NCT01527981|CompletedPhase 2
Cognitive Behavioral Therapy (CBT) for Adherence and Depression in Type 1 Diabetes
CBT for Adherence and Depression in Type 1 Diabetes
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CBT for Adherence and Depression in Type 1 Diabetes
Sponsor study identifier
interventional
9
1 country
1
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2010
Actual (reported)Study Completion
November 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
November 2010
Actual (reported)November 2010
Actual (reported)January 31, 2012
Actual (reported)February 7, 2012
Actual (reported)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
Changes in hemoglobin A1C
Baseline assessment; 4, 8, and 12 months post-intervention assessment
Changes in glucose levels
Baseline assessment; 4, 8, and 12 months post-intervention assessment
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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.
Steven A Safren, Ph.D.
Massachusetts General Hospital
9 participants (actual enrollment reported by the registry).
First Submitted
January 31, 2012
First Posted
February 7, 2012
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Women's Depression Treatment Study
Contact the study team to confirm eligibility.
Primary Completion
November 2010
Actual (reported)Study Completion
November 2010
Actual (reported)Last Updated
February 7, 2012
Record last verified: 2012-02
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Source: ClinicalTrials.gov.
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