eHealth Hub Portfolio

Administrative Core Researchers

Pilot Study: Brief Technology-Supported Cognitive Behavior Therapy (CBT)

Intervention for Type 2 Diabetes Nonadherence
Judith Callan, PhD, Principal Investigator

A significant problem in primary care healthcare delivery is the lack of effective 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 and a significant factor in medication nonadherence and poor glycemic control. 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) have been identified 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. This pilot study is testing a brief CBT approach delivered to persons with T2DM by nurse care managers in primary care and supported by a comprehensive, mobile phone CBT skills practice application (app).

The primary aim is to examine the feasibility and acceptability of the assessment protocol and the strategies used for recruitment and retention of study participants. The secondary aim is to 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).

Infrastructure Enhancement Project: Intervention Fidelity

Addressing intervention fidelity is essential to ensure that an intervention is delivered consistently and to explain study findings, draw accurate conclusions about treatment efficacy, increase internal validity (replication), external validity (generalizability), and translate interventions into practice. Despite proliferation of technology-based behavioral interventions and growing recognition of the importance of evaluating intervention fidelity, descriptions of the unique considerations and practical guidance for evaluating fidelity of technology-based behavioral interventions are lacking.

This project is designed to ensure that intervention trials conducted by eHealth Hub investigators (1) promote, measure, and evaluate intervention fidelity comprehensively and consistently, and (2) test the relationships purported in the intervention fidelity framework for technology-based behavioral interventions.

Enhancement activities include:

  • Planning a training workshop to help investigators develop protocols that address intervention fidelity in technology-based behavioral intervention trials.
  • Ongoing consultation to encourage use of both customized and standardized measures of intervention delivery, receipt, technology acceptance, adoption, and enactment in efficacy or effectiveness trials conducted by Hub investigators.
  • Pooled analysis of technology acceptance data ascertained with common measures across eHealth trials.