Patient Decision Aid for Antidepressant Use in Pregnancy

Depression Clinical Trial

Official title:

Patient Decision Aid (PDA) for Antidepressant Use In Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02308592
• Other study ID #: TBD
• Status: Completed
• Phase: N/A
• First received: December 2, 2014
• Last updated: May 11, 2017
• Start date: January 2015
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Pregnancy

Intervention

Behavioral:
• Electronic 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.
• 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). Women who are assigned the control condition AND who are not receiving care from Women's College Hospital Reproductive Life Stages Program will receive waitlisted access to the intervention after data collected at 4 weeks post-randomization.

Locations

Country	Name	City	State
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Women's College Hospital	Canadian Institutes of Health Research (CIHR), Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	Feasibility: Number of participants recruited into the study over Number of eligible patients	Up to one year from when the study starts enrolling participants
Secondary	Decisional Conflict Scale		Baseline (pre-randomization)
Secondary	Knowledge about antidepressant treatment in pregnancy		Baseline (pre-randomization)
Secondary	Edinburgh Postnatal Depression Scale		Baseline (pre-randomization)
Secondary	Spielburg State-Trait Anxiety Inventory		Baseline (pre-randomization)
Secondary	Edinburgh Postnatal Depression Scale		4 Weeks post-randomization
Secondary	Edinburgh Postnatal Depression Scale		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
Secondary	Spielburg State-Trait Anxiety Inventory		4 Weeks post-randomization
Secondary	Spielburg State-Trait Anxiety Inventory		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
Secondary	Decisional Conflict Scale		4 Weeks post-randomization
Secondary	Knowledge about antidepressant treatment in pregnancy		4 Weeks post-randomization
Secondary	PDA Acceptability Questionnaire		4 Weeks post-randomization
Secondary	Provider Perspective Survey		After all other participant data has been collected
Secondary	Treatment Decision(s)		Baseline (pre-randomization)
Secondary	Treatment Decision(s)		4 Weeks post-randomization
Secondary	Treatment Decision(s)		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
Secondary	Time between recruitment to first log-in to the study website		4 weeks post-randomization
Secondary	Self-reported satisfaction with the PDA by the participants		4 Weeks post-randomization
Secondary	Provider's perspective on the utility of the PDA in clinical practice		After all participant data has been collected
Secondary	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	Number of participants who follow-up with their physician during the intended timeline		4 weeks post-randomization, only for participants who are seeing specialty psychiatric services
Secondary	The rate of follow-up data collection		4 Weeks post-randomization
Secondary	The rate of follow-up data collection		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