NCT02081586.

Trial name or title	mHealth skill enhancement plus phone CBT for type 2 diabetes distress medication nonadherence: pilot study
Methods	Type of study: efficacy study Allocation: randomised Intervention model: parallel assignment Masking: open label Primary purpose: treatment
Participants	Condition: type 2 diabetes Enrollment: estimated 12 Inclusion criteria: have a diagnosis of T2DM have a score of >3 on the DDS be taking at least 1 oral antihyperglycaemic agent (the participant may also be using injectable antihyperglycaemic medications, including insulin) have an HbA1c level of greater than 8 at baseline be receiving treatment for T2DM in the primary care setting be aged 30‐65 years be able to read at the 8th‐grade level and to provide informed consent Exclusion criteria: diagnosis of bipolar disorder or schizophrenia; primary diagnosis of obsessive‐compulsive disorder, post‐traumatic stress disorder, substance abuse, or dependence in the last 6 months; or any psychotic disorder diabetes treated without oral medications inability to read or comprehend English at the 8th‐grade level refusal to provide informed consent dementia or disorders with substantial cognitive impairment serious suicidal risk
Interventions	Intervention(s): 6 Weeks phone CBT plus smart phone app 8 Weeks phone CBT plus smart phone app 12 weeks phone CBT plus smart phone app Comparator(s): Treatment as usual
Outcomes	Timepoint(s): baseline and 16 weeks Primary outcome(s): Acceptability questionnaire; feasibility and acceptability of the assessment protocol. Secondary outcome(s): MEMS cap electronic pill bottle; adherence to medications. DDS Medication Beliefs Scale; change in unhelpful medication beliefs HbA1c level BMI
Starting date	Trial start date: May 2013 Trial completion date: August 2014
Contact information	Responsible party/principal investigator: University of Pittsburgh/Judith A Callan
Study identifier	NCT number: NCT02081586
Official title	mHealth skill enhancement plus phone CBT for type 2 diabetes distress medication nonadherence: pilot study
Stated purpose of study	Quote: "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)."
Notes	Contact: Judith A Callan, callanja@pitt.edu Contact: Lisa Tamres, ltamres@pitt.edu