Psychotherapy program for postpartum depression
Engage & Connect: A Novel Social Reward Psychotherapy for Postpartum Depression
This study is testing a new online therapy program for new moms with postpartum depression to see if it can help them feel less isolated and improve their mood.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Sex | Female |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05585164 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates a novel psychotherapy called Engage & Connect, designed to reduce postpartum depression by enhancing social engagement and support. Over a 9-week period, participants will receive either the Engage & Connect intervention or a Symptom Review and Psychoeducation intervention, both delivered remotely. The study aims to assess changes in social isolation, social reward processing, and depression severity among mothers experiencing postpartum depression.
Who should consider this trial
Good fit: Ideal candidates are mothers who are up to one year postpartum and have a moderate level of postpartum depression as indicated by an EPDS score of 10 or higher.
Not a fit: Patients with severe psychiatric conditions, active substance abuse, or those currently undergoing psychotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the mental health and social well-being of mothers suffering from postpartum depression.
How similar studies have performed: Other studies have shown promise in using psychotherapy to address postpartum depression, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Up to 1 year post-delivery 2. Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10. 3. Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 10 weeks. 4. Capacity to provide consent for research assessment and treatment. 5. Speaks English proficiently Exclusion Criteria: 1. Intent or plan to attempt suicide in the near future 2. Ongoing psychotherapy (no more than once every 8 weeks or during the duration of the intervention) 3. Active substance abuse or dependence 4. Severe fetal anomalies, stillbirth or infant death at time of enrollment for index pregnancy 5. History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, persistent depressive disorder, or specific phobia. 6. Use of psychotropic drugs or cholinesterase inhibitors other than use of ≤ 0.5 mg of lorazepam daily up to seven times per week.
Where this trial is running
New York, New York
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Nili Solomonov, PhD — Weill Medical College of Cornell University
- Study coordinator: Nili Solomonov, PhD
- Email: nis2051@med.cornell.edu
- Phone: 844 999 8746
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.