Responsive e-Health Intervention for Perinatal Depression in Healthcare Settings

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03995316

Acronym

MMB

Enrollment

191

Registered

2019-06-24

Start date

2018-08-24

Completion date

2021-07-31

Last updated

2023-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal Depression

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 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.

Interventions

BEHAVIORALTreatment 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.

BEHAVIORALTreatment 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

2-Arm random control trial

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Primary Health Questionnaire (PHQ-9)	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. 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.

Secondary

Measure	Time frame	Description
Change in General Anxiety Disorder (GAD)	Pretest (at enrollment) and posttest (3 months post enrollment)	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.
Change in Stress	Pretest (at enrollment) and posttest (3 months post enrollment)	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.
Change in Behavioral Activation for Depression Scale (BADS)	Pretest (at enrollment) and posttest (3 months post enrollment)	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.
Change in Automatic Thoughts Questionnaire - Short Form (ATQ)	Pretest (at enrollment) and posttest (3 months post enrollment)	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.
Change in Self-Efficacy	Pretest (at enrollment) and posttest (3 months post enrollment)	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	96
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.	95
Total	191

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	10	3

Baseline characteristics

Characteristic	Treatment As Usual + MMB 2.0	Treatment As Usual Only	Total
Age, Categorical Age <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical Age >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Age Between 18 and 65 years	96 Participants	95 Participants	191 Participants
Age, Continuous	31.7 years STANDARD_DEVIATION 5.2	32.1 years STANDARD_DEVIATION 5.4	31.9 years STANDARD_DEVIATION 5.3
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants	11 Participants	23 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	78 Participants	79 Participants	157 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants	5 Participants	11 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	10 Participants	17 Participants	27 Participants
Race (NIH/OMB) Black or African American	8 Participants	7 Participants	15 Participants
Race (NIH/OMB) More than one race	8 Participants	8 Participants	16 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	3 Participants	6 Participants
Race (NIH/OMB) White	66 Participants	60 Participants	126 Participants
Region of Enrollment United States	96 participants	95 participants	191 participants
Sex: Female, Male Female	96 Participants	95 Participants	191 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	0 / 96	0 / 95
other Total, other adverse events	0 / 96	0 / 95
serious Total, serious adverse events	0 / 96	0 / 95

Outcome results

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.