DepressionNCT03623620
Preventing Depressive Relapse in Pregnant Women With Recurrent Depression
A study testing Digital Delivery of Mindfulness-Based Cognitive Therapy in people with Depression and Pregnancy Related, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The purpose of this investigation is to conduct a pragmatic effectiveness trial comparing digital mindfulness-based cognitive therapy (MBCT) plus usual care to usual care (UC) only among euthymic pregnant women with recurrent depression treated with antidepressants. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Pregnancy Related, Antenatal Depression
- What is being tested?
- Digital Delivery of Mindfulness-Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Mar 2019to 21 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Pregnant women
- Ages 18 or older
- History of recurrent major depression prior to pregnancy (at least 2 prior episodes, one of which may be currently treated)
- Euthymic or with residual symptoms (PHQ-9 ≤ 9)
- No depressive relapse since last menstrual period
- Currently or recently received antidepressants (within the three months prior to last menstrual period)
Show all 24Show fewer
- Presence of ongoing community provider
- Pregnant women (prior to 16 weeks gestation)
- Age 18 or older
- Presence of an ongoing community prescriber / provider
- Suicidal ideation as noted by item #9 of the PHQ-9
- History of recurrent depression, dysthymia or subsyndromal depression
- Age 18 or older
- Current prenatal healthcare provider of a participant enrolled in Arm 1 Aim 1a
- Pregnant women
- Age 18 or older
- Self-reported history of major depressive disorder
- Suicidal ideation as noted by item #9 of the PHQ-9
- Pregnant women (prior to 16 weeks gestation)
- Age 18 or older
- History of recurrent major depression prior to pregnancy (at least two prior episodes, one of which may be currently treated)
- Euthymic or with residual symptoms (PHQ-9 </=9)
- Presence of an ongoing community prescriber / provider
- Current suicidal ideation as noted by item #9 of the PHQ-9 or past suicidal ideation as noted by item A3g on the MINI mood module
Who cannot join
- Diagnosis of bipolar or psychotic disorder
- Active mania, psychosis, or substance abuse (within the last 6 months)
- Immediate risk of self-harm
- Non-English speaking
- Inclusion and exclusion criteria for the participants in the supplemental arms of the study differ from the main study and are as follows:
- Arm 1 Aim 1a
Show all 17Show fewer
- Diagnosis of bipolar or psychotic disorder
- Mania, psychosis, or active substance abuse (within the last 6 months for substance abuse)
- Non-English speaking
- Arm 1 Aim 1b
- Non-English speaking
- Arm 1 Aim 1c
- Non-English speaking
- Arm 2
- Diagnosis of bipolar or psychotic disorder
- Mania, psychosis, or active substance abuse (within the last 6 months for substance abuse)
- Non-English speaking
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Colorado Boulder
Boulder, Colorado, 80309
About this study
The purpose of this investigation is to conduct a pragmatic effectiveness trial comparing digital mindfulness-based cognitive therapy (MBCT) plus usual care to usual care (UC) only among euthymic pregnant women with recurrent depression treated with antidepressants.
In the supplemental arms we will investigate the prevalence, severity, longitudinal course, correlates, and predictors of suicidal ideation and behavior among women during pregnancy and the postpartum period.
Read the detailed description
This study will address a significant gap in the evidence regarding effective approaches to prevent depressive relapse among women with recurrent depression who maintain euthymia using antidepressants and who wish to conceive or who are pregnant. Relapse rates of depression following antidepressant discontinuation among such women has been established, and the efficacy of MBCT in mitigating relapse risk in pregnant women with recurrent depression compared to UC also has been demonstrated. But the effectiveness of MBCT has not been tested in a definitive trial; the question of whether MBCT can mitigate risk for depressive relapse among pregnant women on antidepressants, including among those who discontinue antidepressants proximate to or during pregnancy, also has not been addressed.
Reproductive age women with recurrent depression and their healthcare providers need to know, first, if a scalable digital non-pharmacologic prevention approach is superior to UC in community settings, and second, whether MBCT can attenuate risk for depressive relapse among those who elect to discontinue maintenance antidepressant treatment proximate to or during pregnancy. Lastly, the capacity to identify which women are most likely to benefit from a non-pharmacologic or pharmacologic approach personalizes the risk benefit decision making process for reproductive age women on antidepressants planning to conceive or who are pregnant.
Investigators will test the relative risk for depressive relapse and reduction of symptom burden between women randomized to digital MBCT or UC, explore the specific benefit of MBCT relative to antidepressant discontinuation, and determine whether a treatment selection algorithm can predict whether MBCT or UC will work best for a specific participant.
The supplemental arms of this study will further investigate suicidal ideation and behavior in a perinatal population to better understand the prevalence, severity, longitudinal course, correlates and predictors of suicidal ideation and behavior among women during pregnancy and in the postpartum period.
Investigators will use a mixed methods approach of both cross-sectional and longitudinal study designs to characterize a real-world population of pregnant and postpartum women who have endorsed suicidality. Investigators will also use qualitative interviews, self-report instruments, and medical records to explore the extent to which community healthcare professionals providing care to perinatal women report the knowledge base and requisite skills to address suicidal ideation and behavior in this population.
MMB for Moms delivers digitally both the content and structure of in-person MBCT, and may be a promising intervention for pregnant women with suicidal ideation. Investigators will also explore the safety, feasibility, and acceptability of enrolling pregnant women with any reports of suicidal ideation or behavior in a proof of concept randomized controlled trial comparing MMB for Moms to enhanced usual care.
- Conditions
- Depression, Pregnancy Related, Antenatal Depression
- Being tested
- Digital Delivery of Mindfulness-Based Cognitive Therapy
- Keywords
- Depression, Pregnancy, Antidepressants, Mindfulness, Medication use during pregnancy, Depression Relapse, Suicidal ideation
- Medical subject headings
- Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Delivery of Mindfulness-Based Cognitive TherapyBehavioural
12-week program that emphasizes mindfulness and cognitive behavioral skills
| Study group | Role | What they receive |
|---|---|---|
| Digital delivery of MBCT (Mindful Mood Balance for Moms) | Experimental | Subjects will receive digital delivery of mindfulness-based cognitive therapy (Mindful Mood Balance for Moms) for 12 weeks, along with the usual care they would receive from their provider. Receives: Behavioral: Digital Delivery of Mindfulness-Based Cognitive Therapy |
| Usual Care | No intervention | Subjects will receive only usual care, the care they would normally receive from their community provider, for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Relapse of Depression
Depression relapse from randomization through 6 month postpartum
Measured: Randomization through 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start12 Mar 2019
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Boulder, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lee S. Cohen, MD, Massachusetts General Hospital
- Investigators
- Lee S Cohen, MD, Principal investigator, Massachusetts General HospitalSona Dimidjian, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623620
- Sponsor's protocol ID
- 2018P001472
- Other IDs
- R01MH117253
- Status last verified
- May 2023
- First submitted
- 2 Aug 2018
- Last updated
- 6 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared via the National Database for Clinical Trials related to Mental Illness (NDCT) every 6 months after enrollment begins, and before publication. In addition, de-identified data and accompanying documentation describing and referencing all variables will be available for use by other investigators upon request.
Publications
Cohen LS, Altshuler LL, Harlow BL, Nonacs R, Newport DJ, Viguera AC, Suri R, Burt VK, Hendrick V, Reminick AM, Loughead A, Vitonis AF, Stowe ZN. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006 Feb 1;295(5):499-507. doi: 10.1001/jama.295.5.499.
PubMed 16449615Dimidjian S, Goodman SH, Felder JN, Gallop R, Brown AP, Beck A. Staying well during pregnancy and the postpartum: A pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence. J Consult Clin Psychol. 2016 Feb;84(2):134-45. doi: 10.1037/ccp0000068. Epub 2015 Dec 14.
PubMed 26654212Dimidjian S, Gallop R, Goodman SH, Segal Z, Freeman MP, Hicks LM, Mellinger C, Ellison K, Dunn KAY, Levy J, Kordyban LE, Fritzson A, Clifford C, Nolan E, Vanderkruik R, Wales R, Cohen L. Outcomes of Mindful Mood Balance for Moms, online mindfulness-based cognitive therapy for perinatal depressive relapse prevention in the USA: a two-arm, single-blind, pragmatic randomised clinical trial. Lancet Public Health. 2026 Nov;11(11):e889-e899. doi: 10.1016/S2468-2667(26)00184-2.
PubMed 42901187
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Depressive Relapse in Pregnant Women With Recurrent Depression
- ClinicalTrials.gov ID
- NCT03623620
- Acronym / sponsor ID
- 2018P001472
- Conditions
- Depression, Pregnancy Related, Antenatal Depression
- Keywords
- Depression, Pregnancy, Antidepressants, Mindfulness, Medication use during pregnancy, Depression Relapse, Suicidal ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of Colorado, Boulder, National Institute of Mental Health (NIMH)
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Posted 6 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigation is to conduct a pragmatic effectiveness trial comparing digital mindfulness-based cognitive therapy (MBCT) plus usual care to usual care (UC) only among euthymic pregnant women with recurrent depression treated with antidepressants.
In the supplemental arms we will investigate the prevalence, severity, longitudinal course, correlates, and predictors of suicidal ideation and behavior among women during pregnancy and the postpartum period.
Detailed description
This study will address a significant gap in the evidence regarding effective approaches to prevent depressive relapse among women with recurrent depression who maintain euthymia using antidepressants and who wish to conceive or who are pregnant. Relapse rates of depression following antidepressant discontinuation among such women has been established, and the efficacy of MBCT in mitigating relapse risk in pregnant women with recurrent depression compared to UC also has been demonstrated. But the effectiveness of MBCT has not been tested in a definitive trial; the question of whether MBCT can mitigate risk for depressive relapse among pregnant women on antidepressants, including among those who discontinue antidepressants proximate to or during pregnancy, also has not been addressed.
Reproductive age women with recurrent depression and their healthcare providers need to know, first, if a scalable digital non-pharmacologic prevention approach is superior to UC in community settings, and second, whether MBCT can attenuate risk for depressive relapse among those who elect to discontinue maintenance antidepressant treatment proximate to or during pregnancy. Lastly, the capacity to identify which women are most likely to benefit from a non-pharmacologic or pharmacologic approach personalizes the risk benefit decision making process for reproductive age women on antidepressants planning to conceive or who are pregnant.
Investigators will test the relative risk for depressive relapse and reduction of symptom burden between women randomized to digital MBCT or UC, explore the specific benefit of MBCT relative to antidepressant discontinuation, and determine whether a treatment selection algorithm can predict whether MBCT or UC will work best for a specific participant.
The supplemental arms of this study will further investigate suicidal ideation and behavior in a perinatal population to better understand the prevalence, severity, longitudinal course, correlates and predictors of suicidal ideation and behavior among women during pregnancy and in the postpartum period.
Investigators will use a mixed methods approach of both cross-sectional and longitudinal study designs to characterize a real-world population of pregnant and postpartum women who have endorsed suicidality. Investigators will also use qualitative interviews, self-report instruments, and medical records to explore the extent to which community healthcare professionals providing care to perinatal women report the knowledge base and requisite skills to address suicidal ideation and behavior in this population.
MMB for Moms delivers digitally both the content and structure of in-person MBCT, and may be a promising intervention for pregnant women with suicidal ideation. Investigators will also explore the safety, feasibility, and acceptability of enrolling pregnant women with any reports of suicidal ideation or behavior in a proof of concept randomized controlled trial comparing MMB for Moms to enhanced usual care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital delivery of MBCT (Mindful Mood Balance for Moms) | Experimental | Behavioral: Digital Delivery of Mindfulness-Based Cognitive TherapySubjects will receive digital delivery of mindfulness-based cognitive therapy (Mindful Mood Balance for Moms) for 12 weeks, along with the usual care they would receive from their provider. |
| Usual Care | No intervention | –Subjects will receive only usual care, the care they would normally receive from their community provider, for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Pregnant women
- Ages 18 or older
- History of recurrent major depression prior to pregnancy (at least 2 prior episodes, one of which may be currently treated)
- Euthymic or with residual symptoms (PHQ-9 ≤ 9)
- No depressive relapse since last menstrual period
Key exclusion criteria (17 listed)
- Diagnosis of bipolar or psychotic disorder
- Active mania, psychosis, or substance abuse (within the last 6 months)
- Immediate risk of self-harm
- Non-English speaking
- Inclusion and exclusion criteria for the participants in the supplemental arms of the study differ from the main study and are as follows:
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 |
|---|---|---|
| Digital Delivery of Mindfulness-Based Cognitive Therapy12-week program that emphasizes mindfulness and cognitive behavioral skills | Behavioural | Digital delivery of MBCT (Mindful Mood Balance for Moms) |
Primary outcome
Number of Participants Experiencing Relapse of Depression
Time frame: Randomization through 6 months postpartum
Depression relapse from randomization through 6 month postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16449615Cohen LS, Altshuler LL, Harlow BL, Nonacs R, Newport DJ, Viguera AC, Suri R, Burt VK, Hendrick V, Reminick AM, Loughead A, Vitonis AF, Stowe ZN. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006 Feb 1;295(5):499-507. doi: 10.1001/jama.295.5.499.
- Background: PubMed 26654212Dimidjian S, Goodman SH, Felder JN, Gallop R, Brown AP, Beck A. Staying well during pregnancy and the postpartum: A pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence. J Consult Clin Psychol. 2016 Feb;84(2):134-45. doi: 10.1037/ccp0000068. Epub 2015 Dec 14.
- Derived from this study: PubMed 42901187Dimidjian S, Gallop R, Goodman SH, Segal Z, Freeman MP, Hicks LM, Mellinger C, Ellison K, Dunn KAY, Levy J, Kordyban LE, Fritzson A, Clifford C, Nolan E, Vanderkruik R, Wales R, Cohen L. Outcomes of Mindful Mood Balance for Moms, online mindfulness-based cognitive therapy for perinatal depressive relapse prevention in the USA: a two-arm, single-blind, pragmatic randomised clinical trial. Lancet Public Health. 2026 Nov;11(11):e889-e899. doi: 10.1016/S2468-2667(26)00184-2.
- Individual participant dataSharing planned: Yes. Data will be shared via the National Database for Clinical Trials related to Mental Illness (NDCT) every 6 months after enrollment begins, and before publication. In addition, de-identified data and accompanying documentation describing and referencing all variables will be available for use by other investigators upon request.
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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.
Lee S Cohen, MD principal investigator
Massachusetts General Hospital
Sona Dimidjian, PhD principal investigator
University of Colorado, Boulder
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Delivery of Mindfulness-Based Cognitive Therapy in people with Depression and Pregnancy Related, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 17 exclusion criteria. 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 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Experiencing Relapse of Depression (time frame: Randomization through 6 months postpartum). 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 NCT03623620, which also lists 3 linked publications.
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 6 Jun 2023.