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Postpartum DepressionNCT04138368

The Effect of Early Dyadic Psychotherapy for Mothers Suffering From PPD on Oxytocin Level and on Childrens' Emotional Development

A study testing dyadic psychotherapeutic intervention and supportive intervention in people with Postpartum Depression, run by HaEmek Medical Center, Israel at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background: Postpartum depression follows approximately 10-15% of deliveries. Maternal functional disability, particularly in the relationship with the infant, a hallmark of PPD, causes impairment in the mother's ability to bond with her infant. Read more about this study

Who is it for?
Ages 3 months and older
Conditions the study is for
Postpartum Depression
What is being tested?
dyadic psychotherapeutic intervention and supportive intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIsrael
Study dates
1 Jan 2020to Dec 2021
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 3 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • women age 18 years old +
  • women screening score of Depression EPDS>10 (Edinburgh quastionnnaire)
  • single child delivery
  • babies 3-8 monthes years old

Who cannot join

  • severe MDD
  • intelectual disability
  • women screening score of Depression EPDS<10 (Edinburgh quastionnnaire)
  • pregnant women
  • women diagnosed with Bipolar disorder or Schizophrenia, delirium, psychosis *due to drug abuse, OCD
  • Aggressive intentions towards the baby
Show all 10Show fewer
  • high risk for self and other injury
  • drug abuse
  • physical condition influencing depressive symptoms
  • unstable physical condition due to various illnesses (cancer, diabetes...)

Trial locations and contacts

1 site in 1 country.

Ilanit Elbaz, P.HD contact

972-54-4923334

ilanit_el@clalit.org.il

Israel1 site, 1 recruiting
  • Ilanir shchori

    Afula

    ilanir shchori, phd

    Recruiting

Other trials in Israel

About this study

Official title: The Effect of Early Dyadic Psychotherapeutic Intervention for Mothers Suffering From PPD on Oxytocin Level and on Childrens' Emotional and Behavioral Development

Background: Postpartum depression follows approximately 10-15% of deliveries. Maternal functional disability, particularly in the relationship with the infant, a hallmark of PPD, causes impairment in the mother's ability to bond with her infant. Subsequently, this impairment leads to deleterious long-term consequences for infant cognitive, neurological, and social-emotional growth, and is associated with psychiatric disorders in later life. Therefore, the development of effective short-term treatment in such a highly prevalent phenomenon is of a high clinical priority. While pharmacological and psychological treatments are effective in treating PPD , these interventions have failed to show a significant improvement in mother-child interaction quality and infant development.

The Oxytocin System: Oxytocin (OXT) is a nine amino acid neuro-peptide, found exclusively in mammals and is released during labor and lactation. Among the central influences of OXT on human social behavior are increased trust, empathy and eye contact. Brain imaging found that maternal attachment activates regions in the brain's reward systems that are rich with oxytocin and vasopressin receptors . Such findings led researchers to speculate that OXT may be involved in linking and maintaining the connection between social recognition systems and feelings of pleasure . According to this speculation, pair bonding is a form of conditioned reward learning, whereby OXT promotes the reward in social encounters, thus enhancing the motivation to engage in such interaction .

Read more

Disruptions to the oxytocin system in depression have been repeatedly observed, and woman suffering from PPD have lower plasma OXT concentrations in comparison to the control group . A recent small treatment study of OXT in women suffering from PPD did not show a positive effect on mood; however, it did show improved mother-child interactions.

Studies suggest a bio-behavioral feedback loop of OXT, parenting, and infant social competence. Rationale and Hypotheses of the Current Research: We speculate that mothers suffering from PPD exhibit high levels of depression and low levels of OXT, hence experiencing the interaction with their child as less rewarding, which in turn promote further depressive symptoms and interfere with child development.

The aims of this study are:

  1. To assess the relationship between levels of oxytocin in mothers suffering from postpartum depression and their babies, before and after psychological dyadic treatment compered to supportive treatment.
  2. To study the added value of dyadic treatment over conventional supportive treatment for PPD that does not focus specifically on the mother's relationship with her baby.
  3. To show the effects of dyadic treatment for PPD mothers and their children on the child's emotional and behavioral development.

Methods: Subjects: 50 Mothers will be interviewed and diagnosed as suffering from PPD according to DSM-IV-TR, will be enrolled within 2-8 months postpartum.

Read the detailed description

Background: Postpartum depression follows approximately 10-15% of deliveries. Maternal functional disability, particularly in the relationship with the infant, a hallmark of PPD, causes impairment in the mother's ability to bond with her infant. Subsequently, this impairment leads to deleterious long-term consequences for infant cognitive, neurological, and social-emotional growth, and is associated with psychiatric disorders in later life. Recently, biological correlates of maternal deprivation and maternal depression on the infant's brain in both animal and human studies have been found . Therefore, the development of effective short-term treatment in such a highly prevalent phenomenon is of a high clinical priority. While pharmacological and psychological treatments are effective in treating PPD, these interventions have failed to show a significant improvement in mother-child interaction quality and infant development.

The Oxytocin System: Oxytocin (OXT) is a nine amino acid neuro-peptide, found exclusively in mammals and is released during labor and lactation. The effects of OXT on the anterior cingulate, OFC and vmPFC, suggesting its effect on 'social brain' areas have been reported in the past , including modulation of maternal behaviors and paternal behaviors including positive affect, social gaze, touch, and vocal synchrony with the infant . Among the central influences of OXT on human social behavior are increased trust , empathy and eye contact . Brain imaging found that maternal attachment activates regions in the brain's reward systems that are rich with oxytocin and vasopressin receptors . Such findings led researchers to speculate that OXT may be involved in linking and maintaining the connection between social recognition systems and feelings of pleasure . According to this speculation, pair bonding is a form of conditioned reward learning, whereby OXT promotes the reward in social encounters, thus enhancing the motivation to engage in such interaction .

Disruptions to the oxytocin system in depression have been repeatedly observed, and woman suffering from PPD have lower plasma OXT concentrations in comparison to the control group . Recent studies investigated the therapeutic potential of OXT in psychopathologies involving impaired social functioning such as autism spectrum disorders where OXT was found to facilitate social information processing and retention of social information, in social anxiety disorder , and schizophrenia where OXT administration resulted in a significant improvement in several social cognition measures and symptom reduction. Furthermore, a recent small treatment study of OXT in women suffering from PPD did not show a positive effect on mood; however, it did show improved mother-child interactions.

Studies suggest a bio-behavioral feedback loop of OXT, parenting, and infant social competence. The mechanisms of cross-generation transmission in the OXT system have been observed in human parents and infants in the first months of the infant's life and showed that parent and child's OXT levels are highly correlated and higher parental OXT was associated with higher infant OXT. Studies in non-human primates have shown long-term consequences on the development of social competence and infant's ultimate parental skills.

Rationale and Hypotheses of the Current Research: We speculate that mothers suffering from PPD exhibit high levels of depression and low levels of OXT, hence experiencing the interaction with their child as less rewarding, which in turn promote further depressive symptoms and interfere with child development.

The aims of this study are:

  1. To assess the relationship between levels of oxytocin in mothers suffering from postpartum depression and their babies, before and after psychological dyadic treatment compered to supportive treatment.
  2. To study the added value of dyadic treatment over conventional supportive treatment for PPD that does not focus specifically on the mother's relationship with her baby.
  3. To show the effects of dyadic treatment for PPD mothers and their children on the child's emotional and behavioral development.

Methods: Subjects: 50 Mothers will be interviewed and diagnosed as suffering from PPD according to DSM-IV-TR, will be enrolled within 2-8 months postpartum.

Procedure:

An informed consent will be obtained, inclusion and exclusion criteria will be examined, demographic information, psychiatric and medical history will be obtained, and MADRS, CGI-S, and GAD7 questionnaires will be performed.

The baseline assessment will be conducted at the infant's home, at that time, a mother -infant interaction will be videotaped, and the YIPTA, BDI, EPDS, STAI, PSI, NMR, ERC, IOS, PBI, EQ and IRI questionnaires will be administered. Salivary OXT samples will be collected from the infants and salivary OXTsamples will be collected from the parent .

Women with PPD will be invited for a mid-point clinical evaluation at the outpatient Psychiatric Department, Haemek Medical Center. The evaluation will include a psychiatric evaluation using MADRS, CGI-S, and GAD-7 questionnaires.

the women in the PPD group will participate in 8 weeks of dyadic psychotherapy (DP) combining video feedback. The treatment will be conducted at the subject's home. Additional 25 PPD women will receive only supportive treatment at their home. The supportive treatment will include psychoeducation regarding the development of the infant. During the 8-week treatment, salivary OXT,Estradiol, Progesterone, SIGA and Vasopressin samples will be collected from the mother and infant at the beginning and the end of each session.

Four weeks into DP, women with PPD will undergo another clinical evaluation at the outpatient Psychiatric Department, Haemek Medical Center.

A final end-of-study clinical evaluation, for all women in the groups, will be conducted at the end of 12 weeks. Another assessment will be conducted at the infant's home, including mother -infant interaction. Mother-infant interaction will be filmed and assessed using the CIB Manual and the NOLDOS coding system. Salivary OXT, Estradiol, Progesterone, SIGA and Vasopressin samples will be collected from the mother and from the infant. PPD and control mothers. For PPD mothers, the evaluation will include a psychiatric evaluation (MADRS, CGI-S, and GAD-7 the MADRS) and the emotional conflict task at the outpatient Psychiatric Department, Haemek Medical Center.

Study duration: The study is expected to proceed for approximately 2 years. First year: setting up study infrastructure, preparation of collaborations, beginning of patient recruitment and treatment. Second year: patient recruitment and treatment according to protocol and data analysis.

Being tested
dyadic psychotherapeutic intervention, supportive 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.

  • dyadic psychotherapeutic interventionBehavioural

    Mothers and infants will be treated with dyadic psychotherapy focused on interactions, emphasizing eye contact, body language, empathy, and social reciprocity, using the principles of Interaction Guidance Therapy (Sameroff et al., 2004). Dyadic psychotherapy will be administered one time a week during the 8-week trial period, at the subject's home. Each session, approximately 90 minutes long, will include videotaping mother-infant interaction, watching the last session's interaction as a part of video-feedback technique, and discussing main issues in the mother-infant relationship. In addition, each session will begin and end with a- 5-minute episode of affectionate touch and gaze synchrony between the mother and her infant.

  • supportive interventionBehavioural

    Supportive therapy: mothers will receive psychoeducational knowledge regarding the infants' development. The treatment will be administered one time a week during the 8-week trial period, at the subjects' home.

Study groups in NCT04138368
Study groupRoleWhat they receive
dyadic treatmentExperimentalMothers and infants will be treated with dyadic psychotherapy focused on interactions, emphasizing eye contact, body language, empathy, and social reciprocity, using the principles of Interaction Guidance Therapy (Sameroff et al., 2004). Dyadic psychotherapy will be administered one time a week during the 8-week trial period, at the subject's home. Each session, approximately 90 minutes long, will include videotaping mother-infant interaction, watching the last session's interaction as a part of video-feedback technique, and discussing main issues in the mother-infant relationship. In addition, each session will begin and end with a- 5-minute episode of affectionate touch and gaze synchrony between the mother and her infant.
Receives: Behavioral: dyadic psychotherapeutic intervention
supportive treatmentActive comparatormothers will receive psychoeducational knowledge regarding the infants' development. The treatment will be administered one time a week during the 8-week trial period, at the subjects' home.
Receives: Behavioral: supportive intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the dyadic psychotherapy reinforce mother-child bonding and attachment, over and above the standard supportive care.

    Oxytocin levels under dyadic therapy will be higher compared to the control group

    Measured: 8 weeks of treatment

  2. the dyadic psychotherapy will prevent the development of emotional psychopathology of the child

    Dyadic therapy will reduce behavioral and developmental problems

    Measured: 18 monthes of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2019
  2. Study start1 Jan 2020
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

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
Crossover
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04138368
Sponsor's protocol ID
EMC-0057-19
Status last verified
Mar 2020
First submitted
26 Sep 2019
Last updated
18 Mar 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing dyadic psychotherapeutic intervention and supportive intervention in people with Postpartum Depression, run by HaEmek Medical Center, Israel at 1 site in Israel.

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 4 inclusion and 10 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 18 Mar 2020. 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 Israel. 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 Ilanit Elbaz, P.HD (972-54-4923334, ilanit_el@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the dyadic psychotherapy reinforce mother-child bonding and attachment, over and above the standard supportive care. (time frame: 8 weeks of treatment). 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 18 Mar 2020.

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