Postpartum DepressionbBeAMomNCT04441879
bBeAMom: Effectiveness of a Cognitive-Behavioral Blended Intervention for Postpartum Depression
A study testing Be a Mom Coping with Depression and Be a Mom in people with Postpartum Depression, run by University of Coimbra at 1 site in Portugal.
Trial summary
Be a mom program (a web-based cognitive-behavioral intervention) is being tested in another clinical trial as a preventive intervention for postpartum depression (NCT03024645). However, given its effectiveness in reducing depressive symptoms among women presenting early-onset postpartum depressive symptoms, Be a Mom… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Be a Mom Coping with Depression and Be a Mom
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2022to Jan 2024
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Having 18 years or more;
- Being female;
- Being Portuguese;
- Baby's age up to 12 months;
- Presence of at least 4 symptoms of a major depressive episode according to DSM-5, being one depressed mood or lost of pleasure or interest;
- Having had a live healthy birth, with both woman and the child discharged from hospital;
- Internet and computer access;
- Being able to write and read Portuguese.
Who cannot join
- Presence of psychiatric comorbidity requiring alternative treatment primary to depression treatment (e.g., substance abuse, bipolar disorder);
- Presence of serious suicidal ideation;
- Presence of serious medical condition (either the participant or the baby);
- Currently receiving psychological or psychiatric treatment for depressive symptoms (antidepressant medication is allowed if stabilized for the last 3 months);
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Faculty of Psychology and Education Sciences, University of Coimbra
Coimbra, 3000-115
Mariana Branquinho, 912979399 ext. +351, marianacjbranquinho@hotmail.com
About this study
Official title: bBeAMom Trial: A Randomized Controlled Trial to Test the Effectiveness of a Cognitive-Behavioral Blended Intervention for Postpartum Depression in Portuguese Women
Be a mom program (a web-based cognitive-behavioral intervention) is being tested in another clinical trial as a preventive intervention for postpartum depression (NCT03024645). However, given its effectiveness in reducing depressive symptoms among women presenting early-onset postpartum depressive symptoms, Be a Mom can also have potential as a postpartum depression complement treatment tool. The main goal of this research is to apply and evaluate the acceptability and effectiveness of a blended cognitive-behavioral intervention for the treatment of postpartum depression (Be a Mom Coping with Depression) by integrating face-to-face sessions with the web-based program Be a Mom.
The RCT will be a two-arm trial. Women who have had a child during the prior 12 months will be enrolled in the study. A minimum number of 110 women will be enrolled in the study. After agreeing to participate in the study, women will be screened and evaluated for the presence of clinically significant depressive symptoms (according to DSM-5) by a researcher (licensed psychologist). Participants who meet the eligibility criteria will be randomly assigned to one of the conditions: the blended intervention (Be a Mom Coping with Depression) or the control condition (online intervention - Be a Mom). The sample will be recruited online.
Participation in this study will last 6 months. The blended intervention will last about 3 months. Participants in both conditions will be invited by the researchers via email to complete baseline, post-intervention and follow-up (3-months post-intervention) assessments. Assessments will include self-report questionnaires to assess several indicators (e.g., depressive and anxiety symptoms, quality of life, marital satisfaction, mother-child bonding, and maternal self-efficacy), mechanisms that may be involved in the treatment response (e.g., psychological flexibility, emotional regulation, and self-compassion) and user's acceptability and satisfaction.
Read the detailed description
In the present study, a blended intervention to treat postpartum depression (Be a Mom Coping with Depression) will be tested.
The main goal of this research is to apply and evaluate the acceptability and effectiveness of a blended cognitive-behavioral intervention for the treatment of postpartum depression by integrating face-to-face sessions with the web-based program Be a Mom. The efficacy of the intervention will be assessed considering two indicators: a) decrease or absence of clinically significant depressive symptoms at post-intervention and follow-up; and b) post-intervention and follow-up improvements in mother's psychosocial adjustment indicators (e.g., anxiety symptoms, marital satisfaction, maternal self-efficacy). The present study will also aim to investigate the mechanisms explaining the treatment response (e.g., psychological flexibility, self-compassion) and characteristics moderating the treatment response (e.g., motivation for therapy, therapeutic relationship).
The research design of the trial followed the methodological recommendations for the development and evaluation of blended interventions. A feasibility study was conducted prior to the randomized controlled trial (RCT), in order to evaluate preliminary version of the blended intervention. The feasibility study was conducted with women with a clinical diagnosis of postpartum depression according to the Structured Clinical Interview for DSM-5 (SCID-5) disorders criteria. Pre- and post-intervention assessments, using self-report questionnaires, and individual interviews were used to gather information concerning acceptability (relevance of contents and structure), feasibility, usability and preliminary clinical effectiveness (non-controlled). Appropriate adjustments to the blended protocol were carried out considering the results.
The RCT will be a two-arm trial. The intervention condition (blended intervention - Be a Mom Coping with Depression) will be compared with a control condition (online intervention - Be a Mom). The sample will include adult women who delivered an healthy baby in the postpartum period (up to 12 months postpartum). Women will be enrolled through online recruitment. A minimum number of 45 women per condition will be required (N=90). Accounting for the 20% of expected attrition rate over time, an anticipated sample of 110 women will be enrolled in the study.
Women who demonstrate interest in the study will be informed of the study goals, the structure and arms of the research and the researchers' and participants' roles. Women who agree to participate in the study will sign an informed consent form. All ethical requirements for research with humans are guaranteed.
After women's agreement to participate in the study, women who have a positive screen (indicating the presence of clinically relevant depressive symptoms) and meet the remaining eligibility criteria, will be interviewed (SCID-5) by the researcher (licensed psychologist) to assess the presence of clinically significant depressive symptoms. Women who do not fulfill the eligibility criteria will end their participation in the study and will be referred to intervention by local providers. Participants presenting at least 4 symptoms of a major depressive episode according to DSM-5, being one depressed mood or lost of pleasure or interest, with will be randomly assigned (blocked randomization, with allocation concealment) to one of the conditions: the intervention (blended intervention) or the control condition (online intervention).
Participation in this study will last 6 months. The blended Be a Mom intervention will last about 3 months and will be conducted by the researcher (licensed psychologist). Participants in both conditions will be invited by the researchers via email to complete baseline, post-intervention and follow-up (3-months post-intervention) assessments. Assessments will include self-report questionnaires to assess several indicators (e.g., depressive and anxiety symptoms, quality of life, marital satisfaction, mother-child bonding, and maternal self-efficacy), mechanisms that may be involved in the treatment response (e.g., psychological flexibility, emotional regulation, and self-compassion), and user's acceptability and satisfaction. The necessary statistical analyses will be conducted, using the intention-to-treat and per-protocol principles.
- Conditions
- Postpartum Depression
- Being tested
- Be a Mom Coping with Depression, Be a Mom
- Keywords
- Postpartum Depression, Cognitive-Behavioral Therapy, Web-Based Psychological Intervention, Blended intervention
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Be a Mom Coping with DepressionBehavioural
Be a Mom Coping with Depression is a blended cognitive-behavioral intervention for the treatment of postpartum depression. It consists of 13 weeks of face-to-face and online sessions, each session targeting a specific thematic content, and providing participants with both information and specific therapeutic strategies (with a strong focus on cognitive-behavioral techniques) to address each thematic content.
Be a MomBehavioural
Be a Mom is an online intervention consisting of 6 modules, each one 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. Women will receive biweekly phone calls from a psychologist between completion of each module to provide support.
| Study group | Role | What they receive |
|---|---|---|
| Blended intervention | Experimental | Women will receive a blended intervention (integrating face-to-face and online sessions) for the treatment of postpartum depression. Receives: Behavioral: Be a Mom Coping with Depression |
| Control (online intervention) | Active comparator | Women will receive an online intervention (Be a Mom program). Receives: Behavioral: Be a Mom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in depressive symptoms
Measured with Edinburgh Postnatal Depression Scale (EPDS). The total score can range between 0 and 30, and higher scores are indicative of more severe depressive symptoms.
Measured: Baseline, 3 and 6 months
Secondary outcomes (16)
Changes from baseline in anxiety symptoms
Measured with Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS). The total score for this subscale can range between 0 and 21, and higher scores indicate more anxiety symptomatology.
Measured: Baseline, 3 and 6 months
Changes from baseline in quality of life
Measured with the Euroqol Five Dimension Scale (EQ-5D). The total score is obtained through an algorithm (the digits of the answers to the five dimensions) and it describes the health state.
Measured: Baseline, 3 and 6 months
Changes from baseline in the frequency of negative thoughts
Measured with the Postnatal Negative Thoughts Questionnaire (PNTQ). The total score can range between 0 and 51, and higher scores indicate higher frequency of postpartum negative thoughts.
Measured: Baseline, 3 and 6 months
Changes from baseline in marital satisfaction
Measured with the Satisfaction Subscale of the Investment Model Scale (IMS). The total score can range between 0 and 60, and higher scores indicate higher satisfaction with the relationship.
Measured: Baseline, 3 and 6 months
Changes from baseline in maternal self-efficacy
Measured with the Perceived Maternal Parenting Self-Efficacy Questionnaire (PMP S-E). The total score can range between 20 and 80, and higher scores are indicative of higher perceived maternal self-efficacy.
Measured: Baseline, 3 and 6 months
Changes from baseline in mother-child bonding
Measured with the Postpartum Bonding Questionnaire (PBQ). The total score can range between 0 and 60, and higher scores are indicative of a more impaired mother-child bond.
Measured: Baseline, 3 and 6 months
Changes from baseline in self-compassion
Measured with the Self-Compassion Scale - Short Form (SCS-SF). The total score ranges between 1 and 48, and higher scores indicate higher levels of self-compassion.
Measured: Baseline, 3 and 6 months
Changes from baseline in emotional regulation
Measured with the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF). The total score can range between 18 and 90, and higher scores are indicative of more difficulties in emotion regulation.
Measured: Baseline, 3 and 6 months
Changes from baseline in psychological flexibility
Measured with the Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT). The total score can range between 0 and 108, and higher scores are indicative of higher scores are indicative of higher psychological flexibility.
Measured: Baseline, 3 and 6 months
Changes from baseline in expectancy for therapy
Measured with the Credibility/Expectancy Questionnaire (CEQ). Higher scores indicate greater treatment credibility and expectations.
Measured: Baseline and 3 months
Therapeutic relationship
Measured with the Working Alliance Inventory - Short Revised (WAI-SR). The total score can range between 12 and 60, and higher scores indicate better therapeutic alliance.
Measured: 3 months
Acceptability of the intervention for postpartum women
Measured through specific questions (to be developed by the researchers) to assess acceptability.
Measured: 3 months
Usability of the intervention for postpartum women
Measured through specific questions (to be developed by the researchers) to assess usability.
Measured: 3 months
Feasibility of the online program for postpartum women as measured by number of website logins
Measured through the number of user's website logins.
Measured: 3 months
Feasibility of the program for postpartum women as measured by website average visit length
Measured through the number of user's website average visit length.
Measured: 3 months
Feasibility of the intervention for postpartum women as measured by dropout rate
Measured through the number of participants that dropped out from the intervention before completing it.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Apr 2022
- Primary completionNov 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Ana Fonseca, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441879
- Sponsor's protocol ID
- bBeAMom/145563/2019
- Other IDs
- SFRH/BD/145563/2019
- Acronym
- bBeAMom
- Status last verified
- Jul 2022
- First submitted
- 15 Jun 2020
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After the conclusion of the trial, the investigators plan to share the results of the study both with scientific community and health professionals.
Publications
Branquinho M, Canavarro MC, Fonseca A. Blended CBT Intervention vs. a Guided Web-Based Intervention for Postpartum Depression: Results From a Pilot Randomized Controlled Trial. Clin Psychol Psychother. 2024 Nov-Dec;31(6):e70007. doi: 10.1002/cpp.70007.
PubMed 39500299
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- bBeAMom Trial: A Randomized Controlled Trial to Test the Effectiveness of a Cognitive-Behavioral Blended Intervention for Postpartum Depression in Portuguese Women
- ClinicalTrials.gov ID
- NCT04441879
- Acronym / sponsor ID
- bBeAMom / bBeAMom/145563/2019
- Conditions
- Postpartum Depression
- Keywords
- Postpartum Depression, Cognitive-Behavioral Therapy, Web-Based Psychological Intervention, Blended intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 22 Jun 2020 (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.
Be a mom program (a web-based cognitive-behavioral intervention) is being tested in another clinical trial as a preventive intervention for postpartum depression (NCT03024645). However, given its effectiveness in reducing depressive symptoms among women presenting early-onset postpartum depressive symptoms, Be a Mom can also have potential as a postpartum depression complement treatment tool. The main goal of this research is to apply and evaluate the acceptability and effectiveness of a blended cognitive-behavioral intervention for the treatment of postpartum depression (Be a Mom Coping with Depression) by integrating face-to-face sessions with the web-based program Be a Mom.
The RCT will be a two-arm trial. Women who have had a child during the prior 12 months will be enrolled in the study. A minimum number of 110 women will be enrolled in the study. After agreeing to participate in the study, women will be screened and evaluated for the presence of clinically significant depressive symptoms (according to DSM-5) by a researcher (licensed psychologist). Participants who meet the eligibility criteria will be randomly assigned to one of the conditions: the blended intervention (Be a Mom Coping with Depression) or the control condition (online intervention - Be a Mom). The sample will be recruited online.
Participation in this study will last 6 months. The blended intervention will last about 3 months. Participants in both conditions will be invited by the researchers via email to complete baseline, post-intervention and follow-up (3-months post-intervention) assessments. Assessments will include self-report questionnaires to assess several indicators (e.g., depressive and anxiety symptoms, quality of life, marital satisfaction, mother-child bonding, and maternal self-efficacy), mechanisms that may be involved in the treatment response (e.g., psychological flexibility, emotional regulation, and self-compassion) and user's acceptability and satisfaction.
Detailed description
In the present study, a blended intervention to treat postpartum depression (Be a Mom Coping with Depression) will be tested.
The main goal of this research is to apply and evaluate the acceptability and effectiveness of a blended cognitive-behavioral intervention for the treatment of postpartum depression by integrating face-to-face sessions with the web-based program Be a Mom. The efficacy of the intervention will be assessed considering two indicators: a) decrease or absence of clinically significant depressive symptoms at post-intervention and follow-up; and b) post-intervention and follow-up improvements in mother's psychosocial adjustment indicators (e.g., anxiety symptoms, marital satisfaction, maternal self-efficacy). The present study will also aim to investigate the mechanisms explaining the treatment response (e.g., psychological flexibility, self-compassion) and characteristics moderating the treatment response (e.g., motivation for therapy, therapeutic relationship).
The research design of the trial followed the methodological recommendations for the development and evaluation of blended interventions. A feasibility study was conducted prior to the randomized controlled trial (RCT), in order to evaluate preliminary version of the blended intervention. The feasibility study was conducted with women with a clinical diagnosis of postpartum depression according to the Structured Clinical Interview for DSM-5 (SCID-5) disorders criteria. Pre- and post-intervention assessments, using self-report questionnaires, and individual interviews were used to gather information concerning acceptability (relevance of contents and structure), feasibility, usability and preliminary clinical effectiveness (non-controlled). Appropriate adjustments to the blended protocol were carried out considering the results.
The RCT will be a two-arm trial. The intervention condition (blended intervention - Be a Mom Coping with Depression) will be compared with a control condition (online intervention - Be a Mom). The sample will include adult women who delivered an healthy baby in the postpartum period (up to 12 months postpartum). Women will be enrolled through online recruitment. A minimum number of 45 women per condition will be required (N=90). Accounting for the 20% of expected attrition rate over time, an anticipated sample of 110 women will be enrolled in the study.
Women who demonstrate interest in the study will be informed of the study goals, the structure and arms of the research and the researchers' and participants' roles. Women who agree to participate in the study will sign an informed consent form. All ethical requirements for research with humans are guaranteed.
After women's agreement to participate in the study, women who have a positive screen (indicating the presence of clinically relevant depressive symptoms) and meet the remaining eligibility criteria, will be interviewed (SCID-5) by the researcher (licensed psychologist) to assess the presence of clinically significant depressive symptoms. Women who do not fulfill the eligibility criteria will end their participation in the study and will be referred to intervention by local providers. Participants presenting at least 4 symptoms of a major depressive episode according to DSM-5, being one depressed mood or lost of pleasure or interest, with will be randomly assigned (blocked randomization, with allocation concealment) to one of the conditions: the intervention (blended intervention) or the control condition (online intervention).
Participation in this study will last 6 months. The blended Be a Mom intervention will last about 3 months and will be conducted by the researcher (licensed psychologist). Participants in both conditions will be invited by the researchers via email to complete baseline, post-intervention and follow-up (3-months post-intervention) assessments. Assessments will include self-report questionnaires to assess several indicators (e.g., depressive and anxiety symptoms, quality of life, marital satisfaction, mother-child bonding, and maternal self-efficacy), mechanisms that may be involved in the treatment response (e.g., psychological flexibility, emotional regulation, and self-compassion), and user's acceptability and satisfaction. The necessary statistical analyses will be conducted, using the intention-to-treat and per-protocol principles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blended intervention | Experimental | Behavioral: Be a Mom Coping with DepressionWomen will receive a blended intervention (integrating face-to-face and online sessions) for the treatment of postpartum depression. |
| Control (online intervention) | Active comparator | Behavioral: Be a MomWomen will receive an online intervention (Be a Mom program). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Having 18 years or more;
- Being female;
- Being Portuguese;
- Baby's age up to 12 months;
- Presence of at least 4 symptoms of a major depressive episode according to DSM-5, being one depressed mood or lost of pleasure or interest;
Key exclusion criteria (6 listed)
- Presence of psychiatric comorbidity requiring alternative treatment primary to depression treatment (e.g., substance abuse, bipolar disorder);
- Presence of serious suicidal ideation;
- Presence of serious medical condition (either the participant or the baby);
- Currently receiving psychological or psychiatric treatment for depressive symptoms (antidepressant medication is allowed if stabilized for the last 3 months);
- Language difficulties that impede comprehension/reading-writing.
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 |
|---|---|---|
| Be a Mom Coping with DepressionBe a Mom Coping with Depression is a blended cognitive-behavioral intervention for the treatment of postpartum depression. It consists of 13 weeks of face-to-face and online sessions, each session targeting a specific thematic content, and providing participants with both information and specific therapeutic strategies (with a strong focus on cognitive-behavioral techniques) to address each thematic content. | Behavioural | Blended intervention |
| Be a MomBe a Mom is an online intervention consisting of 6 modules, each one 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. Women will receive biweekly phone calls from a psychologist between completion of each module to provide support. | Behavioural | Control (online intervention) |
Primary outcome
Changes from baseline in depressive symptoms
Time frame: Baseline, 3 and 6 months
Measured with Edinburgh Postnatal Depression Scale (EPDS). The total score can range between 0 and 30, and higher scores are indicative of more severe depressive symptoms.
16 secondary outcomes
Changes from baseline in anxiety symptoms
Time frame: Baseline, 3 and 6 months
Changes from baseline in quality of life
Time frame: Baseline, 3 and 6 months
Changes from baseline in the frequency of negative thoughts
Time frame: Baseline, 3 and 6 months
Changes from baseline in marital satisfaction
Time frame: Baseline, 3 and 6 months
Changes from baseline in maternal self-efficacy
Time frame: Baseline, 3 and 6 months
Changes from baseline in mother-child bonding
Time frame: Baseline, 3 and 6 months
Changes from baseline in self-compassion
Time frame: Baseline, 3 and 6 months
Changes from baseline in emotional regulation
Time frame: Baseline, 3 and 6 months
Changes from baseline in psychological flexibility
Time frame: Baseline, 3 and 6 months
Changes from baseline in expectancy for therapy
Time frame: Baseline and 3 months
Therapeutic relationship
Time frame: 3 months
Acceptability of the intervention for postpartum women
Time frame: 3 months
Usability of the intervention for postpartum women
Time frame: 3 months
Feasibility of the online program for postpartum women as measured by number of website logins
Time frame: 3 months
Feasibility of the program for postpartum women as measured by website average visit length
Time frame: 3 months
Feasibility of the intervention for postpartum women as measured by dropout rate
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Derived from this study: PubMed 39500299Branquinho M, Canavarro MC, Fonseca A. Blended CBT Intervention vs. a Guided Web-Based Intervention for Postpartum Depression: Results From a Pilot Randomized Controlled Trial. Clin Psychol Psychother. 2024 Nov-Dec;31(6):e70007. doi: 10.1002/cpp.70007.
- Individual participant dataSharing planned: Undecided. After the conclusion of the trial, the investigators plan to share the results of the study both with scientific community and health professionals.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Be a Mom Coping with Depression and Be a Mom in people with Postpartum Depression, run by University of Coimbra at 1 site in Portugal.
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 6 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: status not confirmed, as of the sponsor's last update on 15 Jul 2022. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariana Branquinho (912979399 ext. +351, marianacjbranquinho@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in depressive symptoms (time frame: Baseline, 3 and 6 months). 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 NCT04441879, 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 15 Jul 2022.