Patient Decision Aid for Antidepressant Use in Pregnancy

NCT ID: NCT02492009

Last Updated: 2021-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-11-30

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.

Conditions

Depression; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: PLACEBO_COMPARATOR

Standard Resource Sheet

Intervention Type: 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).

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.

Group Type: ACTIVE_COMPARATOR

Patient Decision Aid

Intervention Type: 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.

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.

Interventions

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).

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Toronto

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louise M Howard, PhD

Role: PRINCIPAL_INVESTIGATOR

Section of Women's Mental Health, King's College London

Locations

South London and Maudsley NHS Foundation Trust

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 31822489 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://bjgpopen.org/content/3/4/bjgpopen19X101666

Related Info

Other Identifiers

R&D2015/044

Identifier Type: OTHER

Identifier Source: secondary_id

REC reference 15/LO/0601

Identifier Type: OTHER

Identifier Source: secondary_id

IRAS project ID 166207

Identifier Type: -

Identifier Source: org_study_id