A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients (MOSAIC)

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Jeff C. Huffman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01201967
First received: September 7, 2010
Last updated: September 24, 2014
Last verified: September 2014
Results First Received: May 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depression
Generalized Anxiety Disorder
Panic Disorder
Interventions: Other: Collaborative care
Other: Usual care

  Participant Flow
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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
Collaborative Care

Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.

Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.

Usual Care

Patient's physicians are informed of diagnosis of depression/anxiety disorder

Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis


Participant Flow:   Overall Study
    Collaborative Care     Usual Care  
STARTED     92     91  
COMPLETED     86     86  
NOT COMPLETED     6     5  
Lost to Follow-up                 6                 5  



  Baseline Characteristics
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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.
Intent-to-treat analysis was employed. All randomized participants were included in analysis.

Reporting Groups
  Description
Collaborative Care

Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.

Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.

Usual Care

Patient's physicians are informed of diagnosis of depression/anxiety disorder

Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis

Total Total of all reporting groups

Baseline Measures
    Collaborative Care     Usual Care     Total  
Number of Participants  
[units: participants]
  92     91     183  
Age  
[units: years]
Mean ± Standard Deviation
  60.9  ± 12.7     60.1  ± 12.8     60.5  ± 12.7  
Gender  
[units: participants]
     
Female     43     43     86  
Male     49     48     97  
Region of Enrollment  
[units: participants]
     
United States     92     91     183  
Study-Specific Measure [1]
[units: units on a scale]
Mean ± Standard Deviation
  15.9  ± 4.2     15.6  ± 5.0     15.8  ± 4.6  
Study-Specific Measure [2]
[units: units on a scale]
Mean ± Standard Deviation
  10.9  ± 4.0     11.5  ± 3.9     11.2  ± 3.9  
Study-Specific Measure [3]
[units: units on a scale]
Mean ± Standard Deviation
  19.7  ± 15.8     21.4  ± 16.9     20.5  ± 16.3  
Study-Specific Measure [4]
[units: units on a scale]
Mean ± Standard Deviation
  13.0  ± 3.5     14.2  ± 3.1     13.6  ± 3.3  
Study-Specific Measure [5]
[units: units on a scale]
Mean ± Standard Deviation
  34.2  ± 9.7     36.3  ± 8.9     35.2  ± 9.3  
Study-Specific Measure [6]
[units: units on a scale]
Mean ± Standard Deviation
  32.9  ± 10.8     33.8  ± 11.0     32.9  ± 10.5  
Study-Specific Measure [7]
[units: units on a scale]
Mean ± Standard Deviation
  0.40  ± 0.34     0.44  ± 0.33     0.42  ± 0.34  
[1] The PHQ-9 is a 9-item scale that measures depression severity. Each question asks how often the subject experiences symptoms of depression and offers four answers: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Scores are totaled and range from 0-27. To be considered depressed, subjects had to (a) have a total score of 10 or more, (b) answer five questions with a score of 2 or 3, and (c) one of the five questions had to be question 1 or question 2 (or both). Anyone who did not meet these criteria were not considered depressed.
[2] The HADS-A is a 7-item scale used to measure anxiety severity. Each question asks about a specific symptom of anxiety and offers four answers: 0 = Never / Not at all, 1 = A little / Time to time, 2 = Quite often / Usually, 3 = Most of the time / Very often. Scores are totaled and range from 0-21. A higher score means more anxiety.
[3] The DASI is a 12-item scale that measures physical function. Each question asks about whether the subject can complete a physical activity and are given the following options: Scores range from 0 to 58.2. Lower scores indicate lower levels of physical function.
[4] The MOS-SAS is a 3-item scale used to assess medication adherence, physical activity adherence, and diet adherence. Each question asks how often the subject adheres to the behavior, providing the following options: 1 = None of the time, 2 = A little of the time, 3 = Some of the time, 4 = A good bit of the time, 5 = Most of the time, 6 = All of the time. Scores are totaled and range from (3 to 18). A low score indicates poorer adherence to healthy behaviors.
[5] The SF-12 Mental Component Score is a 6-item scale that assesses mental health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average mental health-related quality of life. Higher scores represent higher than average mental health-related quality of life, and lower scores represent lower mental health-related quality of life.
[6] The SF-12 Physical Component Score is a 6-item scale that assesses physical health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average physical health-related quality of life. Higher scores represent higher than average physical health-related quality of life, and lower scores represent lower physical health-related quality of life.
[7] The Euro Quality of Life-5 Domain is a 5-item scale that assesses quality of life. Each question asks about difficulties with certain areas of health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and offer three possible answers: No problems, Moderate problems, Extreme problems. Scores can range from 0.000-1.000, with lower scores indicating less quality of life, and higher scores indicating higher quality of life.



  Outcome Measures
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1.  Primary:   Change in Mental Health-related Quality of Life From Baseline to 24 Weeks   [ Time Frame: Baseline, 24 weeks ]

2.  Secondary:   Change in Depression Symptoms From Baseline to 24 Weeks   [ Time Frame: Baseline, 24 weeks ]

3.  Secondary:   Change in Anxiety Symptoms From Baseline to 24 Weeks   [ Time Frame: Baseline, 24 weeks ]

4.  Secondary:   Rate of Adequate Treatment of Depression and/or Anxiety Symptoms 5 Days After Enrollment   [ Time Frame: 5 days after enrollment ]

5.  Secondary:   Change in Adherence to Health Behaviors From Baseline to 24 Weeks   [ Time Frame: Baseline, 24 weeks ]

6.  Secondary:   Number of Rehospitalizations From Baseline to 24 Weeks   [ Time Frame: 24 weeks ]

7.  Secondary:   Change in Health Status From Baseline to 24 Weeks   [ Time Frame: Baseline, 24 weeks ]

8.  Secondary:   Change in Physical Function From Baseline to 24 Weeks   [ Time Frame: Baseline, 24 weeks ]

9.  Secondary:   Change in Physical Health-related Quality of Life From Baseline to 24 Weeks   [ Time Frame: Baseline, 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Jeff C. Huffman, MD
Organization: Massachusetts General Hospital
phone: 6177242910
e-mail: jhuffman@partners.org


No publications provided by Massachusetts General Hospital

Publications automatically indexed to this study:

Responsible Party: Jeff C. Huffman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01201967     History of Changes
Other Study ID Numbers: 2010P-001414
Study First Received: September 7, 2010
Results First Received: May 12, 2014
Last Updated: September 24, 2014
Health Authority: United States: Institutional Review Board