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Trial record 1 of 2258 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
Enrollment 205

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Usual Care
Hide Arm/Group Description

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,

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.
Period Title: Overall Study
Started 102 103
Completed 87 94
Not Completed 15 9
Reason Not Completed
Lost to Follow-up             15             9
Arm/Group Title Intervention Usual Care Total
Hide Arm/Group Description

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,

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 of all reporting groups
Overall Number of Baseline Participants 102 103 205
Hide Baseline Analysis Population Description
Baseline data from the intervention arms were examined for statistically significant differences using t tests, chi squares and logistic regression analyses.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 103 participants 205 participants
39.47  (12.11) 38.59  (12.10) 39.02  (12.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 103 participants 205 participants
Female
102
 100.0%
103
 100.0%
205
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Depression Treatment Outcome
Hide Description Impact of the intervention on depression treatment outcomes, including change in depressive symptoms and treatment response. In particular, the depression scale from the Hopkins Symptom Checklist 20 (SCL-20) was used to assess depression severity at the assessments. The SCL-20 ranges from 0 (no depression) to 4 (severe depression),
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Usual Care
Hide Arm/Group Description:

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,

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.
Overall Number of Participants Analyzed 102 103
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.96  (0.65) 1.33  (0.75)
2.Primary Outcome
Title Functional Outcome
Hide Description Impact of the intervention on functional outcomes of patients. Functional impairment was measured using the Sheehan Disability Scale. The Sheehan disability scale is the average of 3 items assessing impairment in social, work and family responsibilities. Each item is rated 0 (no impairment) to 10 (totally impaired) and the 3 ratings are averaged for the Sheehan disability scale reported below.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Usual Care
Hide Arm/Group Description:

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,

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.
Overall Number of Participants Analyzed 102 103
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.69  (2.70) 4.03  (2.70)
3.Secondary Outcome
Title Quality of Depression Care Indicators
Hide Description Intervention impact on quality of depression care indicators and satisfaction with depression care. Number of participants receiving 4 or more mental health visits are reported. Receiving 4 or more mental health visits has previously been used in depression randomized control trials as a measure of the quality of depression treatment received by a patient
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Usual Care
Hide Arm/Group Description:

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,

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.
Overall Number of Participants Analyzed 102 103
Measure Type: Number
Unit of Measure: participants
67 28
4.Secondary Outcome
Title Potential Facilitators and Barriers to Sustainability
Hide Description Providers' and administrators' perceived barriers and facilitators to continue providing the intervention after study end.
Time Frame 18 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Usual Care
Hide Arm/Group Description

The intervention will integrate care between a depression care manager(DCM), consulting study team (psychiatry OB-GYN physician) and OB-GYN clinic providers.

Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). The DCM in 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 12-month intervention. Patients choose either medication or Problem-Solving Treatment. Depressive symptoms are assessed at each visit with the PHQ-9. Patients with inadequate response after 4 to 8 weeks to the first choice will switch or combine treatments. DCMs partcipate in weekly caseload review with a psychiatrist and Ob-Gyn physician who make treatment recommendations that the DCM then communicates to the patient's own Ob-Gyn physician who writes all prescriptions.

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.
All-Cause Mortality
Intervention Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/102 (0.98%)      1/103 (0.97%)    
Psychiatric disorders     
Psychiatric ER visits or hospitalization  [1]  1/102 (0.98%)  1 1/103 (0.97%)  1
Indicates events were collected by systematic assessment
[1]
We assessed at each objective follow-up all psychiatric emergency room visits and psychiatric hospitalizations. These were also spontaneously sent to us via EMR if the ER visit or hospitalization occurred in the University hospitals
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/102 (0.00%)      0/103 (0.00%)    
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.
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
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