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

Massachusetts General Hospital9 enrolled

Overview

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

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Depression Type 1 Diabetes

Interventions

Cognitive behavioral therapy for adherence and depressionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline assessment; 4, 8, and 12 months post-intervention assessments

Changes in insulin adherence

We assessed adherence to participants' self-administered insulin through a self-report questionnaire.

Time frame: Baseline assessment; 4, 8, and 12 months post-intervention assessments

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.

Time frame: Baseline assessment; 4, 8, and 12 months post-intervention assessments

Secondary Outcomes

Changes in hemoglobin A1C

We measured participants hemoglobin A1C by means of a blood draw and laboratory test.

Time frame: Baseline assessment; 4, 8, and 12 months post-intervention assessment

Changes in glucose levels

We measured participants self-monitored glucose levels using electronic glucometers, which record the glucose level of each measurement.

Time frame: Baseline assessment; 4, 8, and 12 months post-intervention assessment

Data from ClinicalTrials.gov

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