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

Phase 2

Completed

• Conditions: Depression; Type 1 Diabetes
• Interventions: Behavioral: Cognitive behavioral therapy for adherence and depression

• Registration Number: NCT01527981
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2012-01-31
• Status Verified: 2012-02
• Study First Submitted QC: 2012-02-03
• Last Update Submitted: 2012-02-03
• Study First Posted: 2012-02-07
• Last Update Posted: 2012-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CBT-AD	Cognitive behavioral therapy for adherence and depression	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in hemoglobin A1C	Baseline assessment; 4, 8, and 12 months post-intervention assessment	We measured participants hemoglobin A1C by means of a blood draw and laboratory test.
Changes in glucose levels	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States