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

Study Overview
=================
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.

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

Conditions
-----------------
Perinatal Anxiety, Perinatal Depression

Intervention / Treatment
-----------------
* Behavioral: Overcoming Anxiety in Pregnancy and Postpartum Online Self-Directed Program


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online Self-Directed Program<br>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<br>* 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.<br>|
| Other: Waitlist<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perinatal Depression Symptoms from Baseline | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anxiety, Pregnancy, Postpartum, Online, Self-Directed, Cognitive Behavioural Therapy, Randomized Controlled Trial, COVID-19