Postpartum DepressionBIEMATNCT05676918
Maternal Well-being in the Postnatal Stage
A study testing Positive Psychology Intervention and Cognitive Behavior Therapy in people with Postpartum Depression and Postpartum Disorder, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
The objective of this study is to design and validate an online intervention aimed at promoting well-being in women with postpartum depression. For this, the design of a multicomponent protocol consisting of empirically validated positive interventions and comparing these with a group Cognitive Behavioral Therapy… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression, Postpartum Disorder
- What is being tested?
- Positive Psychology Intervention and Cognitive Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSpain
- Study dates
- 16 Jan 2023to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women who have been mothers in the last year
Who cannot join
- Women who have been mothers in the last month,
- Women who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for substance abuse and/or dependence within 30 days prior to study participation,
- Women who have a serious mental disorder that makes it difficult to follow the protocol (e.g. serious neurocognitive problems or brain damage; schizophrenia and other psychotic disorders).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Covadonga Chaves Vélez
Madrid, Pozuelo de Alarcón, 28223
Covadonga Chaves Vélez, +36 635321643, cchavesv@psi.ucm.es
Almudena Duque, aduquesa@upsa.es
About this study
Official title: Maternal Well-being in the Postnatal Stage: Evaluation of Cognitive Biases and Validation of a Psychological Intervention
The objective of this study is to design and validate an online intervention aimed at promoting well-being in women with postpartum depression. For this, the design of a multicomponent protocol consisting of empirically validated positive interventions and comparing these with a group Cognitive Behavioral Therapy (CBT) is proposed, following the National Institute for Health and Care Excellence (NICE) recommendations for the treatment of depression. Participants will be screened for inclusion in the program if they meet clinical criteria. After that, they will be randomly assigned to a CBT group or a positive psychology intervention (PPI) group.
Read the detailed description
Participants will be randomly assigned to the CBT group or the PPI group. Both groups will be treated identically except for the type of intervention. Group assignment will be blind to both patients and investigators.
Both interventions have 10 weekly sessions. Sessions will be in groups and online.
CBT includes 3 modules: behavioral activation, cognitive restructuring, and interpersonal skills. Main contents (10 sessions): (1) Symptoms of Depression. Myths about motherhood. CBT approach; (2) Stress and Anxiety. Relaxation; (3 and 4) Increase pleasurable activities. Balance in life. To manage time; (5) Management of negative thoughts. Health concerns; (5 and 6) Increase positive thoughts; (7) social skills; (8) Communication skills and parner support; (9) Plan for the future. New routines and strategies; (10) Relapse prevention. CBT has been shown to be effective in reducing depressive symptoms and modifying attentional biases (Pearson et al., 2013).
On the other hand, a new protocol of positive interventions adapted for women after maternity (PPI) will be designed and applied. This multicomponent protocol includes interventions that have already been empirically validated in treating depression. PPI includes 2 modules: hedonic well-being and eudaimonic well-being. Main contents (10 sessions): (1) Symptoms of Depression. Myths about motherhood. PPI approach; (2) Mindfulness and positive emotions; (3) Gratitude and savoring; (4) Emotion regulation (5) Positive relationships and social support; (6) Compassion; (7) Personal strengths; (8) Goals and values; (9) Resilience; (10) Relapse prevention.
- Conditions
- Postpartum Depression, Postpartum Disorder
- Being tested
- Positive Psychology Intervention, Cognitive Behavior Therapy
- Medical subject headings
- Depression, Postpartum, Puerperal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Psychology InterventionBehavioural
PPI includes 2 modules: hedonic well-being and eudaimonic well-being.
Cognitive Behavior TherapyBehavioural
CBT includes 3 modules: behavioral activation, cognitive restructuring, and interpersonal skills.
| Study group | Role | What they receive |
|---|---|---|
| Positive Psychology Intervention | Experimental | Ten weekly sessions. Session duration: 90 minutes. Receives: Behavioral: Positive Psychology Intervention |
| Cognitive Behavior Therapy | Active comparator | Ten weekly sessions. Session duration: 90 minutes. Receives: Behavioral: Cognitive Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum depression change
Edinburgh Postpartum depression scale (EPDS). Scores range from 0 to 30, where higher scores mean a worse outcome.
Measured: Immediately before and after the intervention
Secondary outcomes (6)
Positive and Negative Affect change
Positive and Negative Affect Scale (PANAS). Positive emotions scores range from 10 to 50, where higher scores mean a better outcome. Negative emotions scores range from 10 to 50, where higher scores mean a worse outcome.
Measured: Immediately before and after the intervention
Satisfaction with life change (SWLS). Scores range from 5 to 35, where higher scores mean a better outcome.
Satisfaction With Life Scale
Measured: Immediately before and after the intervention
Beliefs about pregnancy change
The Pregnancy Related Beliefs Questionnaire (PRBQ-8). Scores range from 8 to 56. Higher scores indicate greater levels of dysfunctional attitudes towards motherhood.
Measured: Immediately before and after the intervention
Psychological well-being change
Psychological well-being scale by Ryff (PWBS). PWBS-29 is composed for 29 items with a minumum score of 29 and a maximum score of 174. Self-acceptance scores range from 4 to 24; Positive Relationships with others scores range from 5 to 30; Autonomy scores range from 6 to 36; Environmental mastery scores range from 5 to 30; Purpose in life scores range from 5 to 30 and Personal Growth scores range from 4 to 24. Higher score in each subscale means a better outcome.
Measured: Immediately before and after the intervention
Maternal filial bond in the postpartum change
The Postpartum Bonding Questionnaire (PBQ). Scores Range from 0 to 120. General factor scores range from 0 to 60 (Cut-off score 11= normal, 12 = high). Rejection of the infant scores range from 0 to 35. (cut-off 16 = normal, 17 = high). Infant-focused anxiety scores range from 0 to 10 (cut- off 9 = normal, 10 = high). Incipient abuse scores range from 0 to 10 ( cut-off 2 = normal, 3 = high). A high score in each factor indicates pathology.
Measured: Immediately before and after the intervention
Maternal self-efficacy change
Maternal Self-efficacy Questionnaire (MSQ). Scores range from 10 to 40, where equal or greater scores than 31 means a high perception of maternal self-efficacy.
Measured: Immediately before and after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start16 Jan 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Mar 2026 (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
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Pontificia de Salamanca
- Responsible party
- Sponsor
- Investigators
- Covadonga Chaves, PhD, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676918
- Sponsor's protocol ID
- UCM-UPS-WELLBEING
- Acronym
- BIEMAT
- Status last verified
- May 2025
- First submitted
- 10 Nov 2022
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information on the evaluation and intervention protocol can be requested from the researchers. Likewise, the individual participant data can be provided on demand to guarantee the transparency of the study.
Publications
Nombela E, Duque A, Salgado G, Chaves C. A Comparative Analysis of the Acceptability of the MATER Positive Psychology Intervention Versus Cognitive Behavioural Therapy in Women With Postpartum Depression. Clin Psychol Psychother. 2026 May-Jun;33(3):e70281. doi: 10.1002/cpp.70281.
PubMed 42089829
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Well-being in the Postnatal Stage: Evaluation of Cognitive Biases and Validation of a Psychological Intervention
- ClinicalTrials.gov ID
- NCT05676918
- Acronym / sponsor ID
- BIEMAT / UCM-UPS-WELLBEING
- Conditions
- Postpartum Depression, Postpartum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Universidad Pontificia de Salamanca
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 9 Jan 2023 (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 objective of this study is to design and validate an online intervention aimed at promoting well-being in women with postpartum depression. For this, the design of a multicomponent protocol consisting of empirically validated positive interventions and comparing these with a group Cognitive Behavioral Therapy (CBT) is proposed, following the National Institute for Health and Care Excellence (NICE) recommendations for the treatment of depression. Participants will be screened for inclusion in the program if they meet clinical criteria. After that, they will be randomly assigned to a CBT group or a positive psychology intervention (PPI) group.
Detailed description
Participants will be randomly assigned to the CBT group or the PPI group. Both groups will be treated identically except for the type of intervention. Group assignment will be blind to both patients and investigators.
Both interventions have 10 weekly sessions. Sessions will be in groups and online.
CBT includes 3 modules: behavioral activation, cognitive restructuring, and interpersonal skills. Main contents (10 sessions): (1) Symptoms of Depression. Myths about motherhood. CBT approach; (2) Stress and Anxiety. Relaxation; (3 and 4) Increase pleasurable activities. Balance in life. To manage time; (5) Management of negative thoughts. Health concerns; (5 and 6) Increase positive thoughts; (7) social skills; (8) Communication skills and parner support; (9) Plan for the future. New routines and strategies; (10) Relapse prevention. CBT has been shown to be effective in reducing depressive symptoms and modifying attentional biases (Pearson et al., 2013).
On the other hand, a new protocol of positive interventions adapted for women after maternity (PPI) will be designed and applied. This multicomponent protocol includes interventions that have already been empirically validated in treating depression. PPI includes 2 modules: hedonic well-being and eudaimonic well-being. Main contents (10 sessions): (1) Symptoms of Depression. Myths about motherhood. PPI approach; (2) Mindfulness and positive emotions; (3) Gratitude and savoring; (4) Emotion regulation (5) Positive relationships and social support; (6) Compassion; (7) Personal strengths; (8) Goals and values; (9) Resilience; (10) Relapse prevention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Psychology Intervention | Experimental | Behavioral: Positive Psychology InterventionTen weekly sessions. Session duration: 90 minutes. |
| Cognitive Behavior Therapy | Active comparator | Behavioral: Cognitive Behavior TherapyTen weekly sessions. Session duration: 90 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women who have been mothers in the last year
Key exclusion criteria (3 listed)
- Women who have been mothers in the last month,
- Women who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for substance abuse and/or dependence within 30 days prior to study participation,
- Women who have a serious mental disorder that makes it difficult to follow the protocol (e.g. serious neurocognitive problems or brain damage; schizophrenia and other psychotic disorders).
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 |
|---|---|---|
| Positive Psychology InterventionPPI includes 2 modules: hedonic well-being and eudaimonic well-being. | Behavioural | Positive Psychology Intervention |
| Cognitive Behavior TherapyCBT includes 3 modules: behavioral activation, cognitive restructuring, and interpersonal skills. | Behavioural | Cognitive Behavior Therapy |
Primary outcome
Postpartum depression change
Time frame: Immediately before and after the intervention
Edinburgh Postpartum depression scale (EPDS). Scores range from 0 to 30, where higher scores mean a worse outcome.
6 secondary outcomes
Positive and Negative Affect change
Time frame: Immediately before and after the intervention
Satisfaction with life change (SWLS). Scores range from 5 to 35, where higher scores mean a better outcome.
Time frame: Immediately before and after the intervention
Beliefs about pregnancy change
Time frame: Immediately before and after the intervention
Psychological well-being change
Time frame: Immediately before and after the intervention
Maternal filial bond in the postpartum change
Time frame: Immediately before and after the intervention
Maternal self-efficacy change
Time frame: Immediately before and after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Derived from this study: PubMed 42089829Nombela E, Duque A, Salgado G, Chaves C. A Comparative Analysis of the Acceptability of the MATER Positive Psychology Intervention Versus Cognitive Behavioural Therapy in Women With Postpartum Depression. Clin Psychol Psychother. 2026 May-Jun;33(3):e70281. doi: 10.1002/cpp.70281.
- Individual participant dataSharing planned: Yes. Information on the evaluation and intervention protocol can be requested from the researchers. Likewise, the individual participant data can be provided on demand to guarantee the transparency of the study.
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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.
Covadonga Chaves, PhD principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Psychology Intervention and Cognitive Behavior Therapy in people with Postpartum Depression and Postpartum Disorder, run by Universidad Complutense de Madrid at 1 site in Spain.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 21 May 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Covadonga Chaves (+34635321643, cchavesv@psi.ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum depression change (time frame: Immediately before and after the intervention). 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 NCT05676918, 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 21 May 2025.