Patient Decision Aid for Antidepressant Use in Pregnancy

Study Overview
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Brief Summary
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The proposed study is a pilot randomized controlled trial (RCT) of an electronic patient decision aid (PDA) for antidepressant use in pregnancy. The overall aim of this pilot RCT is to establish the feasibility of future large international RCT of the PDA's effectiveness.

Detailed Description
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Depression in pregnancy is common, affecting up to 10% of women and represents serious risk to mother and infant. Unfortunately, antidepressant medication, a first-line treatment for depression in pregnancy, also comes with risks, making this a complex decision. Clinical care appears to be insufficient for ensuring that women make decisions that are consistent with their own values and with which they feel satisfied. Patient decision support tools can address such barriers. Canadian colleagues have created a patient decision aid (PDA) that has the potential to improve the decision-making process for women regarding antidepressant use in pregnancy in conjunction with clinical care. This study is a pilot RCT of the above PDA in London, to be conducted in parallel with a pilot RCT in Toronto.The overall objective of this project is to inform the development of a larger, international RCT to assess the efficacy of this PDA for antidepressant use in pregnancy. To achieve this objective, the investigators will assess the feasibility of the trial protocol to evaluate the PDA and determine the preliminary effect size for a larger multisite efficacy study. The primary outcome for this pilot study is the feasibility of conducting a large randomized controlled trial to evaluate the efficacy of the PDA. This includes feasibility (how well the trial protocol can be implemented), acceptability (usability and tolerability of the intervention) and adherence (the degree to which the trial protocol is followed). It is hypothesized that the protocol will be feasible, that the PDA will have a high degree of acceptability, and that adherence to the protocol will be high.

Official Title
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Patient Decision Aid (PDA) for Antidepressant Use In Pregnancy: a Pilot RCT

Conditions
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Depression, Pregnancy

Intervention / Treatment
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* Behavioral: Standard Resource Sheet
* Behavioral: Patient Decision Aid


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Women who meet all of the following criteria: Are aged over 18 Are planning a pregnancy or are <30 weeks pregnant at enrolment Have been offered to start or continue an antidepressant as treatment for depression by their clinician a Have moderate-to-high decisional conflict (score of >25 on the Decisional Conflict Scale) EXCLUSION CRITERIA: Women who meet any of the following criteria: Have had alcohol or drug abuse or dependence in the previous 12 months Have active suicidal ideation or psychosis Are incapable of consenting to participation Have any major obstetric complications or foetal cardiac anomaly in the current or in a past pregnancy, Are visually impaired Do not have sufficient English language proficiency to use the PDA.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard Resource Sheet<br>Women allocated to the control intervention will login to the study website and receive a printable PDF containing references to standard published information on antidepressant use in pregnancy. This ensures women have access to accurate information on the benefits and risks of antidepressant medication in pregnancy (even though they will not receive the PDA). | Behavioral: Standard Resource Sheet<br>* Women allocated to the control intervention will login to the study website and receive a printable PDF containing references to standard published information on antidepressant use in pregnancy. This ensures women have access to accurate information on the benefits and risks of antidepressant medication in pregnancy (even though they will not receive the PDA).<br>|
| Active Comparator: Electronic Patient Decision Aid<br>The electronic Patient Decision Aid (PDA) is an interactive website with 3 main sections: Evidence-based information on (a) depression in pregnancy, (b) each treatment option and procedure; (a) Evidence-based information on the risks and benefits of both untreated depression and antidepressant treatment, (b) exercises to help women determine which risks and benefits are most important to them; and A summary section that outlines the information reviewed and which benefits and risks they deemed most important. At the end of the PDA, women allocated to this intervention will ALSO receive the standard resource sheet which is being used as the placebo comparator. | Behavioral: Patient Decision Aid<br>* The electronic Patient Decision Aid (PDA) is an interactive website with 3 main sections: Evidence-based information on (a) depression in pregnancy, (b) each treatment option and procedure; (a) Evidence-based information on the risks and benefits of both untreated depression and antidepressant treatment, (b) exercises to help women determine which risks and benefits are most important to them; and A summary section that outlines the information reviewed and which benefits and risks they deemed most important. At the end of the PDA, women allocated to this intervention will ALSO receive the standard resource sheet which is being used as the placebo comparator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility, measured by 'Recruitment Rate' |  | Up to one year from when the study starts enrolling participants | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression, measured by the Edinburgh Postnatal Depression Scale |  | (a) Baseline (pre-randomization) and (b) 4 Weeks post-randomization and (c) 12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy) | 
| Anxiety, measured by the Spielburg State-Trait Anxiety Inventory |  | (a) Baseline (pre-randomization) and (b) 4 Weeks post-randomization and (c) 12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy) | 
| Decisional conflict, measured by the Decisional Conflict Scale |  | Baseline (pre-randomization) and 4 Weeks post-randomization | 
| Knowledge about antidepressant treatment in pregnancy |  | Baseline (pre-randomization) and 4 Weeks post-randomization | 
| Intervention acceptability to patients, measured by the PDA Acceptability Questionnaire |  | 4 Weeks post-randomization] | 
| Intervention acceptability to clinicians, measured by the Provider Perspective Survey |  | After follow-up data is complete (12 weeks postpartum if last patient was recruited in pregnancy, or 6 months after baseline interview if last patient was recruited when planning a pregnancy) | 
| Treatment Decision(s) |  | (a) Baseline (pre-randomization) and (b) 4 Weeks post-randomization and (c) 12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy) | 
| Feasibility, measure by 'Time between recruitment to first log-in to the study website' |  | 4 weeks post-randomization | 
| Feasibility, measured by 'Study Website Usage' | Composite measure comprised of: (1) number of participants who complete the PDA, (2)length of time required to complete the PDA, (3) number of log ins, (4) number of times the PDA is completed per participant, (5) total number of webpages viewed). | 4 Weeks post-randomization | 
| Feasibility, measured by 'Number of participants who follow-up with their physician during the intended timeline' |  | 4 weeks post-randomization | 
| Feasibility, measured by 'The rate of follow-up data collection' |  | (a) 4 Weeks post-randomization and (b) 12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy) |