How Does Mindful Mood Balance for Moms Work?

NCT05000879 | Completed

• 1 other identifier: 18-0402
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Pregnancy Related; Antenatal Depression; Depression, Postpartum

Outcome Measures

Primary Outcomes (5)

• 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

• Rate of change in decentering

  Change in decentering will be evaluated by the Experiences Questionnaire-Decentering subscale

  Through 6-month follow-up

• Rate of change in self-compassion

  Change in self-compassion will be evaluated by the Self-Compassion Scale (SCS)

  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.

  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)

  Through 6-month follow-up

Study Arms (2)

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.

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.

Interventions

MMB for Moms BEHAVIORAL

12-week program that emphasizes mindfulness and cognitive behavioral skills

MMB for Moms

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female,
• pregnant or having had a child within the past 36 months, \*
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Boulder: lead

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

Related 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.

  PMID: 26654212 BACKGROUND

MeSH Terms

Conditions

Depression; Depression, Postpartum

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Instructor

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 11, 2021
• Study Start: November 16, 2018
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available after study completion.
• Access Criteria: Interested investigators will be asked to submit a proposal form, which will be reviewed by the principal investigators for scientific integrity and adherence to ethical guidelines.

Locations

US (1)