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Completed

NCT Number: NCT02492009

Patient Decision Aid for Antidepressant Use in Pregnancy

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

South London and Maudsley NHS Foundation Trust

London, SE5 8AF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women who meet all of the following 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

Women who meet any of the following 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.

Treatment and study plan

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).

Patient Decision Aid

Behavioral

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.

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.

Primary outcomes

  1. Feasibility, measured by 'Recruitment Rate'

    Time frame: Up to one year from when the study starts enrolling participants

Secondary outcomes

  1. Depression, measured by the Edinburgh Postnatal Depression Scale

    Time frame: (a) Baseline (pre-randomization) and (b) 4 Weeks post-randomization and (c) 12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy)

  2. Anxiety, measured by the Spielburg State-Trait Anxiety Inventory

    Time frame: (a) Baseline (pre-randomization) and (b) 4 Weeks post-randomization and (c) 12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy)

  3. Decisional conflict, measured by the Decisional Conflict Scale

    Time frame: Baseline (pre-randomization) and 4 Weeks post-randomization

  4. Knowledge about antidepressant treatment in pregnancy

    Time frame: Baseline (pre-randomization) and 4 Weeks post-randomization

  5. Intervention acceptability to patients, measured by the PDA Acceptability Questionnaire

    Time frame: 4 Weeks post-randomization]

  6. Intervention acceptability to clinicians, measured by the Provider Perspective Survey

    Time frame: After follow-up data is complete (12 weeks postpartum if last patient was recruited in pregnancy, or 6 months after baseline interview if last patient was recruited when planning a pregnancy)

  7. Treatment Decision(s)

    Time frame: (a) Baseline (pre-randomization) and (b) 4 Weeks post-randomization and (c) 12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy)

  8. Feasibility, measure by 'Time between recruitment to first log-in to the study website'

    Time frame: 4 weeks post-randomization

  9. Feasibility, measured by '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).

  10. Feasibility, measured by 'Number of participants who follow-up with their physician during the intended timeline'

    Time frame: 4 weeks post-randomization

  11. Feasibility, measured by 'The rate of follow-up data collection'

    Time frame: (a) 4 Weeks post-randomization and (b) 12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy)

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • University of Toronto

Registry information

Official study title

Patient Decision Aid (PDA) for Antidepressant Use In Pregnancy: a Pilot RCT

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 8, 2015
Registry last updated
Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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