PDA for Antidepressant Use in Pregnancy
Maneno muhimu
Kikemikali
Maelezo
A parallel group randomized controlled trial (RCT) will be conducted. Eligible and consenting women with depression will be randomized in a 1:1 ratio to either online PDA or a control condition comprising an online set of publicly available standard resources. The study will be stratified by preconception vs. pregnant, and by province.
The study is based at Women's College Hospital (Toronto) but participants will be recruited from across Canada, as the online intervention does not require any in-person study visits. Participants will be recruited via social media (ex. Facebook, Twitter, mommy/baby blogs) and by provider referrals.
Participants will be given a series of online questionnaires with various measures collected at baseline, 4 weeks post-randomization, in each trimester of pregnancy, and at 1, 3, 6 and 12 months postpartum. Participants who are planning pregnancy will enter the longer-term (pregnancy and postpartum) follow-up phase once they become pregnant; those who do not conceive by one year post-randomization will be sent a final set of questionnaires and exit the study. A process evaluation will also be conducted to gain insights around trial conduct, and perspectives on potential for (or barriers to) scale-up. This, along with the planned economic evaluation, will inform clinical and policy decisions around adopting the PDA into real-world practice.
Tarehe
| Imethibitishwa Mwisho: | 04/30/2020 |
| Iliyowasilishwa Kwanza: | 07/30/2018 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 08/09/2018 |
| Iliyotumwa Kwanza: | 08/15/2018 |
| Sasisho la Mwisho Liliwasilishwa: | 05/04/2020 |
| Sasisho la Mwisho Lilichapishwa: | 05/06/2020 |
| Tarehe halisi ya kuanza kwa masomo: | 10/17/2018 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 09/30/2022 |
| Tarehe ya Kukamilisha Utafiti: | 03/31/2023 |
Hali au ugonjwa
Uingiliaji / matibabu
Behavioral: Electronic Patient Decision Aid
Behavioral: Standard Resource Sheet
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Experimental: Electronic Patient Decision Aid Participants login to a website where they access the interactive PDA as well as access standard published information and resources. | Behavioral: Electronic Patient Decision Aid The electronic PDA is an interactive website with 3 main sections:
Review of depression treatment options (non-pharmacological and pharmacological) along with their respective risks and benefits.
Interactive "values clarification" exercises to help women determine which risks and benefits are most important to them.
Exercises to help women consider how partners, family, providers and the social context impacts decision-making.
A summary of how a woman feels about each option along with risks and benefits is generated which can be provided to treating clinicians for use in follow-up.
A printable pdf with standard published information and resources is also included. |
| Sham Comparator: Standard Resource Sheet Participants login to a website where they access standard published information and resources. |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | Female |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: 1. Women aged ≥ 18 years old; and 2. Diagnosed with major depressive disorder (current or in remission); and 3. Planning conception in the next 12 months or < 30 weeks gestational age; and 4. Deciding whether to start or continue a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) in pregnancy; and 5. Have moderate-to-high decisional conflict regarding the decision to start or continue an SSRI/SNRI in pregnancy; and 6. Live in Canada Exclusion Criteria: 1. Have had alcohol or substance use disorder in prior 12 months; or 2. Have active suicide ideation or psychosis; or 3. Have past/current major obstetrical or fetal complications; or 4. Are unable to complete relevant study procedures online; or 5. Are unable to complete study procedures in English |
Matokeo
Hatua za Matokeo ya Msingi
1. Postpartum depression as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (SCID-I) [3 months postpartum]
Hatua za Matokeo ya Sekondari
1. Postpartum depression as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I) [12 months postpartum]
2. Maternal knowledge of depression, postpartum depression and antidepressant use during pregnancy [baseline and 4 weeks]
3. Decisional conflict as measured by the Decisional Conflict Scale (DCS) [throughout pregnancy (up to 9 months)]
4. Maternal depression as measured by the Edinburgh Postnatal Depression Scale (EPDS) [throughout pregnancy and up to 1 year postpartum (up to 21 months)]
5. Maternal anxiety as measured by the Spielberger State-Trait Anxiety Inventory (STAI) [throughout pregnancy and up to 1 year postpartum (up to 21 months)]
6. Maternal quality of life as measured by the 12-item Short Form (SF-12) Health Survey [throughout pregnancy and up to 1 year postpartum (up to 21 months)]
7. Study website metrics to inform if patterns of PDA use are predictive of clinical outcomes [throughout pregnancy (up to 9 months)]
8. Health service utilization [throughout pregnancy and up to 1 year postpartum (up to 21 months)]
9. Pregnancy complications and neonatal outcomes [1 month postpartum]
10. Infant Outcomes as measured by the Infant Characteristics Questionnaire (ICQ) [3-12 months after birth]
11. Child Development as measured by the Ages and Stages Questionnaire (ASQ-3) [3-12 months after birth]
12. Parenting stress measured by the Parenting Stress Index (PSI) short form [1 month postpartum to 1 year postpartum]
13. Partner relationship outcomes measured by the Dyadic Adjustment Scale (DAS) [throughout pregnancy and up to 1 year postpartum (up to 21 months)]
14. Bipolar disorder as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I) [3 months and 12 months postpartum]
15. Schizophrenia and other psychotic disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I) [3 months and 12 months postpartum]
16. Anxiety disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I) [3 months and 12 months postpartum]
17. Obsessive-compulsive and related disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I) [3 months and 12 months postpartum]
18. Feeding and eating disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I) [3 months and 12 months postpartum]
