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CBT for Adherence and Depression in Diabetes

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ClinicalTrials.gov Identifier: NCT00564070
Recruitment Status : Completed
First Posted : November 27, 2007
Results First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus
Depression
Interventions: Behavioral: Enhanced treatment as usual plus adherence training
Behavioral: Enhanced treatment as usual plus CBT-AD

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Enhanced Treatment as Usual

Enhanced treatment as usual plus single-session life-steps treatment

Enhanced treatment as usual plus adherence training: 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.

CBT-AD

Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)

Enhanced treatment as usual plus CBT-AD: 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.


Participant Flow:   Overall Study
    Enhanced Treatment as Usual   CBT-AD
STARTED   42   45 
COMPLETED   30   38 
NOT COMPLETED   12   7 
Lost to Follow-up                9                7 
Worsening depression, referred to care                3                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Enhanced Treatment as Usual

Enhanced treatment as usual plus single-session life-steps treatment

Enhanced treatment as usual plus adherence training: 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.

CBT-AD

Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)

Enhanced treatment as usual plus CBT-AD: 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.

Total Total of all reporting groups

Baseline Measures
   Enhanced Treatment as Usual   CBT-AD   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   45   87 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.31  (7.41)   55.44  (8.72)   56.87  (8.07) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      20  47.6%      23  51.1%      43  49.4% 
Male      22  52.4%      22  48.9%      44  50.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   2.4%      0   0.0%      1   1.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4   9.5%      3   6.7%      7   8.0% 
White      34  81.0%      38  84.4%      72  82.8% 
More than one race      2   4.8%      0   0.0%      2   2.3% 
Unknown or Not Reported      1   2.4%      4   8.9%      5   5.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      3   7.1%      0   0.0%      3   3.4% 
Not Hispanic or Latino      39  92.9%      45 100.0%      84  96.6% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Clinician-Rated Depression [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 23.31  (7.20)   25.60  (8.99)   24.46  (8.10) 
[1] 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.
HbA1C [1] 
[Units: Percentage of glycosylated hemoglobin]
Mean (Standard Deviation)
 8.74  (1.41)   8.81  (1.78)   8.78  (1.60) 
[1] Hemoglobin A1C value at acute outcome. HbA1c is the number of hemoglobin in red blood cells that is glycosylated (attached to sugar) and is reported here as a percentage.


  Outcome Measures

1.  Primary:   Glucose Monitoring Adherence at Acute Outcome   [ Time Frame: Measured at Month 4 ]

2.  Primary:   Percent Medication Adherence Via MEMS   [ Time Frame: month 4 ]

3.  Primary:   Clinician Rated Depression (MADRS) at the Acute Timepoint   [ Time Frame: month 4 ]

4.  Primary:   Depression on the CGI at Acute Outcome   [ Time Frame: Month 4 ]

5.  Secondary:   Glucose Control   [ Time Frame: Month 4 ]

6.  Other Pre-specified:   Glucose Monitoring During Followup.   [ Time Frame: Aggregate of months 4,8,12 ]

7.  Other Pre-specified:   Percent Medication Adherence During Follow up   [ Time Frame: Aggregate across 4,8,12 months ]

8.  Other Pre-specified:   Depression MADRS Over Follow up   [ Time Frame: Aggregate across 4,8,12 months ]

9.  Other Pre-specified:   Depression CGI   [ Time Frame: Aggregate 4,8,12 months ]

10.  Other Pre-specified:   Glucose Control Over Follow up   [ Time Frame: Aggregate across 4,8,12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Steven Safren
Organization: Behavioral Medicine Service, Massachusetts General Hospital
phone: (305) 284-2818
e-mail: ssafren@miami.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Steven A. Safren, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00564070     History of Changes
Other Study ID Numbers: R01MH078571 ( U.S. NIH Grant/Contract )
First Submitted: November 23, 2007
First Posted: November 27, 2007
Results First Submitted: August 4, 2014
Results First Posted: January 8, 2018
Last Update Posted: January 8, 2018