N/A
Completed N=13
mHealth Skill Enhancement Plus Phone CBT for Type 2 Diabetes Distress Medication Nonadherence: Pilot Study
Source: ClinicalTrials.gov NCT02081586 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: HbA1c Level Change Scores From Baseline to 16 Weeks — -0.60; -2.30; -2.33; -2.15 percent
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Level Change Scores From Baseline to 16 Weeks |
-0.60; -2.30; -2.33; -2.15 | — |
| PRIMARY Computer System Usability Questionnaire (CSUQ) |
3.0 | — |
| SECONDARY MEMS (Medication Electronic Monitoring System) Cap Electronic Pill Bottle Adherence |
37.7; 35.7; 88.69; 84.06 | — |
| SECONDARY Diabetes Distress Scale- Change Score |
-17.98; -8.33; -40.92; -36.22 | — |
| SECONDARY Body Mass Index Change |
.23; -1.2; .53; .35 | — |
Eligibility Criteria
Inclusion Criteria
- have a diagnosis of T2DM;
- have a score of >3 on the Diabetes Distress Scale;
- be taking at least one oral antihyperglycemic agent (the patient may also be using injectable antihyperglycemic 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 and
- 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, posttraumatic 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; and
- serious suicidal risk -
Data sourced from ClinicalTrials.gov (NCT02081586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.