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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
History of Changes
  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:

U.S. FDA Resources

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
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
Behavioral Symptoms
Mood Disorders
 Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013