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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05867680
• Other study ID #: 000686919
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: January 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Disorders Generalized
• Depression
• Depressive Disorder

Intervention

Behavioral:
• Online Mothers and Babies Course (eMB)
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.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	Fahs Beck Fund for Research and Experimentation

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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.

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

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generalized Anxiety Disorder-7 (GAD-7)	The GAD-7 has seven self-reported items assessing general anxiety levels and has good reliability (a =.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
Primary	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 (a = .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
Primary	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
Primary	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
Primary	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 (a = .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