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| Name | Class |
|---|---|
| Ospedale San Paolo | OTHER |
| Humanitas Hospital, Italy | OTHER |
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There is increasing evidence that about 30% of women evaluate their childbirth as traumatic and that women could develop post-traumatic stress disorder (PTSD) in response to events of birth. The mean prevalence of post-partum PTSD (PP-PTSD) was reported as 3-4% in community samples and 15.7-18.95% in high-risk samples.
The primary aim is to investigate the effectiveness of Eye Movement Desesitization and Reprocessing (EMDR) in treating post-traumatic and postpartum depressive symptoms in women who had a traumatic childbirth as compared to Supportive Expressive Dynamic Psychotherapy (SEDP) as therapy as usual.
Secondary outcomes are:
Two follow-up assessments will be scheduled: at 6-weeks post-partum (after the end of the psychotherapeutic intervention) and at 12-weeks post-partum.
About 30% of women evaluate their childbirth as traumatic and 3-4% women could develop post-traumatic stress disorder (PTSD) in response to traumatic childbirth. There is also a high co-morbidity between post-traumatic stress symptoms and post-partum depressive symptoms.
The aims of the present research project are:
The design of this study is a multicenter, randomized controlled clinical trial.
Patients will be consecutively recruited from three clinical centers:
Participants The subjects of the study will be 60 women who have experienced a traumatic childbirth in the previous 2 days. Those who have a score on the Impact of the Event Scale - Revised (IES-R) equal or greater than 24 (in order to consider also sub threshold post-traumatic stress symptoms) will be asked for their participation in the study.
Assessments The psychological evaluation will be performed at baseline (T0), within the third day postdelivery, with a limited number of questionnaires, in order not to weigh down the patient given the context of urgency and hospitalization.
The following instruments will be administered:
Two follow-up assessments will be scheduled in order to evaluate the outcomes of the psychotherapeutic interventions and to monitor symptoms levels over time:
During these follow-ups the following questionnaires will be administrated:
Interventions All the participants, regardless of the type of treatment, will receive between 2 and 4 (according to women's availability) individual 60-min-long treatment sessions conducted over 4-5 weeks.
The first two sessions will be carried out before the woman's discharge from the maternity ward, and the next three sessions will be performed on an outpatient basis.
The EMDR treatment will follow the EMDR Recent Birth Trauma Protocol. This protocol can be used to intervene immediately after birth, or at later times. The main purposes of early intervention is to prevent the onset and development of PTSD and Postpartum Depression in the mother during the months following childbirth and to facilitate mother-newborn bonding.
The SEDP treatment is one of the most widespread treatments and can be considered the treatment as usual in Italian maternity wards. This intervention includes both supportive techniques (to create a positive, helpful and empathic relationship with the patient) and expressive techniques (aimed at helping the patient to express and to understand and change problems).
Physiological measures of psychotherapeutic process During the first and last treatment sessions, women will be asked to wear a simple wristband (similar to a wristwatch) that will monitor the physiological parameters of HRV and skin conductance for the entire duration of the session. These data will be then correlated with the outcome of the interventions detected at the follow-up assessments and with the clinical data obtained at the beginning and end of each session.
PRIMARY AND SECONDARY OUTCOMES The primary outcome of this study will be differences between EMDR and SEDP in reducing the IES- R and the EPDS clinical scores after treatment and at the 12-weeks post-partum follow-up.
Secondary outcomes of the studies are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eye Movement Desensitization and Reprocessing (EMDR) | Experimental | The EMDR treatment will follow the EMDR Recent Birth Trauma Protocol. This protocol was recently developed by some of the colleagues collaborating in this research project (Catteneo et al., 2018). This EMDR protocol can be used to intervene immediately after birth, or at later times. The main purposes of early intervention is to prevent the onset and development of PTSD and Post-partum Depression in the mother during the months following childbirth and to facilitate mother-newborn bonding. |
|
| Supportive Expressive Dynamic Psychotherapy (SEDP) | Active Comparator | The SEDP treatment (Luborsky 1984; Book, 1998) is one of the most widespread treatments and can be considered the treatment as usual in Italian maternity wards. This intervention includes both supportive techniques (to create a positive, helpful and empathic relationship with the patient) and expressive techniques (aimed at helping the patient to express and to understand and change problems). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMDR | Behavioral | 2-4 sessions individual 60-min-long treatment sessions of EMDR Recent birth trauma protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-traumatic stress symptoms | Reduction of post-traumatic stress symptoms, as assessed by Impact of Event Scale -Revised (IES-R). Total score range 0-88. Cut-off for presence post-traumatic symptoms>=33. | 6 weeks post-partum |
| Measure | Description | Time Frame |
|---|---|---|
| Post-partum depression symptoms | Reduction of post-partum depressive symptoms, as assessed by Edimburgh Post-natal Depression Scale (EPDS). Total score range: 0-30, cut-off score for possible depression =8. Possible Depression: 10 or greater | 6 weeks post-partum |
| Post-traumatic stress disorder diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| mother-infant bonding | Levels of mother-infant bonding, as evaluated with Postpartum Bonding Questionnaire (PBQ) | 6 weeks post-partum |
| mother-infant bonding | Levels of mother-infant bonding, as evaluated with Postpartum Bonding Questionnaire (PBQ). The PBQ has four subscales which reflect impaired bonding (Scale 1) (12 items, ranging from 0 to 60), rejection and anger (Scale 2) (7 items, scores ranging from 0 to 35), anxiety about care (Scale 3) (4 items,scores ranging from 0 to 20) and risk of abuse (Scale 4) (2 items,scores ranging from 0 to 10). Brockington et al. (2001) suggest cut-off scores to identify problematic bonding of 12 for Scale 1, 17 for Scale 2, 10 for Scale 3 and 3 for Scale 4. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Carletto, PhD | Contact | 00393333308730 | sara.carletto@unito.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanitas San Pio X Hospital | Not yet recruiting | Milan | Italy |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D057169 | Eye Movement Desensitization Reprocessing |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| SEDP | Behavioral | 2-4 sessions individual 60-min-long treatment sessions of SEDP |
|
proportion of patients with a diagnosis of Post-traumatic stress disorder, as assessed with Mini-International Neuropsychiatric Interview-Plus. |
| 12 weeks post-partum |
| Post-partum depression diagnosis | proportion of patients with a diagnosis of Post-partum depression, as assessed with Mini-International Neuropsychiatric Interview-Plus. | 12 weeks post-partum |
| 12 weeks post-partum |
| anxiety symptoms | levels of anxiety symptoms, as evalueated with Generalized Anxiety Disorder Assessment (GAD-7). Total score ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. | 6 weeks post-partum |
| anxiety symptoms | levels of anxiety symptoms, as evalueated with Generalized Anxiety Disorder Assessment (GAD-7). Total score ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. | 12 weeks post-partum |
| San Paolo Teaching Hospital | Not yet recruiting | Milan | Italy |
|
| AOU Città della Salute e della Scienza di Torino - Sant'Anna Hospital | Recruiting | Torino | 10126 | Italy |
|
| D001519 | Behavior |