CBT for Adherence and Depression in Diabetes
1 other identifier
interventional
87
1 country
1
Brief Summary
This study will evaluate the effectiveness of cognitive behavioral therapy (CBT) in treating people with depression and type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Jun 2007
Longer than P75 for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 23, 2007
CompletedFirst Posted
Study publicly available on registry
November 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
January 8, 2018
CompletedJanuary 8, 2018
December 1, 2017
4.8 years
November 23, 2007
August 4, 2014
December 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Glucose Monitoring Adherence at Acute Outcome
Medical adherence is a percent via the electronic monitoring using glucometer. This is a percent with a possible range of 0-100, with higher scores denoting better adherence.
Measured at Month 4
Percent Medication Adherence Via MEMS
This is an electronic pill cap at the acute outcome assessment. This is a percent with a possible range of 0-100, higher scores indicating greater adherence
month 4
Clinician Rated Depression (MADRS) at the Acute Timepoint
Depression as assessed by the Montgomery Asberg Depression Rating Scale (MADRS). This scale has a range of 0-60 with higher scores indicating greater depression severity.
month 4
Depression on the CGI at Acute Outcome
Clinical Global Impression is a scale from 1-7 with greater numbers meaning more severe depression
Month 4
Secondary Outcomes (1)
Glucose Control
Month 4
Other Outcomes (5)
Glucose Monitoring During Followup.
Aggregate of months 4,8,12
Percent Medication Adherence During Follow up
Aggregate across 4,8,12 months
Depression MADRS Over Follow up
Aggregate across 4,8,12 months
- +2 more other outcomes
Study Arms (2)
Enhanced treatment as usual
ACTIVE COMPARATOREnhanced treatment as usual plus single-session life-steps treatment
CBT-AD
EXPERIMENTALEnhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)
Interventions
The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management.
The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care.
Eligibility Criteria
You may qualify if:
- Diagnosis of type 2 diabetes that is poorly controlled despite treatment with an oral hypoglycemic, insulin, or both
- Diagnosis of major depression or dysthymia, or current subclinical symptoms of depression in spite of prescription of an antidepressant
- If on an antidepressant, oral hypoglycemic medication, or insulin, must have been on a stable dose for the preceding two months
You may not qualify if:
- Active untreated major mental illness (e.g., untreated psychosis), bipolar disorder, eating disorder, mental retardation, or dementia
- Experiencing suicidal thoughts
- History of or currently receiving CBT for depression
- Uses an insulin pump
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Safren SA, Gonzalez JS, Wexler DJ, Psaros C, Delahanty LM, Blashill AJ, Margolina AI, Cagliero E. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in patients with uncontrolled type 2 diabetes. Diabetes Care. 2014;37(3):625-33. doi: 10.2337/dc13-0816. Epub 2013 Oct 29.
PMID: 24170758DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Steven Safren
- Organization
- Behavioral Medicine Service, Massachusetts General Hospital
Study Officials
- STUDY DIRECTOR
Christina Psaros, PhD
Partners HealthCare
- PRINCIPAL INVESTIGATOR
Steven Safren, PhD
University of Miami
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Behavioral Medicine
Study Record Dates
First Submitted
November 23, 2007
First Posted
November 27, 2007
Study Start
June 1, 2007
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
January 8, 2018
Results First Posted
January 8, 2018
Record last verified: 2017-12