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