mHealth Skill Enhancement Plus Phone CBT for Type 2 Diabetes Distress Medication Nonadherence: Pilot Study

May 12, 2017 updated by: Judith A. Callan PhD. RN, University of Pittsburgh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 6 Weeks Phone CBT plus smartphone app
Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
Behavioral: CBT
Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Other Names:
  • Cognitive Behavioral Therapy
Device: Smartphone app
Smartphone app developed to assist patients practice CBT skills throughout the week
Other Names:
  • CBT Mobile Work
Other: Standard Diabetes Care at PCP
Patients receive ADA standard of Care with physician at PCP office
Experimental: 8 Weeks Phone CBT plus smartphone app
Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
Behavioral: CBT
Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Other Names:
  • Cognitive Behavioral Therapy
Device: Smartphone app
Smartphone app developed to assist patients practice CBT skills throughout the week
Other Names:
  • CBT Mobile Work
Other: Standard Diabetes Care at PCP
Patients receive ADA standard of Care with physician at PCP office
Experimental: 12 weeks phone CBT plus smartphone app
Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
Behavioral: CBT
Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Other Names:
  • Cognitive Behavioral Therapy
Device: Smartphone app
Smartphone app developed to assist patients practice CBT skills throughout the week
Other Names:
  • CBT Mobile Work
Other: Standard Diabetes Care at PCP
Patients receive ADA standard of Care with physician at PCP office
Active Comparator: Standard Diabetes Care at PCP
Patients will remain in usual care and not receive study intervention. This will include usual diabetes care at PCP.
Other: Standard Diabetes Care at PCP
Patients receive ADA standard of Care with physician at PCP office

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c Level Change Scores From Baseline to 16 Weeks
Time Frame: baseline to 16 weeks
Change from baseline HbA1c level to post intervention
baseline to 16 weeks
Computer System Usability Questionnaire (CSUQ)
Time Frame: 16 weeks

The CSUQ measures feasibility and acceptability of the phone application. Adapted from Lewis JR.: IBM Computer Usability Satisfaction Questionnaires: Psychometric Evaluation and Instructions for Use. International Journal of Human-Computer Interaction 1995; 7 (1):67-78.

Scale is scored as a mean value, range is from 1 to 7. In this adaptation lower scores are better usability.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MEMS (Medication Electronic Monitoring System) Cap Electronic Pill Bottle Adherence
Time Frame: 16 weeks
Electronically measured medication adherence, percent adherence over entire study phase. Change score was not evaluated, this measure is to determine feasability of use over time. Percent adherence is measured by the number of correct doses per day divided by the number of prescribed doses per day X 100. Percent adherence was calculated as the percentage of the prescribed doses of the medication actually taken by the patient over 16 weeks
16 weeks
Diabetes Distress Scale- Change Score
Time Frame: baseline to 16 weeks
Levels of diabetes distress per standardized questionnaire will be measured before intervention and after intervention. Percent change of mean score between baseline and 16 weeks is reported. Adapted from Fisher, L., Glasgow, R.E., Mullan, J.T., Skaff, M.M., Polonsky, W.H. (2008) Development of a Brief Diabetes Screening Instrument. Annals of Family Medicine; 6:246-252.
baseline to 16 weeks
Body Mass Index Change
Time Frame: baseline to 16 weeks
Change in Body Mass Index from baseline to post intervention
baseline to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Judith A Callan, PhD, University of Pittsburgh School of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 7, 2014

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

May 12, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO13040441
  • KL2TR000146 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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