Intervention to improve mother-baby relationships after postpartum depression
HUGS : Early Intervention to Protect the Mother-Child Relationship After Postpartum Depression: A Randomized Comparative Trial of the Cognitive Behavioral Therapy Program
This study is testing a program called HUGS to see if it can help mothers with postpartum depression build better relationships with their babies compared to a regular playtime group.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 7 sites (Bordeaux and 6 other locations) |
| Trial ID | NCT05209789 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the HUGS program, a cognitive-behavioral therapy intervention designed to enhance the mother-infant relationship in women suffering from postpartum depression (PPD). Conducted in seven French maternity hospitals, the study compares the HUGS intervention to a Playtime control group. The effectiveness will be assessed six months after the intervention using a specific evaluation scale for mother-child interactions. The aim is to address the impairments in mother-infant relationships that often accompany PPD and promote better developmental outcomes for infants.
Who should consider this trial
Good fit: Ideal candidates for this study are women diagnosed with postpartum depression within 12 months of childbirth who are receiving treatment and have given birth in participating maternity hospitals.
Not a fit: Patients with uncontrolled substance use disorders or suicidal ideation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of mother-infant interactions and promote healthier developmental outcomes for babies of mothers with postpartum depression.
How similar studies have performed: Other studies have shown success with similar cognitive-behavioral approaches to improve mother-infant relationships, indicating potential for this intervention.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bordeaux and 6 other locations
- Bordeaux Public Hospital — Bordeaux, France (Recruiting)
- Havre Public Hospital Maternity — Le Havre, France (Recruiting)
- Reims Public Hospital Maternity — Reims, France (Recruiting)
- Rouen Public Hospital Maternity — Rouen, France (Recruiting)
- Toulouse Child Guidance — Toulouse, France (Not_yet_recruiting)
- Toulouse Joseph Ducuing Maternity — Toulouse, France (Not_yet_recruiting)
- Toulouse Public Hospital Maternity — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Carole GENTILLEAU, MD — University Hospital, Toulouse
- Study coordinator: Carole GENTILLEAU, MD
- Email: gentilleau.c@chu-toulouse.fr
- Phone: 33-5 61 77 13 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.