CBT for Adherence and Depression in Diabetes

This study will evaluate the effectiveness of cognitive behavioral therapy (CBT) in treating people with depression and type 2 diabetes.

Study Overview

• Status: Completed
• Conditions: Depression; Diabetes Mellitus
• Intervention / Treatment: Behavioral: Enhanced treatment as usual plus adherence training; Behavioral: Enhanced treatment as usual plus CBT-AD

Detailed Description

Depression is a serious illness that affects a person's mood, thoughts, and physical being. Common symptoms of depression include persistent feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; disinterest in previously enjoyed activities; excessive irritability and restlessness; suicidal thoughts; and inability to concentrate. Depression is highly comorbid, often occurring in the presence of one or more other disorders. Up to 15% to 20% of the time, people with diabetes are also depressed. Diabetes is a disease that interferes with the body's proper production and use of the hormone insulin, which is needed to convert food into the energy required to perform daily life activities. Self-care is a crucial component of diabetes treatment. However, symptoms of depression can interfere with behaviors necessary to carry out this care. Cognitive behavioral therapy (CBT) has shown success in treating people with depression, but the effect of CBT on self-care behaviors and depression of those with diabetes is not well known. This study will evaluate the effectiveness of CBT for medical adherence and depression (CBT-AD) in people with a depressive mood disorder and type 2 diabetes.

Upon study entry, all participants will complete various assessments, including a psychiatric diagnostic interview, a series of paper questionnaires, neuropsychological testing, blood sample analysis, and blood sugar monitoring. Next, all participants will meet with a nutritionist and a nurse diabetes educator. The nutritionist will help set goals for eating, physical activity, weight, and blood glucose. The nurse diabetes educator will review diabetes medication history and blood glucose self-monitoring equipment.

Participants will then be randomly placed in one of two counseling groups. One group will meet for a single session that will be devoted to diabetes medical adherence. The other group will attend 10 to12 individual CBT sessions for diabetes medical adherence and depression management. The CBT sessions will last 45 to 50 minutes and will require practice of coping skills outside the sessions. Participants receiving CBT will also complete weekly assessments of depression, self-care, and diabetes medical adherence. All participants will be asked to monitor a prescribed medication with a pill cap for the course of the study. At Month 2, participants in both groups will also meet again with the nutritionist to review original goals and adjust them as necessary. Most of the previous study assessments will be repeated at Months 4, 8, and 12. The neuropsychological testing will be repeated only at Month 12.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of type 2 diabetes that is poorly controlled despite treatment with an oral hypoglycemic, insulin, or both
• Diagnosis of major depression or dysthymia, or current subclinical symptoms of depression in spite of prescription of an antidepressant
• If on an antidepressant, oral hypoglycemic medication, or insulin, must have been on a stable dose for the preceding two months

Exclusion Criteria:

• Active untreated major mental illness (e.g., untreated psychosis), bipolar disorder, eating disorder, mental retardation, or dementia
• Experiencing suicidal thoughts
• History of or currently receiving CBT for depression
• Uses an insulin pump

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enhanced treatment as usual; Enhanced treatment as usual plus single-session life-steps treatment	Behavioral: Enhanced treatment as usual plus adherence training; The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management.
Experimental: CBT-AD; Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)	Behavioral: Enhanced treatment as usual plus CBT-AD; The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose Monitoring Adherence at Acute Outcome	Medical adherence is a percent via the electronic monitoring using glucometer. This is a percent with a possible range of 0-100, with higher scores denoting better adherence.	Measured at Month 4
Percent Medication Adherence Via MEMS	This is an electronic pill cap at the acute outcome assessment. This is a percent with a possible range of 0-100, higher scores indicating greater adherence	month 4
Clinician Rated Depression (MADRS) at the Acute Timepoint	Depression as assessed by the Montgomery Asberg Depression Rating Scale (MADRS). This scale has a range of 0-60 with higher scores indicating greater depression severity.	month 4
Depression on the CGI at Acute Outcome	Clinical Global Impression is a scale from 1-7 with greater numbers meaning more severe depression	Month 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose Control	Hemoglobin A1C value at acute outcome. HbA1c is the number of hemoglobin in red blood cells that is glycosylated (attached to sugar) and is reported here as a percentage.	Month 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose Monitoring During Followup.	This is a percent with a possible range of 0-100 with higher scores indicating better adherence. One Touch Ultra meters (LifeScan, Inc.) for daily glucose control provided frequency of self-monitoring, which when divided by the individualized goals from the nurse visits and multiplied by 100, yielded a percentage adherence score. This percentage adherence score was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall percentage adherence score for each arm throughout the course of the study.	Aggregate of months 4,8,12
Percent Medication Adherence During Follow up	Electronic pill cap adherence which indicates a percentage of doses taken. This percentage of doses taken was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall percentage of doses taken for each arm throughout the course of the study.	Aggregate across 4,8,12 months
Depression MADRS Over Follow up	Independent (blind) assessor rating using the MADRS. This scale has a range of 0-60 with higher scores indicating greater depression severity. This depression score was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall depression score for each arm throughout the course of the study.	Aggregate across 4,8,12 months
Depression CGI	Clinical Global Impression scale as rated by blinded interviewer. The CGI is a scale from 1-7 with greater numbers meaning more severe depression. This depression score was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall depression score for each arm throughout the course of the study.	Aggregate 4,8,12 months
Glucose Control Over Follow up	Percent of HbA1c as assessed by blood analysis. HbA1c is the number of hemoglobin in red blood cells that is glycosylated (attached to sugar) and is reported here as a percentage. This percentage of HbA1c was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall percentage of HbA1c for each arm throughout the course of the study.	Aggregate across 4,8,12 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Study Director: Christina Psaros, PhD, Partners HealthCare; Principal Investigator: Steven Safren, PhD, University of Miami

Publications and helpful links

General Publications

• Safren SA, Gonzalez JS, Wexler DJ, Psaros C, Delahanty LM, Blashill AJ, Margolina AI, Cagliero E. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in patients with uncontrolled type 2 diabetes. Diabetes Care. 2014;37(3):625-33. doi: 10.2337/dc13-0816. Epub 2013 Oct 29. Erratum In: Diabetes Care. 2016 Jun;39(6):1065.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: November 23, 2007
• First Submitted That Met QC Criteria: November 23, 2007
• First Posted (Estimate): November 27, 2007

Study Record Updates

• Last Update Posted (Actual): January 8, 2018
• Last Update Submitted That Met QC Criteria: December 7, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Diabetes; Adherence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Mood Disorders; Endocrine System Diseases; Depression; Depressive Disorder; Diabetes Mellitus
• Other Study ID Numbers: R01MH078571 (U.S. NIH Grant/Contract)