Feasibility Trial of an Online Course (eMB) to Reduce Anxiety and Depression for Pregnant Women and Their Partners

Study Overview
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Brief Summary
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This pilot study engaged pregnant couples experiencing elevated symptoms of maternal anxiety or depression with an existing online psychoeducation intervention, the Online Mothers and Babies Course (eMB). The study had three primary aims to assess overall feasibility; 1) explore the feasibility of delivering eMB to couples by assessing recruitment, retainment, and adherence, 2) examine eMB's preliminary efficacy for reducing PMAD symptoms, and 3) describe participants' satisfaction and perceptions about eMB acceptability. The intervention group received the 8-week eMB and the control group received an informational resources sheet.

Detailed Description
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Perinatal anxiety and depression are common, often co-morbid, and occur more frequently than outside pregnancy. Preventative measures can reduce the risk of poor mental and physical health outcomes and improve coping self-efficacy and the perception of social support. The antenatal period is an optimal time for intervention. Efficacious interventions include engaging pregnant people in cognitive-behavioral therapy and increasing the pregnant person's perception of social support -particularly partner support. Despite the evidence that partners can buffer stressors and, more generally, that perceived social support is protective, there are few interventions to reduce symptoms of anxiety or depression that involve partners. Online interventions can effectively manage mental health, increase knowledge and access to resources, and improve social connectivity. Online interventions have decreased perinatal anxiety, depression, and perception of stress, increased awareness about mental health risk factors and protective strategies, and improved coping self-efficacy successfully. Although perceived partner support is protective against poor mental health for pregnant people, partners' potential roles in online interventions is an understudied area of intervention innovation. Expanding the number of effective and equitably accessible online interventions is essential, given structural and social barriers to care. Engaging the pregnant person and her partner as a dyad in perinatal studies complicates recruitment, retention, adherence, and longitudinally measuring change. This pilot study engaged pregnant couples experiencing elevated symptoms of maternal anxiety or depression with an existing online psychoeducation intervention, the Online Mothers and Babies Course (eMB). The study had three primary aims to assess overall feasibility; 1) explore the feasibility of delivering eMB to couples by assessing recruitment, retainment, and adherence, 2) examine eMB's preliminary efficacy for reducing PMAD symptoms, and 3) describe participants' satisfaction and perceptions about eMB acceptability. Analytic Approach The approach follows Whitehead et al. (2016) guidance on sample size to complete a pilot feasibility trial; a sample size of 30 people for each condition was necessary. (1) The study uses univariate analysis to calculate descriptive statistics describing the sample and feasibility outcomes. Given the study's aims, the study hypothesized that it would be feasible to deliver the program to pregnant couples and there would be a significant reduction in anxiety and depression symptoms in favor of the intervention group. A factorial Analysis of Variance (ANOVA) with repeated measures on the dyadic role and survey time was used to test the study hypotheses. The analysis used an intention-to-treat analysis approach and a significance level of α = 0.05 or less. Repeated measures were recorded three times for each participant and each outcome of interest to evaluate the effect of the eMB course. Based on the minimum Akaike Information Criterion (AIC), researchers used an optimal residual covariance structure for each outcome. When factor interactions were significant, posthoc comparisons were used. The study retained data when available and dropped cases missing at times two or three. Data missing in this study are considered missing at random and analyzed with maximum likelihood estimation. Analyses were conducted using SPSS software. To assess the degree of program satisfaction, item responses were summed, and the average satisfaction score was calculated for the intervention group. Interview data were analyzed using an inductive thematic approach. Both authors are PhD-trained researchers with extensive qualitative experience and contributions to various health and social science studies. The analysis occurred in stages: preparing transcripts after Zoom download, becoming familiar with the data, creating memos, coding (i.e., applying labels to text segments), searching for patterns in the coding, defining and naming themes from patterns, and writing up results. Analysis was conducted in Dedoose. The study investigator completed each stage first, and a member check was conducted by the second researcher.

Official Title
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A Pilot Feasibility Trial of the Online Mothers and Babies Course (eMB): Improving Perinatal Mental Health for Pregnant Women and Their Partners

Conditions
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Anxiety Disorders Generalized, Depression

Intervention / Treatment
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* Behavioral: Online Mothers and Babies Course (eMB)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Adult, cis-gender and heterosexual pregnant people Pregnancy between 13- and 30 weeks gestation Elevated symptoms of pregnancy anxiety or depression (i.e., above the cut-off of 10 with validated measures - the Patient Health Questionaire-9 (PHQ-9; 33) or the Generalized Anxiety Disorder-7 (GAD-7; 29) Enrolled as a couple with the pregnant person and their partner cohabitating in Missouri and having internet access Exclusion criteria: If either person in the couple did not meet the inclusion criteria Endorsed suicide risk, Could not comprehend the consent document

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Random assignment to the control or treatment group using a 1:1 parallel assignment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment group participants received the eMB intervention during the 8-week trial period. | Behavioral: Online Mothers and Babies Course (eMB)<br>* The eMB is an online, asynchronous, self-administered intervention modeled after the efficacious and in-person Mothers and Babies Course. (4) The eight-week course includes psychoeducational modules containing YouTube videos, vignettes, interactive quizzes, homework, guided meditations, and downloadable resources that teach strategies to promote a healthy outcome for mothers and their newborns: 1) overview, 2) thoughts and my mood, 3) fighting harmful and increasing helpful thoughts, 4) activities and my mood, 5) pleasant activities help make a healthy reality, 6) contact with others and my mood, 7) planning for the future and graduation, 8) relaxation exercises.<br>|
| No Intervention: Control<br>The control group received a PDF community resources informational sheet, also available to the intervention group via the eMB program. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalized Anxiety Disorder-7 (GAD-7) | The GAD-7 has seven self-reported items assessing general anxiety levels and has good reliability (α =.89). The responses are scored zero to three based on symptom severity, and the sum of all items ranges from zero to 21. A score of five, 10, and 15 are cut points for mild, moderate, and severe anxiety. (Spitzer et al.2006) | Change between baseline, week 4 and 8 | 
| Edinburgh Postnatal Depression Scale (EPDS) | The EPDS is a ten-item self-reported questionnaire validated for use in pregnancy, acceptable for use with partners, and found to have good reliability (α = .87). The item responses are scored from zero to three to indicate symptom severity, and three questions are reverse-scored. A total score ranges from zero to 30. A score of ten or more indicates moderate symptom severity and is considered the optimal cut-off for further assessment or intervention.(Murry and Cox, 1990) | Change between baseline, week 4 and 8 | 
| Implementation feasibility | For feasibility measures, we used study tracking data and Qualtrics usage analytics; these include recruitment, retention and attrition rates, and participant intervention adherence. The recruitment rate is the proportion of study inquiries and enrollments. Retention is the portion of survey completions and the reminders at each measurement time for each person. Attrition is the proportion of enrolled dyads and dropouts (i.e., both members failed to complete the final two surveys). | Upon trial completion | 
| Intervention adherence | Intervention adherence is the average number of participants completing one lesson per week, the proportion of fully or partially complete lessons, and the average total lessons visited. An additional descriptive usage measure was captured with a multiple-option survey item asking whether the participant used eMB alone, together with their counterparts, a combination of alone and together, or not at all. | Upon trial completion | 
| Client Satisfaction Questionnaire (CSQ-8) | The CSQ-8 is a 4-point Likert scale with responses ranging from strongly disagree to agree strongly and is sum-scored from eight to 32. A score from eight to 13 is interpreted as poor, 14-19 as fair, 20-25 as good, and 26-32 as excellent satisfaction. The scale has high internal consistency (α = .9) and is used routinely in healthcare research (Attkisson & Greenfield, 1995). Satisfaction and program acceptability are also measured qualitatively using semi-structured interviews. Questions included prompts about the helpfulness of materials, ease of use, areas for improvement, and how the course improved coping behaviors.(Attkisson & Zwick, 1982) | week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prenatal, Online intervention, randomized control trial, feasibility, couples, Cognitive Behavioral Therapy