Patient Decision Aid for Antidepressant Use in Pregnancy

May 11, 2017 updated by: Simone Vigod, Women's College Hospital

Patient Decision Aid (PDA) for Antidepressant Use In Pregnancy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 1B2
        • Women's College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 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).
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).

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.
Active Comparator: Electronic Patient Decision Aid

The electronic Patient Decision Aid (PDA) is an interactive website with 3 main sections:

  1. Evidence-based information on (a) depression in pregnancy, (b) each treatment option and procedure;
  2. (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
  3. 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.
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).

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.

Behavioral: Electronic Patient Decision Aid

The electronic Patient Decision Aid (PDA) is an interactive website with 3 main sections:

  1. Evidence-based information on (a) depression in pregnancy, (b) each treatment option and procedure;
  2. (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
  3. A summary section that outlines the information reviewed and which benefits and risks they deemed most important.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: Up to one year from when the study starts enrolling participants
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Decisional Conflict Scale
Time Frame: Baseline (pre-randomization)
Baseline (pre-randomization)
Knowledge about antidepressant treatment in pregnancy
Time Frame: Baseline (pre-randomization)
Baseline (pre-randomization)
Edinburgh Postnatal Depression Scale
Time Frame: Baseline (pre-randomization)
Baseline (pre-randomization)
Spielburg State-Trait Anxiety Inventory
Time Frame: Baseline (pre-randomization)
Baseline (pre-randomization)
Edinburgh Postnatal Depression Scale
Time Frame: 4 Weeks post-randomization
4 Weeks post-randomization
Edinburgh Postnatal Depression Scale
Time Frame: 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
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
Spielburg State-Trait Anxiety Inventory
Time Frame: 4 Weeks post-randomization
4 Weeks post-randomization
Spielburg State-Trait Anxiety Inventory
Time Frame: 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
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
Decisional Conflict Scale
Time Frame: 4 Weeks post-randomization
4 Weeks post-randomization
Knowledge about antidepressant treatment in pregnancy
Time Frame: 4 Weeks post-randomization
4 Weeks post-randomization
PDA Acceptability Questionnaire
Time Frame: 4 Weeks post-randomization
4 Weeks post-randomization
Provider Perspective Survey
Time Frame: After all other participant data has been collected
After all other participant data has been collected
Treatment Decision(s)
Time Frame: Baseline (pre-randomization)
Baseline (pre-randomization)
Treatment Decision(s)
Time Frame: 4 Weeks post-randomization
4 Weeks post-randomization
Treatment Decision(s)
Time Frame: 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
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
Time between recruitment to first log-in to the study website
Time Frame: 4 weeks post-randomization
4 weeks post-randomization
Self-reported satisfaction with the PDA by the participants
Time Frame: 4 Weeks post-randomization
4 Weeks post-randomization
Provider's perspective on the utility of the PDA in clinical practice
Time Frame: After all participant data has been collected
After all participant data has been collected
Study Website Usage
Time Frame: 4 Weeks post-randomization
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
Number of participants who follow-up with their physician during the intended timeline
Time Frame: 4 weeks post-randomization, only for participants who are seeing specialty psychiatric services
4 weeks post-randomization, only for participants who are seeing specialty psychiatric services
The rate of follow-up data collection
Time Frame: 4 Weeks post-randomization
4 Weeks post-randomization
The rate of follow-up data collection
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Women's College Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
Ontario Ministry of Health and Long Term Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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