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. 2019 Dec 23;2019(12):CD013299. doi: 10.1002/14651858.CD013299.pub2

NCT02027259.

Trial name or title NCT02027259
Methods Design: RCT (pilot), parallel group
Country: US
Setting: Providence VA Medical Center
Participants Inclusion criteria: aged ≥ 18 years, clinical diagnosis of type 2 diabetes; clinical diagnosis of depression; PHQ‐9 score indicating depressive symptoms; most recent haemoglobin A1c ≥ 8.0% within the previous 12 months in the chart and currently have ≥ 1 of the following modifiable CVD risk factors not at target goals: current smoker (any cigarette smoking < 30 days), blood pressure > 130/80 mmHg, document at least twice in the last 6 months or LDL cholesterol > 100 mg/dL within the last 12 months.
Exclusion criteria: aged ≤ 17 years; inability to attend group sessions active psychosis of any type or organic brain injury that precludes diabetic management self‐care; type 1 diabetes as documented in the medical chart; pregnant; actively suicidal; end‐stage medical illness or people currently enrolled in diabetic management group programmes that include medication titration within the group setting would not be eligible due to cointervention.
Interventions Sample size (total randomised): 50
Length of trial: 6 months
Intervention: group visits with behavioural activation, consisting of 4 weekly group visits of a 2‐hour duration followed by monthly booster group visits for 6 months to prevent relapse.
Enrolled: 25 
Control: no intervention, standard group visits consisting of 4 weekly group visits of 2‐hour duration followed by monthly booster group visits for 6 months to prevent relapse
Enrolled: 25 
Outcomes Risk of future coronary events (change in United Kingdom Prospective Diabetes Study risk engine); depression symptoms (PHQ‐9)
Starting date  
Contact information  
Notes Sponsorship source: Providence VA Medical Center
Trial registration identifier: NCT02027259 (ClinicalTrials.gov Identifier) and 12CRP9840018 (other study ID Numbers)
Correspondence: corresponded with the PI in July 2019 and were informed that "the manuscript is still under revision." We were unable to obtain unpublished results.