Perinatal DepressionMMB4MomsNCT04846504
Accelerating Implementation of Mindful Mood Balance for Moms
A study testing MMBFM program with clinician coach support, MMBFM program with peer coach support and Patient facing strategy intervention arm in people with Perinatal Depression, run by Kaiser Permanente at 4 sites in United States.
Trial summary
The Mindful Mood Balance for Moms (MMBFM) study examines whether using an internet program called Mindful Mood Balance for Moms to deliver Mindfulness Based Cognitive Therapy (MBCT) over an 8-week time period, is effective for reducing depression symptoms among pregnant women with a history of prior depression, and… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Depression
- What is being tested?
- MMBFM program with clinician coach support, MMBFM program with peer coach support and Patient facing strategy intervention arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 423 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Sep 2021to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older, receiving prenatal care at one of the 4 participating health systems
- 12-24 weeks gestation
- >= 1 prior episode of major depressive disorder, self-reported
- Current Patient Health Questionnaire 9-item (PHQ9) depression score <=9.
- Have internet access through home computer, smart phone, or similar device
Who cannot join
- Non-English speaking
- Past history of a psychotic, bipolar disorder, or substance misuse disorder within the past 6 months
- Immediate risk of self-harm
- PHQ9 score <5 or >9
- Patients who are on the "do not call" list for research
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kaiser Permanente Georgia
Atlanta, Georgia, 30309
HealthPartners
Bloomington, Minnesota, 55425
Kaiser Permanente Colorado
Denver, Colorado, 80014
Kaiser Permanente Southern California
San Diego, California, 92116
About this study
Official title: Accelerating Implementation of Mindful Mood Balance For Moms
The Mindful Mood Balance for Moms (MMBFM) study examines whether using an internet program called Mindful Mood Balance for Moms to deliver Mindfulness Based Cognitive Therapy (MBCT) over an 8-week time period, is effective for reducing depression symptoms among pregnant women with a history of prior depression, and studies the effects of implementation strategies on the reach of the MMBFM program. This study will enroll 470 women from Kaiser Permanente Colorado, Southern California, Georgia.
The investigators will compare clinical outcomes between those that receive mental health clinician coaching and those that receive peer coaching throughout the 8-week program. Survey data will be collected at 4 time points throughout the study (baseline, 12 weeks, 3rd trimester, and 3 months postpartum). The cost-effectiveness of both the clinical and peer coaching models at each health care system will be evaluated.
For the implementation portion of the study, 30 OB clinics across the 4 health systems will be randomized in equal numbers to provide clinician facing implementation strategies (e.g., recruitment flyers, script pads, electronic medical record prompts) to encourage engagement in the MMBFM program or to usual care where women are only recruited by the study team with no clinician involvement. The primary outcome for testing clinician facing implementation strategies is reach, the percentage of women outreached who initially engage in the MMBFM program.
Read the detailed description
Specific Aims
Informed by the Consolidated Framework for Implementation Research, a leading implementation science framework, this hybrid type III effectiveness implementation study will evaluate specific implementation strategies for MMBFM. Consistent with a hybrid type III study, there are two goals: (1) compare the clinical effectiveness of MMBFM supported by mental health clinician vs. peer coaches in a randomized trial of 470 pregnant women; and (2) compare the reach of MMBFM across OB clinics for two sets of implementation strategies to facilitate access to and initial engagement in MMBFM: patient facing strategies (PFS - direct outreach to women following prenatal visits via secure patient portal, email, text, or mail) vs. patient facing strategies combined with clinician facing strategies (PFS+CFS - Electronic Medical Record (EMR)-embedded prompts for OB providers, printed prescription pads for providers, flyers). A cluster randomized design will be used, randomizing 30 OB clinics across 4 health systems to either of these two implementation conditions, to assess their impact on reach. The investigators will address the following specific aims:
Aim 1: Compare the clinical effectiveness (i.e. engagement and symptom reduction) of MMBFM supported by clinician vs. peer coaches among women with a history of prior depressive episodes. Hypothesis 1: Coaching delivered by mental health clinicians vs. peers with lived experience will be associated with equivalent reductions in depressive symptoms at 6 months post-randomization.
Aim 2: Examine specific mechanisms of action for MMBFM participants receiving clinician vs. peer coaching. Hypothesis 2a: MMBFM participants receiving peer coaching will report less self-stigma and social isolation than those receiving clinician coaching, and MMBFM participants receiving clinician coaching will report less ruminative response to negative affect and greater decentering at 6 months post-randomization than those receiving peer coaching. Hypothesis 2b: Any difference between peer and clinician coaching in depression outcomes will be mediated by treatment-specific targets - at least partially via increased engagement.
Aim 3: Examine the effects of specific implementation strategies on reach of the MMBFM program. Hypothesis 3: Clinician facing implementation strategies (CFS) in combination with patient facing strategies (PFS) will lead to higher rates of reach than patient facing strategies alone.
Aim 4: Estimate the cost-effectiveness of MMBFM supported by clinician vs. peer coaches. Hypothesis 4: MMBFM will be more cost-effective when supported by peer vs. clinician coaches.
The trials of implementation strategies at the individual and clinic levels will be conducted at four health systems representing diversity in geographic location and in racial and ethnic membership: Kaiser Permanente Colorado, Southern California, and Georgia, and HealthPartners in Minnesota. These sites include 95 clinics and more than 400 obstetric clinicians (OB physicians, nurse practitioners, midwives, nurses), providing prenatal care for 53,000 women annually. The implementation trial for Aims 1 and 2 will recruit 470 women following prenatal care visits total across the four health systems and randomize them in equal numbers to participate in one of the two coaching arms for the MMBFM program, lasting 8 weeks. The clinic-level implementation trial (Aim 3) will involve a cluster randomized design in which 30 OB clinics will be recruited from the four health systems and randomized in equal numbers to either the PFS or PFS+CFS intervention arms, lasting 6 months. The individual- and clinic-level trials will be conducted in parallel.
The 8-session MMBFM program teaches mindfulness practice and cognitive behavioral skills to help reduce automatic, depressogenic modes of thoughts, emotions, and sensations. MMBFM is delivered in a mobile first digital format, accessible from desktop or mobile devices, and provided in an individually tailored manner that includes experiential practice, video-based vicarious learning, and didactic information.
- Conditions
- Perinatal Depression
- Being tested
- MMBFM program with clinician coach support, MMBFM program with peer coach support, Patient facing strategy intervention arm, Patient facing plus clinic facing strategy intervention arm
- Keywords
- Mindfulness Based Cognitive Therapy, Mindfulness, Perinatal Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMBFM program with clinician coach supportBehavioural
Clinician-delivered telephonic coaching to support participants in the Mindful Mood Balance for Moms online course for prevention of depression relapse/recurrence among perinatal women who have had prior episodes of depression but are not currently depressed.
MMBFM program with peer coach supportBehavioural
Peer-delivered telephonic coaching to support participants in the Mindful Mood Balance for Moms online course for prevention of depression relapse/recurrence among perinatal women who have had prior episodes of depression but are not currently depressed. Peers will be women with lived experience of perinatal depression who are trained on the coaching protocol.
Patient facing strategy intervention armBehavioural
Direct outreach and recruitment of participants into Mindful Mood Balance for Moms study by study teams. Participants will be women receiving prenatal care at the 4 study sites: Kaiser Permanente Colorado, Southern California, and Georgia, and HealthPartners.
Patient facing plus clinic facing strategy intervention armBehavioural
Direct outreach and recruitment of participants into Mindful Mood Balance for Moms study by study teams, plus recommendation of / referral to the Mindful Mood Balance for Moms study by OB clinicians at the 4 study sites. OB clinicians will choose from printed materials (e.g., flyers, posters in exam rooms and waiting rooms, prescription pads) and electronic medical record prompts (e.g., smart lists, dot phrases) to facilitate engagement in the Mindful Mood Balance for Moms course. Participants will be women receiving prenatal care at the 4 study sites: Kaiser Permanente Colorado, Southern California, and Georgia, and HealthPartners.
| Study group | Role | What they receive |
|---|---|---|
| MMBFM program with clinician coach support | Active comparator | Telephonic coaching provided by licensed mental health professionals to support and encourage participants' engagement in and completion of the 8-session online MMBFM program. Receives: Behavioral: MMBFM program with clinician coach support |
| MMBFM program with peer coach support | Active comparator | 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. Receives: Behavioral: MMBFM program with peer coach support |
| Patient facing strategy intervention arm | Active comparator | Centralized outreach and recruitment of women receiving prenatal care by study team using email, letter, or text, without direct involvement of OB providers. Receives: Behavioral: MMBFM program with clinician coach support; Behavioral: MMBFM program with peer coach support; Behavioral: Patient facing strategy intervention arm |
| Patient facing plus clinic facing strategy intervention arm | Active comparator | OB 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 Receives: Behavioral: MMBFM program with clinician coach support; Behavioral: MMBFM program with peer coach support; Behavioral: Patient facing plus clinic facing strategy intervention arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire 9-item (PHQ-9) scores from baseline through 3 months postpartum
Depression symptom severity, scores range from 0 (low) to 27 (high)
Measured: Baseline, 3 months post-randomization, 3rd trimester, 3 months postpartum
Reach
The percentage of participants who initially engage in the Mindful Mood Balance for Moms course.
Measured: 6 months post-intervention involving patient facing vs. clinician facing implementation strategies
Secondary outcomes (6)
Change in Generalized Anxiety Disorder 7-item (GAD-7) questionnaire scores from baseline through 3 months postpartum
Anxiety symptom severity, scores range from 0 (low) to 21 (high)
Measured: Baseline, 3 months post-randomization, 3rd trimester, 3 months postpartum
Change in Perceived Stress Scale scores from baseline through 3 months postpartum
Stress symptoms measured by a 10-item likert-type scores range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Baseline, 3 months post-randomization, 3rd trimester, 3 months post partum
Change in Attitudes Toward Motherhood (AToM) Scale scores from baseline through 3 months postpartum
Change in attitudes toward motherhood. The 12-item AToM will measure participants' attitudes toward their infants using likert-type responses. Scores range from 0 (positive attitudes) to 60 (negative attitudes).
Measured: Baseline, 3 months post-randomization, 3rd trimester, 3 months post partum
Change in Short Form 12 (SF-12) scores from baseline through 3 months postpartum
The SF-12 is a 12-item measure of physical and mental functional status. Scores range from 0 (low functional status) to 100 (high functional status)
Measured: Baseline, 3 months post-randomization, 3rd trimester, 3 months post partum
The TWente Engagement with Ehealth Technologies Scale (TWEETS)
TWEETS will measure user engagement with the Mindful Mood Balance for Moms program. TWEETS is a 9-item Likert-type scale with scores ranging from 9 (high engagement) to 45 (low engagement)
Measured: 3 months post-randomization
Client Satisfaction Questionnaire (CSQ)
The CSQ will measure satisfaction with the Mindful Mood Balance for Moms program. It is an 8-item questionnaire using different Likert-type responses for each item. Scores range from 8 to 32, with higher values indicating higher satisfaction.
Measured: 3 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start27 Sep 2021
- Primary completion30 Jun 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid type III effectiveness implementation model testing implementation strategies at the individual and OB clinical level. Individual level strategies involve randomizing participants to receive telephonic coaching by professional or peer coach. Clinic level strategies involve randomizing OB clinics to use printed materials and/or electronic medical record prompts to recommend/refer participants to the Mindful Mood Balance for Moms (MMB4M) program or to usual care with no recommendations/referrals to the MMBFM program.
- Masking
- None (open label)
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- HealthPartners Institute, Georgia State University, University of Colorado, Boulder, University of Toronto, Emory University, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Arne Beck, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846504
- Sponsor's protocol ID
- U19MH121738
- Other IDs
- 5U19MH121738-02
- Acronym
- MMB4Moms
- Status last verified
- Oct 2023
- First submitted
- 23 Mar 2021
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerating Implementation of Mindful Mood Balance For Moms
- ClinicalTrials.gov ID
- NCT04846504
- Acronym / sponsor ID
- MMB4Moms / U19MH121738
- Conditions
- Perinatal Depression
- Keywords
- Mindfulness Based Cognitive Therapy, Mindfulness, Perinatal Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- HealthPartners Institute, Georgia State University, University of Colorado, Boulder, University of Toronto, Emory University, National Institute of Mental Health (NIMH)
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Mindful Mood Balance for Moms (MMBFM) study examines whether using an internet program called Mindful Mood Balance for Moms to deliver Mindfulness Based Cognitive Therapy (MBCT) over an 8-week time period, is effective for reducing depression symptoms among pregnant women with a history of prior depression, and studies the effects of implementation strategies on the reach of the MMBFM program. This study will enroll 470 women from Kaiser Permanente Colorado, Southern California, Georgia.
The investigators will compare clinical outcomes between those that receive mental health clinician coaching and those that receive peer coaching throughout the 8-week program. Survey data will be collected at 4 time points throughout the study (baseline, 12 weeks, 3rd trimester, and 3 months postpartum). The cost-effectiveness of both the clinical and peer coaching models at each health care system will be evaluated.
For the implementation portion of the study, 30 OB clinics across the 4 health systems will be randomized in equal numbers to provide clinician facing implementation strategies (e.g., recruitment flyers, script pads, electronic medical record prompts) to encourage engagement in the MMBFM program or to usual care where women are only recruited by the study team with no clinician involvement. The primary outcome for testing clinician facing implementation strategies is reach, the percentage of women outreached who initially engage in the MMBFM program.
Detailed description
Specific Aims
Informed by the Consolidated Framework for Implementation Research, a leading implementation science framework, this hybrid type III effectiveness implementation study will evaluate specific implementation strategies for MMBFM. Consistent with a hybrid type III study, there are two goals: (1) compare the clinical effectiveness of MMBFM supported by mental health clinician vs. peer coaches in a randomized trial of 470 pregnant women; and (2) compare the reach of MMBFM across OB clinics for two sets of implementation strategies to facilitate access to and initial engagement in MMBFM: patient facing strategies (PFS - direct outreach to women following prenatal visits via secure patient portal, email, text, or mail) vs. patient facing strategies combined with clinician facing strategies (PFS+CFS - Electronic Medical Record (EMR)-embedded prompts for OB providers, printed prescription pads for providers, flyers). A cluster randomized design will be used, randomizing 30 OB clinics across 4 health systems to either of these two implementation conditions, to assess their impact on reach. The investigators will address the following specific aims:
Aim 1: Compare the clinical effectiveness (i.e. engagement and symptom reduction) of MMBFM supported by clinician vs. peer coaches among women with a history of prior depressive episodes. Hypothesis 1: Coaching delivered by mental health clinicians vs. peers with lived experience will be associated with equivalent reductions in depressive symptoms at 6 months post-randomization.
Aim 2: Examine specific mechanisms of action for MMBFM participants receiving clinician vs. peer coaching. Hypothesis 2a: MMBFM participants receiving peer coaching will report less self-stigma and social isolation than those receiving clinician coaching, and MMBFM participants receiving clinician coaching will report less ruminative response to negative affect and greater decentering at 6 months post-randomization than those receiving peer coaching. Hypothesis 2b: Any difference between peer and clinician coaching in depression outcomes will be mediated by treatment-specific targets - at least partially via increased engagement.
Aim 3: Examine the effects of specific implementation strategies on reach of the MMBFM program. Hypothesis 3: Clinician facing implementation strategies (CFS) in combination with patient facing strategies (PFS) will lead to higher rates of reach than patient facing strategies alone.
Aim 4: Estimate the cost-effectiveness of MMBFM supported by clinician vs. peer coaches. Hypothesis 4: MMBFM will be more cost-effective when supported by peer vs. clinician coaches.
The trials of implementation strategies at the individual and clinic levels will be conducted at four health systems representing diversity in geographic location and in racial and ethnic membership: Kaiser Permanente Colorado, Southern California, and Georgia, and HealthPartners in Minnesota. These sites include 95 clinics and more than 400 obstetric clinicians (OB physicians, nurse practitioners, midwives, nurses), providing prenatal care for 53,000 women annually. The implementation trial for Aims 1 and 2 will recruit 470 women following prenatal care visits total across the four health systems and randomize them in equal numbers to participate in one of the two coaching arms for the MMBFM program, lasting 8 weeks. The clinic-level implementation trial (Aim 3) will involve a cluster randomized design in which 30 OB clinics will be recruited from the four health systems and randomized in equal numbers to either the PFS or PFS+CFS intervention arms, lasting 6 months. The individual- and clinic-level trials will be conducted in parallel.
The 8-session MMBFM program teaches mindfulness practice and cognitive behavioral skills to help reduce automatic, depressogenic modes of thoughts, emotions, and sensations. MMBFM is delivered in a mobile first digital format, accessible from desktop or mobile devices, and provided in an individually tailored manner that includes experiential practice, video-based vicarious learning, and didactic information.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Hybrid type III effectiveness implementation model testing implementation strategies at the individual and OB clinical level. Individual level strategies involve randomizing participants to receive telephonic coaching by professional or peer coach. Clinic level strategies involve randomizing OB clinics to use printed materials and/or electronic medical record prompts to recommend/refer participants to the Mindful Mood Balance for Moms (MMB4M) program or to usual care with no recommendations/referrals to the MMBFM program.
| Arm | Type | Receives |
|---|---|---|
| MMBFM program with clinician coach support | Active comparator | Behavioral: MMBFM program with clinician coach supportTelephonic coaching provided by licensed mental health professionals to support and encourage participants' engagement in and completion of the 8-session online MMBFM program. |
| MMBFM program with peer coach support | Active comparator | Behavioral: MMBFM program with peer coach supportTelephonic 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 strategy intervention arm | Active comparator | Behavioral: MMBFM program with clinician coach support, Behavioral: MMBFM program with peer coach support, Behavioral: 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. |
| Patient facing plus clinic facing strategy intervention arm | Active comparator | Behavioral: MMBFM program with clinician coach support, Behavioral: MMBFM program with peer coach support, Behavioral: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or older, receiving prenatal care at one of the 4 participating health systems
- 12-24 weeks gestation
- >= 1 prior episode of major depressive disorder, self-reported
- Current Patient Health Questionnaire 9-item (PHQ9) depression score <=9.
- Have internet access through home computer, smart phone, or similar device
Key exclusion criteria (5 listed)
- Non-English speaking
- Past history of a psychotic, bipolar disorder, or substance misuse disorder within the past 6 months
- Immediate risk of self-harm
- PHQ9 score <5 or >9
- Patients who are on the "do not call" list for research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMBFM program with clinician coach supportClinician-delivered telephonic coaching to support participants in the Mindful Mood Balance for Moms online course for prevention of depression relapse/recurrence among perinatal women who have had prior episodes of depression but are not currently depressed. | Behavioural | MMBFM program with clinician coach support, Patient facing plus clinic facing strategy intervention arm, Patient facing strategy intervention arm |
| MMBFM program with peer coach supportPeer-delivered telephonic coaching to support participants in the Mindful Mood Balance for Moms online course for prevention of depression relapse/recurrence among perinatal women who have had prior episodes of depression but are not currently depressed. Peers will be women with lived experience of perinatal depression who are trained on the coaching protocol. | Behavioural | MMBFM program with peer coach support, Patient facing plus clinic facing strategy intervention arm, Patient facing strategy intervention arm |
| Patient facing strategy intervention armDirect outreach and recruitment of participants into Mindful Mood Balance for Moms study by study teams. Participants will be women receiving prenatal care at the 4 study sites: Kaiser Permanente Colorado, Southern California, and Georgia, and HealthPartners. | Behavioural | Patient facing strategy intervention arm |
| Patient facing plus clinic facing strategy intervention armDirect outreach and recruitment of participants into Mindful Mood Balance for Moms study by study teams, plus recommendation of / referral to the Mindful Mood Balance for Moms study by OB clinicians at the 4 study sites. OB clinicians will choose from printed materials (e.g., flyers, posters in exam rooms and waiting rooms, prescription pads) and electronic medical record prompts (e.g., smart lists, dot phrases) to facilitate engagement in the Mindful Mood Balance for Moms course. Participants will be women receiving prenatal care at the 4 study sites: Kaiser Permanente Colorado, Southern California, and Georgia, and HealthPartners. | Behavioural | Patient facing plus clinic facing strategy intervention arm |
Primary outcome
Change in Patient Health Questionnaire 9-item (PHQ-9) scores from baseline through 3 months postpartum
Time frame: Baseline, 3 months post-randomization, 3rd trimester, 3 months postpartum
Depression symptom severity, scores range from 0 (low) to 27 (high)
Reach
Time frame: 6 months post-intervention involving patient facing vs. clinician facing implementation strategies
The percentage of participants who initially engage in the Mindful Mood Balance for Moms course.
6 secondary outcomes
Change in Generalized Anxiety Disorder 7-item (GAD-7) questionnaire scores from baseline through 3 months postpartum
Time frame: Baseline, 3 months post-randomization, 3rd trimester, 3 months postpartum
Change in Perceived Stress Scale scores from baseline through 3 months postpartum
Time frame: Baseline, 3 months post-randomization, 3rd trimester, 3 months post partum
Change in Attitudes Toward Motherhood (AToM) Scale scores from baseline through 3 months postpartum
Time frame: Baseline, 3 months post-randomization, 3rd trimester, 3 months post partum
Change in Short Form 12 (SF-12) scores from baseline through 3 months postpartum
Time frame: Baseline, 3 months post-randomization, 3rd trimester, 3 months post partum
The TWente Engagement with Ehealth Technologies Scale (TWEETS)
Time frame: 3 months post-randomization
Client Satisfaction Questionnaire (CSQ)
Time frame: 3 months post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Beck, PhD principal investigator
Kaiser Permanente
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMBFM program with clinician coach support, MMBFM program with peer coach support and Patient facing strategy intervention arm in people with Perinatal Depression, run by Kaiser Permanente at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire 9-item (PHQ-9) scores from baseline through 3 months postpartum (time frame: Baseline, 3 months post-randomization, 3rd trimester, 3 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.