Recruiting

Engage & Connect

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05585164

Conditions

Postpartum Depression

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Engage & Connect (E&C)

Symptom Review and Psychoeducation (SRP)

Study Details

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.

Conditions

Postpartum Depression

Study ID

NCT05585164

Start date

Nov 1, 2022

Status verified date

Aug, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Jul, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Engage & Connect

experimental: Symptom Review and Psychoeducation

Interventions

Engage & Connect (E&C)

Engage \& Connect, is a remotely-delivered extension of Engage psychotherapy. It is aimed to increase engagement in rewarding social activities and in turn, reduce postpartum depression. In each session, the therapist will work with the patient to develop "action plans" to pursue rewarding social activities of their choice with the goal of reducing social isolation.

Symptom Review and Psychoeducation (SRP)

SPR is a remotely-delivered intervention aimed to increase knowledge of postpartum depression and monitor mental health changes. In each session, the therapist will review the participant's symptoms and discuss information related to postpartum depression and changes after birth.

Primary outcome measure

  • Change in Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: the EPDS will be measured Weekly for 9 weeks ]

Central Contacts and Locations

Central contacts

Nili Solomonov, PhD

212-746-5886nis2051@med.cornell.edu

Joohyun Kang

914-270-7732jok4025@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10022

Contacts

Nili Solomonov, PhD

844 999 8746nis2051@med.cornell.edu

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-08-20.