Cognitive Behavioral Therapy (CBT) for Adherence and Depression in Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT01527981|
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : February 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Depression Type 1 Diabetes||Behavioral: Cognitive behavioral therapy for adherence and depression||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||CBT for Adherence and Depression in Type 1 Diabetes|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
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
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 Name: CBT-AD
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527981
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Steven A Safren, Ph.D.||Massachusetts General Hospital|