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

Study Overview
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Brief Summary
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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.

Official Title
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CBT for Adherence and Depression in Type 1 Diabetes

Conditions
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Depression, Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy for adherence and depression


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-AD<br>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. | Behavioral: Cognitive behavioral therapy for adherence and depression<br>* 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.<br>* Other names: CBT-AD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Diabetes, Adherence, Medication, Glucose, Insulin