How Does Mindful Mood Balance for Moms Work?

Depression Clinical Trial

Official title:

A Randomized Controlled Trial of Mental Health Outcomes and Putative Targets of an Online Mindfulness Program for New and Expectant Mothers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05000879
• Other study ID #: 18-0402
• Status: Completed
• Phase: N/A
• Start date: November 16, 2018
• Est. completion date: August 20, 2019

Study information

• Verified date: August 2021
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 20, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Antenatal Depression
• Depression
• Depression, Postpartum
• Depressive Disorder
• Pregnancy Related

Intervention

Behavioral:
• MMB for Moms
12-week program that emphasizes mindfulness and cognitive behavioral skills

Locations

Country	Name	City	State
United States	University of Colorado Boulder	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of change in depression symptoms	Change in the severity of depressive symptoms will be evaluated by the Patient Health Questionnaire-9 (PHQ-9)	Through 6-month follow-up
Primary	Rate of change in decentering	Change in decentering will be evaluated by the Experiences Questionnaire-Decentering subscale	Through 6-month follow-up
Primary	Rate of change in self-compassion	Change in self-compassion will be evaluated by the Self-Compassion Scale (SCS)	Through 6-month follow-up
Primary	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.	Through 6-month follow-up
Primary	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)	Through 6-month follow-up