Cognitive Behavioral Therapy (CBT) for Adherence and Depression in Type 1 Diabetes
CBT for Adherence and Depression in Type 1 Diabetes
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 depression
Started Mar 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 31, 2012
CompletedFirst Posted
Study publicly available on registry
February 7, 2012
CompletedFebruary 7, 2012
February 1, 2012
2.7 years
January 31, 2012
February 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (2)
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
Study Arms (1)
CBT-AD
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
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.
PMID: 22943030DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven A Safren, Ph.D.
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Behavioral Medicine
Study Record Dates
First Submitted
January 31, 2012
First Posted
February 7, 2012
Study Start
March 1, 2008
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
February 7, 2012
Record last verified: 2012-02