Perinatal AnxietyNCT04844138

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

A study testing Overcoming Anxiety in Pregnancy and Postpartum Online Self-Directed Program in people with Perinatal Anxiety and Perinatal Depression, run by University of Manitoba at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Perinatal Anxiety, Perinatal Depression
What is being tested?: Overcoming Anxiety in Pregnancy and Postpartum Online Self-Directed Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 95 participants
Where: 1 siteCanada
Study dates: 30 Apr 2021to 29 Jun 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of Manitoba
Winnipeg, Manitoba, R3T 2N2

Other trials in Canada

About this study

Official title: 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.

Conditions: Perinatal Anxiety, Perinatal Depression
Being tested: Overcoming Anxiety in Pregnancy and Postpartum Online Self-Directed Program
Keywords: Anxiety, Pregnancy, Postpartum, Online, Self-Directed, Cognitive Behavioural Therapy, Randomized Controlled Trial, COVID-19
Medical subject headings: Anxiety Disorders, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Overcoming Anxiety in Pregnancy and Postpartum Online Self-Directed ProgramBehavioural
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.

Study groups in NCT04844138
Study group	Role	What they receive
Online Self-Directed Program	Experimental	Participants in this condition will complete our six-week online self-directed program as soon as it's available. Receives: 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. Receives: Behavioral: Overcoming Anxiety in Pregnancy and Postpartum Online Self-Directed Program

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 202129 Jun 2022

First posted14 Apr 2021
Study start30 Apr 2021
Primary completion29 Jun 2022
Study completion29 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Perinatal AnxietyStudies of the same condition, open and under way.
More trials run by University of ManitobaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04844138
Sponsor's protocol ID: P2020:104
Other IDs: 53294
Status last verified: Jul 2022
First submitted: 5 Apr 2021
Last updated: 7 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Andrews G, Titov N. Is internet treatment for depressive and anxiety disorders ready for prime time? Med J Aust. 2010 Jun 7;192(S11):S45-7. doi: 10.5694/j.1326-5377.2010.tb03693.x.
PubMed 20528709
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.
PubMed 20643724
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.
PubMed 6668417
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.
PubMed 8353110
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.
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.
PubMed 3651732
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.
PubMed 27131505
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.
PubMed 26433622
Furer P, Reynolds K. Overcoming anxiety in pregnancy and postpartum. Unpublished treatment manual. Winnipeg, MB: University of Manitoba; 2015.
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.
PubMed 16260528
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.
PubMed 27317922
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.
PubMed 12214795
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.
PubMed 26091250
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.
PubMed 9881538
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.
PubMed 24699796

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
Depressive Symptoms, Perinatal Loss
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications
Not yet recruiting
Improving Perinatal Mental Health Through a Collaborative, Community Health Worker and Social Worker Intervention
Perinatal Anxiety, Perinatal Depression
Recruiting
Deconstructing Maternal Burdens: Doulas and the Community Unite for Health
Pregnancy, Post Partum
Not yet recruiting
Healthy Adaptation to Pregnancy, Postpartum and Parenthood
Perinatal Mental Health, Gestational Weight Gain

All Perinatal Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating a Self-Directed Cognitive Behavioural Therapy E-Health and M-Health Program for Anxiety in Pregnancy and Postpartum During COVID-19
ClinicalTrials.gov ID: NCT04844138
Acronym / sponsor ID: P2020:104
Conditions: Perinatal Anxiety, Perinatal Depression
Keywords: Anxiety, Pregnancy, Postpartum, Online, Self-Directed, Cognitive Behavioural Therapy, Randomized Controlled Trial, COVID-19
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: University of ManitobaUniversity, hospital or other
Study start: 30 Apr 2021 (actual)
Primary completion: 29 Jun 2022 (actual)
Study completion: 29 Jun 2022 (actual)
First posted: 14 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Online Self-Directed Program	Experimental	Behavioral: Overcoming Anxiety in Pregnancy and Postpartum Online Self-Directed ProgramParticipants in this condition will complete our six-week online self-directed program as soon as it's available.
Waitlist	Other	Behavioral: Overcoming Anxiety in Pregnancy and Postpartum Online Self-Directed ProgramParticipants in this condition will receive treatment as usual for six weeks, after which point they will be invited to complete our online program.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Overcoming Anxiety in Pregnancy and Postpartum Online Self-Directed ProgramThe 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.	Behavioural	Online Self-Directed Program, Waitlist

Primary outcome

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.

10 secondary outcomes

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.
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.
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.
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.
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.
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.
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.
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.
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).
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
Background: PubMed 20528709Andrews G, Titov N. Is internet treatment for depressive and anxiety disorders ready for prime time? Med J Aust. 2010 Jun 7;192(S11):S45-7. doi: 10.5694/j.1326-5377.2010.tb03693.x.
Background: PubMed 20643724Beijers 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.
Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
Background: PubMed 8353110Condon 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.
BackgroundCondon 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: PubMed 3651732Cox 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.
Background: PubMed 27131505Fairbrother 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.
Background: PubMed 26433622Fonseca 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.
BackgroundFurer P, Reynolds K. Overcoming anxiety in pregnancy and postpartum. Unpublished treatment manual. Winnipeg, MB: University of Manitoba; 2015.
Background: PubMed 16260528Gavin 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.
Background: PubMed 27317922Goodman 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.
Background: PubMed 12214795Kessler 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.
Individual participant dataSharing planned: No

Related trials for Perinatal Anxiety

Not yet recruiting
e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
Depressive Symptoms, Perinatal Loss
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications
Not yet recruiting
Improving Perinatal Mental Health Through a Collaborative, Community Health Worker and Social Worker Intervention
Perinatal Anxiety, Perinatal Depression
Recruiting
Deconstructing Maternal Burdens: Doulas and the Community Unite for Health
Pregnancy, Post Partum
Not yet recruiting
Healthy Adaptation to Pregnancy, Postpartum and Parenthood
Perinatal Mental Health, Gestational Weight Gain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kristin Reynolds, Ph.D. principal investigator

University of Manitoba

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04844138, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.