CBT for Adherence and Depression in Diabetes

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven A. Safren, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00564070
First received: November 23, 2007
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention
Diabetes Mellitus
Depression
Behavioral: Enhanced treatment as usual plus adherence training
Behavioral: Enhanced treatment as usual plus CBT-AD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CBT for Adherence and Depression in Diabetes

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • changes in Medical adherence (glucose monitoring and hypoglycemic medications) and depression severity [ Time Frame: Measured at Months 4, 8, and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in Biomedical outcomes (hemoglobin A1C and self-monitored blood glucose values) [ Time Frame: Measured at Months 4, 8, and 12 ] [ Designated as safety issue: Yes ]

Enrollment: 87
Study Start Date: June 2007
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564070

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Study Director: Christina Psaros, PhD Partners HealthCare
Principal Investigator: Steven Safren, PhD Partners HealthCare
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven A. Safren, Director, Behavioral Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00564070     History of Changes
Other Study ID Numbers: R01 MH078571, R01MH078571
Study First Received: November 23, 2007
Last Updated: March 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Depression
Diabetes
Adherence

Additional relevant MeSH terms:
Depression
Depressive Disorder
Diabetes Mellitus
Behavioral Symptoms
Endocrine System Diseases
Glucose Metabolism Disorders
Mental Disorders
Metabolic Diseases
Mood Disorders

ClinicalTrials.gov processed this record on October 20, 2014