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Randomized Controlled Trial
. 2013 Sep;36(9):2551-8.
doi: 10.2337/dc12-2493. Epub 2013 Jun 4.

REDEEM: a pragmatic trial to reduce diabetes distress

Affiliations
Randomized Controlled Trial

REDEEM: a pragmatic trial to reduce diabetes distress

Lawrence Fisher et al. Diabetes Care. 2013 Sep.

Abstract

Objective: To compare three interventions to reduce diabetes distress (DD) and improve self-management among non-clinically depressed adults with type 2 diabetes mellitus (T2DM).

Research design and methods: In REDEEM, 392 adults with T2DM and DD were randomized to computer-assisted self-management (CASM), CASM plus DD-specific problem solving (CAPS), or a computer-administered minimal supportive intervention. Primary outcomes were Diabetes Distress Scale (DDS) total, the Emotional Burden (EB) and Regimen Distress (RD) DDS subscales, and diet, exercise, and medication adherence.

Results: Significant and clinically meaningful reductions in DD (DDS, EB, and RD) and self-management behaviors occurred in all three conditions (P < 0.001), with no significant between-group differences. There was, however, a significant group × baseline distress interaction (P < 0.02), in which patients with high baseline RD in the CAPS condition displayed significantly larger RD reductions than those in the other two conditions. RD generated the most distress and displayed the greatest distress reduction as a result of intervention. The pace of DD reduction varied by patient age: older patients demonstrated significant reductions in DD early in the intervention, whereas younger adults displayed similar reductions later. Reductions in DD were accompanied by significant improvements in healthy eating, physical activity, and medication adherence, although not by change in HbA1c.

Conclusions: DD is malleable and highly responsive to intervention. Interventions that enhance self-management also reduce DD significantly, but DD-specific interventions may be necessary for patients with high initial levels of DD. Future research should identify the minimal, most cost-effective interventions to reduce DD and improve self-management.

Trial registration: ClinicalTrials.gov NCT00714441.

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Figures

Figure 1
Figure 1
Consort diagram of REDEEM study participation and retention. “Missed” indicates the participant missed the stage, but this did not preclude them from participating in a later stage of the project. assess., assessment.

References

    1. Gonzalez JS, Fisher L, Polonsky WH. Depression in diabetes: have we been missing something important? Diabetes Care 2011;34:236–239 - PMC - PubMed
    1. Fisher L, Hessler DM, Polonsky WH, Mullan JT. When is diabetes distress clinically meaningful?: establishing cut points for the Diabetes Distress Scale. Diabetes Care 2012;35:259–264 - PMC - PubMed
    1. Fisher L, Glasgow RE, Strycker LA. The relationship between diabetes distress and clinical depression with glycemic control among patients with type 2 diabetes. Diabetes Care 2010;33:1034–1036 - PMC - PubMed
    1. Fisher L, Mullan JT, Arean P, Glasgow RE, Hessler D, Masharani U. Diabetes distress but not clinical depression or depressive symptoms is associated with glycemic control in both cross-sectional and longitudinal analyses. Diabetes Care 2010;33:23–28 - PMC - PubMed
    1. Tsujii S, Hayashino Y, Ishii H, Diabetes Distress and Care Registry at Tenri Study Group Diabetes distress, but not depressive symptoms, is associated with glycaemic control among Japanese patients with type 2 diabetes: Diabetes Distress and Care Registry at Tenri (DDCRT 1). Diabet Med 2012;29:1451–1455 - PubMed

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