Post Partum DepressionHUGSNCT05209789
Early Intervention to Protect the Mother-Child Relationship After Postpartum Depression
A study testing HUGS and Playtime in people with Post Partum Depression, run by University Hospital, Toulouse at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Post Partum Depression
- What is being tested?
- HUGS and Playtime
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 7 sitesFrance
- Study dates
- 18 Dec 2023to 25 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Bordeaux Public Hospital
Bordeaux
Havre Public Hospital Maternity
Le Havre
Reims Public Hospital Maternity
Reims
Rouen Public Hospital Maternity
Rouen
Toulouse Child Guidance
Toulouse
Toulouse Joseph Ducuing Maternity
Toulouse
Toulouse Public Hospital Maternity
Toulouse
About this study
Official title: HUGS : Early Intervention to Protect the Mother-Child Relationship After Postpartum Depression: A Randomized Comparative Trial of the Cognitive Behavioral Therapy Program
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.
Read the 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.
- Conditions
- Post Partum Depression
- Being tested
- HUGS, Playtime
- Keywords
- Mother-baby interaction, Group therapy, Cognitive behavioral therapy, mother-infant relationship
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HUGSBehavioural
Group therapy with the participation of two therapist positively encouraging mother-baby interactions in a non-judgmental manner
PlaytimeBehavioural
Very little intervention from the therapists
| Study group | Role | What they receive |
|---|---|---|
| HUGS therapy | Experimental | 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. Receives: Behavioral: HUGS |
| Playtime | Active comparator | 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. Receives: Behavioral: Playtime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother-infant interaction
The primary endpoint will be the score of factor 1 ("positive affective commitment of the mother as well as her verbalization skills with her baby") of the mother-baby interaction assessment scale The Parent-Child Early Relational Assessment ( PCERA) between the two study groups : HUGS and Playtime.
PCERA factor 1 will be measured by analysis of video footage of each mother-baby duo by two independent blind assessors from allocation groups.The score taken into account will be the consensus score between the two evaluators.
Measured: 6 months after the end of the intervention
Secondary outcomes (3)
Mothers' stress
Parental Stress Index (PSI-3) measured on both groups. This index is categorised in various items (stressors), each including a Likert style index from 1 to 5. The PSI-3 sums up all the items into a score : a high score representing a high stress for the parent.
Measured: Right before the intervention (Baseline)
Mothers' stress
Parental Stress Index (PSI-3) measured on both groups. This index is categorised in various items (stressors), each including a Likert style index from 1 to 5. The PSI-3 sums up all the items into a score : a high score representing a high stress for the parent.
Measured: Right at the end of the intervention : 28 days after the start of the study
Mothers' stress
Parental Stress Index (PSI-3) measured on both groups. This index is categorised in various items (stressors), each including a Likert style index from 1 to 5. The PSI-3 sums up all the items into a score : a high score representing a high stress for the parent.
Measured: 6 months after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start18 Dec 2023
- Primary completion25 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, interregional, comparative, prospective therapeutic study in 2 parallel groups (1: 1), superiority, randomized, blinded for the evaluation of the primary endpoint.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carole GENTILLEAU, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209789
- Sponsor's protocol ID
- RC31/21/0166
- Acronym
- HUGS
- Status last verified
- May 2026
- First submitted
- 11 Jan 2022
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HUGS : Early Intervention to Protect the Mother-Child Relationship After Postpartum Depression: A Randomized Comparative Trial of the Cognitive Behavioral Therapy Program
- ClinicalTrials.gov ID
- NCT05209789
- Acronym / sponsor ID
- HUGS / RC31/21/0166
- Conditions
- Post Partum Depression
- Keywords
- Mother-baby interaction, Group therapy, Cognitive behavioral therapy, mother-infant relationship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Multicenter, interregional, comparative, prospective therapeutic study in 2 parallel groups (1: 1), superiority, randomized, blinded for the evaluation of the primary endpoint.
| Arm | Type | Receives |
|---|---|---|
| HUGS therapy | Experimental | Behavioral: HUGSA 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. |
| Playtime | Active comparator | Behavioral: PlaytimeThe 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HUGSGroup therapy with the participation of two therapist positively encouraging mother-baby interactions in a non-judgmental manner | Behavioural | HUGS therapy |
| PlaytimeVery little intervention from the therapists | Behavioural | Playtime |
Primary outcome
Mother-infant interaction
Time frame: 6 months after the end of the intervention
The primary endpoint will be the score of factor 1 ("positive affective commitment of the mother as well as her verbalization skills with her baby") of the mother-baby interaction assessment scale The Parent-Child Early Relational Assessment ( PCERA) between the two study groups : HUGS and Playtime. PCERA factor 1 will be measured by analysis of video footage of each mother-baby duo by two independent blind assessors from allocation groups.The score taken into account will be the consensus score between the two evaluators.
3 secondary outcomes
Mothers' stress
Time frame: Right before the intervention (Baseline)
Mothers' stress
Time frame: Right at the end of the intervention : 28 days after the start of the study
Mothers' stress
Time frame: 6 months after the end of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carole GENTILLEAU, MD principal investigator
University Hospital, Toulouse
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HUGS and Playtime in people with Post Partum Depression, run by University Hospital, Toulouse at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother-infant interaction (time frame: 6 months after the end of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.