Depressive Disorder
Conditions
Keywords
mood disorders, depressive disorder, women, depression
Brief summary
Major depressive disorder (MDD) is a common disabling illness that disproportionately affects women, with prevalence rates two times those of men. In addition to suffering, MDD has been shown to have a marked effect on social and vocational functioning, with increased disability, lost productivity, and excess mortality. Women with MDD have an increased prevalence of comorbid anxiety disorders and medical conditions. Our model of care utilizes a social worker as a depression care manager (DCM) to support both patients and physicians in optimizing care in the OB-GYN clinical setting. This intervention will be compared to usual care for depression.
Detailed description
A large number of women receive their routine care in OB-GYN clinics, including a disproportionate percentage of low-income and minority women. For many of these women, OG-GYNs are the only provider they see on a regular basis. OB-GYNs take care of women across their lifespan, addressing gynecologic, health care maintenance, pregnancy and primary care concerns in their everyday practices. There are multiple aspects of OG-GYN care that are uniquely suited for detection and treatment of depression, but there are also significant barriers to such care that must be addressed. In this randomized controlled trial, we are testing this depression care management program for women attending two OB-GYN clinics in the University of Washington health care system. Our research aims to test the hypothesis that a depression care management intervention, integrated into the OB-GYN clinic setting, will improve treatment outcomes for depression, functional outcomes, and satisfaction with depression care. The results of our research will greatly impact clinical care by satisfying an unmet need for effective depression services for women seen in OB-GYN clinical settings. The study compares a depression care management intervention, delivered by a depression care manager, to usual care for depression in the clinics. The primary aims of the study are to evaluate, compared to usual care, a depression intervention consisting of enhanced education, engagement, and depression care management (with a choice of antidepressant medication monitoring and/or provision of brief psychotherapy).
Interventions
BEHAVIORALDepression 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, with a total of 8 PST-PC sessions. Patients with inadequate response after 8 weeks to the first choice will switch or combine treatments. Providers are given extensive feedback about the patient's health care concerns.
Sponsors
National Institute of Mental Health (NIMH)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PHQ-9 score ≥10 for Major Depressive Disorder (with 1 cardinal symptom) and/or ≥10 for Dysthymia (with 1 cardinal symptom) * MINI confirmation of PHQ-9 diagnoses * Access to a telephone * English-speaking
Exclusion criteria
* High suicide risk (PHQ-9 response) * ≥2 prior suicide attempts * Lifetime history of schizophrenia or bipolar disorder (MINI response) * Substance abuse/dependence within the previous 3 months (CAGE-AID) * Current severe intimate partner violence * Currently seeing a psychiatrist
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Treatment Outcome | 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), |
| Functional Outcome | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Depression Care Indicators | 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 |
| Potential Facilitators and Barriers to Sustainability | 18 months | Providers' and administrators' perceived barriers and facilitators to continue providing the intervention after study end. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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, | 102 |
| 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. | 103 |
| Total | 205 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 15 | 9 |
Baseline characteristics
| Characteristic | Intervention | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 39.47 years STANDARD_DEVIATION 12.11 | 38.59 years STANDARD_DEVIATION 12.1 | 39.02 years STANDARD_DEVIATION 12.09 |
| Sex: Female, Male Female | 102 Participants | 103 Participants | 205 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 102 | 0 / 103 |
| serious Total, serious adverse events | 1 / 102 | 1 / 103 |
Outcome results
Primary
Depression Treatment Outcome
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Depression Treatment Outcome | 0.96 units on a scale | Standard Deviation 0.65 |
| Usual Care | Depression Treatment Outcome | 1.33 units on a scale | Standard Deviation 0.75 |
Primary
Functional Outcome
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Functional Outcome | 3.69 units on a scale | Standard Deviation 2.7 |
| Usual Care | Functional Outcome | 4.03 units on a scale | Standard Deviation 2.7 |
Secondary
Potential Facilitators and Barriers to Sustainability
Providers' and administrators' perceived barriers and facilitators to continue providing the intervention after study end.
Time frame: 18 months
Secondary
Quality of Depression Care Indicators
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Quality of Depression Care Indicators | 67 participants |
| Usual Care | Quality of Depression Care Indicators | 28 participants |