Cognitive Behavioral Therapy (CBT) for Adherence and Depression in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven A. Safren, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01527981
First received: January 31, 2012
Last updated: February 3, 2012
Last verified: February 2012
  Purpose

This study is a pilot behavioral intervention trial, designed to initially examine cognitive behavioral therapy for medical adherence and depression (CBT-AD) in patients with depression and poorly controlled type 1 diabetes.


Condition Intervention Phase
Depression
Type 1 Diabetes
Behavioral: Cognitive behavioral therapy for adherence and depression
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CBT for Adherence and Depression in Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Changes in glucose monitoring [ Time Frame: Baseline assessment; 4, 8, and 12 months post-intervention assessments ] [ Designated as safety issue: No ]
    We used electronic glucometers to measure participants' adherence to prescribed glucose self-monitoring, which record each time glucose was measured and the glucose level of each measurement.

  • Changes in insulin adherence [ Time Frame: Baseline assessment; 4, 8, and 12 months post-intervention assessments ] [ Designated as safety issue: No ]
    We assessed adherence to participants' self-administered insulin through a self-report questionnaire.

  • Changes in depression severity [ Time Frame: Baseline assessment; 4, 8, and 12 months post-intervention assessments ] [ Designated as safety issue: No ]
    Participants' depression severity was measured by clinician-administered measures (Montgomery-Asberg Depression Rating Scale) and self-report measures (Center for Epidemiological Studies Depression Scale). Clinician-delivered measures were administered at baseline and follow-up assessments by assessors blinded to participants' randomization status.


Secondary Outcome Measures:
  • Changes in hemoglobin A1C [ Time Frame: Baseline assessment; 4, 8, and 12 months post-intervention assessment ] [ Designated as safety issue: No ]
    We measured participants hemoglobin A1C by means of a blood draw and laboratory test.

  • Changes in glucose levels [ Time Frame: Baseline assessment; 4, 8, and 12 months post-intervention assessment ] [ Designated as safety issue: No ]
    We measured participants self-monitored glucose levels using electronic glucometers, which record the glucose level of each measurement.


Enrollment: 9
Study Start Date: March 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT-AD
Participants received weekly one-hour CBT-AD sessions focusing on diabetes self-care and depression for approximately 10 sessions. Participants also had meetings with a registered dietitian and a nurse educator, focusing on nutritional management of diabetes and diabetes self-care education, respectively.
Behavioral: Cognitive behavioral therapy for adherence and depression
Cognitive-behavioral therapy for adherence and depression (CBT-AD) is a weekly, psychosocial treatment focusing on depression and patients' adherence to diabetes self-care. Treatment consists of weekly one-hour sessions for approximately 10 sessions.
Other Name: CBT-AD

  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 1 diabetes that is poorly controlled (HbA1C greater than or equal to 8.0%) despite treatment with insulin.
  • Diagnosis of major depression and/or dysthymia, or current subclinical symptoms of depression in spite of being treated with antidepressants.
  • Age 18-80.
  • If on an antidepressant, stable for two months. Oral hypoglycemic medications stable for 2 months, and insulin prescription stable for 2 months (if prescribed).

Exclusion Criteria:

  • Active or untreated major mental illness that would interfere with participation (e.g., untreated psychosis), untreated/unstable bipolar disorder, eating disorder, mental retardation, dementia, or active suicidality.
  • Unable or unwilling to provide informed consent.
  • History of or current CBT for depression.
  • Currently on dialysis.
  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: NCT01527981

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Steven A Safren, Ph.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Steven A. Safren, Director, Behavioral Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01527981     History of Changes
Other Study ID Numbers: MGHBMED2172010
Study First Received: January 31, 2012
Last Updated: February 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Depression
Diabetes
Adherence
Medication
Glucose
Insulin

Additional relevant MeSH terms:
Depression
Depressive Disorder
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Behavioral Symptoms
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Mental Disorders
Metabolic Diseases
Mood Disorders

ClinicalTrials.gov processed this record on October 23, 2014