Patient Decision Aid for Antidepressant Use in Pregnancy
- Conditions
- PregnancyDepression
- Interventions
- Behavioral: Standard Resource SheetBehavioral: Patient Decision Aid
- Registration Number
- NCT02492009
- Lead Sponsor
- King's College London
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 51
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Resource Sheet Standard Resource Sheet 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). Electronic Patient Decision Aid Patient Decision Aid The electronic Patient Decision Aid (PDA) is an interactive website with 3 main sections: 1. Evidence-based information on (a) depression in pregnancy, (b) each treatment option and procedure; 2. (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 3. 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.
- Primary Outcome Measures
Name Time Method Feasibility, measured by 'Recruitment Rate' Up to one year from when the study starts enrolling participants
- Secondary Outcome Measures
Name Time Method 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) 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) Decisional conflict, measured by the Decisional Conflict Scale 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) 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) Knowledge about antidepressant treatment in pregnancy Baseline (pre-randomization) and 4 Weeks post-randomization Feasibility, measured by 'Study Website Usage' 4 Weeks post-randomization 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).
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) Feasibility, measure by 'Time between recruitment to first log-in to the study website' 4 weeks post-randomization
Trial Locations
- Locations (1)
South London and Maudsley NHS Foundation Trust
🇬🇧London, United Kingdom