Patient Decision Aid for Antidepressant Use in Pregnancy

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492009
• Other study ID #: IRAS project ID 166207
• Secondary ID: R&D2015/044REC r
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: November 2017

Study information

• Verified date: September 2016
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Pregnancy

Intervention

Behavioral:
• 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).
• Patient Decision Aid
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.

Locations

Country	Name	City	State
United Kingdom	South London and Maudsley NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	University of Toronto

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. pii: bjgpopen19X101666. doi: 10.3399/bjgpopen19X101666. [Epub ahead of — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility, measured by 'Recruitment Rate'		Up to one year from when the study starts enrolling participants
Secondary	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)
Secondary	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)
Secondary	Decisional conflict, measured by the Decisional Conflict Scale		Baseline (pre-randomization) and 4 Weeks post-randomization
Secondary	Knowledge about antidepressant treatment in pregnancy		Baseline (pre-randomization) and 4 Weeks post-randomization
Secondary	Intervention acceptability to patients, measured by the PDA Acceptability Questionnaire		4 Weeks post-randomization]
Secondary	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)
Secondary	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)
Secondary	Feasibility, measure by 'Time between recruitment to first log-in to the study website'		4 weeks post-randomization
Secondary	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
Secondary	Feasibility, measured by 'Number of participants who follow-up with their physician during the intended timeline'		4 weeks post-randomization
Secondary	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)

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