Clinical trial NCT02081586: mHealth Skill Enhancement Plus Phone CBT for Type 2 Diabetes Distress Medication Nonadherence: Pilot Study
Official title: mHealth Skill Enhancement Plus Phone CBT for Type 2 Diabetes Distress Medication Nonadherence: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: CBT
Type 2 Diabetes
Diabetes Distress
Adherence
Smartphone App
Self-management
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2014-03-07
Enrollment: 13
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

1. have a diagnosis of T2DM;
2. have a score of \>3 on the Diabetes Distress Scale;
3. be taking at least one oral antihyperglycemic agent (the patient may also be using injectable antihyperglycemic medications, including insulin);
4. have an HbA1c level of greater than 8 at baseline;
5. be receiving treatment for T2DM in the primary care setting;
6. be aged 30 - 65 years and
7. be able to read at the 8th-grade level and to provide informed consent. -

Exclusion Criteria:

1. 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;
2. diabetes treated without oral medications;
3. inability to read or comprehend English at the 8th-grade level;
4. refusal to provide informed consent;
5. dementia or disorders with substantial cognitive impairment; and
6. serious suicidal risk -

Primary outcomes:
measure: HbA1c Level Change Scores From Baseline to 16 Weeks
timeFrame: baseline to 16 weeks
measure: Computer System Usability Questionnaire (CSUQ)
timeFrame: 16 weeks
Secondary outcomes:
measure: MEMS (Medication Electronic Monitoring System) Cap Electronic Pill Bottle Adherence
timeFrame: 16 weeks
measure: Diabetes Distress Scale- Change Score
timeFrame: baseline to 16 weeks
measure: Body Mass Index Change
timeFrame: baseline to 16 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Nursing
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh School of Nursing
name: Judith A Callan, PhD
role: PRINCIPAL_INVESTIGATOR
References: