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Trial record 1 of 2180 for:    depression AND (woman OR women OR female)
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Depression Attention for Women Now (The DAWN Study) (DAWN)

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ClinicalTrials.gov Identifier: NCT01096316
Recruitment Status : Completed
First Posted : March 31, 2010
Results First Posted : August 27, 2014
Last Update Posted : February 4, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jurgen Unutzer, University of Washington

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Depressive Disorder
Intervention: Behavioral: Depression Care Management

  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
Intervention

The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:

  • enhanced education of patients and providers
  • engagement of patients
  • depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.

Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,

Usual Care Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.

Participant Flow:   Overall Study
    Intervention   Usual Care
STARTED   102   103 
COMPLETED   87   94 
NOT COMPLETED   15   9 
Lost to Follow-up                15                9 



  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.
Baseline data from the intervention arms were examined for statistically significant differences using t tests, chi squares and logistic regression analyses.

Reporting Groups
  Description
Intervention

The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:

  • enhanced education of patients and providers
  • engagement of patients
  • depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.

Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,

Usual Care Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
Total Total of all reporting groups

Baseline Measures
   Intervention   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 102   103   205 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.47  (12.11)   38.59  (12.10)   39.02  (12.09) 
Gender 
[Units: Participants]
     
Female   102   103   205 
Male   0   0   0 


  Outcome Measures

1.  Primary:   Depression Treatment Outcome   [ Time Frame: 12 months ]

2.  Primary:   Functional Outcome   [ Time Frame: 12 months ]

3.  Secondary:   Quality of Depression Care Indicators   [ Time Frame: 12 months ]

4.  Secondary:   Potential Facilitators and Barriers to Sustainability   [ Time Frame: 18 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
Patients were recruited from university-affiliated OB/GYN clinics, which potentially limits generalizability to other OB/GYN populations; non-English speaking women were not included; and antidepressant adherence was based on self-report data.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jurgen Unutzer MD MPH MA, Professor and Chair
Organization: Dept Psychiatry & Behavioral Sciences University of Washington
phone: 206-543-3752
e-mail: unutzer@uw.edu


Publications of Results:

Responsible Party: Jurgen Unutzer, University of Washington
ClinicalTrials.gov Identifier: NCT01096316     History of Changes
Other Study ID Numbers: 37061-G
1R01MH085668 ( U.S. NIH Grant/Contract )
First Submitted: March 25, 2010
First Posted: March 31, 2010
Results First Submitted: June 27, 2014
Results First Posted: August 27, 2014
Last Update Posted: February 4, 2016