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Completed

NCT Number: NCT01527981

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

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.

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Key information

Conditions

Depression Autoimmune Diseases Behavior Behavioral Symptoms Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Type 1 Diabetes

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavioral Therapy for Adherence and Depression

Behavioral

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.

Other names: CBT-AD

Primary outcomes

  1. Changes in glucose monitoring

    Time frame: 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.

  2. Changes in insulin adherence

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

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

  3. Changes in depression severity

    Time frame: 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 outcomes

  1. Changes in hemoglobin A1C

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

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

  2. Changes in glucose levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

CBT for Adherence and Depression in Type 1 Diabetes

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 7, 2012
Registry last updated
Feb 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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