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NCT Number: NCT05585164

Engage & Connect: A Psychotherapy for Postpartum Depression

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10022, United States

Location status: Recruiting

Location contact

Nili Solomonov, PhD

CONTACT

[email protected]

844 999 8746 ext. 718

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: the EPDS will be measured Weekly for 9 weeks

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

Secondary outcomes

  1. Change in Behavioral Activation for Depression Scale (BADS)

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

    25-item measure self-report measure of behavioral activation. Scores range from 0 (very low behavioral activation) to 150 (high behavioral activation).

  2. Change in Social Reward Processing on STAR task

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

    Performance on the "Social Task for Assessment of Reward" [STAR]. Measured by reaction time to social feedback during reward trials on the task. Higher values of reaction time indicate slower response to social feedback.

Study contacts

Contact information is provided by the study sponsor or research team.

Maddy Schier

CONTACT

[email protected]

646-289-5271 ext. 720

Nili Solomonov, PhD

CONTACT

[email protected]

844 999 8746 ext. 718

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

Engage & Connect: A Novel Social Reward Psychotherapy for Postpartum Depression

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Oct 18, 2022
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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