Postnatal DepressionMCT-DPPNCT06253390
New Cognitive Treatment for Peripartum Depression
A study testing Metacognitive training in people with Postnatal Depression, run by CHU de Reims at 1 site in France.
Trial summary
The peripartum period is the period between the last month of pregnancy and up to a year after childbirth. It can be considered a difficult time for women, as it is a period of transition during which vulnerability to psychiatric disorders and in particular to major depressive disorder (MDD) (Vesga-Lopez, Blanco… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postnatal Depression
- What is being tested?
- Metacognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2024to Dec 2028
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women over 18 years
- Meets the diagnostic criteria for depressive disorder with peripartum onset (PPD) (APA, 2013) and has already given birth
- EPDS score over 10
- Have given their consent to take part in the study
- Be affiliated to a social security system
- Have an adequate knowledge of written, understood and spoken French (French mother tongue or primary education in the French education system) All women with PPD, whether breastfeeding or not, can be included in the study. Baby care can be organised if mothers are unable to have their babies looked after. This service is provided by nurses from the UPPE in the unit's reception room, which has all the equipment needed to care for infants. Mothers meet the nurses before the group and tell them what they expect, and the nurses give them feedback when they come to collect their baby.
Who cannot join
- - Be the subject of a protection measure
- Being a minor
- Meets the diagnostic criteria for schizophrenia spectrum disorders (brief psychotic disorder; schizophrenic disorder; schizoaffective disorder; delusional disorder; brief psychotic disorder with peripartum onset)
- Meet the criteria for substance abuse or dependence (alcohol, drugs)
- With insufficient command of the French language
- People with a deceased child
- People who do not meet the diagnostic criteria for depressive disorder with peripartum onset (APA, 2013)
- People who do not agree to take part in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Reims
Reims, 51092
Damien JOLLY, 326788472 ext. 33, djolly@chu-reims.fr
About this study
Official title: Effect of the Metacognitive Training Programme (D-MCT) in Patients With Peripartum Depression
The peripartum period is the period between the last month of pregnancy and up to a year after childbirth. It can be considered a difficult time for women, as it is a period of transition during which vulnerability to psychiatric disorders and in particular to major depressive disorder (MDD) (Vesga-Lopez, Blanco, Olfson, Grant \& Hasin, 2008). Depression with peripartum onset (PPD) is characterised by the fact that the onset of symptoms may occur during pregnancy or within four weeks of delivery, but may also persist for up to 12 months after delivery (American Psychiatric Association, 2013). PPD affects 10 to 20% of women who have given birth (Tebeka et al. 2021). In addition, the psychological distress experienced by the mother during the peripartum period can disrupt interactions with her newborn (Lefkovics et al. 2014). Depression during this period can therefore have long-term consequences, not only for the women who suffer it, but also for their children (Gavin et al. 2005).
The investigators now know that women with PPD have deficits in metacognition. Metacognition is the body of knowledge, processes and practices that enable individuals to control and evaluate their own cognitive activities, thereby enabling them to regulate them (Flavell, 1976). Patients with PPD therefore have difficulty identifying, controlling and evaluating their own cognitive activities. These deficits may also represent a risk factor for the development of PPD if they are present at an early stage (Diop et al. 2022).
Read more
In patients with PPD, metacognitive therapies appear to be effective in reducing symptoms. In 2013, Bevan, Wittkowski and Wells conducted a pilot study to test the effects associated with metacognitive therapy in depression. This was the first published study to evaluate the effects of metacognitive therapy on patients with depression in the peripartum period. It shows promising results which it would be interesting to replicate, as this is a pilot study. A metacognitive training program for depression (D-MCT) was developed by Jelinek, Hauschildt, Moritz and Dubreucq in 2016, it is a brief group intervention that is easy to manage to participants. To date, no study has yet tested this specific program in patients with PPD, but it has been able to show its effectiveness in reducing the metacognitive deficits.
In the light of the scientific literature, the aims of this study are, firstly, to demonstrate the efficacy of D-MCT therapy in subjects with post-partum depression. Secondly, to examine the effects of this therapy on mother-child interactions.
The investigators make the following assumptions:
- Women in the experimental group showed a greater reduction in depressive symptoms and an improvement in metacognitive functioning than those in the control group.
- Women in the experimental group showed a reduction in depressive symptoms after therapy (v2) and maintenance of this improvement (v3).
- Improvement in the quality of mother-child bonding for women who took part in the program compared with those in the control group.
- Improvement in the quality of mother-child bonding after the program (v2 and v3) for women in the experimental group compared with when they entered the program.
Read the detailed description
In peripartum depression (PPD), metacognition is affected, resulting in altered memories of parental experiences. The psychological distress endured by the mother during the peripartum period can disrupt interactions with her newborn. Depression during this period can have long-term consequences, not only for the women who suffers it, but also for their children (3). In an attempt to prevent the deleterious consequences of PPD, a number of treatment techniques have been shown to be effective. These include not only antidepressants, but also psychological supports. Cognitive behavioural therapy (CBT) was shown in a meta-analysis to be significantly associated with a reduction in symptoms on the Edinburgh Postnatal Depression Scale. However, although this meta-analysis showed a reduction in depressive symptoms, it did not demonstrate a significant reduction in anxiety symptoms specific to PPD. Most of the studies carried out to date on the efficacy of CBT in the treatment of PPD focus essentially on depressive symptoms, which could explain the relapse after six months. In order to minimise the risk of relapse, it would be worthwhile turning to a therapy that is effective on both depressive and anxiety symptoms. One therapy that could be adapted to this type of care is metacognitive therapy (MCT). Normann, Emmerik and Morina in 2014 showed the effectiveness of metacognitive therapy on anxiety and depression through their meta-analysis. The meta-analysis included 384 patients suffering from anxiety and depression. This study showed that MCT was effective in the treatment of both anxiety disorders and depression. The study also showed that MCT was more effective than cognitive behavioural therapy. The authors also demonstrated that maladaptive metacognitive beliefs were responsible for maintaining psychological distress. In other words, acting on maladaptive metacognitive processes would enable MCT to be effective. In patients with PPD, metacognitive therapies also appear to be effective in reducing symptoms. Bevan, Wittkowski and Wells in 2013 carried out a pilot study to test the effects associated with this metacognitive therapy in peripartum depression. The results showed a significant reduction in symptoms of anxiety and depression. This pilot study provides preliminary evidence that metacognitive therapy is associated with significant improvements in PPD symptoms. The results of this pilot study are promising and call for a case-control study with a larger sample of patients and a form of metacognitive therapy developed specifically for the management of PDD (Metacognitive Training Therapy, D-MCT) by Stephen Moritz's team (University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Hamburg, Germany) and translated into French by Julien Dubreucq (Centre Référent de Réhabilitation Psychosociale et de Remédiation Cognitive (C3R), Centre Hospitalier Alpes Isère, Grenoble).
D-MCT is a brief group intervention that is easy to manage to participants. The program proved to be well accepted by participants, with high acceptance rates. The program not only proved feasible and acceptable, but also effective in reducing cognitive biases and rumination and increasing self-esteem.
In view of the efficacy of this programme in patients presenting with a characterised depressive episode, it seems essential to test it in patients with PPD by comparing it in a prospective randomised study with a non-metacognitive group usually practised in the department (control group). Our main objective is therefore to find out, without any preconceived ideas, whether D-MCT therapy is more effective than the usual treatment (control group) in reducing depressive symptoms during the peripartum period. The secondary objective is to determine the impact of D-MCT on the attachment relationship between mother and child.
- Conditions
- Postnatal Depression
- Being tested
- Metacognitive training, control
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive trainingBehavioural
Metacognitive training therapy
controlBehavioural
management technique as usual
| Study group | Role | What they receive |
|---|---|---|
| D-MCT group | Active comparator | Not described Receives: Behavioral: Metacognitive training |
| DPN group | Other | Not described Receives: Behavioral: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale score
Edinburgh Postnatal Depression Scale (EPDS), Cox, Holdent \& Sagovsky, 1987, translated and validated in French by Guedeney \& Fermanian, 1998.
the minimum value is 0 and maximum value is 30. Higher scores mean a worse outcome
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 posted12 Feb 2024
- Study start10 Jan 2024
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal DepressionStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253390
- Sponsor's protocol ID
- PO23063*
- Acronym
- MCT-DPP
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Metacognitive Training Programme (D-MCT) in Patients With Peripartum Depression
- ClinicalTrials.gov ID
- NCT06253390
- Acronym / sponsor ID
- MCT-DPP / PO23063*
- Conditions
- Postnatal Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Feb 2024 (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 peripartum period is the period between the last month of pregnancy and up to a year after childbirth. It can be considered a difficult time for women, as it is a period of transition during which vulnerability to psychiatric disorders and in particular to major depressive disorder (MDD) (Vesga-Lopez, Blanco, Olfson, Grant \& Hasin, 2008). Depression with peripartum onset (PPD) is characterised by the fact that the onset of symptoms may occur during pregnancy or within four weeks of delivery, but may also persist for up to 12 months after delivery (American Psychiatric Association, 2013). PPD affects 10 to 20% of women who have given birth (Tebeka et al. 2021). In addition, the psychological distress experienced by the mother during the peripartum period can disrupt interactions with her newborn (Lefkovics et al. 2014). Depression during this period can therefore have long-term consequences, not only for the women who suffer it, but also for their children (Gavin et al. 2005).
The investigators now know that women with PPD have deficits in metacognition. Metacognition is the body of knowledge, processes and practices that enable individuals to control and evaluate their own cognitive activities, thereby enabling them to regulate them (Flavell, 1976). Patients with PPD therefore have difficulty identifying, controlling and evaluating their own cognitive activities. These deficits may also represent a risk factor for the development of PPD if they are present at an early stage (Diop et al. 2022).
In patients with PPD, metacognitive therapies appear to be effective in reducing symptoms. In 2013, Bevan, Wittkowski and Wells conducted a pilot study to test the effects associated with metacognitive therapy in depression. This was the first published study to evaluate the effects of metacognitive therapy on patients with depression in the peripartum period. It shows promising results which it would be interesting to replicate, as this is a pilot study. A metacognitive training program for depression (D-MCT) was developed by Jelinek, Hauschildt, Moritz and Dubreucq in 2016, it is a brief group intervention that is easy to manage to participants. To date, no study has yet tested this specific program in patients with PPD, but it has been able to show its effectiveness in reducing the metacognitive deficits.
In the light of the scientific literature, the aims of this study are, firstly, to demonstrate the efficacy of D-MCT therapy in subjects with post-partum depression. Secondly, to examine the effects of this therapy on mother-child interactions.
The investigators make the following assumptions:
- Women in the experimental group showed a greater reduction in depressive symptoms and an improvement in metacognitive functioning than those in the control group.
- Women in the experimental group showed a reduction in depressive symptoms after therapy (v2) and maintenance of this improvement (v3).
- Improvement in the quality of mother-child bonding for women who took part in the program compared with those in the control group.
- Improvement in the quality of mother-child bonding after the program (v2 and v3) for women in the experimental group compared with when they entered the program.
Detailed description
In peripartum depression (PPD), metacognition is affected, resulting in altered memories of parental experiences. The psychological distress endured by the mother during the peripartum period can disrupt interactions with her newborn. Depression during this period can have long-term consequences, not only for the women who suffers it, but also for their children (3). In an attempt to prevent the deleterious consequences of PPD, a number of treatment techniques have been shown to be effective. These include not only antidepressants, but also psychological supports. Cognitive behavioural therapy (CBT) was shown in a meta-analysis to be significantly associated with a reduction in symptoms on the Edinburgh Postnatal Depression Scale. However, although this meta-analysis showed a reduction in depressive symptoms, it did not demonstrate a significant reduction in anxiety symptoms specific to PPD. Most of the studies carried out to date on the efficacy of CBT in the treatment of PPD focus essentially on depressive symptoms, which could explain the relapse after six months. In order to minimise the risk of relapse, it would be worthwhile turning to a therapy that is effective on both depressive and anxiety symptoms. One therapy that could be adapted to this type of care is metacognitive therapy (MCT). Normann, Emmerik and Morina in 2014 showed the effectiveness of metacognitive therapy on anxiety and depression through their meta-analysis. The meta-analysis included 384 patients suffering from anxiety and depression. This study showed that MCT was effective in the treatment of both anxiety disorders and depression. The study also showed that MCT was more effective than cognitive behavioural therapy. The authors also demonstrated that maladaptive metacognitive beliefs were responsible for maintaining psychological distress. In other words, acting on maladaptive metacognitive processes would enable MCT to be effective. In patients with PPD, metacognitive therapies also appear to be effective in reducing symptoms. Bevan, Wittkowski and Wells in 2013 carried out a pilot study to test the effects associated with this metacognitive therapy in peripartum depression. The results showed a significant reduction in symptoms of anxiety and depression. This pilot study provides preliminary evidence that metacognitive therapy is associated with significant improvements in PPD symptoms. The results of this pilot study are promising and call for a case-control study with a larger sample of patients and a form of metacognitive therapy developed specifically for the management of PDD (Metacognitive Training Therapy, D-MCT) by Stephen Moritz's team (University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Hamburg, Germany) and translated into French by Julien Dubreucq (Centre Référent de Réhabilitation Psychosociale et de Remédiation Cognitive (C3R), Centre Hospitalier Alpes Isère, Grenoble).
D-MCT is a brief group intervention that is easy to manage to participants. The program proved to be well accepted by participants, with high acceptance rates. The program not only proved feasible and acceptable, but also effective in reducing cognitive biases and rumination and increasing self-esteem.
In view of the efficacy of this programme in patients presenting with a characterised depressive episode, it seems essential to test it in patients with PPD by comparing it in a prospective randomised study with a non-metacognitive group usually practised in the department (control group). Our main objective is therefore to find out, without any preconceived ideas, whether D-MCT therapy is more effective than the usual treatment (control group) in reducing depressive symptoms during the peripartum period. The secondary objective is to determine the impact of D-MCT on the attachment relationship between mother and child.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-MCT group | Active comparator | Behavioral: Metacognitive training |
| DPN group | Other | Behavioral: control |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women over 18 years
- Meets the diagnostic criteria for depressive disorder with peripartum onset (PPD) (APA, 2013) and has already given birth
- EPDS score over 10
- Have given their consent to take part in the study
- Be affiliated to a social security system
Key exclusion criteria (8 listed)
- - Be the subject of a protection measure
- Being a minor
- Meets the diagnostic criteria for schizophrenia spectrum disorders (brief psychotic disorder; schizophrenic disorder; schizoaffective disorder; delusional disorder; brief psychotic disorder with peripartum onset)
- Meet the criteria for substance abuse or dependence (alcohol, drugs)
- With insufficient command of the French language
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 |
|---|---|---|
| Metacognitive trainingMetacognitive training therapy | Behavioural | D-MCT group |
| controlmanagement technique as usual | Behavioural | DPN group |
Primary outcome
Edinburgh Postnatal Depression Scale score
Time frame: 3 months
Edinburgh Postnatal Depression Scale (EPDS), Cox, Holdent \& Sagovsky, 1987, translated and validated in French by Guedeney \& Fermanian, 1998. the minimum value is 0 and maximum value is 30. Higher scores mean a worse outcome
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 20 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive training in people with Postnatal Depression, run by CHU de Reims at 1 site in France.
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 6 inclusion and 8 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 20 Feb 2026. 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 France. 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 Anne Catherine ROLLAND (03 26 78 72 18 ext. 0033, acrolland@cu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2026.