Evaluating Overcoming Anxiety in Pregnancy and Postpartum as an Online Self-Directed Program

NCT04844138 | Completed

• 2 other identifiers: P2020:10453294
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

The pregnancy and postpartum periods can be joyous times in life; however, they can also be filled with challenging physical, emotional, and lifestyle changes. These changes may lead to feelings of stress, anxiety, and depression amongst new and expecting mothers, which can have negative effects on fetal and infant development (Beijers et al., 2010; Goodman et al., 2016). The impacts of increased worry about health and safety due to COVID-19 as well as future-related uncertainties, paired with social (physical) distancing, may be felt especially strongly in this population. Of concern, pregnant and postpartum women have low rates of mental health service use even prior to the pandemic (Fonseca et al., 2015). E-health (Internet) and m-health (mobile application) psychological interventions are accessible, available at reduced cost, and can be accessed within users' homes, a factor that is particularly important during the pandemic (Andrews \& Titov, 2010). In this study, the investigators will disseminate a free, online, self-directed Cognitive Behavioural Therapy program to women experiencing symptoms of anxiety during pregnancy and postpartum. This program has shown to be effective at improving symptoms of anxiety and depression when delivered in an in-person group format, and has high acceptability (Furer \& Reynolds, 2015). The investigators will transfer this program into an online format so that pregnant and postpartum users can navigate the sessions on their own, without the support of a clinician. This program contains six modules which include topics such as coping with negative thoughts, unpacking the myth of the supermom, and managing expectations during pregnancy and postpartum. Additionally, material related to COVID-19 has been added to the program to target any pandemic-related stress participants may be experiencing. The investigators will collect information about the program's feasibility, acceptability, and effectiveness, which will inform future improvements to the program. This program is expected to reduce participants' feelings of stress, anxiety, and depression, in addition to improving maternal attachment. It is anticipated that these gains will be maintained when the investigators follow-up with participants one month after program completion. This program has the potential to provide accessible and affordable mental health services to pregnant and postpartum women struggling during the pandemic.

Conditions

Perinatal Anxiety; Perinatal Depression

Keywords

Anxiety; Pregnancy; Postpartum; Online; Self-Directed; Cognitive Behavioural Therapy; Randomized Controlled Trial; COVID-19

Outcome Measures

Primary Outcomes (1)

• Change in Perinatal Anxiety Symptoms from Baseline

  To assess changes in perinatal anxiety symptoms throughout the study, the Perinatal Anxiety Screening Scale (PASS; Somerville et al., 2014) will be administered. The PASS is a 31-item self-report measure assessing symptoms of anxiety during the perinatal period. The scale has excellent reliability, adequate test-retest reliability, and strong evidence of convergent validity (Somerville et al., 2014). A shortened version of the PASS will be administered to participants in both conditions when they are completing the online program. This measure will help determine the effectiveness of this program.

  The online self-directed program condition will complete it at weeks 1, 6, and 10, while the waitlist condition will complete it at weeks 1, 6, 12, and 16. Both conditions will complete the short version weekly during the program.

Secondary Outcomes (10)

• Change in Perinatal Depression Symptoms from Baseline

  The online self-directed program condition will complete it at weeks 1, 6, and 10, while the waitlist condition will complete it at weeks 1, 6, 12, and 16. Both conditions will complete it weekly during the program.

• Change in COVID-19 Stress from Baseline

  The online self-directed program condition will complete it at weeks 1, 6, 10, while the waitlist condition will complete it at weeks 1, 6, 12, and 16.

• Change in Non-Specific Psychological Distress from Baseline

  The online self-directed program condition will complete it at weeks 1, 6, 10, while the waitlist condition will complete it at weeks 1, 6, 12 and 16.

• Change in Life Stress from Baseline

  The online self-directed program condition will complete it at weeks 1, 6, 10, while the waitlist condition will complete it at weeks 1, 6, 12, and 16.

• Change in Maternal Antenatal Attachment from Baseline

  The online self-directed program condition will complete it at weeks 1, 6, 10, while the waitlist condition will complete it at weeks 1, 6, 12, and 16.

Study Arms (2)

Online Self-Directed Program

EXPERIMENTAL

Participants in this condition will complete our six-week online self-directed program as soon as it's available.

Behavioral: Overcoming Anxiety in Pregnancy and Postpartum Online Self-Directed Program

Waitlist

OTHER

Participants in this condition will receive treatment as usual for six weeks, after which point they will be invited to complete our online program.

Behavioral: Overcoming Anxiety in Pregnancy and Postpartum Online Self-Directed Program

Interventions

Overcoming Anxiety in Pregnancy and Postpartum Online Self-Directed Program BEHAVIORAL

The investigators will administer the Overcoming Anxiety in Pregnancy and Postpartum program in an online self-directed format. This program is grounded in Cognitive Behavioural Therapy and will teach participants strategies to manage their anxiety. Participants will complete six modules that will be released to them on a bi-weekly basis.

Online Self-Directed Program; Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently pregnant or within 12 months postpartum
• Age 18 or older
• Experiencing symptoms of anxiety
• Have access to a computer, tablet, or smartphone
• Have access to the Internet
• Speak English
• Manitoba resident
• Willing to provide their name, email address, home address, and phone number

You may not qualify if:

• Current substance use disorder
• Diagnoses of bipolar disorder or schizophrenia
• Current suicidality

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (18)

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  PMID: 20528709 BACKGROUND

• Beijers R, Jansen J, Riksen-Walraven M, de Weerth C. Maternal prenatal anxiety and stress predict infant illnesses and health complaints. Pediatrics. 2010 Aug;126(2):e401-9. doi: 10.1542/peds.2009-3226. Epub 2010 Jul 19.

  PMID: 20643724 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Condon JT. The assessment of antenatal emotional attachment: development of a questionnaire instrument. Br J Med Psychol. 1993 Jun;66(2):167-83. doi: 10.1111/j.2044-8341.1993.tb01739.x.

  PMID: 8353110 BACKGROUND

• Condon JT, Corkindale CJ. The assessment of parent-to-infant attachment: Development of a self-report questionnaire instrument. Journal of Reproductive and Infant Psychology. 1998; 16(1): 57-76.

  BACKGROUND

• Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

  PMID: 3651732 BACKGROUND

• Fairbrother N, Janssen P, Antony MM, Tucker E, Young AH. Perinatal anxiety disorder prevalence and incidence. J Affect Disord. 2016 Aug;200:148-55. doi: 10.1016/j.jad.2015.12.082. Epub 2016 Apr 14.

  PMID: 27131505 BACKGROUND

• Fonseca A, Gorayeb R, Canavarro MC. Women׳s help-seeking behaviours for depressive symptoms during the perinatal period: Socio-demographic and clinical correlates and perceived barriers to seeking professional help. Midwifery. 2015 Dec;31(12):1177-85. doi: 10.1016/j.midw.2015.09.002. Epub 2015 Sep 21.

  PMID: 26433622 BACKGROUND

• Furer P, Reynolds K. Overcoming anxiety in pregnancy and postpartum. Unpublished treatment manual. Winnipeg, MB: University of Manitoba; 2015.

  BACKGROUND

• Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db.

  PMID: 16260528 BACKGROUND

• Goodman JH, Watson GR, Stubbs B. Anxiety disorders in postpartum women: A systematic review and meta-analysis. J Affect Disord. 2016 Oct;203:292-331. doi: 10.1016/j.jad.2016.05.033. Epub 2016 Jun 1.

  PMID: 27317922 BACKGROUND

• Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002 Aug;32(6):959-76. doi: 10.1017/s0033291702006074.

  PMID: 12214795 BACKGROUND

• Milosevic I, Levy HC, Alcolado GM, Radomsky AS. The Treatment Acceptability/Adherence Scale: Moving Beyond the Assessment of Treatment Effectiveness. Cogn Behav Ther. 2015;44(6):456-69. doi: 10.1080/16506073.2015.1053407. Epub 2015 Jun 19.

  PMID: 26091250 BACKGROUND

• Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.

  PMID: 9881538 BACKGROUND

• Somerville S, Dedman K, Hagan R, Oxnam E, Wettinger M, Byrne S, Coo S, Doherty D, Page AC. The Perinatal Anxiety Screening Scale: development and preliminary validation. Arch Womens Ment Health. 2014 Oct;17(5):443-54. doi: 10.1007/s00737-014-0425-8. Epub 2014 Apr 4.

  PMID: 24699796 BACKGROUND

• Taylor S, Landry CA, Paluszek MM, Fergus TA, McKay D, Asmundson GJG. Development and initial validation of the COVID Stress Scales. J Anxiety Disord. 2020 May;72:102232. doi: 10.1016/j.janxdis.2020.102232. Epub 2020 May 4.

  PMID: 32408047 BACKGROUND

• Teti DM, Gelfand DM. Behavioral competence among mothers of infants in the first year: the mediational role of maternal self-efficacy. Child Dev. 1991 Oct;62(5):918-29. doi: 10.1111/j.1467-8624.1991.tb01580.x.

  PMID: 1756667 BACKGROUND

• Uchechukwu L, Hardman MP, Hadley I, Gornik ME, Petty SK, Pryor TAM, Alcolado GM, Furer P, Reynolds KA. "I'm not alone": perinatal women's experiences in an online self-directed program for perinatal anxiety. BMC Pregnancy Childbirth. 2025 Feb 21;25(1):190. doi: 10.1186/s12884-025-07270-3.

  PMID: 39984893 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; COVID-19

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Kristin Reynolds, Ph.D.

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The research team (principal investigator, co-investigators, research coordinator, and research assistants) will be blinded during the randomization process. To protect participants' identifying information throughout the study, a non-team member will generate a randomized list of unique participant IDs prior to starting recruitment. The non-team member will then randomly assign these IDs to the online self-directed program or waitlist conditions, and will black out this information to conceal it from the research team. The research coordinator will assign participants to a participant ID when they are enrolled in our study. After participants complete their second screening interview (clinical symptom interview), the research coordinator will access the blacked-out information and reveal the participant's condition. Once revealed, this information may be viewed by all members of the research team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned to either the online self-directed program condition or the waitlist condition. Throughout the study, participant outcomes for both conditions will be measured to evaluate the effects of our online program compared to treatment as usual.

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 14, 2021
• Study Start: April 30, 2021
• Primary Completion: June 29, 2022
• Study Completion: June 29, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)