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

Depression Clinical Trial

Official title:

CBT for Adherence and Depression in Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527981
• Other study ID #: MGHBMED2172010
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2012
• Last updated: February 3, 2012
• Start date: March 2008
• Est. completion date: November 2010

Study information

• Verified date: February 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in glucose monitoring	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	No
Primary	Changes in insulin adherence	We assessed adherence to participants' self-administered insulin through a self-report questionnaire.	Baseline assessment; 4, 8, and 12 months post-intervention assessments	No
Primary	Changes in depression severity	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	No
Secondary	Changes in hemoglobin A1C	We measured participants hemoglobin A1C by means of a blood draw and laboratory test.	Baseline assessment; 4, 8, and 12 months post-intervention assessment	No
Secondary	Changes in glucose levels	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	No