Clinical trial NCT05000879: How Does Mindful Mood Balance for Moms Work?
Official title: A Randomized Controlled Trial of Mental Health Outcomes and Putative Targets of an Online Mindfulness Program for New and Expectant Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Pregnancy Related
Antenatal Depression
Depression, Postpartum
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. female,
2. pregnant or having had a child within the past 36 months, \*
3. 18 years of age or older,
4. 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?")
5. a current PHQ-9 score of \<= 14, and
6. endorses ability to read and write fluently in English.

Exclusion Criteria:

1. meeting criteria for current moderately severe depression symptoms (as assessed by the PHQ-9 \>= 15),
2. current imminent suicidality (as assessed by the PHQ-9), and
3. indication of other disorders or symptoms that necessitate priority treatment.

Primary outcomes:
measure: Rate of change in depression symptoms
timeFrame: Through 6-month follow-up
measure: Rate of change in decentering
timeFrame: Through 6-month follow-up
measure: Rate of change in self-compassion
timeFrame: Through 6-month follow-up
measure: Depressive Relapse Status
timeFrame: Through 6-month follow-up
measure: Rate of change in anxiety symptoms
timeFrame: Through 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
Study officials:
References:
citation: 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.