intervention experienced marginally significant improvements in HbA1c (-0.92 ± 1.81 vs. -0.31 ± 2.04; P = 0.06) compared with usual care. However, intervention patients experienced significantly greater improvements in RRD (-1.12 ± 1.05 vs. -0.31 ± 1.22; P = 0.001), depressive symptoms (-3.39 ± 5.00 vs. -0.90 ± 6.17; P = 0.01), self-care behaviors (1.10 ± 1.30 vs. 0.58 ± 1.45; P = 0.03), and medication adherence (1.00 ± 2.0 vs. 0.17 ± 1.0; P = 0.02) versus usual care. Improvement in HbA1c correlated with improvement in RRD (r = 0.3; P = 0.0001) and adherence (r = -0.23; P = 0.007). CONCLUSIONS: Tailored CBT with lifestyle counseling improves behavioral outcomes and may improve HbA1c in rural patients with T2D and comorbid depressive and/or RRD symptoms.

COMRADE: A randomized trial of an individually tailored integrated care intervention for uncontrolled type 2 diabetes with depression and/or distress in the rural southeastern US.

BACKGROUND: Emerging evidence suggests that people living with Type 2 diabetes mellitus (T2D) are also at greater risk for depression and distress. If left untreated, these comorbid mental health concerns can have long-lasting impacts on medical and physical health outcomes. DESIGN: This prospective trial randomized rural men and women with uncontrolled T2D (HbA1c ≥ 7.0) who screened positive for co-morbid depressive (PHQ-2 > 3) or distress (DDS-2 > 3) symptoms in a primary medical care setting to receive either: 1) 16 sessions of cognitive and/or behavioral intervention tailored to symptom severity across 12 months along with routine medical care, or 2) usual primary care. Outcomes included change from baseline to 12-months in HbA1c, diabetes related distress, depressive symptoms, and diabetes self-care activities. BASELINE RESULTS: 139 patients (Mean age = 52.6 ±â€¯9.6 years) with T2D from impoverished rural communities were enrolled (almost half reporting annual income of <$10,000 per year). Baseline data indicated that patients were experiencing profoundly uncontrolled T2D of a long duration (Mean HbA1c = 9.61 ±â€¯2.0; Mean BMI = 37.0 ±â€¯9.1; Mean duration = 11.2 ±â€¯8.9 years) along with high levels of distress (Mean DDS-17 Scale Score = 2.5 ±â€¯1.0) and/or depressive symptoms (Mean PHQ-9 Scale Score = 9.3 ±â€¯6.1). CONCLUSION: Patients with uncontrolled T2D of long duration manifest complex co-morbidities including associated obesity, depressive symptoms and/or diabetes related distress. A behavioral intervention for T2D that concurrently targets symptoms of depression and distress may lead to more effective outcomes in this high-risk population. CLINICAL TRIAL REGISTRATION: NCT02863523.

Consequences of Comorbidity of Elevated Stress and/or Depressive Symptoms and Incident Cardiovascular Outcomes in Diabetes: Results From the REasons for Geographic And Racial Differences in Stroke (REGARDS) Study.

OBJECTIVE: To evaluate the impact of comorbid depressive symptoms and/or stress on adverse cardiovascular (CV) outcomes in individuals with diabetes compared with those without diabetes. RESEARCH DESIGN AND METHODS: Investigators examined the relationship between baseline depressive symptoms and/or stress in adults with and without diabetes and physician-adjudicated incident CV outcomes including stroke, myocardial infarction/acute coronary heart disease, and CV death over a median follow-up of 5.95 years in the national REGARDS cohort study. RESULTS: Subjects included 22,003 adults (4,090 with diabetes) (mean age 64 years, 58% female, 42% black, and 56% living in the southeastern "Stroke Belt"). Elevated stress and/or depressive symptoms were more common in subjects with diabetes (36.8% vs. 29.5%; P < 0.001). In fully adjusted models, reporting either elevated stress or depressive symptoms was associated with a significantly increased incidence of stroke (HR 1.57 [95% CI 1.05, 2.33] vs. 1.01 [0.79, 1.30]) and CV death (1.53 [1.08, 2.17] vs. 1.12 [0.90, 1.38]) in subjects with diabetes but not in those without diabetes. The combination of both elevated stress and depressive symptoms in subjects with diabetes was associated with a higher incidence of CV death (2.15 [1.33, 3.47]) than either behavioral comorbidity alone (1.53 [1.08, 2.17]) and higher than in those with both elevated stress and depressive symptoms but without diabetes (1.27 [0.86, 1.88]). CONCLUSIONS: Comorbid stress and/or depressive symptoms are common in individuals with diabetes and together are associated with progressively increased risks for adverse CV outcomes.

The implantable cardioverter defibrillator: its history, current psychological impact and future.

The innovation of the implantable cardioverter defibrillator (ICD) represents a modern medical achievement with substantial life-saving benefits for patients at risk for potentially life-threatening arrhythmias. Over a decade of research resulted in the first ICD implantation in 1980, dramatically changing the face of cardiac care. The introduction of the device was met by skepticism and outright rejection by some, yet large-scale clinical trials clearly demonstrated the mortality benefit of the ICD. Today, specific challenges for this technology have emerged, including barriers to individual and social acceptance of the ICD as a viable form of technology, as well as psychosocial adjustment difficulties and fears in patients. To address these challenges, scientific research, improved communication regarding devices and psychosocial interventions have been developed and extended to this patient population. As such, it is hypothesized that the future will hold expanding indications for ICD implantation, while further meeting patients' medical and psychosocial adjustment needs. The purposes of this paper are to review the history of ICD innovation, describe past and present research on psychosocial adjustment to the ICD, and corresponding psychosocial interventions, analyze individual and social acceptance and utilization of device technology, and forecast future applications and developments of the ICD.