Clinical trial NCT02492009: Patient Decision Aid for Antidepressant Use in Pregnancy
Official title: Patient Decision Aid (PDA) for Antidepressant Use In Pregnancy: a Pilot RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Pregnancy
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2015-07-08
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility, measured by 'Recruitment Rate'
timeFrame: Up to one year from when the study starts enrolling participants
Secondary outcomes:
measure: Depression, measured by the Edinburgh Postnatal Depression Scale
timeFrame: (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)
measure: Anxiety, measured by the Spielburg State-Trait Anxiety Inventory
timeFrame: (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)
measure: Decisional conflict, measured by the Decisional Conflict Scale
timeFrame: Baseline (pre-randomization) and 4 Weeks post-randomization
measure: Knowledge about antidepressant treatment in pregnancy
timeFrame: Baseline (pre-randomization) and 4 Weeks post-randomization
measure: Intervention acceptability to patients, measured by the PDA Acceptability Questionnaire
timeFrame: 4 Weeks post-randomization]
measure: Intervention acceptability to clinicians, measured by the Provider Perspective Survey
timeFrame: 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)
measure: Treatment Decision(s)
timeFrame: (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)
measure: Feasibility, measure by 'Time between recruitment to first log-in to the study website'
timeFrame: 4 weeks post-randomization
measure: Feasibility, measured by 'Study Website Usage'
timeFrame: 4 Weeks post-randomization
measure: Feasibility, measured by 'Number of participants who follow-up with their physician during the intended timeline'
timeFrame: 4 weeks post-randomization
measure: Feasibility, measured by 'The rate of follow-up data collection'
timeFrame: (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)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: South London and Maudsley NHS Foundation Trust
Study officials:
affiliation: Section of Women's Mental Health, King's College London
name: Louise M Howard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.