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RECRUITING Not applicable ClinicalTrials.gov

Engage & Connect: A Psychotherapy for Postpartum Depression

Sponsor: Weill Medical College of Cornell University • ClinicalTrials.gov ID: NCT05585164

Registry updated: 2026-08-20
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Description

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.

Interventions

  • Engage & Connect (E&C) (Behavioral)
    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) (Behavioral)
    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.

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.

Conditions

Postpartum Depression

Locations

  • Weill Cornell Medicine — New York, New York, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record