mHealth Skill Enhancement Plus Phone CBT for Type 2 Diabetes Distress Medication Nonadherence: Pilot Study
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This is a pilot study examining the clinical effects of a brief Cognitive Therapy phone
      approach augmented with a CBT smartphone app geared towards patients with type 2 diabetes
      patients in poor control.
    

Detailed 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. The investigators
      propose to test a brief phone CBT approach that is supported by a comprehensive mobile phone
      CBT skills practice application (app) within primary care. The promising results of the
      investigators 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).
    

Intervention name(s): CBT; Smartphone app; Standard Diabetes Care at PCP
Intervention type(s): Behavioral; Device; Other
Intervention description(s): Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.; Smartphone app developed to assist patients practice CBT skills throughout the week; Patients receive ADA standard of Care with physician at PCP office
Other intervention name(s): Cognitive Behavioral Therapy; CBT Mobile Work
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CBT; Type 2 Diabetes; Diabetes Distress; Adherence; Smartphone App; Self-management