Treatment for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Kaiser Permanente Colorado, Denver, CO
Depression+1 More
Eligibility
18+
Female
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Study Summary

Accelerating Implementation of Mindful Mood Balance for Moms

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Eligible Conditions

  • Depression
  • Perinatal Depression

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes, 7 secondary outcomes, and 5 other outcomes in patients with Depression. Measurement will happen over the course of Baseline.

3 months post-randomization
Client Satisfaction Questionnaire (CSQ)
TWente Engagement with e-health Technologies Scale (TWEETS)
The TWente Engagement with Ehealth Technologies Scale (TWEETS)
Month 6
Reach
Baseline
Attitudes toward coaches
Baseline, 3 months post-randomization
Change in Experiences Questionnaire (EQ) scores from baseline through 3 months post-randomization
Change in Ruminative Responses Scale (RRS) short form scores from baseline through 3 months post-randomization
Change in Self-stigma of depression scale (SSDS) scores scores from baseline through 3 months post-randomization
Change in University of California, Los Angeles (UCLA) Loneliness Scale (ULS-6) scores scores from baseline through 3 months post-randomization
Month 3
Change in Attitudes Toward Motherhood (AToM) Scale scores from baseline through 3 months postpartum
Change in Perceived Stress Scale scores from baseline through 3 months postpartum
Change in Short Form 12 (SF-12) scores from baseline through 3 months postpartum
Month 3
Change in Generalized Anxiety Disorder 7-item (GAD-7) questionnaire scores from baseline through 3 months postpartum
Change in Patient Health Questionnaire 9-item (PHQ-9) scores from baseline through 3 months postpartum

Trial Safety

Trial Design

4 Treatment Groups

Patient facing strategy intervention arm
1 of 4
MMBFM program with peer coach support
1 of 4
Patient facing plus clinic facing strategy intervention arm
1 of 4
MMBFM program with clinician coach support
1 of 4
Active Control

This trial requires 470 total participants across 4 different treatment groups

This trial involves 4 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Patient facing strategy intervention armCentralized outreach and recruitment of women receiving prenatal care by study team using email, letter, or text, without direct involvement of OB providers.
MMBFM program with peer coach support
Behavioral
Telephonic coaching provided by trained peers with lived experience of perinatal depression to support and encourage participants' engagement in and completion of the 8-session online MMBFM program.
Patient facing plus clinic facing strategy intervention armOB clinic providers' use of printed recruitment materials and/or electronic medical records prompts to recommend/refer women receiving prenatal care to access the MMBFM program. These clinic facing implementation strategies will be added to the patient facing strategies of centralized outreach and recruitment of women receiving prenatal care by study team using email, letter, or text
MMBFM program with clinician coach support
Behavioral
Telephonic coaching provided by licensed mental health professionals to support and encourage participants' engagement in and completion of the 8-session online MMBFM program.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 months post-randomization, 3rd trimester, 3 months postpartum
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 3 months post-randomization, 3rd trimester, 3 months postpartum for reporting.

Closest Location

Kaiser Permanente Colorado - Denver, CO

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patient health questionnaire 9-item (PHQ9) depression score is less than or equal to nine. show original
, English-speaking, and pregnant with a single baby People who are 18 years or older, who are receiving prenatal care at one of the 4 participating health systems, who are English-speaking, and who are pregnant with a single baby are eligible to participate in the study. show original
You can access the internet through your home computer, smartphone, or other device. show original
12-24 weeks gestation
The individual has reported at least one prior episode of major depressive disorder. show original

Patient Q&A Section

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Depression by sharing your contact details with the study coordinator.