Maternal Psychological DistressNCT03809572
Mindfulness Based Cognitive Therapy (MBCT) During Pregnancy
A study testing Mindfulness Based Cognitive Therapy in people with Maternal Psychological Distress and Postpartum Depression, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The study is a pilot randomized control trial of a validated intervention, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnancy, developed to reduce risk for postpartum depression. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Psychological Distress, Postpartum Depression, Prenatal Stress
- What is being tested?
- 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
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2019to 8 Mar 2021
- 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 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female who is currently pregnant (8-22 weeks gestational age (GA) at time of screen)
- 21-45 years old
- single gestation
- fluently speak English
- be available and physically able to attend scheduled group meetings
- have a prior history of at least 1 major depressive episode (as determined through psychiatric interviewing).
Who cannot join
- Magnetic Resonance Imaging (MRI) contraindication (e.g., metal in their body)
- major neurological or medical illness (e.g., diabetes, multiple sclerosis)
- history of head trauma (loss of conscious > 2 minutes)
- Intelligence Quotient (IQ) < 80
- uncorrectable vision or hearing impairments (including color blindness)
- use of psychotropic medications, corticosteroids, insulin, or any other medications that might impact the central nervous system
Show all 16Show fewer
- current illicit drug use or diagnosis of a current substance use disorder
- current diagnosis of an eating disorder
- current depressive or manic episode
- diagnosis of a neurodevelopmental disorder (Autism, Intellectual Disability)
- any history of psychosis
- current active suicidality and/or homicidality, or interpersonal violence
- prior history of engaging in mindfulness-based psychotherapeutic interventions (e.g., Mindfulness Based Cognitive Therapy (MBCT), Mindfulness Based Stress Reduction (MBSR), Dialectical Behavior Therapy (DBT))
- known congenital, genetic, or neurologic disorder of the fetus (e.g., Down syndrome, fragile X)
- pregnancy-specific medical conditions or complications that significantly increase risk (e.g., placental separation, placenta previa)
- History of meningitis or seizures (except infantile or febrile)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Mechanisms of Action of MBCT-PD: A Pilot Study
The study is a pilot randomized control trial of a validated intervention, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnancy, developed to reduce risk for postpartum depression. This study examines emotion regulation as a potential mechanism of action, at both the behavioral and neurobiological level, that carries forward to the postpartum period. A secondary mechanism of action to be explored is cognitive control. This study will also consider other potential influences on treatment response and psychiatric outcomes, including perinatal stress and depressive symptoms. The study population is pregnant women age 21-45.
Read the detailed description
The study will involve an online screen of potentially eligible pregnant women. If participants are eligible after the online screen, they will be invited in for an in person assessment, including cognitive testing and a diagnostic interview, to determine eligibility. After the assessment, they will be informed of their eligibility status and, if applicable, randomized to Mindfulness Based Cognitive Therapy (MBCT) or treatment as usual (TAU). Participants in the MBCT group will complete 8 weekly, 2 hr group therapy sessions during pregnancy, as well as receive TAU. The TAU group will engage in regular care during pregnancy and be offered the option to attend one mindfulness psychoeducation session postpartum. Participants in the MBCT group will complete questionnaires prior to the 1st group session, after the 4th session, and after the 8th/final session. Participants in the TAU group will complete the same questionnaires at equivalent time points. All participants will come in for an in-person session at 34 weeks GA, during which they will complete questionnaires and a brief clinical interview. Participants will come in for an MRI scan session at 6 weeks postpartum. In addition to structural and functional MRI scanning, they will also complete questionnaires, a cognitive task, and brief psychiatric interview. At 6 months postpartum, participants will return for a visit, during which they will complete questionnaires, cognitive measures, and a clinical interview. This will be the final visit for women in the MBCT group. Women in the TAU group will complete a singe mindfulness psychoeducation session between 6 and 9 months postpartum; this must occur after their 6 month visit. Some visits will be adapted as needed to accommodate institutional requirements with regard to restrictions due to COVID-19.
- Being tested
- Mindfulness Based Cognitive Therapy
- Keywords
- fMRI, pregnancy, postpartum, MBCT, Mindfulness Based Cognitive Therapy, emotion regulation
- Medical subject headings
- Depression, Postpartum, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive TherapyBehavioural
Also called Mindfulness Based Cognitive Therapy for Perinatal Depression
See Arm description
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Cognitive Therapy | Experimental | Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnancy includes 8 sequential, weekly 2-hour group sessions co-led by two master's level therapists. Sessions include: 1) introducing new mindfulness skills through in-session practice, 2) reviewing mindfulness practices and troubleshooting barriers to practice, 3) reinforcing mindfulness skills through in-session practice and debriefing, 4) learning about how thoughts influence feelings and behaviors (not all sessions), 5) providing psychoeducational information to support skills, and 6) encouraging the establishment of social support. Receives: Behavioral: Mindfulness Based Cognitive Therapy |
| Treatment as usual (TAU) | No intervention | All participants will receive routine prenatal care from an identified medical provider, which they have initiated on their own. They will be able to engage in any services recommended by their primary medical provider or that they voluntarily initiate. For ethical reasons, they are not prohibited from engaging in any type of therapeutic, complementary, or medication treatment (after enrollment). The TAU group will be offered a delayed treatment option, after the 6 month follow-up. This will be a 2 hour mindfulness psychoeducation session, offered between 6 and 9 months postpartum. Several core mindfulness concepts included in the full MBCT curriculum will be taught and participants will complete several brief mindfulness activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiologic Studies Depression Scale - Revised (CESD-R)
Self-reported depressive symptoms over the past two weeks. There are 20 items, each scored from 0-4. The total score range is from 0-80. Total score will be used, with higher scores indicate more depressive symptoms.
Measured: 6 Weeks Postpartum
Emotion Regulation Questionnaire (ERQ)
Self-report of emotion regulation skills. There are two primary subscales, cognitive reappraisal (range: 6-42) and expressive suppression (range: 4-28). Outcome will be total score on the cognitive reappraisal scale. Higher scores for reappraisal indicate better emotion regulation.
Measured: 6 Weeks Postpartum
Stroop Task
The classic Stroop task is a robust measure of cognitive control. Participants will view a color word in a different color ink, naming the ink color. A control condition is included with neutral words. Interference score will be calculated using reaction times.
Measured: 6 Weeks Postpartum
Brain activation during an emotion regulation task
An emotion regulation task will be completed during a functional magnetic resonance imaging (fMRI) scan in order to examine whole-brain functional activation. Individuals will view negative and neutral pictures from the International Affective Picture System. For some pictures, they will just view the images. For some negative pictures, they will be asked to regulate their responding using a distancing technique that has been introduced to them.
Measured: 6 Weeks Postpartum
Brain activation during the Stroop task
The Stroop task will be completed during a functional magnetic resonance imaging (fMRI) scan in order to examine whole-brain functional activation when cognitive control must be exerted.
Measured: 6 Weeks Postpartum
Secondary outcomes (4)
Rate of Postpartum Depression
Presence of a major depressive episode will be used to determine the presence of postpartum depression. Major depressive episodes will be assessed using the Mood Module of the Structured Clinical Interview for the Diagnostic and Statistical Manual, Fifth Edition (SCID-5).
Measured: 6 Weeks Postpartum, 6 Months Postpartum
Emotion Regulation Questionnaire (ERQ)
Self-report of emotion regulation skills. There are two primary subscales, cognitive reappraisal (range: 6-42) and expressive suppression (range: 4-28). Outcome will be total score on the cognitive reappraisal scale. Higher scores for reappraisal indicate better emotion regulation.
Measured: 6 Months Postpartum
Stroop Task
The classic Stroop task is a robust measure of cognitive control. Participants will view a color word in a different color ink, naming the ink color. A control condition is included with neutral words. Interference score will be calculated using reaction times.
Measured: 6 Months Postpartum
Infant Behavior Questionnaire - Revised (IBQ-R)
A 193 item self-report measure completed by mothers about specific temperament-related behaviors displayed by their infant over the past two weeks. There are 14 sub-scales derived, each ranging from 0-7. A negative emotionality composite will be derived from the fear, sadness, and distress to limitations sub-scales.
Measured: 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 posted18 Jan 2019
- Study start22 Mar 2019
- Primary completion1 Oct 2020
- Study completion8 Mar 2021
Why it stopped: Due to restrictions to in-person research due to COVID-19
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 Maternal Psychological DistressStudies of the same condition, open and under way.
- 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
- Model description
- The study is a randomized, control trial with an intervention arm, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnant women (Dimidjian, Goodman, et al., 2016), and treatment as usual (TAU) arm. The study will be blinded to staff (except for the study coordinator(s) and interventionists), but participant blinding is not possible due to the nature of the intervention. Participants will be randomized using a stratified block design after initial eligibility determination. Randomization will be stratified based on current depressive symptoms and current stress levels.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen Mackiewicz Seghete, Oregon Health and Science University
- Investigators
- Kristen Mackiewicz Seghete, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809572
- Sponsor's protocol ID
- 1R21AT010292-01
- Status last verified
- Dec 2021
- First submitted
- 11 Jan 2019
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We propose to share de-identified individual participant data that underlie the results of this study, with proper approval.
Publications
Dimidjian 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 26654212
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Action of MBCT-PD: A Pilot Study
- ClinicalTrials.gov ID
- NCT03809572
- Acronym / sponsor ID
- 1R21AT010292-01
- Keywords
- fMRI, pregnancy, postpartum, MBCT, Mindfulness Based Cognitive Therapy, emotion regulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to restrictions to in-person research due to COVID-19
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 18 Jan 2019 (actual)
- 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 study is a pilot randomized control trial of a validated intervention, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnancy, developed to reduce risk for postpartum depression. This study examines emotion regulation as a potential mechanism of action, at both the behavioral and neurobiological level, that carries forward to the postpartum period. A secondary mechanism of action to be explored is cognitive control. This study will also consider other potential influences on treatment response and psychiatric outcomes, including perinatal stress and depressive symptoms. The study population is pregnant women age 21-45.
Detailed description
The study will involve an online screen of potentially eligible pregnant women. If participants are eligible after the online screen, they will be invited in for an in person assessment, including cognitive testing and a diagnostic interview, to determine eligibility. After the assessment, they will be informed of their eligibility status and, if applicable, randomized to Mindfulness Based Cognitive Therapy (MBCT) or treatment as usual (TAU). Participants in the MBCT group will complete 8 weekly, 2 hr group therapy sessions during pregnancy, as well as receive TAU. The TAU group will engage in regular care during pregnancy and be offered the option to attend one mindfulness psychoeducation session postpartum. Participants in the MBCT group will complete questionnaires prior to the 1st group session, after the 4th session, and after the 8th/final session. Participants in the TAU group will complete the same questionnaires at equivalent time points. All participants will come in for an in-person session at 34 weeks GA, during which they will complete questionnaires and a brief clinical interview. Participants will come in for an MRI scan session at 6 weeks postpartum. In addition to structural and functional MRI scanning, they will also complete questionnaires, a cognitive task, and brief psychiatric interview. At 6 months postpartum, participants will return for a visit, during which they will complete questionnaires, cognitive measures, and a clinical interview. This will be the final visit for women in the MBCT group. Women in the TAU group will complete a singe mindfulness psychoeducation session between 6 and 9 months postpartum; this must occur after their 6 month visit. Some visits will be adapted as needed to accommodate institutional requirements with regard to restrictions due to COVID-19.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a randomized, control trial with an intervention arm, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnant women (Dimidjian, Goodman, et al., 2016), and treatment as usual (TAU) arm. The study will be blinded to staff (except for the study coordinator(s) and interventionists), but participant blinding is not possible due to the nature of the intervention. Participants will be randomized using a stratified block design after initial eligibility determination. Randomization will be stratified based on current depressive symptoms and current stress levels.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Cognitive Therapy | Experimental | Behavioral: Mindfulness Based Cognitive TherapyMindfulness Based Cognitive Therapy (MBCT) adapted for pregnancy includes 8 sequential, weekly 2-hour group sessions co-led by two master's level therapists. Sessions include: 1) introducing new mindfulness skills through in-session practice, 2) reviewing mindfulness practices and troubleshooting barriers to practice, 3) reinforcing mindfulness skills through in-session practice and debriefing, 4) learning about how thoughts influence feelings and behaviors (not all sessions), 5) providing psychoeducational information to support skills, and 6) encouraging the establishment of social support. |
| Treatment as usual (TAU) | No intervention | –All participants will receive routine prenatal care from an identified medical provider, which they have initiated on their own. They will be able to engage in any services recommended by their primary medical provider or that they voluntarily initiate. For ethical reasons, they are not prohibited from engaging in any type of therapeutic, complementary, or medication treatment (after enrollment). The TAU group will be offered a delayed treatment option, after the 6 month follow-up. This will be a 2 hour mindfulness psychoeducation session, offered between 6 and 9 months postpartum. Several core mindfulness concepts included in the full MBCT curriculum will be taught and participants will complete several brief mindfulness activities. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- female who is currently pregnant (8-22 weeks gestational age (GA) at time of screen)
- 21-45 years old
- single gestation
- fluently speak English
- be available and physically able to attend scheduled group meetings
Key exclusion criteria (16 listed)
- Magnetic Resonance Imaging (MRI) contraindication (e.g., metal in their body)
- major neurological or medical illness (e.g., diabetes, multiple sclerosis)
- history of head trauma (loss of conscious > 2 minutes)
- Intelligence Quotient (IQ) < 80
- uncorrectable vision or hearing impairments (including color blindness)
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 |
|---|---|---|
| Mindfulness Based Cognitive TherapyAlso: Mindfulness Based Cognitive Therapy for Perinatal DepressionSee Arm description | Behavioural | Mindfulness Based Cognitive Therapy |
Primary outcome
Center for Epidemiologic Studies Depression Scale - Revised (CESD-R)
Time frame: 6 Weeks Postpartum
Self-reported depressive symptoms over the past two weeks. There are 20 items, each scored from 0-4. The total score range is from 0-80. Total score will be used, with higher scores indicate more depressive symptoms.
Emotion Regulation Questionnaire (ERQ)
Time frame: 6 Weeks Postpartum
Self-report of emotion regulation skills. There are two primary subscales, cognitive reappraisal (range: 6-42) and expressive suppression (range: 4-28). Outcome will be total score on the cognitive reappraisal scale. Higher scores for reappraisal indicate better emotion regulation.
Stroop Task
Time frame: 6 Weeks Postpartum
The classic Stroop task is a robust measure of cognitive control. Participants will view a color word in a different color ink, naming the ink color. A control condition is included with neutral words. Interference score will be calculated using reaction times.
Brain activation during an emotion regulation task
Time frame: 6 Weeks Postpartum
An emotion regulation task will be completed during a functional magnetic resonance imaging (fMRI) scan in order to examine whole-brain functional activation. Individuals will view negative and neutral pictures from the International Affective Picture System. For some pictures, they will just view the images. For some negative pictures, they will be asked to regulate their responding using a distancing technique that has been introduced to them.
Brain activation during the Stroop task
Time frame: 6 Weeks Postpartum
The Stroop task will be completed during a functional magnetic resonance imaging (fMRI) scan in order to examine whole-brain functional activation when cognitive control must be exerted.
4 secondary outcomes
Rate of Postpartum Depression
Time frame: 6 Weeks Postpartum, 6 Months Postpartum
Emotion Regulation Questionnaire (ERQ)
Time frame: 6 Months Postpartum
Stroop Task
Time frame: 6 Months Postpartum
Infant Behavior Questionnaire - Revised (IBQ-R)
Time frame: 6 Months Postpartum
Results and safety
The study was stopped early (reason given: Due to restrictions to in-person research due to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- 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.
- Individual participant dataSharing planned: Yes. We propose to share de-identified individual participant data that underlie the results of this study, with proper approval.
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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.
Kristen Mackiewicz Seghete, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Cognitive Therapy in people with Maternal Psychological Distress and Postpartum Depression, run by Oregon Health and Science University at 1 site 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 6 inclusion and 16 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: stopped early, as of the sponsor's last update on 20 Dec 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 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?
The study was stopped early (reason given: Due to restrictions to in-person research due to COVID-19). Results are not available in the source record.
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?
Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) (time frame: 6 Weeks Postpartum). The study lists 5 primary outcomes in all. 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 NCT03809572, 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 20 Dec 2021.