Engage & Connect: A Psychotherapy for Postpartum Depression

NCT05585164 | Recruiting

• 1 other identifier: 22-04024696
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Edinburgh Postnatal Depression Scale (EPDS)

  Measure of depression Severity. Scores range from 0 (no depression severity) to 30 (high depression severity)

  the EPDS will be measured Weekly for 9 weeks

Secondary Outcomes (2)

• Change in Behavioral Activation for Depression Scale (BADS)

  Baseline, Early Treatment (Week 3), Mid-treatment (Week 6) and Post Treatment (Week 9)

• Change in Social Reward Processing on STAR task

  Baseline, Early Treatment (Week 3), Mid-treatment (Week 6) and Post Treatment (Week 9)

Study Arms (2)

Engage & Connect

EXPERIMENTAL

Behavioral: Engage & Connect (E&C)

Symptom Review and Psychoeducation

EXPERIMENTAL

Behavioral: Symptom Review and Psychoeducation (SRP)

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.

Engage & Connect

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.

Symptom Review and Psychoeducation

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Up to 1 year post-delivery
• Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10.
• 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.
• Capacity to provide consent for research assessment and treatment.
• Speaks English proficiently

You may not qualify if:

• Intent or plan to attempt suicide in the near future
• Ongoing psychotherapy (no more than once every 8 weeks or during the duration of the intervention)
• Active substance abuse or dependence
• Severe fetal anomalies, stillbirth or infant death at time of enrollment for index pregnancy
• History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, persistent depressive disorder, or specific phobia.
• Use of psychotropic drugs or cholinesterase inhibitors other than use of ≤ 0.5 mg of lorazepam daily up to seven times per week.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10022, United States

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Nili Solomonov, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nili Solomonov, PhD

CONTACT

844 999 8746; nis2051@med.cornell.edu

Maddy Schier

CONTACT

646-289-5271; mas4019@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 18, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)