Engage & Connect: A Psychotherapy for Postpartum Depression

NCT ID: NCT05585164

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2030-07-31

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.

Detailed Description

Postpartum depression is linked with decreased motivation to seek rewarding activities and enjoyment of pleasurable experiences. Social isolation and low perceived social support predict persistence of postpartum depression. Engagement in rewarding social activities with significant others may increase motivation and enjoyment, motivating utilization of a therapy that addresses social isolation and reward response. The investigators developed Engage & Connect (E&C), a 9-week psychotherapy program that focuses on increasing meaningful social activities with significant others. This study will be a pilot Randomized Controlled Trial that will compare the 9-week E&C course for mothers with postpartum depression with a Symptom Review and Psychoeducation condition (SRP) for mothers with postpartum depression.

Conditions

Postpartum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Engage & Connect

Group Type: EXPERIMENTAL

Engage & Connect (E&C)

Intervention Type: 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

Group Type: EXPERIMENTAL

Symptom Review and Psychoeducation (SRP)

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nili Solomonov, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nili Solomonov, PhD

Role: CONTACT

nis2051@med.cornell.edu

844 999 8746 ext. 718

Maddy Schier

Role: CONTACT

mas4019@med.cornell.edu

646-289-5271 ext. 720

Facility Contacts

Nili Solomonov, PhD

Role: primary

nis2051@med.cornell.edu

844 999 8746 ext. 718

Other Identifiers

22-04024696

Identifier Type: -

Identifier Source: org_study_id