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

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes; Depression

Treatments: Behavioral: Cognitive behavioral therapy for adherence and depression

Study type: Interventional

Funder types: Other

Identifiers

NCT01527981

MGHBMED2172010

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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9 participants in 1 patient group

CBT-AD

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive behavioral therapy for adherence and depression