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

NCT ID: NCT02081586

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-07-31

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).

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CBT

Intervention Type: BEHAVIORAL

Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.

Smartphone app

Intervention Type: DEVICE

Smartphone app developed to assist patients practice CBT skills throughout the week

Standard Diabetes Care at PCP

Intervention Type: OTHER

Patients receive ADA standard of Care with physician at PCP office

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.

Group Type: EXPERIMENTAL

CBT

Intervention Type: BEHAVIORAL

Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.

Smartphone app

Intervention Type: DEVICE

Smartphone app developed to assist patients practice CBT skills throughout the week

Standard Diabetes Care at PCP

Intervention Type: OTHER

Patients receive ADA standard of Care with physician at PCP office

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.

Group Type: EXPERIMENTAL

CBT

Intervention Type: BEHAVIORAL

Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.

Smartphone app

Intervention Type: DEVICE

Smartphone app developed to assist patients practice CBT skills throughout the week

Standard Diabetes Care at PCP

Intervention Type: OTHER

Patients receive ADA standard of Care with physician at PCP office

Standard Diabetes Care at PCP

Patients will remain in usual care and not receive study intervention. This will include usual diabetes care at PCP.

Group Type: ACTIVE_COMPARATOR

Standard Diabetes Care at PCP

Intervention Type: OTHER

Patients receive ADA standard of Care with physician at PCP office

Interventions

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.

Intervention Type: BEHAVIORAL

Smartphone app

Smartphone app developed to assist patients practice CBT skills throughout the week

Intervention Type: DEVICE

Standard Diabetes Care at PCP

Patients receive ADA standard of Care with physician at PCP office

Intervention Type: OTHER

Other Intervention Names

Cognitive Behavioral Therapy; CBT Mobile Work

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 -

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Judith A. Callan PhD. RN

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judith A Callan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh School of Nursing

Locations

University of Pittsburgh School of Nursing

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Callan JA, Sereika SM, Cui R, Tamres LK, Tarneja M, Greene B, Van Slyke A, Wu M, Lukac GR, Dunbar-Jacob J. Cognitive Behavioral Therapy (CBT) Telehealth Augmented With a CBT Smartphone Application to Address Type 2 Diabetes Self-Management: A Randomized Pilot Trial. Sci Diabetes Self Manag Care. 2022 Dec;48(6):492-504. doi: 10.1177/26350106221133027. Epub 2022 Nov 9.

Reference Type: DERIVED

PMID: 36350066 (View on PubMed)

Other Identifiers

KL2TR000146

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO13040441

Identifier Type: -

Identifier Source: org_study_id