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Remote Peer Support in Prevention of Postpartum Depression

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ClinicalTrials.gov Identifier: NCT04639752
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Antonin Sebela, National Institute of Mental Health, Czech Republic

Brief Summary:

The project aims to test the clinical effectiveness of the Mom´s Supporting Moms intervention, a newly developed approach to the prevention of postpartum depression (PPD) and to determine its cost-effectiveness. The approach consists of online screening for risk of PPD in obstetric settings, and subsequent remote peer support intervention for women at risk of PPD development. As a preparation for proposed study, investigators have developed the Mom´s Supporting Moms intervention which is based in mother-to-mother delivered psychoeducation, basic procedures of cognitive behavioral therapy and mindfulness, shared personal experience with postpartum depression and, if necessary, referring to a professional consultation. Proposed study will allow investigators to bring missing Czech methodological procedures for the early screening of PPD development risk, and for subsequent non-pharmacological intervention. Further, investigators will be able to present economic data on proposed intervention to relevant stakeholders in mental health policy.

To achieve these aims, investigators will 1) set up a screening program in five Czech maternity hospitals 2) conduct a randomized controlled trial (n= 60 per each arm), and 3) conduct a cost-effectiveness analysis of the Mom´s Supporting Moms intervention.

Investigators will test the following primary hypotheses: H1: Mom´s Supporting Moms intervention will decrease depressive symptoms in women at risk of PPD development. Secondary hypotheses: SH1: Mom´s Supporting Moms intervention will reduce anxiety symptoms in women at risk of PPD development. SH2: Mom´s Supporting Moms intervention will increase women's health-related quality of life. SH3: Mom´s Supporting Moms intervention is cost-effective in comparison to treatment as usual.


Condition or disease Intervention/treatment Phase
Postpartum Depression Behavioral: Mom´s Supporting Mom Behavioral: Enhanced Treatment As Usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups: One receives MSM prevention intervention and the other group receives Enhanced Treatment as Usual (referral and monitoring).
Masking: Single (Outcomes Assessor)
Masking Description: The person administering the outcome measures is blind to participant group.
Primary Purpose: Prevention
Official Title: Effectiveness of Remote Peer Support in Prevention of Postpartum Depression: a Randomized Controlled Trial
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mom´s Supporting Mom (MSM)
A preventive intervention that involves psychoeducation and peer techniques described in study detailed description.
Behavioral: Mom´s Supporting Mom
A preventive peer consultation intervention for Postpartum Depression.
Other Name: MSM

Active Comparator: Enhanced Treatment as Usual
Referral to treatment in the community and monitoring
Behavioral: Enhanced Treatment As Usual
Referral to treatment in the community, clinical monitoring
Other Name: ETAU




Primary Outcome Measures :
  1. Postpartum depressive symptoms [ Time Frame: 6 weeks postpartum ]
    self-rated depressive symptomatology measured by Edinburgh Postnatal Depression Scale. Score range 0-30, higher score represents worse outcome.


Secondary Outcome Measures :
  1. Postpartum anxiety symptoms [ Time Frame: 6 weeks postpartum ]
    self-rated anxiety symptomatology measured by Perinatal Anxiety Screening Scale. Score range 0-93, higher score represents worse outcome.

  2. Postpartum health-related quality of life [ Time Frame: 6 weeks postpartum ]
    self-rated health-related quality of life measured by Assessment of Quality of Life- 8 dimensions. Score range 0 - 177, higher score represents worse outcome.

  3. Cost-effectiveness [ Time Frame: 6 weeks, 3 months, and year 1 postpartum ]
    The effectiveness Mom´s Supporting Moms will be measured by the quality-adjusted life-years (QALYs) determined by the AQoL-8D data. The estimation of costs of health-care services and medication use will be done according to appropriate Czech payment decree.


Other Outcome Measures:
  1. Postpartum depressive symptoms [ Time Frame: 3 months postpartum ]
    self-rated depressive symptomatology measured by Edinburgh Postnatal Depression Scale. Score range 0-30, higher score represents worse outcome.

  2. Postpartum anxiety symptoms [ Time Frame: 3 months postpartum ]
    self-rated anxiety symptomatology measured by Perinatal Anxiety Screening Scale. Score range 0-93, higher score represents worse outcome.

  3. Postpartum health-related quality of life [ Time Frame: 3 months postpartum ]
    self-rated health-related quality of life measured by Assessment of Quality of Life- 8 dimensions. Score range 0 - 177, higher score represents worse outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

SCREENING PHASE

Criteria for inclusion:

  • sex-female
  • childbirth in the hospital
  • signing of informed consent
  • email address ownership
  • age 18 - 45 years

Exclusion Criteria:

- acute medical illness or significant pregnancy complication (based on self-report)

INTERVENTION PHASE

Criteria for inclusion:

  • Edinburgh Postpartum Depression Scale score ≥10.
  • participant identified through the Screening Phase of the study

Exclusion Criteria:

- acute suicidal behavior (based on self-report)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04639752


Contacts
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Contact: Pavla Spadova +420 283 088 436 Pavla.Spadova@nudz.cz

Locations
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Czechia
National Institute of Mental Health Recruiting
Klecany, Czechia, 25067
Contact: Antonin Sebela, Ph.D.    +420 283 088 111    antonin.sebela@nudz.cz   
Principal Investigator: Antonin Sebela, Ph.D.         
Sponsors and Collaborators
National Institute of Mental Health, Czech Republic
Investigators
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Principal Investigator: Antonin Sebela, Ph.D. National Institute of Mental Health, Klecany, Czechia
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Responsible Party: Antonin Sebela, Principal Investigator, National Institute of Mental Health, Czech Republic
ClinicalTrials.gov Identifier: NCT04639752    
Other Study ID Numbers: NU21J-09-00064
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data may be made available to other researchers.
Supporting Materials: Informed Consent Form (ICF)
Time Frame: After the completion of the study
Access Criteria: Permission of the PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications