Patient Decision Aid for Antidepressant Use in Pregnancy

NCT02308592 | Completed

• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Depression

Keywords

Pregnancy; Depression; Antidepressant Use; Decision Aid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Decisional Conflict Scale

  Baseline (pre-randomization)

• Knowledge about antidepressant treatment in pregnancy

  Baseline (pre-randomization)

• Edinburgh Postnatal Depression Scale

  Baseline (pre-randomization)

• Spielburg State-Trait Anxiety Inventory

  Baseline (pre-randomization)

• Edinburgh Postnatal Depression Scale

  4 Weeks post-randomization

Study Arms (2)

Standard Resource Sheet

PLACEBO COMPARATOR

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

Electronic Patient Decision Aid

ACTIVE COMPARATOR

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: Electronic Patient Decision Aid; Behavioral: Standard Resource Sheet

Interventions

Electronic Patient Decision Aid BEHAVIORAL

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.

Electronic Patient Decision Aid

Standard Resource Sheet BEHAVIORAL

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.

Electronic Patient Decision Aid; Standard Resource Sheet

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are females aged \>18 years old, and
• Are either planning a pregnancy OR are \<30 weeks gestation at enrollment, and
• 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
• Have moderate-to-high decisional conflict (score of \>25 on the Decisional Conflict Scale)

You may not qualify if:

• Have had alcohol or substance abuse or dependence in the previous 12 months, or
• Have active suicidal ideation or psychosis, or
• Are incapable of consenting to participation, or
• 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
• Are unable to read or unable to speak or understand English and do not have someone that can read the PDA to them, or
• Have a visual impairment that would prevent them from being able to view the website.

Sponsors & Collaborators

• Women's College Hospital: lead
• Ontario Ministry of Health and Long Term Care: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (2)

• 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.

  PMID: 30913472 DERIVED

• 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.

  PMID: 26923796 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Simone Vigod, MD, MSc

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 4, 2014
• Study Start: January 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 12, 2017

Record last verified: 2017-05

Locations

CA (1)