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 We were unable to obtain unpublished results. |