Clinical trial NCT02308592: Patient Decision Aid for Antidepressant Use in Pregnancy
Official title: Patient Decision Aid (PDA) for Antidepressant Use In Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Depression
Keywords: Pregnancy
Depression
Antidepressant Use
Decision Aid
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-12-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this pilot study is to examine the feasibility of conducting a multi-site randomized controlled trial whose aim will be to evaluate the effectiveness of a Patient Decision Aid (PDA) for antidepressant use in pregnancy.

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. We 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. The overall objective of this project is to inform the development of a larger, international RCT to assess the efficacy of our PDA for antidepressant use in pregnancy. To achieve this objective, we will assess the feasibility of our clinical trial protocol to evaluate the PDA and determine the preliminary effect size for a larger multi-site 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). We hypothesize that our 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:

1. Are females aged \>18 years old, and
2. Are either planning a pregnancy OR are \<30 weeks gestation at enrollment, and
3. Have been offered to start or continue SSRI or SNRI anti-depressant medication as a treatment option for depression by their clinical provider at one of the study sites, and
4. Have moderate-to-high decisional conflict (score of \>25 on the Decisional Conflict Scale)

Exclusion criteria:

1. Have had alcohol or substance abuse or dependence in the previous 12 months, or
2. Have active suicidal ideation or psychosis, or
3. Are incapable of consenting to participation, or
4. Have any major obstetrical complications or fetal cardiac anomaly in the current or in a past pregnancy (as this changes the risk/benefit ratio discussion in regards to antidepressant use), or
5. Are unable to read or unable to speak or understand English and do not have someone that can read the PDA to them, or
6. Have a visual impairment that would prevent them from being able to view the website.

Primary outcomes:
measure: Recruitment Rate
timeFrame: Up to one year from when the study starts enrolling participants
Secondary outcomes:
measure: Decisional Conflict Scale
timeFrame: Baseline (pre-randomization)
measure: Knowledge about antidepressant treatment in pregnancy
timeFrame: Baseline (pre-randomization)
measure: Edinburgh Postnatal Depression Scale
timeFrame: Baseline (pre-randomization)
measure: Spielburg State-Trait Anxiety Inventory
timeFrame: Baseline (pre-randomization)
measure: Edinburgh Postnatal Depression Scale
timeFrame: 4 Weeks post-randomization
measure: Edinburgh Postnatal Depression Scale
timeFrame: 12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy), only for participants who are seeing specialty psychiatric services
measure: Spielburg State-Trait Anxiety Inventory
timeFrame: 4 Weeks post-randomization
measure: Spielburg State-Trait Anxiety Inventory
timeFrame: 12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy), only for participants who are seeing specialty psychiatric services
measure: Decisional Conflict Scale
timeFrame: 4 Weeks post-randomization
measure: Knowledge about antidepressant treatment in pregnancy
timeFrame: 4 Weeks post-randomization
measure: PDA Acceptability Questionnaire
timeFrame: 4 Weeks post-randomization
measure: Provider Perspective Survey
timeFrame: After all other participant data has been collected
measure: Treatment Decision(s)
timeFrame: Baseline (pre-randomization)
measure: Treatment Decision(s)
timeFrame: 4 Weeks post-randomization
measure: Treatment Decision(s)
timeFrame: 12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy), only for participants who are seeing specialty psychiatric services
measure: Time between recruitment to first log-in to the study website
timeFrame: 4 weeks post-randomization
measure: Self-reported satisfaction with the PDA by the participants
timeFrame: 4 Weeks post-randomization
measure: Provider's perspective on the utility of the PDA in clinical practice
timeFrame: After all participant data has been collected
measure: Study Website Usage
timeFrame: 4 Weeks post-randomization
measure: Number of participants who follow-up with their physician during the intended timeline
timeFrame: 4 weeks post-randomization, only for participants who are seeing specialty psychiatric services
measure: The rate of follow-up data collection
timeFrame: 4 Weeks post-randomization
measure: The rate of follow-up data collection
timeFrame: 12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy), OR at 4 weeks post-randomization for women who are NOT seeing specialty perinatal psychiatry services
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Simone Vigod, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vigod SN, Hussain-Shamsy N, Stewart DE, Grigoriadis S, Metcalfe K, Oberlander TF, Schram C, Taylor VH, Dennis CL. A patient decision aid for antidepressant use in pregnancy: Pilot randomized controlled trial. J Affect Disord. 2019 May 15;251:91-99. doi: 10.1016/j.jad.2019.01.051. Epub 2019 Mar 18.
citation: Vigod S, Hussain-Shamsy N, Grigoriadis S, Howard LM, Metcalfe K, Oberlander TF, Schram C, Stewart DE, Taylor VH, Dennis CL. A patient decision aid for antidepressant use in pregnancy: study protocol for a randomized controlled trial. Trials. 2016 Feb 29;17(1):110. doi: 10.1186/s13063-016-1233-4.