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

NCT ID: NCT04844138

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2022-06-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Online Self-Directed Program

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

Group Type: EXPERIMENTAL

Overcoming Anxiety in Pregnancy and Postpartum Online Self-Directed Program

Intervention Type: 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.

Waitlist

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

Group Type: OTHER

Overcoming Anxiety in Pregnancy and Postpartum Online Self-Directed Program

Intervention Type: 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.

Interventions

Overcoming Anxiety in Pregnancy and Postpartum Online Self-Directed Program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Kristin Reynolds

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin Reynolds, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

University of Manitoba

Winnipeg, Manitoba, Canada

Countries

Canada

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Other Identifiers

53294

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

P2020:104

Identifier Type: -

Identifier Source: org_study_id