RT Journal Article SR Electronic T1 Effects of an integrated mindfulness intervention for veterans with diabetes distress: a randomized controlled trial JF BMJ Open Diabetes Research & Care JO BMJ Open Diab Res Care FD American Diabetes Association SP e002631 DO 10.1136/bmjdrc-2021-002631 VO 10 IS 2 A1 Monica M DiNardo A1 Carol Greco A1 Angela D Phares A1 Nicole M Beyer A1 Ada O Youk A1 D Scott Obrosky A1 Natalia E Morone A1 Jason E Owen A1 Shaddy K Saba A1 Stephen J Suss A1 Linda Siminerio YR 2022 UL http://drc.bmj.com/content/10/2/e002631.abstract AB Introduction US military veterans have disproportionately high rates of diabetes and diabetes-related morbidity in addition to being at risk of comorbid stress-related conditions. This study aimed to examine the effects of a technology-supported mindfulness intervention integrated into usual diabetes care and education on psychological and biobehavioral outcomes.Research design and methods Veterans (N=132) with type 1 or 2 diabetes participated in this two-arm randomized controlled efficacy trial. The intervention arm received a one-session mindfulness intervention integrated into a pre-existing program of diabetes self-management education and support (DSMES) plus one booster session and 24 weeks of home practice supported by a mobile application. The control arm received one 3-hour comprehensive DSMES group session. The primary outcome was change in diabetes distress (DD). The secondary outcomes were diabetes self-care behaviors, diabetes self-efficacy, post-traumatic stress disorder (PTSD), depression, mindfulness, hemoglobin A1C (HbA1C), body weight, and blood pressure. Assessments were conducted at baseline, 12 weeks, and 24 weeks. Participant satisfaction and engagement in home practice were assessed in the intervention group at 12 and 24 weeks.Results Intention-to-treat group by time analyses showed a statistically significant improvement in DD in both arms without significant intervention effect from baseline to 24 weeks. Examination of distal effects on DD between weeks 12 and 24 showed significantly greater improvement in the intervention arm. Improvement in DD was greater when baseline HbA1C was <8.5%. A significant intervention effect was also shown for general dietary behaviors. The secondary outcomes diabetes self-efficacy, PTSD, depression, and HbA1C significantly improved in both arms without significant intervention effects. Mindfulness and body weight were unchanged in either group.Conclusions A technology-supported mindfulness intervention integrated with DSMES showed stronger distal effects on DD compared with DSMES control. Examination of longer-term outcomes, underlying mechanisms, and the feasibility of virtual delivery is warranted.Trial registration number NCT02928952.All data relevant to the study are included in the article or uploaded as supplementary information.