免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Responsive eHealth Intervention for Perinatal Depression in Healthcare Settings (MMB)
Responsive eHealth Intervention for Perinatal Depression in Healthcare Settings (MMB)
Study Description
Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Perinatal Depression | Behavioral: Treatment As Usual + MMB 2.0 Behavioral: Treatment As Usual Only | Not Applicable |
Detailed Description:
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 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 (Small Business Innovation Research) 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, smartphone). 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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 210 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | 2-Arm random control trial |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Responsive eHealth Intervention for Perinatal Depression in Healthcare Settings |
| Actual Study Start Date : | August 24, 2018 |
| Estimated Primary Completion Date : | May 31, 2021 |
| Estimated Study Completion Date : | July 31, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
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.
|
Behavioral: 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.
|
|
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.
|
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures :
- Change in Primary Health Questionnaire (PHQ-9) [ Time Frame: Pretest (at enrollment) and posttest (3 months post enrollment) ]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. Finally, it includes an item, "Thoughts you would be better off dead or hurting yourself in some way," that will trigger our safety monitoring procedure. The minimum overall score is 0 and the maximum overall score for the PHQ-9 is 27. Higher values represent more severe depression status. To evaluate the clinical significance of the intervention effects, the investigators will calculate the minimal clinically important difference, which for the PHQ-9 is a score of 5 points difference from Pretest to posttest.
Secondary Outcome Measures :
- Change in Behavioral Activation for Depression Scale (BADS) [ Time Frame: Pretest (at enrollment) and posttest (3 months post enrollment) ]The 25-item BADS measures self-reports of activation, avoidance/rumination, work/school impairment, and social impairments. The minimum overall score is 0 and the maximum overall score is 150. Higher values represent more severe depression status related to behavioral activation.
- Change in Automatic Thoughts Questionnaire (ATQ) [ Time Frame: Pretest (at enrollment) and posttest (3 months post enrollment) ]The 30-item ATQ will measure negative thoughts associated with depression. The minimum overall score is 0 and the maximum overall score is 120. Higher values represent more severe depression status related to experiencing automatic thoughts.
- Change in General Anxiety Disorder (GAD) [ Time Frame: Pretest (at enrollment) and posttest (3 months post enrollment) ]The 7-item GAD will measure generalized anxiety. The minimum overall score is 0 and the maximum overall score is 21. Higher values represent more severe symptoms of generalized anxiety.
- Number of Program Visits [ Time Frame: From enrollment to 3-month posttest ]MMB 2.0 will unobtrusively track the overall number of each visit each woman participant makes to the MMB program. The occurrence of a visit will be tracked automatically based on a scripted programming logic in the project database with a time/date stamp.
- Duration of Program Visits [ Time Frame: From enrollment to 3-month posttest ]MMB 2.0 will unobtrusively track the overall length of time or duration (in seconds) of each visit each woman participant makes to the MMB program. The duration of a visit will be tracked automatically based on a scripted programming logic in the project database with a time/date stamp.
- Other treatment use [ Time Frame: Posttest (3 months post enrollment) ]Participants will be asked to self-report the extent to which they used additional therapies, such as psychotherapy, medication, informal support, or other treatment types while enrolled in the study.
- Satisfaction with Treatment: questions [ Time Frame: Posttest (3 months post enrollment) ]Three individual questions will assess participant self-reported satisfaction with using the MMB program. Each question will have a minimum rating of 0 and a maximum rating of 5. A higher overall rating indicates greater satisfaction with using the MMB program.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- pregnant or postpartum
- have elevated Edinburgh Postnatal Depression Scale (EPDS) of ≥ 12
- access to broadband internet and a computer at home (desktop, laptop, tablet) or a smartphone (iOS or Android)
- English language proficiency sufficient to enable completion of the informed consent and to engage in all study activities that are delivered in English
Exclusion Criteria:
- Women assessed with active suicidal ideation will be excluded and provided with immediate psychiatric care consistent with NorthShore's established safety protocol
Contacts and Locations
Contacts
| Contact: David R Smith, PhD, PMP | 541-484-2123 ext 2966 | David.Smith@influentsin.com |
Locations
| United States, Illinois | |
| NorthShore University HealthSystem | Recruiting |
| Chicago, Illinois, United States, 60201 | |
| Contact: Richard Silver, MD 847-570-2860 RSilver@northshore.org | |
| Contact: Jo Kim, PhD 847.570.2878 jkim@northshore.org | |
| United States, Oregon | |
| Oregon Research Behavioral Intervention Strategies, Inc. | Active, not recruiting |
| Eugene, Oregon, United States, 97403 | |
Sponsors and Collaborators
Oregon Research Behavioral Intervention Strategies, Inc.
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 17, 2019 | ||||
| First Posted Date ICMJE | June 24, 2019 | ||||
| Last Update Posted Date | October 5, 2020 | ||||
| Actual Study Start Date ICMJE | August 24, 2018 | ||||
| Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in Primary Health Questionnaire (PHQ-9) [ Time Frame: Pretest (at enrollment) and posttest (3 months post enrollment) ] 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. Finally, it includes an item, "Thoughts you would be better off dead or hurting yourself in some way," that will trigger our safety monitoring procedure. The minimum overall score is 0 and the maximum overall score for the PHQ-9 is 27. Higher values represent more severe depression status. To evaluate the clinical significance of the intervention effects, the investigators will calculate the minimal clinically important difference, which for the PHQ-9 is a score of 5 points difference from Pretest to posttest.
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Responsive eHealth Intervention for Perinatal Depression in Healthcare Settings | ||||
| Official Title ICMJE | Responsive eHealth Intervention for Perinatal Depression in Healthcare Settings | ||||
| Brief Summary | 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. | ||||
| Detailed Description | 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 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 (Small Business Innovation Research) 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, smartphone). 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. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: 2-Arm random control trial Masking: None (Open Label)Primary Purpose: Treatment |
||||
| Condition ICMJE | Perinatal Depression | ||||
| Intervention ICMJE |
|
||||
| Study Arms ICMJE |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
210 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | July 31, 2021 | ||||
| Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03995316 | ||||
| Other Study ID Numbers ICMJE | MH109191 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Oregon Research Behavioral Intervention Strategies, Inc. | ||||
| Study Sponsor ICMJE | Oregon Research Behavioral Intervention Strategies, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Oregon Research Behavioral Intervention Strategies, Inc. | ||||
| Verification Date | September 2020 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||
