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

Primary Purpose

Depression, Type 1 Diabetes

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cognitive behavioral therapy for adherence and depression

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Diabetes, Adherence, Medication, Glucose, Insulin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBT-AD

Arm 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.

Outcomes

Primary Outcome Measures

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.

Changes in insulin adherence

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

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.

Secondary Outcome Measures

Changes in hemoglobin A1C

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

Changes in glucose levels

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

Full Information

NCT ID

NCT01527981

First Posted

January 31, 2012

Last Updated

February 3, 2012

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01527981

Brief Title

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

Official Title

CBT for Adherence and Depression in Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Type 1 Diabetes

Keywords

Depression, Diabetes, Adherence, Medication, Glucose, Insulin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBT-AD

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Cognitive behavioral therapy for adherence and depression

Other Intervention Name(s)

CBT-AD

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes in glucose monitoring

Description

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

Title

Changes in insulin adherence

Description

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

Title

Changes in depression severity

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Changes in hemoglobin A1C

Description

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

Title

Changes in glucose levels

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven A Safren, Ph.D.

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22943030

Citation

Markowitz SM, Carper MM, Gonzalez JS, Delahanty LM, Safren SA. Cognitive-behavioral therapy for the treatment of depression and adherence in patients with type 1 diabetes: pilot data and feasibility. Prim Care Companion CNS Disord. 2012;14(2):PCC.11m01220. doi: 10.4088/PCC.11m01220. Epub 2012 Mar 15.

Results Reference

derived

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

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