Brief CBT Interventions Delivered by Nurse Care Managers to Improve Type 2 Diabetes Outcomes: Pilot Study

Diabetes Mellitus, Type 2 Clinical Trial

Official title: Brief CBT Interventions Delivered by Nurse Care Managers to Improve Type 2 Diabetes Outcomes: Pilot Study

Status Completed

Clinical Trial Summary

Primary aim: examine feasibility and acceptability of a brief cognitive therapy protocol for type II diabetes administered by nurse care managers or health coaches via phone.

Clinical Trial Description

A significant problem in primary care healthcare delivery is the lack of interventions to improve medication and overall regimen adherence in persons with Type 2 diabetes (T2DM). Diabetes distress, a negative response to the diagnosis of T2DM, danger of complications, and self-management burdens is present in up to 70% of persons with T2DM. Distress is a significant factor in medication nonadherence and poor glycemic control. Treatment adherence is vital to maintain glucose control and reduce complications.

The literature has identified dysfunctional thinking patterns such as beliefs (e.g., I can't handle taking these medications), assumptions (e.g., I know I will have side effects to these medications) and interpretations (e.g., I'm too overwhelmed to do all of this stuff) as critical variables that impact both distress and T2DM treatment adherence. Current treatment strategies within primary care do not address the dysfunctional thinking patterns that affect the patient's distress level, T2DM medication adherence, and complex daily self-care activities.

Cognitive behavior therapy (CBT), a well-established evidenced-based treatment, helps patients to identify, and restructure dysfunctional thinking patterns. We propose to test a brief CBT approach delivered by nurse care managers and supported by a comprehensive mobile phone CBT skills practice application (app) within primary care. The promising results of our preliminary studies using a mobile phone app to stimulate real-time CBT skills practice prompt us to propose a pilot of its use with patients with T2DM with the following aims:

Primary aim: examine feasibility and acceptability of the assessment protocol, and the recruitment, and retention of study participants.

Secondary aim: 1) collect preliminary data on the effect of the intervention on clinical outcomes, e.g., self-reported adherence to medication and self-management adherence, e.g., diet, exercise; levels of diabetes distress, diabetes medication beliefs, and distal T2DM outcomes (HbA1c level and body mass index). ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

• NCT number: NCT02081573
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Completion date: July 2016