Trial Outcomes & Findings for Depression Attention for Women Now (The DAWN Study) (NCT NCT01096316)

NCT ID: NCT01096316

Last Updated: 2016-02-04

Results Overview

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),

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 205 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2016-02-04

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	102	103
Overall Study COMPLETED	87	94
Overall Study NOT COMPLETED	15	9

Reasons for withdrawal

Measure	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.
Overall Study Lost to Follow-up	15	9

Baseline Characteristics

Depression Attention for Women Now (The DAWN Study)

Baseline characteristics by cohort

Measure	Intervention n=102 Participants 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 n=103 Participants 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 n=205 Participants Total of all reporting groups
Age, Continuous	39.47 years STANDARD_DEVIATION 12.11 • n=5 Participants	38.59 years STANDARD_DEVIATION 12.10 • n=7 Participants	39.02 years STANDARD_DEVIATION 12.09 • n=5 Participants
Sex: Female, Male Female	102 Participants n=5 Participants	103 Participants n=7 Participants	205 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

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),

Outcome measures

Measure	Intervention n=102 Participants 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 n=103 Participants 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.
Depression Treatment Outcome	0.96 units on a scale Standard Deviation 0.65	1.33 units on a scale Standard Deviation 0.75

PRIMARY outcome

Timeframe: 12 months

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.

Outcome measures

Measure	Intervention n=102 Participants 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 n=103 Participants 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.
Functional Outcome	3.69 units on a scale Standard Deviation 2.70	4.03 units on a scale Standard Deviation 2.70

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	Intervention n=102 Participants 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 n=103 Participants 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.
Quality of Depression Care Indicators	67 participants	28 participants

SECONDARY outcome

Timeframe: 18 months

Providers' and administrators' perceived barriers and facilitators to continue providing the intervention after study end.

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention n=102 participants at risk 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.	Usual Care n=103 participants at risk 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.
Psychiatric disorders Psychiatric ER visits or hospitalization	0.98% 1/102 • Number of events 1	0.97% 1/103 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Jurgen Unutzer MD MPH MA, Professor and Chair

Dept Psychiatry & Behavioral Sciences University of Washington

Phone: 206-543-3752

Email: unutzer@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place