How Does Mindful Mood Balance for Moms Work?

NCT ID: NCT05000879

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-16
• Study Completion Date: 2019-08-20

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.

Conditions

Depression; Pregnancy Related; Antenatal Depression; Depression, Postpartum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MMB for Moms

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.

Group Type: EXPERIMENTAL

MMB for Moms

Intervention Type: BEHAVIORAL

12-week program that emphasizes mindfulness and cognitive behavioral skills

Waitlist Control

Subjects will be unconstrained in the types of treatments or other wellness activities they could receive while participating in the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MMB for Moms

12-week program that emphasizes mindfulness and cognitive behavioral skills

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Boulder

OTHER

Sponsor Role: lead

Responsible Party

CHRISTINA METCALF

Senior Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Colorado Boulder

Boulder, Colorado, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26654212 (View on PubMed)

Other Identifiers

18-0402

Identifier Type: -

Identifier Source: org_study_id