N/A
N=87
CBT for Adherence and Depression in Diabetes
Diabetes Mellitus · Depression
Bottom Line
View on ClinicalTrials.gov: NCT00564070 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Glucose Monitoring Adherence at Acute Outcome — 49.63; 79.79 percentage of glucose monitoring goal — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enhanced treatment as usual plus adherence training (Behavioral); Enhanced treatment as usual plus CBT-AD (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glucose Monitoring Adherence at Acute Outcome |
49.63; 79.79 | <.0001 sig |
| PRIMARY Percent Medication Adherence Via MEMS |
69.69; 90.37 | <0.0001 sig |
| PRIMARY Clinician Rated Depression (MADRS) at the Acute Timepoint |
20.66; 14.22 | =.002 sig |
| PRIMARY Depression on the CGI at Acute Outcome |
3.17; 2.44 | =.01 sig |
| SECONDARY Glucose Control |
8.58; 7.86 | =.001 sig |
Summary
This study will evaluate the effectiveness of cognitive behavioral therapy (CBT) in treating people with depression and type 2 diabetes.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00564070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.