Condition or disease | Intervention/treatment | Phase |
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Maternal Psychological Distress Postpartum Depression Prenatal Stress | Behavioral: Mindfulness Based Cognitive Therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 74 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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 (Investigator, Outcomes Assessor) |
Masking Description: | Given the use of group therapy, participants and interventionists cannot be blinded to group assignment. The study is designed to minimize the extent to which study staff, aside from interventionists and the primary Study Coordinator(s), are aware of group assignment. The Study Coordinator(s) needs to know group assignment because they will inform participants of their group assignment and will be the main point of contact for participants throughout the study, as to reduce risk of participants revealing their group assignment to other study staff. Participants will be informed that only the Study Coordinator(s) and interventionists, if applicable, are aware of their group assignment. Therefore, in order to ensure the integrity of the research study, they should refrain from discussing their group assignment with other staff members. |
Primary Purpose: | Prevention |
Official Title: | Mechanisms of Action of MBCT-PD: A Pilot Study |
Actual Study Start Date : | March 22, 2019 |
Estimated Primary Completion Date : | January 1, 2022 |
Estimated Study Completion Date : | June 30, 2022 |
Arm | Intervention/treatment |
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Experimental: Mindfulness Based Cognitive Therapy
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.
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Behavioral: Mindfulness Based Cognitive Therapy
See Arm description
Other Name: Mindfulness Based Cognitive Therapy for Perinatal Depression
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No Intervention: Treatment as usual (TAU)
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.
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Ages Eligible for Study: | 21 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion:
Exclusion (at enrollment):
Contact: Gracie Arnone, BA | 5034944476 | arnone@ohsu.edu | |
Contact: Julia Grieser Painter, PhD | 5034181898 | grieserp@ohsu.edu |
United States, Oregon | |
Oregon Health and Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Gracie Arnone, BA 503-494-4476 arnone@ohsu.edu | |
Contact: Julia Grieser Painter, PhD 5034181898 grieserp@ohsu.edu | |
Principal Investigator: Kristen Mackiewicz Seghete, PhD | |
Sub-Investigator: Alice Graham, PhD | |
Sub-Investigator: Jodi Lapidus, PhD |
Principal Investigator: | Kristen Mackiewicz Seghete, PhD | Oregon Health and Science University |
Tracking Information | |||||||||||||
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First Submitted Date ICMJE | January 11, 2019 | ||||||||||||
First Posted Date ICMJE | January 18, 2019 | ||||||||||||
Last Update Posted Date | August 7, 2020 | ||||||||||||
Actual Study Start Date ICMJE | March 22, 2019 | ||||||||||||
Estimated Primary Completion Date | January 1, 2022 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
Change History | |||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Mindfulness Based Cognitive Therapy (MBCT) During Pregnancy | ||||||||||||
Official Title ICMJE | Mechanisms of Action of MBCT-PD: A Pilot Study | ||||||||||||
Brief 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. 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. | ||||||||||||
Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention 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 (Investigator, Outcomes Assessor)Masking Description: Given the use of group therapy, participants and interventionists cannot be blinded to group assignment. The study is designed to minimize the extent to which study staff, aside from interventionists and the primary Study Coordinator(s), are aware of group assignment. The Study Coordinator(s) needs to know group assignment because they will inform participants of their group assignment and will be the main point of contact for participants throughout the study, as to reduce risk of participants revealing their group assignment to other study staff. Participants will be informed that only the Study Coordinator(s) and interventionists, if applicable, are aware of their group assignment. Therefore, in order to ensure the integrity of the research study, they should refrain from discussing their group assignment with other staff members. Primary Purpose: Prevention
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Mindfulness Based Cognitive Therapy
See Arm description
Other Name: Mindfulness Based Cognitive Therapy for Perinatal Depression
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Study Arms ICMJE |
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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. | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||
Estimated Enrollment ICMJE |
74 | ||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||
Estimated Study Completion Date ICMJE | June 30, 2022 | ||||||||||||
Estimated Primary Completion Date | January 1, 2022 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE |
Inclusion:
Exclusion (at enrollment):
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 45 Years (Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT03809572 | ||||||||||||
Other Study ID Numbers ICMJE | 1R21AT010292-01( U.S. NIH Grant/Contract ) | ||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Kristen Mackiewicz Seghete, Oregon Health and Science University | ||||||||||||
Study Sponsor ICMJE | Oregon Health and Science University | ||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||
Investigators ICMJE |
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PRS Account | Oregon Health and Science University | ||||||||||||
Verification Date | August 2020 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |