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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44MH109191-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Perinatal depression is experienced by at least 14-20% of pregnant and postpartum women, and is recognized as the most common complication of childbirth. In this project, the investigators plan to complete the process of making MomMoodBooster (MMB), a web-based cognitive-behavioral depression intervention, into a commercial ready product, MMB 2.0, that fits the workflow and staffing of healthcare organizations and is designed for both prenatal and postpartum women who are depressed. The investigators will also conduct a 2-arm randomized controlled trial to evaluate the efficacy of treatment as usual plus MMB 2.0 compared to treatment as usual in a large healthcare setting.
Perinatal depression (experienced by at least 14-20% of pregnant and postpartum women) is recognized as the most common complication of childbirth and as having extremely serious consequences, including significant suffering for pregnant women/new mothers and their families, and adverse impacts on infant development. Unfortunately, there are many barriers that make it difficult for women with perinatal depression to access clinic-based mental health treatments, and participation is low. Treatment uptake is limited by psychological barriers (stigma, feelings of failure, and embarrassment); knowledge barriers (poor understanding about impact of perinatal depression on infant health, uncertainty about where to get treatment); infrastructure barriers (fear of negative judgment from care providers, avoidance of prescription medications while breastfeeding); physical barriers in rural settings (too few care providers, unacceptable logistical demands on time, transportation, and childcare); and provider-level barriers (inadequate skills, fear of liability, dearth of treatment options, and inadequate reimbursement). To address this need, investigators obtained funding (National Institutes of Health (NIH) R01MH084931) to develop and test the MomMoodBooster program (MMB), an innovative Web-based program for treating postpartum depression (PPD). Based on cognitive behavioral therapy (CBT) and incorporating multimedia modeling and engaging activities, MMB is designed to enable women to identify patterns in their thoughts and behaviors and to develop a personal action plan to make helpful changes. MMB also has an administrative website designed for use by both project managers and supportive phone coaches to monitor the overall progress of participants. In our Small Business Innovation Research (SBIR) Phase I grant (R43MH109191), the investigators began a redesign of MMB so that it could be used more effectively as a product for delivering PPD treatment by practical healthcare delivery organizations. Specifically, the investigators enhanced the underlying database architecture (and the related administration website interface) to make it easier for multiple organizations in multiple settings to use MMB. In our proposed SBIR Phase II, the investigators propose to complete the process of making a commercial-ready product (MMB 2.0) that fits the workflow and staffing of healthcare organizations. Specifically, the investigators propose to finish the enhancement of the database architecture and its administrative site, to expand MMB to include prenatal as well as postpartum depressed women, and to deliver MMB using a new responsive design technology so that women will be able to use it interchangeably with any internet-accessible computer device (desktop, laptop, tablet, smart-phone). Finally, the investigators plan to use a 2-arm randomized controlled trial to evaluate the efficacy of MMB 2.0 compared to treatment as usual in a large healthcare setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment As Usual + MMB 2.0 | Other | Women assigned to use MMB 2.0, along with NorthShore HealthSystem's well established usual care, will be guided by the program to move sequentially through 6 sessions, one of which becomes available for use each week, while interacting with engaging activities within each session along with recommended practice activities to encourage transfer of learning and skills to everyday routines. Content is presented using text, interactions, animations, and videos. MMB includes daily tracking and charting of mood and pleasant activities as well as online access to a library, covering a range of issues of concern to pregnant women and new mothers. Integrated text messages offer both motivational messages and links to access specific portions of session content in the MMB 2.0 program. The study coordinator will also provide up to 3 supportive coaching calls to each woman in the MMB 2.0 condition. These calls complement and thus are adjunctive to the MMB 2.0 program. |
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| Treatment As Usual Only | Other | NorthShore HealthSystem's treatment as usual, or usual care, has been in place since 2003. Screen positive women randomized to this condition will receive social work assessment by phone, followed by community mental health referral as indicated. Referrals will vary by need and may include psychotherapy, support groups, or psychiatry. Referrals will include consideration of geographic proximity, insurance, and acuity. Consistent with routine practice, NorthShore staff will document time spent during evaluation and in making specific referrals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment As Usual + MMB 2.0 | Behavioral | Women assigned to use MMB 2.0, along with NorthShore HealthSystem's well established usual care, will be guided by the program to move sequentially through 6 sessions, one of which becomes available for use each week, while interacting with engaging activities within each session along with recommended practice activities to encourage transfer of learning and skills to everyday routines. Content is presented using text, interactions, animations, and videos. MMB includes daily tracking and charting of mood and pleasant activities as well as online access to a library, covering a range of issues of concern to pregnant women and new mothers. Integrated text messages offer both motivational messages and links to access specific portions of session content in the MMB 2.0 program. The study coordinator will also provide up to 3 supportive coaching calls to each woman in the MMB 2.0 condition. These calls complement and thus are adjunctive to the MMB 2.0 program. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Primary Health Questionnaire (PHQ-9) | The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options are on a 4-point scale (0 = not at all, 3 = nearly every day). The minimum overall score is 0 and the maximum overall score for the PHQ-9 is 27. Higher values represent more severe depression status. | Pretest (at enrollment) and posttest (3 months post enrollment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in General Anxiety Disorder (GAD) | The 7-item GAD measures generalized anxiety. Response options are on a 4-point scale (0 = did not apply to me, 3 = applied to me most of the time). A total sum score was computed. The minimum overall score is 0 and the maximum overall score is 21. Higher values represent more severe symptoms of generalized anxiety. | Pretest (at enrollment) and posttest (3 months post enrollment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University HealthSystem | Chicago | Illinois | 60201 | United States | ||
| Oregon Research Behavioral Intervention Strategies, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36174746 | Derived | Danaher BG, Seeley JR, Silver RK, Tyler MS, Kim JJ, La Porte LM, Cleveland E, Smith DR, Milgrom J, Gau JM. Trial of a patient-directed eHealth program to ameliorate perinatal depression: the MomMoodBooster2 practical effectiveness study. Am J Obstet Gynecol. 2023 Apr;228(4):453.e1-453.e10. doi: 10.1016/j.ajog.2022.09.027. Epub 2022 Sep 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment As Usual + MMB 2.0 | Women assigned to use MMB 2.0, along with NorthShore HealthSystem's well established usual care, will be guided by the program to move sequentially through 6 sessions, one of which becomes available for use each week, while interacting with engaging activities within each session along with recommended practice activities to encourage transfer of learning and skills to everyday routines. Content is presented using text, interactions, animations, and videos. MMB includes daily tracking and charting of mood and pleasant activities as well as online access to a library, covering a range of issues of concern to pregnant women and new mothers. Integrated text messages offer both motivational messages and links to access specific portions of session content in the MMB 2.0 program. The study coordinator will also provide up to 3 supportive coaching calls to each woman in the MMB 2.0 condition. These calls complement and thus are adjunctive to the MMB 2.0 program. |
| FG001 | Treatment As Usual Only | NorthShore HealthSystem's treatment as usual, or usual care, has been in place since 2003. Screen positive women randomized to this condition will receive social work assessment by phone, followed by community mental health referral as indicated. Referrals will vary by need and may include psychotherapy, support groups, or psychiatry. Referrals will include consideration of geographic proximity, insurance, and acuity. Consistent with routine practice, NorthShore staff will document time spent during evaluation and in making specific referrals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The analyses population was intent-to-treat and thus does not differ from the randomized sample.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment As Usual + MMB 2.0 | Women assigned to use MMB 2.0, along with NorthShore HealthSystem's well established usual care, will be guided by the program to move sequentially through 6 sessions, one of which becomes available for use each week, while interacting with engaging activities within each session along with recommended practice activities to encourage transfer of learning and skills to everyday routines. Content is presented using text, interactions, animations, and videos. MMB includes daily tracking and charting of mood and pleasant activities as well as online access to a library, covering a range of issues of concern to pregnant women and new mothers. Integrated text messages offer both motivational messages and links to access specific portions of session content in the MMB 2.0 program. The study coordinator will also provide up to 3 supportive coaching calls to each woman in the MMB 2.0 condition. These calls complement and thus are adjunctive to the MMB 2.0 program. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Primary Health Questionnaire (PHQ-9) | The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options are on a 4-point scale (0 = not at all, 3 = nearly every day). The minimum overall score is 0 and the maximum overall score for the PHQ-9 is 27. Higher values represent more severe depression status. | Posted | Mean | Standard Deviation | score on a scale | Pretest (at enrollment) and posttest (3 months post enrollment) |
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Adverse event data was collected from completion randomization through the final 12-week assessment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment As Usual + MMB 2.0 | Women assigned to use MMB 2.0, along with NorthShore HealthSystem's well established usual care, will be guided by the program to move sequentially through 6 sessions, one of which becomes available for use each week, while interacting with engaging activities within each session along with recommended practice activities to encourage transfer of learning and skills to everyday routines. Content is presented using text, interactions, animations, and videos. MMB includes daily tracking and charting of mood and pleasant activities as well as online access to a library, covering a range of issues of concern to pregnant women and new mothers. Integrated text messages offer both motivational messages and links to access specific portions of session content in the MMB 2.0 program. The study coordinator will also provide up to 3 supportive coaching calls to each woman in the MMB 2.0 condition. These calls complement and thus are adjunctive to the MMB 2.0 program. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Smith | Oregon Research Behavior Intervention Strategies, Inc. dba Influents Innovations | 541-484-2123 | david.smith@influetnsin.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 15, 2018 | Aug 23, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 15, 2018 | Aug 23, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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2-Arm random control trial
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| Treatment As Usual Only | Behavioral | NorthShore HealthSystem's treatment as usual, or usual care, has been in place since 2003. Screen positive women randomized to this condition will receive social work assessment by phone, followed by community mental health referral as indicated. Referrals will vary by need and may include psychotherapy, support groups, or psychiatry. Referrals will include consideration of geographic proximity, insurance, and acuity. Consistent with routine practice, NorthShore staff will document time spent during evaluation and in making specific referrals. |
|
| Change in Stress | The 7-item stress will measure generalized stress. Response options are on a 4-point response option (0 = did not apply to me, 3 = applied to me most of the time). A total sum score was computed. The minimum overall score is 0 and the maximum overall score is 21. Higher values represent more severe symptoms of generalized stress. | Pretest (at enrollment) and posttest (3 months post enrollment) |
| Change in Behavioral Activation for Depression Scale (BADS) | The 9-item BADS measures self-reports of activation, avoidance/rumination, work/school impairment, and social impairments. Response options are on a 7-point scale (0 = nota at all, 6 = completely) and a total sum score was computed. The minimum overall score is 0 and the maximum overall score is 54. Higher values represent more severe depression status related to behavioral activation. | Pretest (at enrollment) and posttest (3 months post enrollment) |
| Change in Automatic Thoughts Questionnaire - Short Form (ATQ) | The 8-item ATQ measures negative thoughts associated with depression. Response options are on a 4-point scale (0 = not at all, 3 = all the time) and a total mean score was computed and can range from 0 to 3. Higher values represent more severe depression status related to experiencing automatic thoughts. | Pretest (at enrollment) and posttest (3 months post enrollment) |
| Change in Self-Efficacy | The 8-item self-efficacy score measures confidence in one's ability to implement the skills taught in the program (e.g., how confident are you that you can increase your daily pleasant activities?). Response options are on 5-point scale (1 = not at all confident, , 5 = Very confident) and scores were averaged across the 8-items and can range from 1 to 5. A higher score indicates more self-efficacy to perform the tasks taught in the program. | Pretest (at enrollment) and posttest (3 months post enrollment) |
| Springfield |
| Oregon |
| 97477 |
| United States |
| BG001 | Treatment As Usual Only | NorthShore HealthSystem's treatment as usual, or usual care, has been in place since 2003. Screen positive women randomized to this condition will receive social work assessment by phone, followed by community mental health referral as indicated. Referrals will vary by need and may include psychotherapy, support groups, or psychiatry. Referrals will include consideration of geographic proximity, insurance, and acuity. Consistent with routine practice, NorthShore staff will document time spent during evaluation and in making specific referrals. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Age determined from date of birth and date of baseline assessment. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Treatment As Usual Only | NorthShore HealthSystem's treatment as usual, or usual care, has been in place since 2003. Screen positive women randomized to this condition will receive social work assessment by phone, followed by community mental health referral as indicated. Referrals will vary by need and may include psychotherapy, support groups, or psychiatry. Referrals will include consideration of geographic proximity, insurance, and acuity. Consistent with routine practice, NorthShore staff will document time spent during evaluation and in making specific referrals. |
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| Secondary | Change in General Anxiety Disorder (GAD) | The 7-item GAD measures generalized anxiety. Response options are on a 4-point scale (0 = did not apply to me, 3 = applied to me most of the time). A total sum score was computed. The minimum overall score is 0 and the maximum overall score is 21. Higher values represent more severe symptoms of generalized anxiety. | Posted | Mean | Standard Deviation | score on a scale | Pretest (at enrollment) and posttest (3 months post enrollment) |
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| Secondary | Change in Stress | The 7-item stress will measure generalized stress. Response options are on a 4-point response option (0 = did not apply to me, 3 = applied to me most of the time). A total sum score was computed. The minimum overall score is 0 and the maximum overall score is 21. Higher values represent more severe symptoms of generalized stress. | Posted | Mean | Standard Deviation | score on a scale | Pretest (at enrollment) and posttest (3 months post enrollment) |
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| Secondary | Change in Behavioral Activation for Depression Scale (BADS) | The 9-item BADS measures self-reports of activation, avoidance/rumination, work/school impairment, and social impairments. Response options are on a 7-point scale (0 = nota at all, 6 = completely) and a total sum score was computed. The minimum overall score is 0 and the maximum overall score is 54. Higher values represent more severe depression status related to behavioral activation. | Posted | Mean | Standard Deviation | score on a scale | Pretest (at enrollment) and posttest (3 months post enrollment) |
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| Secondary | Change in Automatic Thoughts Questionnaire - Short Form (ATQ) | The 8-item ATQ measures negative thoughts associated with depression. Response options are on a 4-point scale (0 = not at all, 3 = all the time) and a total mean score was computed and can range from 0 to 3. Higher values represent more severe depression status related to experiencing automatic thoughts. | Posted | Mean | Standard Deviation | score on a scale | Pretest (at enrollment) and posttest (3 months post enrollment) |
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| Secondary | Change in Self-Efficacy | The 8-item self-efficacy score measures confidence in one's ability to implement the skills taught in the program (e.g., how confident are you that you can increase your daily pleasant activities?). Response options are on 5-point scale (1 = not at all confident, , 5 = Very confident) and scores were averaged across the 8-items and can range from 1 to 5. A higher score indicates more self-efficacy to perform the tasks taught in the program. | Posted | Mean | Standard Deviation | score on a scale | Pretest (at enrollment) and posttest (3 months post enrollment) |
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| 0 |
| 96 |
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | Treatment As Usual Only | NorthShore HealthSystem's treatment as usual, or usual care, has been in place since 2003. Screen positive women randomized to this condition will receive social work assessment by phone, followed by community mental health referral as indicated. Referrals will vary by need and may include psychotherapy, support groups, or psychiatry. Referrals will include consideration of geographic proximity, insurance, and acuity. Consistent with routine practice, NorthShore staff will document time spent during evaluation and in making specific referrals. | 0 | 95 | 0 | 95 | 0 | 95 |
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