NCT05585164 Engage & Connect: A Psychotherapy for Postpartum Depression
| NCT ID | NCT05585164 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Postpartum Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2030-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-11-01 with a primary completion date of 2030-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This randomized controlled trial compares a novel psychotherapy, Engage \& Connect, with a Symptom Review and Psychoeducation intervention, tailored to reduce postpartum depression. The study includes 9-weeks interventions, delivered remotely. It will examine changes in social isolation, processing of social rewards and depression severity over 9 weeks of treatment.
Eligibility 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.
Contact & Investigator
Nili Solomonov, PhD
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT05585164 clinical trial?
This trial is open to female participants only, studying Postpartum Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05585164 currently recruiting?
Yes, NCT05585164 is actively recruiting participants. Contact the research team at nis2051@med.cornell.edu for enrollment information.
Where is the NCT05585164 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05585164 clinical trial?
NCT05585164 is sponsored by Weill Medical College of Cornell University. The principal investigator is Nili Solomonov, PhD at Weill Medical College of Cornell University. The trial plans to enroll 60 participants.
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