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

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: November 2010

Interventions Used in this Clinical Trial

  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • Changes in glucose monitoring
    • Time Frame: Baseline assessment; 4, 8, and 12 months post-intervention assessments
      Safety Issue?: No
  • Changes in insulin adherence
    • Time Frame: Baseline assessment; 4, 8, and 12 months post-intervention assessments
      Safety Issue?: No
  • Changes in depression severity
    • Time Frame: Baseline assessment; 4, 8, and 12 months post-intervention assessments
      Safety Issue?: No

Secondary Measures

  • Changes in hemoglobin A1C
    • Time Frame: Baseline assessment; 4, 8, and 12 months post-intervention assessment
      Safety Issue?: No
  • Changes in glucose levels
    • Time Frame: Baseline assessment; 4, 8, and 12 months post-intervention assessment
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Massachusetts General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Steven A. Safren, Director, Behavioral Medicine – Massachusetts General Hospital
  • Overall Official(s)
    • Steven A Safren, Ph.D., Principal Investigator, Massachusetts General Hospital

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01527981