Clinical trial NCT05867680: Feasibility Trial of an Online Course (eMB) to Reduce Anxiety and Depression for Pregnant Women and Their Partners
Official title: A Pilot Feasibility Trial of the Online Mothers and Babies Course (eMB): Improving Perinatal Mental Health for Pregnant Women and Their Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders Generalized
Depression
Keywords: prenatal
Online intervention
randomized control trial
feasibility
couples
Cognitive Behavioral Therapy
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Fahs Beck Fund for Research and Experimentation
First posted: 2023-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random assignment to the control or treatment group using a 1:1 parallel assignment.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Change between baseline, week 4 and 8
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Change between baseline, week 4 and 8
measure: Implementation feasibility
timeFrame: Upon trial completion
measure: Intervention adherence
timeFrame: Upon trial completion
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
References:
citation: Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
citation: R. F. Muñoz, H.-N. Le, C. G. Ippen, M. A. Diaz, G. G. Urizar Jr, J. Soto, et al. Cognitive and Behavioral Practice 2007 Vol. 14 Issue 1 Pages 70-83
citation: Moran TE, O'Hara MW. A partner-rating scale of postpartum depression: the Edinburgh Postnatal Depression Scale - Partner (EPDS-P). Arch Womens Ment Health. 2006 Jul;9(4):173-80. doi: 10.1007/s00737-006-0136-x. Epub 2006 Jun 8.
citation: Murray D, Cox JL. Screening for depression during pregnancy with the Edinburgh Depression Scale (EDDS). J Reprod Infant Psyc. 1990;8(2):99-107.
citation: Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.