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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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:
- 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.
- 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.
- 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:
- 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.
- 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.
- 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.
- Conditions
- Postpartum Depression
- 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 group | Role | What they receive |
|---|---|---|
| dyadic treatment | Experimental | 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. Receives: Behavioral: dyadic psychotherapeutic intervention |
| supportive treatment | Active comparator | 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. Receives: Behavioral: supportive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
- First posted24 Oct 2019
- Study start1 Jan 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Schusheim, HaEmek Medical Center, Israel
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Dyadic Psychotherapeutic Intervention for Mothers Suffering From PPD on Oxytocin Level and on Childrens' Emotional and Behavioral Development
- ClinicalTrials.gov ID
- NCT04138368
- Acronym / sponsor ID
- EMC-0057-19
- Conditions
- Postpartum Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 24 Oct 2019 (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.
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 .
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:
- 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.
- 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.
- 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.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dyadic treatment | Experimental | Behavioral: dyadic psychotherapeutic interventionMothers 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 treatment | Active comparator | Behavioral: supportive interventionmothers 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. |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- women age 18 years old +
- women screening score of Depression EPDS>10 (Edinburgh quastionnnaire)
- single child delivery
- babies 3-8 monthes years old
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| dyadic psychotherapeutic interventionMothers 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. | Behavioural | dyadic treatment |
| supportive interventionSupportive 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. | Behavioural | supportive treatment |
Primary outcome
the dyadic psychotherapy reinforce mother-child bonding and attachment, over and above the standard supportive care.
Time frame: 8 weeks of treatment
Oxytocin levels under dyadic therapy will be higher compared to the control group
the dyadic psychotherapy will prevent the development of emotional psychopathology of the child
Time frame: 18 monthes of life
Dyadic therapy will reduce behavioral and developmental problems
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- 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 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.