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| ID | Type | Description | Link |
|---|---|---|---|
| R&D2015/044 | Other Identifier | South London and Maudsley / IOP Office | |
| REC reference 15/LO/0601 | Other Identifier | RES Committee London - Queen Square |
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| Name | Class |
|---|---|
| University of Toronto | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Resource Sheet | Placebo Comparator | 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). |
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| Electronic Patient Decision Aid | Active Comparator | The electronic Patient Decision Aid (PDA) is an interactive website with 3 main sections:
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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Resource Sheet | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility, measured by 'Recruitment Rate' | Up to one year from when the study starts enrolling participants |
| 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 |
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INCLUSION CRITERIA: Women who meet all of the following criteria:
EXCLUSION CRITERIA: Women who meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louise M Howard, PhD | Section of Women's Mental Health, King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South London and Maudsley NHS Foundation Trust | London | SE5 8AF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31822489 | Result | Khalifeh H, Molyneaux E, Brauer R, Vigod S, Howard LM. Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK. BJGP Open. 2019 Dec 10;3(4):bjgpopen19X101666. doi: 10.3399/bjgpopen19X101666. Online ahead of print. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2016 | Oct 15, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 27, 2015 | Oct 15, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Patient Decision Aid | Behavioral | The electronic Patient Decision Aid (PDA) is an interactive website with 3 main sections:
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. |
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| (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) |