DepressionNCT05000879
How Does Mindful Mood Balance for Moms Work?
A study testing MMB for Moms in people with Depression and Pregnancy Related, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
The purpose of this investigation is to conduct a randomized trial comparing a web-based Mindful Mood Balance for Moms course without coaching support to waitlist control among pregnant or early parenting women with depression histories. 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?
- MMB for Moms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2018to 20 Aug 2019
- 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
Who may be able to join
- female,
- pregnant or having had a child within the past 36 months, *
- 18 years of age or older,
- having a history of one or more prior major depressive episode (as assessed by a single question, "Have you had a history of mood concerns or major depression?")
- a current PHQ-9 score of <= 14, and
- endorses ability to read and write fluently in English.
Who cannot join
- meeting criteria for current moderately severe depression symptoms (as assessed by the PHQ-9 >= 15),
- current imminent suicidality (as assessed by the PHQ-9), and
- indication of other disorders or symptoms that necessitate priority treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Boulder
Boulder, Colorado, 80309
About this study
Official title: A Randomized Controlled Trial of Mental Health Outcomes and Putative Targets of an Online Mindfulness Program for New and Expectant Mothers
The purpose of this investigation is to conduct a randomized trial comparing a web-based Mindful Mood Balance for Moms course without coaching support to waitlist control among pregnant or early parenting women with depression histories.
Read the detailed description
Mindfulness-based cognitive therapy (MBCT) prevents depressive relapse and reduces residual depression symptoms among adults with recurrent depression not currently in episode. Women in perinatal or early parenting years constitute a significant portion of this at-risk population with a history of depression for whom MBCT was designed. Novel delivery formats that provide access to core knowledge and skills of MBCT could increase public health impact-particularly for perinatal or early parenting women-but it is unclear whether such formats have comparable mental health outcomes and changes in putative targets as in-person MBCT.
In the present study, we planned to randomize 60 pregnant or early parenting women with a history of major depression and current residual depressive symptoms to MMB for Moms, a web-based course that teaches skills from MBCT customized specifically for pregnant and postpartum women, or waitlist control. We planned to address the following specific aims:
Aim 1. We evaluated the extent to MMB for Moms was associated with significant reduction in residual depression symptoms as compared to WLC. We predicted the rate of change in depression symptoms across the study would be greater on average for participants randomized to MMB for Moms relative to those randomized to WLC.
Aim 2. We evaluated the extent to MMB for Moms significantly engaged the putative target of decentering as compared to WLC. We predicted the rate of change in decentering across the study would be greater on average for participants randomized to MMB for Moms relative to participants randomized to WLC.
Aim 3. We evaluated the extent to MMB for Moms significantly engaged the putative target of self-compassion as compared to WLC. We predicted the rate of change in self-compassion across the study would be greater on average for participants randomized to MMB for Moms relative to participants randomized to WLC.
- Being tested
- MMB for Moms
- Medical subject headings
- Depression, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMB for MomsBehavioural
12-week program that emphasizes mindfulness and cognitive behavioral skills
| Study group | Role | What they receive |
|---|---|---|
| MMB for Moms | Experimental | Subjects will receive digital delivery of Mindful Mood Balance for Moms for 12 weeks. Subjects will be unconstrained in the types of treatments or other wellness activities they could receive while participating in the study. Receives: Behavioral: MMB for Moms |
| Waitlist Control | No intervention | Subjects will be unconstrained in the types of treatments or other wellness activities they could receive while participating in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in depression symptoms
Change in the severity of depressive symptoms will be evaluated by the Patient Health Questionnaire-9 (PHQ-9)
Measured: Through 6-month follow-up
Rate of change in decentering
Change in decentering will be evaluated by the Experiences Questionnaire-Decentering subscale
Measured: Through 6-month follow-up
Rate of change in self-compassion
Change in self-compassion will be evaluated by the Self-Compassion Scale (SCS)
Measured: Through 6-month follow-up
Depressive Relapse Status
Rate of depressive relapse will be assessed using the Lifetime Depression Assessment Self-report (LIDAS), adapted to reference the past 3 or 6 months based on survey completion.
Measured: Through 6-month follow-up
Rate of change in anxiety symptoms
Change in the severity of anxiety symptoms will be evaluated by the 3. Generalized Anxiety Disorder-7 (GAD-7)
Measured: Through 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start16 Nov 2018
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
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.
- 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHRISTINA METCALF, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000879
- Sponsor's protocol ID
- 18-0402
- Status last verified
- May 2024
- First submitted
- 5 Aug 2021
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data and accompanying documentation will be available for use by other investigators upon request.
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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Mental Health Outcomes and Putative Targets of an Online Mindfulness Program for New and Expectant Mothers
- ClinicalTrials.gov ID
- NCT05000879
- Acronym / sponsor ID
- 18-0402
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 11 Aug 2021 (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 purpose of this investigation is to conduct a randomized trial comparing a web-based Mindful Mood Balance for Moms course without coaching support to waitlist control among pregnant or early parenting women with depression histories.
Detailed description
Mindfulness-based cognitive therapy (MBCT) prevents depressive relapse and reduces residual depression symptoms among adults with recurrent depression not currently in episode. Women in perinatal or early parenting years constitute a significant portion of this at-risk population with a history of depression for whom MBCT was designed. Novel delivery formats that provide access to core knowledge and skills of MBCT could increase public health impact-particularly for perinatal or early parenting women-but it is unclear whether such formats have comparable mental health outcomes and changes in putative targets as in-person MBCT.
In the present study, we planned to randomize 60 pregnant or early parenting women with a history of major depression and current residual depressive symptoms to MMB for Moms, a web-based course that teaches skills from MBCT customized specifically for pregnant and postpartum women, or waitlist control. We planned to address the following specific aims:
Aim 1. We evaluated the extent to MMB for Moms was associated with significant reduction in residual depression symptoms as compared to WLC. We predicted the rate of change in depression symptoms across the study would be greater on average for participants randomized to MMB for Moms relative to those randomized to WLC.
Aim 2. We evaluated the extent to MMB for Moms significantly engaged the putative target of decentering as compared to WLC. We predicted the rate of change in decentering across the study would be greater on average for participants randomized to MMB for Moms relative to participants randomized to WLC.
Aim 3. We evaluated the extent to MMB for Moms significantly engaged the putative target of self-compassion as compared to WLC. We predicted the rate of change in self-compassion across the study would be greater on average for participants randomized to MMB for Moms relative to participants randomized to WLC.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMB for Moms | Experimental | Behavioral: MMB for MomsSubjects will receive digital delivery of Mindful Mood Balance for Moms for 12 weeks. Subjects will be unconstrained in the types of treatments or other wellness activities they could receive while participating in the study. |
| Waitlist Control | No intervention | –Subjects will be unconstrained in the types of treatments or other wellness activities they could receive while participating in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- female,
- pregnant or having had a child within the past 36 months, *
- 18 years of age or older,
- having a history of one or more prior major depressive episode (as assessed by a single question, "Have you had a history of mood concerns or major depression?")
- a current PHQ-9 score of <= 14, and
Key exclusion criteria (3 listed)
- meeting criteria for current moderately severe depression symptoms (as assessed by the PHQ-9 >= 15),
- current imminent suicidality (as assessed by the PHQ-9), and
- indication of other disorders or symptoms that necessitate priority treatment.
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 |
|---|---|---|
| MMB for Moms12-week program that emphasizes mindfulness and cognitive behavioral skills | Behavioural | MMB for Moms |
Primary outcome
Rate of change in depression symptoms
Time frame: Through 6-month follow-up
Change in the severity of depressive symptoms will be evaluated by the Patient Health Questionnaire-9 (PHQ-9)
Rate of change in decentering
Time frame: Through 6-month follow-up
Change in decentering will be evaluated by the Experiences Questionnaire-Decentering subscale
Rate of change in self-compassion
Time frame: Through 6-month follow-up
Change in self-compassion will be evaluated by the Self-Compassion Scale (SCS)
Depressive Relapse Status
Time frame: Through 6-month follow-up
Rate of depressive relapse will be assessed using the Lifetime Depression Assessment Self-report (LIDAS), adapted to reference the past 3 or 6 months based on survey completion.
Rate of change in anxiety symptoms
Time frame: Through 6-month follow-up
Change in the severity of anxiety symptoms will be evaluated by the 3. Generalized Anxiety Disorder-7 (GAD-7)
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 23 May 2024.
- 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. De-identified data and accompanying documentation 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMB for Moms in people with Depression and Pregnancy Related, run by University of Colorado, Boulder 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 3 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 23 May 2024. 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 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?
Rate of change in depression symptoms (time frame: Through 6-month follow-up). 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 NCT05000879, 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 23 May 2024.