CBT for Adherence and Depression in Diabetes

Depression Clinical Trial

Official title:

CBT for Adherence and Depression in Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564070
• Other study ID #: R01MH078571
• Secondary ID: R01MH078571
• Status: Completed
• Phase: N/A
• First received: November 23, 2007
• Last updated: December 7, 2017
• Start date: June 2007
• Est. completion date: March 2012

Study information

• Verified date: December 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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	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