DepressionNCT02953990
Self-Management of Chronic Depressive Symptoms in Pregnancy
A study testing MOMS Program in people with Depression, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study will provide information about the feasibility, acceptability, and preliminary effects of a biobehavioral self-management approach for perinatal depressive symptoms. This line of research will contribute to the body of knowledge about adjunctive therapies for depressive symptoms in pregnancy, a serious… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression
- What is being tested?
- MOMS Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 12 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ age 18;
- self-report of depressive symptoms prior to pregnancy;
- current depressive symptoms at a moderate-to-severe level, as defined by a score ≥10 on the Patient Health Questionnaire-9;
- able to read, write, and understand English;
- self-identify as black/African American (AA) or White;
- absence of suicidal ideations (measured as low risk on the M.I.N.I. Neuropsychiatric Interview tool);
- absence of pregnancy complications/physical conditions making physical activity (PA) inadvisable;
- has not engaged in a consistent mindfulness-based PA routine during the pregnancy (such as yoga or similar activities more than once per month).
Who cannot join
- If individual does not meet the inclusion criteria listed above, they are ineligible for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University School of Nursing
Richmond, Virginia, 23298
About this study
This study will provide information about the feasibility, acceptability, and preliminary effects of a biobehavioral self-management approach for perinatal depressive symptoms. This line of research will contribute to the body of knowledge about adjunctive therapies for depressive symptoms in pregnancy, a serious problem which contributes to poor maternal-child outcomes. Ultimately, this will contribute to the development and implementation of theoretically driven depression prevention/ resiliency building interventions and measurement of appropriate biobehavioral outcomes to determine the effectiveness of interventions.
Read the detailed description
The investigators longitudinal mixed-methods study will use a one-group repeated measures intervention design coupled with qualitative methods to provide a comprehensive view of the feasibility, acceptability, and preliminary effects of the MOMS intervention. Semi-structured interviews, recruitment and retention numbers, and participant logs will be used to evaluate feasibility and acceptability of the intervention (Specific Aim 1). Recently collected archival comparison group data from an existing study will be used to contribute to explorations of preliminary effects of the intervention by comparing longitudinal psychobehavioral data, birth weight data (Specific Aims 2 and 3).
- Conditions
- Depression
- Being tested
- MOMS Program
- Keywords
- Pregnancy, Self-Management, Yoga
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOMS ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| MOMS Program | Experimental | The MOMS Program involves: (1) mindfulness of symptoms and goal-setting through a nurse-participant partnership, and (2) 12 weeks of weekly community-based group prenatal yoga classes (75 minutes each) and self-directed home activity. Participants will engage in 12 weeks of weekly community-based group prenatal yoga classes (75 minutes each) and self-directed home practice. Receives: Behavioral: MOMS Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Data
# individuals who enrolled in study/ # individuals who expressed interest in the study
Measured: baseline
Retention Data
# of participants enrolled/ # of participants completing study
Measured: 18 weeks post-baseline
Adherence
Measure of those who attended at least 50% of the yoga sessions (measured analyzing class rosters)
Measured: End of 12 week intervention
Completed Interviews
The number of participants who completed the intervention and completed a postpartum semi-structured interview
Measured: End of 6 week postpartum visit
Edinburgh Postnatal Depression Scale (EPDS)
Pregnancy-specific Depressive Symptoms/Perinatal-specific depressive symptoms were measured by the 10-item Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987); scores range from0 to 30, and a score of≥10 is considered indicative of possible depressive symptoms.
Measured: baseline and end of 12 week intervention
Secondary outcomes (8)
Patient Health Questionnaire-9 (PHQ9)
Depressive Symptoms/ Perceived stress was measured with the 10-item Perceived Stress Scale; scores range from 0 to 40, and higher scores represent higher perceived stress.
Measured: baseline and end of 12 week intervention
State-Trait Anxiety Inventory-State (STAI-S)
State Anxiety/ Anxiety was measured with the State Anxiety Form Y ; scores range from20 to 80, and higher scores indicate higher state anxiety.
Measured: baseline and at the end of the 12 week intervention
Ruminations Response Scale (RRS-10)
Ruminations/ The Ruminative Responses Scale was used to measure ruminations; total scores range from 10 to 40, where higher scores indicate higher rumination.
Measured: baseline and at the end of the 12 week intervention
Self-Efficacy for Physical Activity
Self-Efficacy for Physical Activity: The Physical Activity Self-Efficacy Scale is an eight-question scale that contains items about self-management of physical activities and social support regarding physical activity. A higher score indicates higher self-efficacy. The scores may range form 0-90
Measured: Baseline visit to end of 12 week intervention visit
Maternal Fetal Attachment Scale (MFAS)
Maternal-Child Attachment/ Maternal-fetal/ child attachment was measured using the Maternal-Fetal Attachment Scale with wording adapted slightly for the postpartum use; scores range from 24 to 120,with higher scores indicating higher attachment.
Measured: baseline and at the end of the 12 week intervention
Baby's Birth Weight
Baby's birth weight in pounds per mother's report at postpartum visit
Measured: postpartum visit
Stress
Perceived Stress Scale (PSS): 10-item scale; scores range from 0 to 40, and higher scores represent higher perceived stress
Measured: Change from Baseline visit to end of 12 week intervention visit
Total # of Minutes in Physical Activity (Including Yoga)
Adherence to physical activity aspect of intervention (including yoga)
Measured: End of 12 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startSep 2016
- Primary completion12 Feb 2019
- Study completion12 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Patricia A Kinser, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953990
- Sponsor's protocol ID
- HM20006941
- Other IDs
- 1R15HD086835-01A1
- Status last verified
- Mar 2024
- First submitted
- 31 Oct 2016
- Last updated
- 25 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kinser PA, Thacker LR, Rider A, Moyer S, Amstadter AB, Mazzeo SE, Bodnar-Deren S, Starkweather A. Feasibility, Acceptability, and Preliminary Effects of "Mindful Moms": A Mindful Physical Activity Intervention for Pregnant Women with Depression. Nurs Res. 2021 Mar-Apr 01;70(2):95-105. doi: 10.1097/NNR.0000000000000485.
PubMed 33630532
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management of Chronic Depressive Symptoms in Pregnancy
- ClinicalTrials.gov ID
- NCT02953990
- Acronym / sponsor ID
- HM20006941
- Conditions
- Depression
- Keywords
- Pregnancy, Self-Management, Yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Sep 2016
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 3 Nov 2016 (estimated)
- Results
- Posted 25 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will provide information about the feasibility, acceptability, and preliminary effects of a biobehavioral self-management approach for perinatal depressive symptoms. This line of research will contribute to the body of knowledge about adjunctive therapies for depressive symptoms in pregnancy, a serious problem which contributes to poor maternal-child outcomes. Ultimately, this will contribute to the development and implementation of theoretically driven depression prevention/ resiliency building interventions and measurement of appropriate biobehavioral outcomes to determine the effectiveness of interventions.
Detailed description
The investigators longitudinal mixed-methods study will use a one-group repeated measures intervention design coupled with qualitative methods to provide a comprehensive view of the feasibility, acceptability, and preliminary effects of the MOMS intervention. Semi-structured interviews, recruitment and retention numbers, and participant logs will be used to evaluate feasibility and acceptability of the intervention (Specific Aim 1). Recently collected archival comparison group data from an existing study will be used to contribute to explorations of preliminary effects of the intervention by comparing longitudinal psychobehavioral data, birth weight data (Specific Aims 2 and 3).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOMS Program | Experimental | Behavioral: MOMS ProgramThe MOMS Program involves: (1) mindfulness of symptoms and goal-setting through a nurse-participant partnership, and (2) 12 weeks of weekly community-based group prenatal yoga classes (75 minutes each) and self-directed home activity. Participants will engage in 12 weeks of weekly community-based group prenatal yoga classes (75 minutes each) and self-directed home practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ age 18;
- self-report of depressive symptoms prior to pregnancy;
- current depressive symptoms at a moderate-to-severe level, as defined by a score ≥10 on the Patient Health Questionnaire-9;
- able to read, write, and understand English;
- self-identify as black/African American (AA) or White;
Key exclusion criteria (1 listed)
- If individual does not meet the inclusion criteria listed above, they are ineligible for the study.
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 |
|---|---|---|
| MOMS Program | Behavioural | MOMS Program |
Primary outcome
Recruitment Data
Time frame: baseline
# individuals who enrolled in study/ # individuals who expressed interest in the study
Retention Data
Time frame: 18 weeks post-baseline
# of participants enrolled/ # of participants completing study
Adherence
Time frame: End of 12 week intervention
Measure of those who attended at least 50% of the yoga sessions (measured analyzing class rosters)
Completed Interviews
Time frame: End of 6 week postpartum visit
The number of participants who completed the intervention and completed a postpartum semi-structured interview
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: baseline and end of 12 week intervention
Pregnancy-specific Depressive Symptoms/Perinatal-specific depressive symptoms were measured by the 10-item Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987); scores range from0 to 30, and a score of≥10 is considered indicative of possible depressive symptoms.
8 secondary outcomes
Patient Health Questionnaire-9 (PHQ9)
Time frame: baseline and end of 12 week intervention
State-Trait Anxiety Inventory-State (STAI-S)
Time frame: baseline and at the end of the 12 week intervention
Ruminations Response Scale (RRS-10)
Time frame: baseline and at the end of the 12 week intervention
Self-Efficacy for Physical Activity
Time frame: Baseline visit to end of 12 week intervention visit
Maternal Fetal Attachment Scale (MFAS)
Time frame: baseline and at the end of the 12 week intervention
Baby's Birth Weight
Time frame: postpartum visit
Stress
Time frame: Change from Baseline visit to end of 12 week intervention visit
Total # of Minutes in Physical Activity (Including Yoga)
Time frame: End of 12 week intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33630532Kinser PA, Thacker LR, Rider A, Moyer S, Amstadter AB, Mazzeo SE, Bodnar-Deren S, Starkweather A. Feasibility, Acceptability, and Preliminary Effects of "Mindful Moms": A Mindful Physical Activity Intervention for Pregnant Women with Depression. Nurs Res. 2021 Mar-Apr 01;70(2):95-105. doi: 10.1097/NNR.0000000000000485.
- 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.
Patricia A Kinser, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOMS Program in people with Depression, run by Virginia Commonwealth University at 1 site 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 8 inclusion and 1 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 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 25 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recruitment Data (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02953990, which also lists 1 linked publication.
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 25 Mar 2024.