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Trial record 19 of 49 for:    Postpartum Depression AND PPD | "Depression" AND "Depression"

Be a Mom: Effectiveness of a Web-based Preventive Intervention for Postpartum Depression (BeAMom)

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ClinicalTrials.gov Identifier: NCT03024645
Recruitment Status : Enrolling by invitation
First Posted : January 19, 2017
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Ana Fonseca, University of Coimbra

Brief Summary:

The main goal of the research is to apply and evaluate the web-based preventive intervention (the Be a Mom program), in terms of its efficacy, acceptability and feasibility (user's adherence, dropout), and user's satisfaction. Prior to the randomized controlled trial (RCT), the investigators will conduct a pilot trial to evaluate the preliminary version of the Be a Mom program in high-risk women (random assignment to the intervention or to the control condition).

The RCT will be a two-arm prevention trial. Women who have had a child during the prior month will be enrolled in the study. A minimum number of 1000 women will be enrolled in the study. After agreeing to participate in the study, the women will be screened for the presence of risk factors for PPD and early-onset PPD symptoms (using self-report questionnaires) by a researcher (licensed psychologist). In case of a negative screen, women's participation in the study will end. In case of a positive screen (high-risk women), women will be randomly assigned to one of the conditions: the intervention (Be a Mom program) or the control condition. The sample will be recruited online and at the maternities of Coimbra University Hospitals-CHUC, EPE.

Participation in the study will last 11 months. The Be a Mom program will last 5 weeks. Participants in both conditions will be invited by the researchers via email to complete baseline, post-intervention and follow-up (4-months and 12-months after childbirth) assessments. Assessments will include self-report questionnaires to assess several indicators (e.g., depressive and anxiety symptoms, dyadic adjustment, mother-child bonding, and maternal confidence), mechanisms that may be involved in the treatment response (e.g., npsychological flexibility, emotional regulation) and user's acceptability and satisfaction.


Condition or disease Intervention/treatment Phase
PostPartum Depression Behavioral: Be A Mom Other: Treatment as usually (TAU) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Be a Mom: A Randomized Controlled Trial of the Effectiveness of a Web-based Preventive Intervention for Postpartum Depression.
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BeAMom
High-risk (HR) women will receive a web-based preventive intervention for PPD (the Be a Mom program). In addition, women will receive postpartum and and pediatric treatment as usually performed in primary care settings (TAU).
Behavioral: Be A Mom
The Be a Mom program is a web-based self-guided cognitive-behavioral intervention to prevent postpartum depression, targeting postpartum women. It consists of 5 weekly modules, each module targeting a specific thematic content, and providing women with both information and specific therapeutic strategies (with a strong focus on cognitive-behavioral techniques) to address each thematic content. Modules are sequential.

Other: Treatment as usually (TAU)
performed in primary care settings

Active Comparator: Control
High-risk (HR) women will receive postpartum and pediatric treatment as usually performed in primary care settings (TAU). During medical appointments, health professionals may ask women and provide information about psychological problems during the postpartum period.
Other: Treatment as usually (TAU)
performed in primary care settings




Primary Outcome Measures :
  1. Number of women with clinically significant postpartum depressive symptoms (EPDS > 12) at 4 months postpartum [ Time Frame: 4 months postpartum ]
    Measured with EPDS

  2. Number of women with clinically significant postpartum depressive symptoms (EPDS > 12) at 12 months postpartum [ Time Frame: 12 months postpartum ]
    Measured with EPDS

  3. Changes from baseline in the severity of depressive symptoms [ Time Frame: From baseline to 12 months postpartum ]
    Measured with EPDS


Secondary Outcome Measures :
  1. Changes from baseline in anxiety symptoms [ Time Frame: From baseline to 12 months postpartum ]
    Measured with Anxiety Subscale of HADS

  2. Changes from baseline in quality of life [ Time Frame: From baseline to 12 months postpartum ]
    Measured with EQ-5D

  3. Changes from baseline in dyadic adjustment [ Time Frame: From baseline to 12 months postpartum ]
    Measured with Dyadic Adjustment Scale - Revised

  4. Changes from baseline in maternal confidence [ Time Frame: From baseline to 12 months postpartum ]
    Measured with the Parental Confidence Questionnaire

  5. Changes from baseline in the frequency of negative automatic thoughts [ Time Frame: From baseline to 12 months postpartum ]
    Measured with the Postnatal Negative Thoughts Questionnaire

  6. Changes from baseline in psychological flexibility [ Time Frame: From baseline to 12 months postpartum ]
    Measured with the Acceptance and Action Questionnaire-II

  7. Changes from baseline in self-criticism and self-compassion [ Time Frame: From baseline to 12 months postpartum ]
    Measured with the Self-Compassion Scale (short form)

  8. Changes from baseline in emotional regulation [ Time Frame: From baseline to 12 months postpartum ]
    Measured with the Difficulties in Emotional Regulation Scale

  9. Acceptability of the program for postpartum women [ Time Frame: Measured at post-intervention (2,5 months postpartum) ]
    Measured through specific questions (to be developed by the researchers) to assess acceptability.

  10. Feasibility of the program for postpartum women as measured by number of website logins [ Time Frame: Measured at post-intervention (2,5 months postpartum). ]
    Measured through the number of user's website logins.

  11. Feasibility of the program for postpartum women as measured by website average visit length [ Time Frame: Measured at post-intervention (2,5 months postpartum). ]
    Measured through the number of user's website average visit length.

  12. Feasibility of the program for postpartum women as measured by number of exercises completed [ Time Frame: Measured at post-intervention (2,5 months postpartum). ]
    Measured through the total number of exercises completed by the users.

  13. Feasibility of the program for postpartum women as measured by dropout rate. [ Time Frame: Measured at post-intervention (2,5 months postpartum). ]
    Measured through the number of users that dropped out from the web-based intervention before completing it.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  • Having 18 years or more (being an adult);
  • Being female;
  • Having had a live healthy birth in the last women, with both women and the child discharged from hospital;
  • Home access to the internet.

Inclusion criteria for the High-Risk women group (to continue the participation in the study):

  • Presence of risk factors for PPD (PDPI-R ≥ 5.5) and/or early-onset depressive symptoms (EPDS > 9);

Exclusion Criteria:

  • Current diagnosis of serious mental health condition (substance abuse, bipolar disorder);
  • Currently receiving treatment for depressive symptoms, including antidepressant medication or psychotherapy;
  • Language difficulties that impede comprehension/reading-writing;

All participants will be informed that they will be randomized to one of the study groups and that will only be included if they give informed consent to participate in the study.


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): NCT03024645


Locations
Portugal
Ana Fonseca
Coimbra, Portugal, 3000
Sponsors and Collaborators
University of Coimbra
Investigators
Principal Investigator: Ana Fonseca, PhD Post-doctoral fellow at CINEICC

Publications:
Fonseca, A., Pereira, M., Araújo-Pedrosa, A., Gorayeb, R., & Canavarro, M. C. (2016, november). Web-based preventive intervention for postpartum depression: Development and formative evaluation of a CBT intervention. Poster presented at the IX International Congress and XIV National Congress in Clinical Psychology, Santander, Spain. https://www.researchgate.net/publication/311733757_Web-based_preventive_intervention_for_postpartum_depression_Development_and_formative_evaluation_of_a_CBT_intervention
Fonseca, A., Pereira, M., Araújo-Pedrosa, A., Moura-Ramos, M., Gorayeb, R., & Canavarro, M. C. (in press). Be a Mom: Formative evaluation of a web-based psychological intervention to prevent postpartum depression. Cognitive and Behavioral Practice. doi:10.1016/j.cbpra.2018.02.002

Responsible Party: Ana Fonseca, Principal Investigator, University of Coimbra
ClinicalTrials.gov Identifier: NCT03024645     History of Changes
Other Study ID Numbers: CINEICC-2-BaM
SFRH/BPD/93996/2013 ( Other Grant/Funding Number: Portuguese Scientific Foundation )
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: After the conclusion of the trial, the investigators plan to share the results of the study both with scientific community and health professionals.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ana Fonseca, University of Coimbra:
Postpartum Depression
Cognitive-Behavioral Therapy
Prevention
Web-Based Psychological Intervention

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications