An Emotion-Focused Intervention for Glycemic Control in T2D
Condition: Type2 Diabetes
Study type: Interventional

Summary: 
      The primary aim of this proposed project is to collect pilot data using an Emotion-Focused
      CBT Psycho-social Intervention i individuals with T2D to obtain the effect sizes on
      hypothesized changes in Negative Emotionality, Diabetes Distress, and HbA1c values that will
      be needed for a more appropriately sized clinical trial for an RO1 submission to the National
      Institutes of Health.
    

Detailed description: 
      Our interest in aberrant Emotional Regulation / Emotional Intelligence in Type 2 Diabetes
      stems from observations that while many patients with Type 2 Diabetes have greater incidence
      of mood and anxiety (and even anger) disorders than controls, targeting psychiatric
      conditions, such as depression, is not sufficient to improve glycemic control in patients
      with diabetes. Thus, the key issue for such patients is not what specific psychiatric
      disorder they have, but the presence of an impairment in the fundamental regulation of
      emotional regulation and in how such individuals modulate their emotional response to
      aversive events in their lives (e.g., emotional intelligence), now suggested by a recent
      study. As part of a new study, we examined the relationship between glycemic control (HbA1c)
      and Emotional Experience (ER-Exp) and Skill at Emotional Regulation (ER-Skill) in 100 adult
      patients with Type 2 Diabetes. We found significant relationships between ER-Exp and ER-Skill
      and HbA1c levels that accounted for nearly 24% of the variance in HbA1c levels. These
      relationships with HbA1c levels remained even after accounting for other relevant behavioral
      variables such as depression/anxiety scores and diabetes self-care/literacy scores.
      Accordingly, the tendency of an individual to have intense emotional responses (higher scores
      on ER-Exp), and/or to have a reduced ability to understand/modulate one's emotions in order
      to cope with daily stresses/threats (lower scores on ER-Skill), may well be linked with poor
      glycemic control (HbA1c) in adult patients with Type 2 Diabetes. If so, it will be important
      to develop psycho-social methods to improve ER-Exp and DR-Skill in Type 2 Diabetes patients
      to determine if one can improve aberrant Emotional Regulation (ER-Exp/ER-Skill), Diabetes
      Distress (DD), and HbA1c (A1c) levels as suggested by treatment studies showing that such
      treatment can improve ER-Skill with a sustained reduction in A1c levels in Type 2 Diabetes
      for up to nine months. Supporting these findings are data from a recent study showing that
      increasing positive emotion reduces (and increasing negative emotion increases) blood glucose
      levels, especially in those with poor emotion regulation skills.

      Specific Study Objectives:

        -  Develop an integrated Emotion - Focused Psycho-social EF-CBT) from three (3) existing
           sources that contain elements to improve ER-Exp and ER-Skill.

        -  Conduct a pilot study in 10 patients with Type 2 Diabetes with aberrant
           ER-ER-Exp/ER-Skill and compare treatment outcomes in emotionality, diabetes distress,
           and in A1c levels with 10 patients with Type 2 Diabetes undergoing treatment as usual
           (TAU).
    

Intervention name(s): Emotion-Focused CBT
Intervention type(s): Behavioral
Intervention description(s): 10 CBT Sessions to improve emotional regulation and emotional intelligence.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Emotion-Focused CBT
Masking: None (Open Label)
Primary purpose: Treatment