Patient Decision Aid for Antidepressant Use in Pregnancy

NCT02492009 | Completed

• 3 other identifiers: IRAS project ID 166207R&D2015/044REC reference 15/LO/0601
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Feasibility, measured by 'Recruitment Rate'

  Up to one year from when the study starts enrolling participants

Secondary Outcomes (11)

• Depression, measured by the Edinburgh Postnatal Depression Scale

  (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)

• Anxiety, measured by the Spielburg State-Trait Anxiety Inventory

  (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)

• Decisional conflict, measured by the Decisional Conflict Scale

  Baseline (pre-randomization) and 4 Weeks post-randomization

• Knowledge about antidepressant treatment in pregnancy

  Baseline (pre-randomization) and 4 Weeks post-randomization

• Intervention acceptability to patients, measured by the PDA Acceptability Questionnaire

  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: Patient Decision Aid

Interventions

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).

Standard Resource Sheet

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. 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.

Electronic Patient Decision Aid

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• University of Toronto: collaborator

Study Sites (1)

South London and Maudsley NHS Foundation Trust

London, SE5 8AF, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31822489 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Louise M Howard, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: July 8, 2015
• Study Start: June 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 27, 2021

Record last verified: 2016-09

Locations

GB (1)