DepressionNCT02492009
Patient Decision Aid for Antidepressant Use in Pregnancy
A study testing Standard Resource Sheet and Patient Decision Aid in people with Depression and Pregnancy, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Pregnancy
- What is being tested?
- Standard Resource Sheet and Patient Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South London and Maudsley NHS Foundation Trust
London, SE5 8AF
About this study
Official title: Patient Decision Aid (PDA) for Antidepressant Use In Pregnancy: a Pilot RCT
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.
Read the 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
- Being tested
- Standard Resource Sheet, Patient Decision Aid
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Resource SheetBehavioural
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 AidBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Patient Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, measured by 'Recruitment Rate'
Measured: Up to one year from when the study starts enrolling participants
Secondary outcomes (11)
Depression, measured by the Edinburgh Postnatal Depression Scale
Measured: (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
Measured: (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
Measured: Baseline (pre-randomization) and 4 Weeks post-randomization
Knowledge about antidepressant treatment in pregnancy
Measured: Baseline (pre-randomization) and 4 Weeks post-randomization
Intervention acceptability to patients, measured by the PDA Acceptability Questionnaire
Measured: 4 Weeks post-randomization]
Intervention acceptability to clinicians, measured by the Provider Perspective Survey
Measured: 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)
Treatment Decision(s)
Measured: (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)
Feasibility, measure by 'Time between recruitment to first log-in to the study website'
Measured: 4 weeks post-randomization
Feasibility, measured by 'Study Website Usage'
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).
Measured: 4 Weeks post-randomization
Feasibility, measured by 'Number of participants who follow-up with their physician during the intended timeline'
Measured: 4 weeks post-randomization
Feasibility, measured by 'The rate of follow-up data collection'
Measured: (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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Sponsor
- Investigators
- Louise M Howard, PhD, Principal investigator, Section of Women's Mental Health, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492009
- Sponsor's protocol ID
- IRAS project ID 166207
- Other IDs
- R&D2015/044, REC reference 15/LO/0601
- Status last verified
- Sep 2016
- First submitted
- 22 Jun 2015
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31822489
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Decision Aid (PDA) for Antidepressant Use In Pregnancy: a Pilot RCT
- ClinicalTrials.gov ID
- NCT02492009
- Acronym / sponsor ID
- IRAS project ID 166207
- Conditions
- Depression, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- Jun 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Resource Sheet | Placebo comparator | Behavioral: Standard Resource SheetWomen 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 | Active comparator | Behavioral: Patient Decision AidThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Resource SheetWomen 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). | Behavioural | Standard Resource Sheet |
| Patient Decision AidThe 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. | Behavioural | Electronic Patient Decision Aid |
Primary outcome
Feasibility, measured by 'Recruitment Rate'
Time frame: Up to one year from when the study starts enrolling participants
11 secondary outcomes
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)
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)
Decisional conflict, measured by the Decisional Conflict Scale
Time frame: Baseline (pre-randomization) and 4 Weeks post-randomization
Knowledge about antidepressant treatment in pregnancy
Time frame: Baseline (pre-randomization) and 4 Weeks post-randomization
Intervention acceptability to patients, measured by the PDA Acceptability Questionnaire
Time frame: 4 Weeks post-randomization]
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)
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)
Feasibility, measure by 'Time between recruitment to first log-in to the study website'
Time frame: 4 weeks post-randomization
Feasibility, measured by 'Study Website Usage'
Time frame: 4 Weeks post-randomization
Feasibility, measured by 'Number of participants who follow-up with their physician during the intended timeline'
Time frame: 4 weeks post-randomization
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Results publication: PubMed 31822489Khalifeh 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise M Howard, PhD principal investigator
Section of Women's Mental Health, King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Resource Sheet and Patient Decision Aid in people with Depression and Pregnancy, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, measured by 'Recruitment Rate' (time frame: Up to one year from when the study starts enrolling participants). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02492009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.