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

July 5, 2022 updated by: Kristin Reynolds, University of Manitoba

Evaluating a Self-Directed Cognitive Behavioural Therapy E-Health and M-Health Program for Anxiety in Pregnancy and Postpartum During COVID-19

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3T 2N2
        • University of Manitoba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Online Self-Directed Program
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
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.
Other: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Perinatal Anxiety Symptoms from Baseline
Time Frame: 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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Perinatal Depression Symptoms from Baseline
Time Frame: 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.
To examine changes in perinatal depression symptoms throughout the study, the Edinburgh Postnatal Depression Scale (Cox et al., 1987) will be administered. The EPDS is a 10-item self-report measure assessing symptoms of postnatal depression on a 0 to 4 scale. Higher scores indicate higher levels of depression symptoms. This scale exhibits satisfactory psychometric properties and is sensitive to change (Cox et al., 1987). It has also been validated in pregnant populations. The investigators have removed item 10 (suicidality measure) as participants with suicidal ideations will be screened out at the initial screening interview. This outcome 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 it weekly during the program.
Change in COVID-19 Stress from Baseline
Time Frame: 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.
To assess changes in COVID-19 related stress, the COVID-19 Stress Scales (Taylor et al., 2020) will be administered. This is a 36-item measure, with higher scores indicating higher levels of stress. It measures specific factors that may contribute to pandemic-related distress, including danger and contamination fears, fears about the socio-economic consequences of the pandemic, xenophobia (i.e. foreigners carrying the disease), compulsive checking and reassurance seeking, and traumatic stress symptoms about the virus. When tested in a North American sample, these scales were found to be intercorrelated and had acceptable reliability and validity (Taylor et al., 2020). This outcome measure will help determine the effectiveness of this program.
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
Time Frame: 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.
To assess changes in non-specific psychological distress across this study, the Kessler Distress Scale-Short Form-6-item version (K6; Kessler et al., 2002) will be administered. The K6 is a 6-item self-report measure and has been shown to have excellent internal reliability. This outcome measure will help determine the effectiveness of this program.
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
Time Frame: 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.
To assess changes in life stress across this study, the Perceived Stress Scale (PSS; Cohen et al., 1983) will be administered. The PSS is a 10-item self-report measure that assesses the extent to which one's life is appraised as stressful. This outcome measure will help determine the effectiveness of this program.
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
Time Frame: 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.
To evaluate changes in maternal antenatal attachment throughout this study, the Maternal Antenatal Attachment Scale (MAAS; Condon, 1993) will be administered to pregnant participants in both conditions. The MAAS is a 15-item self-report measure that assesses maternal attachment towards an unborn baby in the antenatal period. This outcome measure will help determine the effectiveness of this program.
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 Postnatal Attachment from Baseline
Time Frame: 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.
To evaluate changes in maternal antenatal attachment throughout this study, the Maternal Antenatal Postnatal Scale (MPAS; Condon & Corkindale, 1998) will be administered to postpartum participants in both conditions. The MPAS is a 19-tem self-report measure that assesses maternal attachment towards an infant during the postnatal period. This outcome measure will help determine the effectiveness of this program.
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 Efficacy from Baseline
Time Frame: 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.
To evaluate changes in maternal efficacy throughout this study, the Maternal Efficacy Questionnaire (MEQ; Teti & Gelfand, 1991) will be administered to postpartum participants in both conditions. The MEQ is a 10-item self-report measure that assesses a mother's perception of her own parenting competence. This outcome measure will help determine the effectiveness of this program.
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.
Acceptability of the Online Self-Directed Program
Time Frame: The TAAS will be administered to the online self-directed program condition at week 2 and the waitlist condition at week 7.
To assess the acceptability of our online self-directed program, the Treatment Acceptability/Adherence Scale (TAAS; Milosevic et al., 2015) will be administered. The TAAS is a self-report measure of treatment acceptability which exhibits sound psychometric properties. The TAAS will be administered to participants in both conditions once they have completed the second module of the online program. This measure will help determine the acceptability of this program with pregnant and postpartum persons.
The TAAS will be administered to the online self-directed program condition at week 2 and the waitlist condition at week 7.
Participant Satisfaction with the Online Self-Directed Program
Time Frame: This measure will be administered to the online self-directed program condition at program completion (week 6) and to the waitlist condition at program completion (week 12).
To assess participants' satisfaction with the Overcoming Anxiety in Pregnancy and Postpartum online self-directed program, the Treatment Satisfaction Measure (Furer & Reynolds, 2015) will be administered. This measure was created for the Overcoming Anxiety in Pregnancy and Postpartum Group Treatment Program and has been adapted for this online program. Two items ask about the helpfulness of the workbook and its focus on perinatal issues and are rated on a 5-point scale (i.e., from "very helpful" to "not at all helpful"). Two additional yes/no questions are included, regarding whether participants would recommend the program to other individuals in the perinatal period and whether they themselves would participate in the program again if needed. Two final open-ended questions are included regarding what patients liked about the program, and any suggestions they would have for changes to it.
This measure will be administered to the online self-directed program condition at program completion (week 6) and to the waitlist condition at program completion (week 12).
Participant Experiences in the Online Self-Directed Program
Time Frame: The weekly feedback measure will be administered weekly during the program (online self-directed program condition: weeks 1-6; waitlist condition: weeks 6-12). The interview will take place at week 6.
To obtain more detailed feedback from participants about their experiences in this online program, the investigators have developed a weekly feedback measure. This measure asks participants about their engagement with each module and allows them to provide specific feedback about the content of each module. The investigators will also invite 25 participants from each condition to complete a qualitative interview to discuss their experiences in the program and on the waitlist for the program. This will allow the investigators to collect more detailed data about what participants (dis)liked about the online program. This data will allow the investigators to improve the program for future users.
The weekly feedback measure will be administered weekly during the program (online self-directed program condition: weeks 1-6; waitlist condition: weeks 6-12). The interview will take place at week 6.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kristin Reynolds, Ph.D., University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P2020:104
  • 53294 (Research Manitoba)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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