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

NCT05867680 | Completed

• 1 other identifier: 000686919
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders Generalized; Depression

Keywords

prenatal; Online intervention; randomized control trial; feasibility; couples; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Treatment

EXPERIMENTAL

Treatment group participants received the eMB intervention during the 8-week trial period.

Behavioral: Online Mothers and Babies Course (eMB)

Control

NO INTERVENTION

The control group received a PDF community resources informational sheet, also available to the intervention group via the eMB program.

Interventions

Online Mothers and Babies Course (eMB) BEHAVIORAL

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender women; cisgender men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Endorsed suicide risk,
• Could not comprehend the consent document

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Fahs Beck Fund for Research and Experimentation: collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

Related Publications (8)

• 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.

  PMID: 26092476 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 16755331 BACKGROUND

• Murray D, Cox JL. Screening for depression during pregnancy with the Edinburgh Depression Scale (EDDS). J Reprod Infant Psyc. 1990;8(2):99-107.

  BACKGROUND

• 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.

  PMID: 10259963 BACKGROUND

• Canfield SM, Canada KE, Rolbiecki AJ, Petroski GF. Feasibility and acceptability of an online mental health intervention for pregnant women and their partners: a mixed method study with a pilot randomized control trial. BMC Pregnancy Childbirth. 2023 Oct 18;23(1):739. doi: 10.1186/s12884-023-06031-4.

  PMID: 37853333 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder; Depression

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Model Details: Random assignment to the control or treatment group using a 1:1 parallel assignment.

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 22, 2023
• Study Start: June 1, 2020
• Primary Completion: January 8, 2021
• Study Completion: December 31, 2022
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

US (1)