mHealth Skill Enhancement Plus Phone CBT for Type 2 Diabetes Distress Medication Nonadherence: Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 30 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | May 2013 |
| End Date: | August 2014 |
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).
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).
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 -
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