Clinical trial NCT04844138: Evaluating Overcoming Anxiety in Pregnancy and Postpartum as an Online Self-Directed Program
Official title: Evaluating a Self-Directed Cognitive Behavioural Therapy E-Health and M-Health Program for Anxiety in Pregnancy and Postpartum During COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Anxiety
Perinatal Depression
Keywords: Anxiety
Pregnancy
Postpartum
Online
Self-Directed
Cognitive Behavioural Therapy
Randomized Controlled Trial
COVID-19
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Perinatal Anxiety Symptoms from Baseline
timeFrame: 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:
measure: Change in Perinatal Depression Symptoms from Baseline
timeFrame: 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.
measure: Change in COVID-19 Stress from Baseline
timeFrame: 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.
measure: Change in Non-Specific Psychological Distress from Baseline
timeFrame: 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.
measure: Change in Life Stress from Baseline
timeFrame: 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.
measure: Change in Maternal Antenatal Attachment from Baseline
timeFrame: 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.
measure: Change in Maternal Postnatal Attachment from Baseline
timeFrame: 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.
measure: Change in Maternal Efficacy from Baseline
timeFrame: 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.
measure: Acceptability of the Online Self-Directed Program
timeFrame: The TAAS will be administered to the online self-directed program condition at week 2 and the waitlist condition at week 7.
measure: Participant Satisfaction with the Online Self-Directed Program
timeFrame: 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).
measure: Participant Experiences in the Online Self-Directed Program
timeFrame: 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.
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Kristin Reynolds, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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