Effectiveness of Cognitive Behavioral Therapy in Improving Adherence and Depressive Symptoms in People With Diabetes
Effectiveness of Cognitive Behavioral Therapy in Improving Adherence and Depressive Symptoms in People With Diabetes
December 03, 2008
Clinicaltrials.gov
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), October 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00564070
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
MedlinePlus related topics: Depression Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: CBT for Adherence and Depression in Diabetes
Further study details as provided by National Institute of Mental Health (NIMH):
Primary Outcome Measures:
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:
Biomedical outcomes (hemoglobin A1C and self-monitored blood glucose values) [ Time Frame: Measured at Months 4, 8, and 12 ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 100
Study Start Date: July 2007
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
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.
2: Experimental
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 4 months during treatment. 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 70 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564070
Contacts
Contact: Jesse Wilkinson, BS 617-643-2149
Contact: Luis Serpa, BA 617-643-4566 lserpa@partners.org
Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Steven Safren, PhD
Sub-Investigator: Jeffrey Gonzalez, PhD
Sub-Investigator: Enrico Cagliero, MD
Sub-Investigator: Linda Delahanty
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Christina Psaros Partners HealthCare
Study Director: Jeffrey Gonzalez, PhD Partners HealthCare
More Information
Responsible Party: Partners Healthcare ( Christina Psaros and Jeffrey Gonzalez, PhD )
Study ID Numbers: R01 MH78571, DAHBR 96-BHA
First Received: November 23, 2007
Last Updated: October 24, 2008
ClinicalTrials.gov Identifier: NCT00564070
Health Authority: United States: Federal Government
Keywords provided by National Institute of Mental Health (NIMH):
Depression
Diabetes
Adherence
Study placed in the following topic categories:
Metabolic Diseases
Depression
Mental Disorders
Mood Disorders
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Depressive Disorder
Behavioral Symptoms
ClinicalTrials.gov processed this record on December 03, 2008
