Clinical trial NCT05209789: Early Intervention to Protect the Mother-Child Relationship After Postpartum Depression
Official title: HUGS : Early Intervention to Protect the Mother-Child Relationship After Postpartum Depression: A Randomized Comparative Trial of the Cognitive Behavioral Therapy Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Partum Depression
Keywords: Mother-baby interaction
Group therapy
Cognitive behavioral therapy
mother-infant relationship
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, interregional, comparative, prospective therapeutic study in 2 parallel groups (1: 1), superiority, randomized, blinded for the evaluation of the primary endpoint.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Postpartum depression (PPD) may impair the mother-infant relationship and lead to both short and long-term suboptimal development of the baby. This study aims to evaluate the effectiveness of a targeted intervention (HUGS: Happiness Understanding Giving and Sharing) for enhancing the mother-infant relationship.

Detailed description: Post-partum depression (PPD) is the most common psychological pathology following childbirth and affects 12% of women in France. This pathology may impair the mother-infant relationship and lead to suboptimal development of the baby in the short and long-term. The prevalence of early interaction disorders is estimated at 73% among women suffering from PPD. Although treatments for PDD are effective, the mother-infant interaction remains impaired, as well as the short, medium and long-term development of the child. It is therefore essential to develop at a very early stage an intervention specifically targeting the mother-infant interaction, and to integrate this care into the general care given to mothers suffering from PPD.

A short cognitive-behavioural therapy intervention focused on improving the quality of the mother-infant relationship (the HUGS program: Happiness, Understanding, Giving and Sharing) has been created and validated by Prof. Jeannette Milgrom's Australian team. The objective of our study is to evaluate the effectiveness of the HUGS programme compared to a Playtime control group using a randomised controlled trial in a population of women suffering from PPD and being cared for in 7 French maternity hospitals. The comparison will be made 6 months after intervention initiation using "Factor 1: Mother Positive Affective Involvement and Verbalization" of the PCERA (Parent-Child Early Relational Assessment) mother-child interaction evaluation scale.

Eligibility criteria: Inclusion criteria regarding the mother:

* Person affiliated or beneficiary of a social security plan;
* Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research);
* Woman who gave birth in one of the maternity hospitals participating in the study;
* Diagnosis of postpartum depression made by the perinatal psychiatry team according to the clinical criteria of the DSM-5;
* Time to onset of depressive symptoms within the first 12 months after childbirth;
* Treatment for postpartum depression that started at least 8 weeks ago with improved mood as assessed by the psychiatrist.

Inclusion criteria for the baby:

* Baby aged less than 1 year at inclusion;
* Twins will be able to participate in the study and benefit from the interventions;

Non-inclusion criteria concerning the mother:

* Uncontrolled substance use disorder;
* Presence of suicidal ideas at inclusion;
* Manic episode of a bipolar disease
* Psychiatric pathology decompensated upon inclusion and corresponding to the following list: Schizophrenic disorder, Schizoaffective disorder, Mood disorders with psychotic symptoms;
* Non French speaker.

Non-inclusion criteria for the baby:

- Baby hospitalized or having sustained medical care upon inclusion in the context of a somatic pathology.

Primary outcomes:
measure: Mother-infant interaction
timeFrame: 6 months after the end of the intervention
Secondary outcomes:
measure: Mothers' stress
timeFrame: Right before the intervention (Baseline)
measure: Mothers' stress
timeFrame: Right at the end of the intervention : 28 days after the start of the study
measure: Mothers' stress
timeFrame: 6 months after the end of the intervention
Other outcomes:
measure: Socio-economic analysis
timeFrame: 6 months after the end of the intervention
Locations:
city: Bordeaux
country: France
facility: Bordeaux Public Hospital
city: Le Havre
country: France
facility: Havre Public Hospital Maternity
city: Reims
country: France
facility: Reims Public Hospital Maternity
city: Rouen
country: France
facility: Rouen Public Hospital Maternity
city: Toulouse
country: France
facility: Toulouse Child Guidance
city: Toulouse
country: France
facility: Toulouse Joseph Ducuing Maternity
city: Toulouse
country: France
facility: Toulouse Public Hospital Maternity
Study officials:
affiliation: University Hospital, Toulouse
name: Carole GENTILLEAU, MD
role: PRINCIPAL_INVESTIGATOR
References: