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

January 31, 2012
February 3, 2012
March 2008
November 2010   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01527981 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Cognitive Behavioral Therapy (CBT) for Adherence and Depression in Type 1 Diabetes
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Type 1 Diabetes
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
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.
Intervention: Behavioral: Cognitive behavioral therapy for adherence and depression
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01527981
MGHBMED2172010
No
Steven A. Safren, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Steven A Safren, Ph.D. Massachusetts General Hospital
Massachusetts General Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP