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Effective Care Management of Depressed Diabetes Patients (The Positive Steps Study)

NCT01106885 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 339

Last updated 2015-04-28

No results posted yet for this study

Summary

Evaluation of telephone care management intervention designed to improve outcomes among depressed diabetes patients.

Conditions

Interventions

BEHAVIORAL

Medication Care Management (MCM)

* Basic physical activity counseling * Notify PCP and facilitate initiation of antidepressants * Medication monitoring calls at 1, 2, 4, 6, 8, 10, and 12 weeks\* * 1/mo monitoring in continuation phase (mos. 4-12)\* * Report \& recommendations to PCP after each patient call * Note: \*average of 10 minutes of telephone time each (series is repeated if second antidepressant trial is needed)

BEHAVIORAL

Cognitive-Behavioral Therapy (CBT)

* Notify PCP * CBT Manual * Weekly CBT focused counseling for 12 weeks\*\* * Monthly CBT in months 4-12\*\* * Behavioral physical activity counseling * Report \& recommendations to PCP after each patient call * Note: \*\*average of 50 minutes of telephone time each

Sponsors & Collaborators

Principal Investigators

  • John D Piette, PhD · VA Ann Arbor Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2009-10-31
Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01106885 on ClinicalTrials.gov