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

February 3, 2012 updated by: Steven A. Safren, Massachusetts General Hospital

CBT for Adherence and Depression in Type 1 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • CBT-AD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in glucose monitoring
Time Frame: Baseline assessment; 4, 8, and 12 months post-intervention assessments
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.
Baseline assessment; 4, 8, and 12 months post-intervention assessments
Changes in insulin adherence
Time Frame: Baseline assessment; 4, 8, and 12 months post-intervention assessments
We assessed adherence to participants' self-administered insulin through a self-report questionnaire.
Baseline assessment; 4, 8, and 12 months post-intervention assessments
Changes in depression severity
Time Frame: Baseline assessment; 4, 8, and 12 months post-intervention assessments
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.
Baseline assessment; 4, 8, and 12 months post-intervention assessments

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in hemoglobin A1C
Time Frame: Baseline assessment; 4, 8, and 12 months post-intervention assessment
We measured participants hemoglobin A1C by means of a blood draw and laboratory test.
Baseline assessment; 4, 8, and 12 months post-intervention assessment
Changes in glucose levels
Time Frame: Baseline assessment; 4, 8, and 12 months post-intervention assessment
We measured participants self-monitored glucose levels using electronic glucometers, which record the glucose level of each measurement.
Baseline assessment; 4, 8, and 12 months post-intervention assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Steven A Safren, Ph.D., Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

January 31, 2012

First Submitted That Met QC Criteria

February 3, 2012

First Posted (Estimate)

February 7, 2012

Study Record Updates

Last Update Posted (Estimate)

February 7, 2012

Last Update Submitted That Met QC Criteria

February 3, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGHBMED2172010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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