Evaluation of the integrated intervention for dual problems and early action among latino immigrants with co-occurring mental health and substance misuse symptoms: A randomized clinical trial

Importance: Immigrants are at an increased risk for co-occurring mental health and substance misuse symptoms; however, effective treatments are lacking. Objective: To evaluate the effectiveness of the Integrated Intervention for Dual Problems and Early Action (IIDEA) program compared with enhanced usual care. Design, Setting, and Participants: This effectiveness randomized clinical trial was conducted from September 2, 2014, to February 2, 2017, in 17 clinics or emergency departments and 24 community sites in Boston, Massachusetts, as well as in Madrid and Barcelona, Spain. Equal randomization (1:1) in 2-person blocks was used, assigning participants to either the IIDEA treatment group (n = 172) or the enhanced usual care control group (n = 169). Intent-to-treat analyses assessed effectiveness, and post hoc analyses examined whether results varied by symptom severity or treatment dose. Eligible participants were between 18 and 70 years of age, self-identified as Latino, screened positive for co-occurring symptoms, and were not receiving specialty behavioral health services. Interventions: Participants were randomized to a 10-session IIDEA treatment or to enhanced usual care. Main Outcomes and Measures: Primary outcomes were changes in alcohol and drug misuse and results of a urine test for drug metabolites but not for alcohol misuse. Secondary outcomes were symptoms of depression, generalized anxiety, posttraumatic stress disorder, and overall mental health. Results: In total, 341 participants were randomized to either the IIDEA treatment group (n = 172; 94 [54.7%] female, mean [SD] age, 33.5 [11.6] years) or the enhanced usual care control group (n = 169; 80 [47.3%] female, mean [SD] age, 34.3 [11.8] years). No statistically significant effects of IIDEA were found for primary drug and alcohol outcomes (ASI Lite-drug score: β = -0.02 [SE, 0.69; P = .88; Cohen d, 0.00; 95% CI, -0.17 to 0.17]; ASI Lite-alcohol score: β = -0.01 [SE, 1.19; P = .66; Cohen d, 0.00; 95% CI, -0.12 to 0.12]; urine drug test result: β = -0.36 [SE, 0.43; P = .50; OR, 0.70; 95% CI, 0.30-1.61]), but statistically significant effects were observed for secondary mental health outcomes. The IIDEA treatment was effective in reducing depressive symptoms per the Public Health Questionnaire-9 score (β = -1.14; SE, 0.47; P = .02; Cohen d, 0.20 [95% CI, 0.04-0.36]), posttraumatic stress disorder symptoms per the Posttraumatic Stress Disorder Checklist-5 score (β = -3.23; SE, 1.59; P = .04; Cohen d, 0.25 [95% CI, 0.01-0.37]), and overall mental health symptoms per the Hopkins Symptom Checklist-20 (β = -0.20; SE, 0.07; P = .01; Cohen d, 0.25 [95% CI, 0.08-0.42]) and composite mental health (β = -3.70; SE, 1.75; P = .04; Cohen d, 0.19 [95% CI, 0.01-0.36]) scores at the 6-month follow-up. Exploratory analyses suggested that 6-month treatment effects occurred for patients whose drug misuse was moderate to severe at the baseline assessment. Among patients with moderate to severe substance misuse, IIDEA substantially reduced substance use per the urine test results (odds ratio, 0.25 [95% CI, 0.09-0.67]; P = .01). Treatment dose showed small to large effect sizes by outcome. Conclusions and Relevance: The IIDEA treatment did not change drug misuse but did improve secondary mental health and substance misuse outcomes for a heterogeneous population with moderate to severe symptoms; this finding provides a path for treating Latino immigrants with co-occurring mental health and substance misuse symptoms. Trial Registration: ClinicalTrials.gov Identifier: NCT02038855.This study was funded in part by grant R01DA034952 from NIDA of the National Institutes of Health; grant R01MH100155-01S1 from NIMH; and grants ISCII PI13/02200 and PI16/01852 from Instituto de Salud Carlos III, grant 20151073 from Delegación del Gobierno para el Plan Nacional de Drogas, and grant LSRG-1-005-16 from the American Foundation for Suicide Prevention (Dr Baca-García

Canagliflozin and renal outcomes in type 2 diabetes and nephropathy

BACKGROUND Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium–glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes. METHODS In this double-blind, randomized trial, we assigned patients with type 2 diabetes and albuminuric chronic kidney disease to receive canagliflozin, an oral SGLT2 inhibitor, at a dose of 100 mg daily or placebo. All the patients had an estimated glomerular filtration rate (GFR) of 30 to <90 ml per minute per 1.73 m2 of body-surface area and albuminuria (ratio of albumin [mg] to creatinine [g], >300 to 5000) and were treated with renin–angiotensin system blockade. The primary outcome was a composite of end-stage kidney disease (dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m2), a doubling of the serum creatinine level, or death from renal or cardiovascular causes. Prespecified secondary outcomes were tested hierarchically. RESULTS The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. At that time, 4401 patients had undergone randomization, with a median follow-up of 2.62 years. The relative risk of the primary outcome was 30% lower in the canagliflozin group than in the placebo group, with event rates of 43.2 and 61.2 per 1000 patient-years, respectively (hazard ratio, 0.70; 95% confidence interval [CI], 0.59 to 0.82; P=0.00001). The relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34% (hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P<0.001), and the relative risk of end-stage kidney disease was lower by 32% (hazard ratio, 0.68; 95% CI, 0.54 to 0.86; P=0.002). The canagliflozin group also had a lower risk of cardiovascular death, myocardial infarction, or stroke (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P=0.01) and hospitalization for heart failure (hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P<0.001). There were no significant differences in rates of amputation or fracture. CONCLUSIONS In patients with type 2 diabetes and kidney disease, the risk of kidney failure and cardiovascular events was lower in the canagliflozin group than in the placebo group at a median follow-up of 2.62 years

Evaluation of the Integrated Intervention for Dual Problems and Early Action Among Latino Immigrants With Co-occurring Mental Health and Substance Misuse Symptoms

Would a tailored behavioral health intervention reduce substance misuse and mental health symptoms, compared with enhanced usual care, in Latino immigrants with co-occurring mental health and substance misuse symptoms? In this randomized clinical trial from 3 sites of 341 immigrants with co-occurring mental health and substance misuse symptoms, the primary outcome of substance misuse did not change in the intent-to-treat analysis. Patients who received the treatment statistically significantly experienced decreased mental health symptoms, compared with controls under enhanced usual care, and only participants with moderate to severe symptoms who received the intervention statistically significantly reduced their substance misuse. The intervention did not change drug misuse in a heterogeneous sample but did improve secondary mental health outcomes, a finding that might provide a path for treating Latino immigrants with co-occurring mental health symptoms whose symptoms are in the moderate-to-severe range. Immigrants are at an increased risk for co-occurring mental health and substance misuse symptoms; however, effective treatments are lacking. To evaluate the effectiveness of the Integrated Intervention for Dual Problems and Early Action (IIDEA) program compared with enhanced usual care. This effectiveness randomized clinical trial was conducted from September 2, 2014, to February 2, 2017, in 17 clinics or emergency departments and 24 community sites in Boston, Massachusetts, as well as in Madrid and Barcelona, Spain. Equal randomization (1:1) in 2-person blocks was used, assigning participants to either the IIDEA treatment group (n = 172) or the enhanced usual care control group (n = 169). Intent-to-treat analyses assessed effectiveness, and post hoc analyses examined whether results varied by symptom severity or treatment dose. Eligible participants were between 18 and 70 years of age, self-identified as Latino, screened positive for co-occurring symptoms, and were not receiving specialty behavioral health services. Participants were randomized to a 10-session IIDEA treatment or to enhanced usual care. Primary outcomes were changes in alcohol and drug misuse and results of a urine test for drug metabolites but not for alcohol misuse. Secondary outcomes were symptoms of depression, generalized anxiety, posttraumatic stress disorder, and overall mental health. In total, 341 participants were randomized to either the IIDEA treatment group (n = 172; 94 [54.7%] female, mean [SD] age, 33.5 [11.6] years) or the enhanced usual care control group (n = 169; 80 [47.3%] female, mean [SD] age, 34.3 [11.8] years). No statistically significant effects of IIDEA were found for primary drug and alcohol outcomes (ASI Lite-drug score: β = −0.02 [SE, 0.69; P = .88; Cohen d, 0.00; 95% CI, −0.17 to 0.17]; ASI Lite-alcohol score: β = −0.01 [SE, 1.19; P = .66; Cohen d, 0.00; 95% CI, −0.12 to 0.12]; urine drug test result: β = −0.36 [SE, 0.43; P = .50; OR, 0.70; 95% CI, 0.30-1.61]), but statistically significant effects were observed for secondary mental health outcomes. The IIDEA treatment was effective in reducing depressive symptoms per the Patient Health Questionnaire-9 score (β = −1.14; SE, 0.47; P = .02; Cohen d, 0.20 [95% CI, 0.04-0.36]), posttraumatic stress disorder symptoms per the Posttraumatic Stress Disorder Checklist-5 score (β = −3.23; SE, 1.59; P = .04; Cohen d, 0.25 [95% CI, 0.01-0.37]), and overall mental health symptoms per the Hopkins Symptom Checklist-20 (β = −0.20; SE, 0.07; P = .01; Cohen d, 0.25 [95% CI, 0.08-0.42]) and composite mental health (β = −3.70; SE, 1.75; P = .04; Cohen d, 0.19 [95% CI, 0.01-0.36]) scores at the 6-month follow-up. Exploratory analyses suggested that 6-month treatment effects occurred for patients whose drug misuse was moderate to severe at the baseline assessment. Among patients with moderate to severe substance misuse, IIDEA substantially reduced substance use per the urine test results (odds ratio, 0.25 [95% CI, 0.09-0.67]; P = .01). Treatment dose showed small to large effect sizes by outcome. The IIDEA treatment did not change drug misuse but did improve secondary mental health and substance misuse outcomes for a heterogeneous population with moderate to severe symptoms; this finding provides a path for treating Latino immigrants with co-occurring mental health and substance misuse symptoms. ClinicalTrials.gov Identifier: This randomized clinical trial evaluates the effectiveness of an integrated, multiyear cognitive behavior therapy, the Integrated Intervention for Dual Problems and Early Action (IIDEA), compared with enhanced usual care among Latino immigrants with dual mental health and substance misuse symptoms