Postnatal DepressionPNDattachMEMONCT03346551
Postnatal Depression, Attachment and Self-defining Memories
A study testing Evaluation of the quality attachment : "Adult Attachment Narratives" and "CaMir scale" and Evaluation of the self-defining memories : "Specific Questionnaire during an interview" in people with Postnatal Depression, run by CHU de Reims at 1 site in France.
Trial summary
The specificity of postnatal depression (PND) was acted as full entity within the depressions, by B. Pitt in 1968, through the description of a specific nosography which describes "an atypical depression of the post-partum ". Actually, the epidemiological studies agree on prevalence from 10 to 15 % of PND. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postnatal Depression
- What is being tested?
- Evaluation of the quality attachment : "Adult Attachment Narratives" and "CaMir scale" and Evaluation of the self-defining memories : "Specific Questionnaire during an interview"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2017to 13 Dec 2019
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group 1 : women with postnatal depression
- Group 2 : women without postnatal depression
- women consenting to participate to the study
- women enrolled in the national healthcare insurance program
- women older than 18 years old
Who cannot join
- women younger than 18 years old
- women protected by the law
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Anne-Catherine ROLLAND, acrolland@chu-reims.fr
About this study
The specificity of postnatal depression (PND) was acted as full entity within the depressions, by B. Pitt in 1968, through the description of a specific nosography which describes "an atypical depression of the post-partum ".
Actually, the epidemiological studies agree on prevalence from 10 to 15 % of PND. With two peaks of frequency, the first one around the 6th and 12th week comment native and the second during the second half-year. This rate of PND represents in France 75000 to 100000 women a year.
Read more
The professionals of the perinatal period are interested in this disorder because of the consequences for the woman herself, and of the impact on the premature interactions mother-baby. These interactions and the direct effects of the PND on the mother will have for influence an important slowing down on the development of the baby. Moreover, the study of Lemaitre and Candilis in 1999, brings the figure of 15 % of the PND which will have an impact on the development of the baby.
The sensation of the depression testifies of a process of change and of psychic conflict favored by the psychic transparency of the pregnancy.
Although the first treaty on this specific nosography dates more than 150 years of numerous questions stay suspends it.
These questions and the reflections which surround them found on their path tools ensuing from the theory of the attachment, formalized by John Bowlby. For more than three decades, these profiles of attachment, specified by Mary Ainsworth: secure, anxious-ambivalent, anxious-avoided and disorganized later, disrupted, is studied, estimated and their evolution during a life is observed. Thanks to these models well known for the same person at a time t, it is now their effects in the interpersonal relations which are studied. Between the people but also on the person himself, its image of her, and its autobiographical memory.
The autobiographical memory represents a central component of the human memory. At a very general level, it's possible to define it as the capacity of a person to remember its past experiences. The review of the literature on the functioning of the episodic autobiographical memory during the depression highlights three main results: the too bi generalization of the memories, the congruence in the humor and the frequency of the intrusive memories characterized by an involuntary reminder, fast and effortlessly (Lemogne and al., 2006; Lemogne and al., 2012). The authors specify that there are links between strategies of avoidance of the intrusive memories and the phenomenon of generalization. These links ask to be explored within a model integrating, self and episodic autobiographical memory in the field of the depression. The use of the memories defining the one could allow to study more specifically this kind of memories. The memories defining the one were introduced to Ape and Moffitt (1991) to characterize a specific category of autobiographical memories. The memories defining the one are important personal memories which help a person to understand whom this person is as individual. In a way, they build the life story and support the personal identity. Connected to other similar memories, the self-defining memories contain numerous sensory details and are often associated to a strong emotional charge. They are also connected to long-term purposes, to concerns or to unsolved conflicts.
Recent studies used the self-defining memories (French version adapted by Mr van der Linden's team, Switzerland) as tool to understand better the psychological disorders from which certain people suffer. The studies show that the self-defining memories undergo modifications the characteristics of which are in connection with every pathology (works of the team of J.M. Danion).
In 1994, Moffit and al. studied a group of students with evaluation of the depressive symptomatology. They established that the presenting subjects of high scores of depression develop more generalized memories than the other participants when is asked to them a self-defining memorie positive. For the memories with negative valence, no difference is found among the tested students. There are no data in the literature on the self-defining memories and the postnatal depression. Besides, there is only a single search, not published which explores the links between the attachment and the memories defining the one (Tagini, Conway and Meins, looks for not published, quoted by Conway, to Ape and Tagini, on 2004). The authors present the results according to the styles of attachment. So, autobiographical memories would vary according to the cognitive and emotional dimensions, in connection with differences in the style of attachment. In every style of attachment would correspond certain specificities in the contents and in the form of the self-defining memories.
Read the detailed description
In this context, it seems important to look for if there are specificities concerning the profiles of attachment and the self-defining memories at the patients suffering from postnatal depression. Especially as the current literature approaches only little this subject of public health.
To analyze these specificities, two groups (group postnatal depression versus group control) will compare by estimating the type of maternal attachment and theirs self-definig memories, without omitting to look for a possible psychiatric pathology, and a personality problem at the mother.
The main objective of this study will be to highlight specificities of the style of attachment and the personal identity in the postnatal depression.
The secondary objectives of this study will on one hand be to look for the existence of links between the various clinical variables in the postnatal depression.
And on the other hand to look for psychological and clinical factors which can be markers of vulnerability and\or factors of protection of the depression comment native (comparison between both groups of subjects).
The participation to this study will be proposed to all the women of both centers, throughout the inclusion. Those who will have accepted will fill a scale Edinburgh Post-natal Depression Scale (EPDS). The score which will decide in which group women will be assigned :
- < 11 group control
- > 11 group PND The specific visit in the study will take place in a identical way for the cases and the witnesses.
The patients will be seen at first by a doctor a child psychiatrist who will make a data collection sociodemographic and clinical and the signing of various questionnaires : Mini International Neurospychiatric Interview (MINI), Adult Attachment Narratives (AAN), Camir scale and Perceived Social Support Questionnaire (QSSP).
Secondly, the patients will be seen by a psychologist to pursue the clinical evaluation (Trait Anxiety Inventory (STAI), Beck Depression Inventory and self-esteem scale (EES), Scale of vocabulary (MILL-HILL) and to realize the signing of the questionnaire of the self-defining memories.
- Conditions
- Postnatal Depression
- Being tested
- Evaluation of the quality attachment : "Adult Attachment Narratives" and "CaMir scale", Evaluation of the self-defining memories : "Specific Questionnaire during an interview"
- Keywords
- Postnatal depression, Attachment, Self-defining memories
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the quality attachment : "Adult Attachment Narratives" and "CaMir scale"Behavioural
Evaluation of the quality attachment : "Adult Attachment Narratives" and "CaMir scale"
Evaluation of the self-defining memories : "Specific Questionnaire during an interview"Behavioural
Evaluation of the self-defining memories : "Specific Questionnaire during an interview"
| Study group | Role | What they receive |
|---|---|---|
| women with postnatal depression | Experimental | Not described Receives: Behavioral: Evaluation of the quality attachment : "Adult Attachment Narratives" and "CaMir scale"; Behavioral: Evaluation of the self-defining memories : "Specific Questionnaire during an interview" |
| women without postnatal depression | Other | Not described Receives: Behavioral: Evaluation of the quality attachment : "Adult Attachment Narratives" and "CaMir scale"; Behavioral: Evaluation of the self-defining memories : "Specific Questionnaire during an interview" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality attachment
Evaluation of the quality attachment using "Adult Attachment Narratives"
Measured: Day 0
Quality attachment
Evaluation of the quality attachment using "CaMir scale"
Measured: Day 0
Secondary outcomes (3)
First Self-defining memory
Evaluation of the self-defining memory using a specific questionnaire from Singer, J. A., \& Moffitt, K. H. (1991-1992) and Thorne, A., \& McLean, K. C. (2001), translate in French
Measured: Day 0
Second Self-defining memory
Evaluation of the self-defining memory using a specific questionnaire from Singer, J. A., \& Moffitt, K. H. (1991-1992) and Thorne, A., \& McLean, K. C. (2001), translate in French
Measured: Day 0
Third Self-defining memory
Evaluation of the self-defining memory using a specific questionnaire from Singer, J. A., \& Moffitt, K. H. (1991-1992) and Thorne, A., \& McLean, K. C. (2001), translate in French
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start13 Oct 2017
- Primary completion13 Nov 2019 (estimated)
- Study completion13 Dec 2019 (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.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT03346551
- Sponsor's protocol ID
- PA17012
- Acronym
- PNDattachMEMO
- Status last verified
- Nov 2018
- First submitted
- 23 Oct 2017
- Last updated
- 13 Nov 2018
- 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 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postnatal Depression, Attachment and Self-defining Memories
- ClinicalTrials.gov ID
- NCT03346551
- Acronym / sponsor ID
- PNDattachMEMO / PA17012
- Conditions
- Postnatal Depression
- Keywords
- Postnatal depression, Attachment, Self-defining memories
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 13 Nov 2019 (estimated)
- Study completion
- 13 Dec 2019 (estimated)
- First posted
- 17 Nov 2017 (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 specificity of postnatal depression (PND) was acted as full entity within the depressions, by B. Pitt in 1968, through the description of a specific nosography which describes "an atypical depression of the post-partum ".
Actually, the epidemiological studies agree on prevalence from 10 to 15 % of PND. With two peaks of frequency, the first one around the 6th and 12th week comment native and the second during the second half-year. This rate of PND represents in France 75000 to 100000 women a year.
The professionals of the perinatal period are interested in this disorder because of the consequences for the woman herself, and of the impact on the premature interactions mother-baby. These interactions and the direct effects of the PND on the mother will have for influence an important slowing down on the development of the baby. Moreover, the study of Lemaitre and Candilis in 1999, brings the figure of 15 % of the PND which will have an impact on the development of the baby.
The sensation of the depression testifies of a process of change and of psychic conflict favored by the psychic transparency of the pregnancy.
Although the first treaty on this specific nosography dates more than 150 years of numerous questions stay suspends it.
These questions and the reflections which surround them found on their path tools ensuing from the theory of the attachment, formalized by John Bowlby. For more than three decades, these profiles of attachment, specified by Mary Ainsworth: secure, anxious-ambivalent, anxious-avoided and disorganized later, disrupted, is studied, estimated and their evolution during a life is observed. Thanks to these models well known for the same person at a time t, it is now their effects in the interpersonal relations which are studied. Between the people but also on the person himself, its image of her, and its autobiographical memory.
The autobiographical memory represents a central component of the human memory. At a very general level, it's possible to define it as the capacity of a person to remember its past experiences. The review of the literature on the functioning of the episodic autobiographical memory during the depression highlights three main results: the too bi generalization of the memories, the congruence in the humor and the frequency of the intrusive memories characterized by an involuntary reminder, fast and effortlessly (Lemogne and al., 2006; Lemogne and al., 2012). The authors specify that there are links between strategies of avoidance of the intrusive memories and the phenomenon of generalization. These links ask to be explored within a model integrating, self and episodic autobiographical memory in the field of the depression. The use of the memories defining the one could allow to study more specifically this kind of memories. The memories defining the one were introduced to Ape and Moffitt (1991) to characterize a specific category of autobiographical memories. The memories defining the one are important personal memories which help a person to understand whom this person is as individual. In a way, they build the life story and support the personal identity. Connected to other similar memories, the self-defining memories contain numerous sensory details and are often associated to a strong emotional charge. They are also connected to long-term purposes, to concerns or to unsolved conflicts.
Recent studies used the self-defining memories (French version adapted by Mr van der Linden's team, Switzerland) as tool to understand better the psychological disorders from which certain people suffer. The studies show that the self-defining memories undergo modifications the characteristics of which are in connection with every pathology (works of the team of J.M. Danion).
In 1994, Moffit and al. studied a group of students with evaluation of the depressive symptomatology. They established that the presenting subjects of high scores of depression develop more generalized memories than the other participants when is asked to them a self-defining memorie positive. For the memories with negative valence, no difference is found among the tested students. There are no data in the literature on the self-defining memories and the postnatal depression. Besides, there is only a single search, not published which explores the links between the attachment and the memories defining the one (Tagini, Conway and Meins, looks for not published, quoted by Conway, to Ape and Tagini, on 2004). The authors present the results according to the styles of attachment. So, autobiographical memories would vary according to the cognitive and emotional dimensions, in connection with differences in the style of attachment. In every style of attachment would correspond certain specificities in the contents and in the form of the self-defining memories.
Detailed description
In this context, it seems important to look for if there are specificities concerning the profiles of attachment and the self-defining memories at the patients suffering from postnatal depression. Especially as the current literature approaches only little this subject of public health.
To analyze these specificities, two groups (group postnatal depression versus group control) will compare by estimating the type of maternal attachment and theirs self-definig memories, without omitting to look for a possible psychiatric pathology, and a personality problem at the mother.
The main objective of this study will be to highlight specificities of the style of attachment and the personal identity in the postnatal depression.
The secondary objectives of this study will on one hand be to look for the existence of links between the various clinical variables in the postnatal depression.
And on the other hand to look for psychological and clinical factors which can be markers of vulnerability and\or factors of protection of the depression comment native (comparison between both groups of subjects).
The participation to this study will be proposed to all the women of both centers, throughout the inclusion. Those who will have accepted will fill a scale Edinburgh Post-natal Depression Scale (EPDS). The score which will decide in which group women will be assigned :
- < 11 group control
- > 11 group PND The specific visit in the study will take place in a identical way for the cases and the witnesses.
The patients will be seen at first by a doctor a child psychiatrist who will make a data collection sociodemographic and clinical and the signing of various questionnaires : Mini International Neurospychiatric Interview (MINI), Adult Attachment Narratives (AAN), Camir scale and Perceived Social Support Questionnaire (QSSP).
Secondly, the patients will be seen by a psychologist to pursue the clinical evaluation (Trait Anxiety Inventory (STAI), Beck Depression Inventory and self-esteem scale (EES), Scale of vocabulary (MILL-HILL) and to realize the signing of the questionnaire of the self-defining memories.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women with postnatal depression | Experimental | Behavioral: Evaluation of the quality attachment : "Adult Attachment Narratives" and "CaMir scale", Behavioral: Evaluation of the self-defining memories : "Specific Questionnaire during an interview" |
| women without postnatal depression | Other | Behavioral: Evaluation of the quality attachment : "Adult Attachment Narratives" and "CaMir scale", Behavioral: Evaluation of the self-defining memories : "Specific Questionnaire during an interview" |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Group 1 : women with postnatal depression
- Group 2 : women without postnatal depression
- women consenting to participate to the study
- women enrolled in the national healthcare insurance program
- women older than 18 years old
Key exclusion criteria (2 listed)
- women younger than 18 years old
- women protected by the law
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 |
|---|---|---|
| Evaluation of the quality attachment : "Adult Attachment Narratives" and "CaMir scale"Evaluation of the quality attachment : "Adult Attachment Narratives" and "CaMir scale" | Behavioural | women with postnatal depression, women without postnatal depression |
| Evaluation of the self-defining memories : "Specific Questionnaire during an interview"Evaluation of the self-defining memories : "Specific Questionnaire during an interview" | Behavioural | women with postnatal depression, women without postnatal depression |
Primary outcome
Quality attachment
Time frame: Day 0
Evaluation of the quality attachment using "Adult Attachment Narratives"
Quality attachment
Time frame: Day 0
Evaluation of the quality attachment using "CaMir scale"
3 secondary outcomes
First Self-defining memory
Time frame: Day 0
Second Self-defining memory
Time frame: Day 0
Third Self-defining memory
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- 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. 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 Evaluation of the quality attachment : "Adult Attachment Narratives" and "CaMir scale" and Evaluation of the self-defining memories : "Specific Questionnaire during an interview" 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 5 inclusion and 2 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 13 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Catherine ROLLAND (0326787218, acrolland@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality attachment (time frame: Day 0). The study lists 2 primary outcomes in all. 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 13 Nov 2018.