Depression, Type 1 Diabetes
Conditions
Keywords
Depression, Diabetes, Adherence, Medication, Glucose, Insulin
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.
Interventions
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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed