HUGS : Early Intervention to Protect the Mother-Child Relationship After Postpartum Depression: A Randomized Comparative Trial of the Cognitive Behavioral Therapy Program

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

• Baby aged less than 1 year at inclusion;

• Twins will be able to participate in the study and benefit from the interventions;

Locations
Other Locations
France
Bordeaux Public Hospital
RECRUITING
Bordeaux
Havre Public Hospital Maternity
RECRUITING
Le Havre
Reims Public Hospital Maternity
RECRUITING
Reims
Rouen Public Hospital Maternity
RECRUITING
Rouen
Toulouse Child Guidance
NOT_YET_RECRUITING
Toulouse
Toulouse Joseph Ducuing Maternity
NOT_YET_RECRUITING
Toulouse
Toulouse Public Hospital Maternity
RECRUITING
Toulouse
Contact Information
Primary
Carole GENTILLEAU, MD
gentilleau.c@chu-toulouse.fr
33-5 61 77 13 15
Backup
Isabelle KIEFFER, CRA
kieffer.i@chu-toulouse.fr
Time Frame
Start Date: 2023-12-18
Estimated Completion Date: 2026-12
Participants
Target number of participants: 104
Treatments
Experimental: HUGS therapy
A structured group intervention that aims to observe mother's behavior and responses with her baby, promote mother-baby interaction through play, and provide tools for positive interaction. This therapy involves cognitive and behavioral work. Therapists observe the mother-baby duo and share their observations from a perspective of encouragement and support. A playful and non-judgmental interaction is cultivated within the group. The main objective is to change the negative trajectory of mother-child interactions through tools from cognitive-behavioral therapies as well as using knowledge about child development.
Active_comparator: Playtime
The participants assigned to the control group will also be in the presence of two therapists, allowing to reproduce the framework of the HUGS therapy. The difference will be the lack of direct therapeutic intervention from the therapists, but only classic psychoeducational guidance. The mothers are offered a time to play with their baby as well as the opportunity to discuss and share their experiences with other mothers, which is generally seen as supportive by them.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov