Back to resultsOxytocin and Dyadic Psychotherapy in the Treatment of Post Partum Depression
Primary Purpose
Postpartum Depression
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Oxytocin
placebo
Dyadic psychotherapy
Sponsored by
About this trial
This is an interventional diagnostic trial for Postpartum Depression focused on measuring postpartum Depression, Diadic psychotherapy, Oxytocin, fMRI, attachment, empathy
Eligibility Criteria
Inclusion Criteria:
- Women of all ages who are 3 to 8 months post-partum.
- Women who have completed a minimum of 12 years of education.
- Women who are willing and able to provide informed consent for their participation and after the study has been explained. Infant participation will be allowed after consent has been obtained from mothers.
- Current DSM-IV-TR diagnosis of PPD disorder as confirmed by SCID (administered as part of the study of protocol number PPD1, proposed to the Helsinki committee on June 2014).
- Symptoms: BDI total score >9, EPDS total score >10
- Treatment with antidepressants will be allowed provided that patients have been on the medication for at least 4 weeks prior to entry into the pre-treatment assessment phase of the study.
Exclusion Criteria:
- Unwilling or unable, in the opinion of the investigator, to comply with study instructions.
- Pregnant women.
- Clinically significant medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning).
- Women with significant risk of committing suicide or harming others in the opinion of the psychiatrist.
- Women with a current DSM-IV-TR substance or alcohol abuse. However, patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.
- Women who suffers from depression due to physical condition.
- Women who suffers from severe major depression (MADRAS>30)
- Women who suffers from chronic depression (over 6 months)
Sites / Locations
- The Tel-Aviv Sourasky Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
postpartum depression
normal controls
Arm Description
Women suffering from postpartum depression, assessed by fMRI and then treated by dyadic psychotherapy All participants will undergo two functional brain scans at the Tel Aviv Medical Center. The two scans will take place one week apart, one scan will include administration of oxytocin (24IU) and the other will include the use of placebo (the order in which the two different treatments is applied will be random). All women in this group participate in 8-weeks of dyadic psychotherapy (DP) at the outpatient Psychiatric Department, Tel-Aviv Medical Center. A final end-of-study clinical evaluation, will be conducted at the end of 8 weeks. The evaluation will include a psychiatric evaluation, the MADRS, and a physical examination, the mother-infant interaction will be videotaped, and the YIPTA, BDI, EPDS & STAI will be administered. Salivary OXT samples will be collected from the mother and from the infant and infants will undergo a developmental assessment.
Normal control women not suffering from postpartum depression assessed by fMRI All participants will undergo two functional brain scans at the Tel Aviv Medical Center. The two scans will take place one week apart, one scan will include administration of oxytocin (24IU) and the other will include the use of placebo (the order in which the two different treatments is applied will be random). A final end-of-study clinical evaluation, will be conducted at the end of 8 weeks. The evaluation will include a psychiatric evaluation, the MADRS, and a physical examination, the mother-infant interaction will be videotaped, and the YIPTA, BDI, EPDS & STAI will be administered. Salivary OXT samples will be collected from the mother and from the infant and infants will undergo a developmental assessment.
Outcomes
Primary Outcome Measures
Effect of the administration of oxytocin on cerebral circuit processing
1. This paradigm assesses empathic responses to images of individuals experiencing sad, anxious and happy events. Images are preceded by social context (i.e. "this person just won the lottery"). Control condition presents participants with images of people performing everyday actions.
3.we generated 15 short screenplays containing triggers for both types of empathy. Each of the screenplays depicts a situation in which the characters pose a negatively-valenced bodily state (e.g. crying, itching, choking), which we expect to elicit embodied simulation in the viewer.
2. This paradigm examines maternal FMRI responses to infant related video vignettes. Stimuli include movies of mothers' own infant vs strange infant during solitary play and mother-infant interaction.
Interactional measures-CIB
The Coding Interactive Behavior Manual (CIB) (Feldman 1998), a well-validated system for coding dyadic interactions, by individuals blind to the study group that the participant is a member in. The following behaviors will be compute: Parents behavior; Child behavior; Dyadic behavior; Lead-Lag Relationship
Interactional measures-Noldus
Micro-analytic coding of synchrony- on a computerized system (Noldus, The Vaggenigen, Netherlands), coded on a computerized system that allows for .01-second exactness. Consistent with previous research on parent-infant synchrony (Feldman and Eidelman, 2004, 2007). Four non-verbal categories of parenting behavior and four non-verbal categories of infant behavior will be coded and each category will include a set of mutually exclusive codes.
Secondary Outcome Measures
Maternal depression symptoms measures- BDI
Beck Depression Inventory- BDI (Beck, Ward, Mendelson, Mock, and Erbaugh, 1961) is designed to assess the severity of depression while referring to affective, cognitive, physical and behavioral aspects.
The BDI consists of 21 items, divided in to 3 factors: sadness / negative self perception, psycho-motor deceleration and somatic depression. Every item consists of 4 sentences for self-esteem, in a scale of 0-3, according to the degree of depression. Scores of 9 or above indicate elevated depressive symptoms and a risk for MDD (Kendall, Hollon, Beck, et al 1987). The BDI is a widely used inventory which was found to be well validated and highly coefficient (for a meta analysis see: Beck, Steer, & Garbin, 1988).
Maternal depression symptoms measures - EPDS
Edinburgh Postnatal Depression Scale- EPDS, (Cox, Holden, Sagovsky, 1987) is designed in order to screen for postnatal depression in the community. The EPDS is a brief (10-item) scale. The questions focus on the psychological rather than the somatic aspects of depression and explore 2 distinct domains of negative affect: depressive symptoms (7 items) and anxiety (3 items) (Kabir, Sheeder and Kelly, 2008). Subjects respond to items on a 4 point Likert scale (of 0-3), resulting in a total score range between 0 and 30. Scores of 10 or above indicate elevated depressive symptoms and a risk for PPD (Cox, Holden, Sagovsky, 1987). The EPDS is a widely used scale which was found to be well validated and highly coefficient (Cox, Holden, Sagovsky, 1987; Kabir, Sheeder and Kelly ,2008; Murray & Carothers, 1990).
Maternal anxiety measures-STAI
State- Trait Anxiety Inventory- STAI (Spielberger, Gorsuch, and Lushene, 1970) assesses levels of situational and trait anxiety. The STAI contains 40 declarations, 20 of which refer to situational anxiety and 20 of which refer to trait anxiety. Subjects will indicate on a scale of 1-4 (1=not it all, 4=to a large extent) to what extent they think the declaration is accurate in their case. Trait anxiety scores of above 43 are considered a risk indicator for anxiety disorders (Spielberger, et al., 1970). The STAI is a widely used inventory which was found to be well validated and highly coefficient (Anastasi, 1988).
Physiological measures-Salivary OXT
Salivary OXT -in order to examine OXT and reactivity curve in PPD women and their infants
Maternal thought and action measures
Maternal thoughts and actions will be assessed with the Yale Inventory of Parental Thoughts and Actions (YIPTA) - a semi-structured interview which provides a validated measure of parental worries, comprising a range of anxious intrusive thoughts and harm avoidant behaviors (AITHAR; Feldman, Weller, Leckman, Kuint, & Eidelman, 1999; Leckman et al., 2004; Leckman et al., 1999; Mayes, Swain, Feldman, & Leckman, 2008). Such thoughts and behaviors include concerns about the baby's physical environment.
Full Information
NCT ID
NCT02191423
First Posted
July 9, 2014
Last Updated
July 13, 2014
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02191423
Brief Title
Oxytocin and Dyadic Psychotherapy in the Treatment of Post Partum Depression
Official Title
The Effect of Oxytocin on Brain Attachment and Empathy Networks, and the Association Between the Brain Response and Treatment Outcome of Brief Dyadic Psychotherapy - in Women Suffering From Postpartum Depression
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Rationale and Hypotheses of the Current Research: the investigators 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. While dyadic psychotherapy has been studied in this context, it is unknown which depressed women will respond to this type of therapy, and whether such a response is mediated by the pro-bonding effect of oxytocin.
The aim of this study is three-fold:
To study the effect of the administration of a single dose (24IU) of oxytocin on cerebral circuit processing and connectivity of empathy and attachment.
To examine whether the clinical response of mothers suffering from postpartum depression to short term dyadic psychotherapy (based on improved mother-child interactions) can be predicted by a unique brain response pattern to oxytocin.
To assess the relationship between levels of oxytocin in mother and baby and the effectiveness of psychological dyadic treatment on mothers suffering from postpartum depression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
postpartum Depression, Diadic psychotherapy, Oxytocin, fMRI, attachment, empathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
postpartum depression
Arm Type
Experimental
Arm Description
Women suffering from postpartum depression, assessed by fMRI and then treated by dyadic psychotherapy
All participants will undergo two functional brain scans at the Tel Aviv Medical Center. The two scans will take place one week apart, one scan will include administration of oxytocin (24IU) and the other will include the use of placebo (the order in which the two different treatments is applied will be random).
All women in this group participate in 8-weeks of dyadic psychotherapy (DP) at the outpatient Psychiatric Department, Tel-Aviv Medical Center.
A final end-of-study clinical evaluation, will be conducted at the end of 8 weeks. The evaluation will include a psychiatric evaluation, the MADRS, and a physical examination, the mother-infant interaction will be videotaped, and the YIPTA, BDI, EPDS & STAI will be administered. Salivary OXT samples will be collected from the mother and from the infant and infants will undergo a developmental assessment.
Arm Title
normal controls
Arm Type
Other
Arm Description
Normal control women not suffering from postpartum depression assessed by fMRI
All participants will undergo two functional brain scans at the Tel Aviv Medical Center. The two scans will take place one week apart, one scan will include administration of oxytocin (24IU) and the other will include the use of placebo (the order in which the two different treatments is applied will be random).
A final end-of-study clinical evaluation, will be conducted at the end of 8 weeks. The evaluation will include a psychiatric evaluation, the MADRS, and a physical examination, the mother-infant interaction will be videotaped, and the YIPTA, BDI, EPDS & STAI will be administered. Salivary OXT samples will be collected from the mother and from the infant and infants will undergo a developmental assessment.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Syntocinon
Intervention Description
administered pre-fMRI assessment
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
administered pre-fMRI assessment
Intervention Type
Behavioral
Intervention Name(s)
Dyadic psychotherapy
Primary Outcome Measure Information:
Title
Effect of the administration of oxytocin on cerebral circuit processing
Description
1. This paradigm assesses empathic responses to images of individuals experiencing sad, anxious and happy events. Images are preceded by social context (i.e. "this person just won the lottery"). Control condition presents participants with images of people performing everyday actions.
3.we generated 15 short screenplays containing triggers for both types of empathy. Each of the screenplays depicts a situation in which the characters pose a negatively-valenced bodily state (e.g. crying, itching, choking), which we expect to elicit embodied simulation in the viewer.
2. This paradigm examines maternal FMRI responses to infant related video vignettes. Stimuli include movies of mothers' own infant vs strange infant during solitary play and mother-infant interaction.
Time Frame
Two functional brain scans one week after admission to the study (week2)
Title
Interactional measures-CIB
Description
The Coding Interactive Behavior Manual (CIB) (Feldman 1998), a well-validated system for coding dyadic interactions, by individuals blind to the study group that the participant is a member in. The following behaviors will be compute: Parents behavior; Child behavior; Dyadic behavior; Lead-Lag Relationship
Time Frame
pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Title
Interactional measures-Noldus
Description
Micro-analytic coding of synchrony- on a computerized system (Noldus, The Vaggenigen, Netherlands), coded on a computerized system that allows for .01-second exactness. Consistent with previous research on parent-infant synchrony (Feldman and Eidelman, 2004, 2007). Four non-verbal categories of parenting behavior and four non-verbal categories of infant behavior will be coded and each category will include a set of mutually exclusive codes.
Time Frame
pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Secondary Outcome Measure Information:
Title
Maternal depression symptoms measures- BDI
Description
Beck Depression Inventory- BDI (Beck, Ward, Mendelson, Mock, and Erbaugh, 1961) is designed to assess the severity of depression while referring to affective, cognitive, physical and behavioral aspects.
The BDI consists of 21 items, divided in to 3 factors: sadness / negative self perception, psycho-motor deceleration and somatic depression. Every item consists of 4 sentences for self-esteem, in a scale of 0-3, according to the degree of depression. Scores of 9 or above indicate elevated depressive symptoms and a risk for MDD (Kendall, Hollon, Beck, et al 1987). The BDI is a widely used inventory which was found to be well validated and highly coefficient (for a meta analysis see: Beck, Steer, & Garbin, 1988).
Time Frame
mothers will complete the BDI once a week during the 8-week trial, as well as in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Title
Maternal depression symptoms measures - EPDS
Description
Edinburgh Postnatal Depression Scale- EPDS, (Cox, Holden, Sagovsky, 1987) is designed in order to screen for postnatal depression in the community. The EPDS is a brief (10-item) scale. The questions focus on the psychological rather than the somatic aspects of depression and explore 2 distinct domains of negative affect: depressive symptoms (7 items) and anxiety (3 items) (Kabir, Sheeder and Kelly, 2008). Subjects respond to items on a 4 point Likert scale (of 0-3), resulting in a total score range between 0 and 30. Scores of 10 or above indicate elevated depressive symptoms and a risk for PPD (Cox, Holden, Sagovsky, 1987). The EPDS is a widely used scale which was found to be well validated and highly coefficient (Cox, Holden, Sagovsky, 1987; Kabir, Sheeder and Kelly ,2008; Murray & Carothers, 1990).
Time Frame
pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Title
Maternal anxiety measures-STAI
Description
State- Trait Anxiety Inventory- STAI (Spielberger, Gorsuch, and Lushene, 1970) assesses levels of situational and trait anxiety. The STAI contains 40 declarations, 20 of which refer to situational anxiety and 20 of which refer to trait anxiety. Subjects will indicate on a scale of 1-4 (1=not it all, 4=to a large extent) to what extent they think the declaration is accurate in their case. Trait anxiety scores of above 43 are considered a risk indicator for anxiety disorders (Spielberger, et al., 1970). The STAI is a widely used inventory which was found to be well validated and highly coefficient (Anastasi, 1988).
Time Frame
mothers will complete the STAI once a week during the 8-week trial, as well as in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Title
Physiological measures-Salivary OXT
Description
Salivary OXT -in order to examine OXT and reactivity curve in PPD women and their infants
Time Frame
both mothers and infants will give six saliva samples; once a other week during the 8-week trial, as well as in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Title
Maternal thought and action measures
Description
Maternal thoughts and actions will be assessed with the Yale Inventory of Parental Thoughts and Actions (YIPTA) - a semi-structured interview which provides a validated measure of parental worries, comprising a range of anxious intrusive thoughts and harm avoidant behaviors (AITHAR; Feldman, Weller, Leckman, Kuint, & Eidelman, 1999; Leckman et al., 2004; Leckman et al., 1999; Mayes, Swain, Feldman, & Leckman, 2008). Such thoughts and behaviors include concerns about the baby's physical environment.
Time Frame
mothers will complete the YIPTA twice; in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women of all ages who are 3 to 8 months post-partum.
Women who have completed a minimum of 12 years of education.
Women who are willing and able to provide informed consent for their participation and after the study has been explained. Infant participation will be allowed after consent has been obtained from mothers.
Current DSM-IV-TR diagnosis of PPD disorder as confirmed by SCID (administered as part of the study of protocol number PPD1, proposed to the Helsinki committee on June 2014).
Symptoms: BDI total score >9, EPDS total score >10
Treatment with antidepressants will be allowed provided that patients have been on the medication for at least 4 weeks prior to entry into the pre-treatment assessment phase of the study.
Exclusion Criteria:
Unwilling or unable, in the opinion of the investigator, to comply with study instructions.
Pregnant women.
Clinically significant medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning).
Women with significant risk of committing suicide or harming others in the opinion of the psychiatrist.
Women with a current DSM-IV-TR substance or alcohol abuse. However, patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.
Women who suffers from depression due to physical condition.
Women who suffers from severe major depression (MADRAS>30)
Women who suffers from chronic depression (over 6 months)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miki Bloch, Prof.
Phone
972-3-6974707
Email
mikib@tlvmc.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth Feldman, PhD
Phone
972-3-5317943
Email
ortalsh@hotmail.com
Facility Information:
Facility Name
The Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miki Bloch, Prof.
12. IPD Sharing Statement
Learn more about this trial
Oxytocin and Dyadic Psychotherapy in the Treatment of Post Partum Depression
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