Engage & Connect: A Psychotherapy for Postpartum Depression

Not Applicable

Recruiting

• Conditions: Postpartum Depression
• Interventions: Behavioral: Engage & Connect (E&C); Behavioral: Symptom Review and Psychoeducation (SRP)

• Registration Number: NCT05585164
• Lead Sponsor: Weill Medical College of Cornell University

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.

Study Timeline

• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-18
• Study Start: 2022-11-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Engage & Connect	Engage & Connect (E&C)	-
Symptom Review and Psychoeducation	Symptom Review and Psychoeducation (SRP)	-

Primary Outcome Measures

Name	Time	Method
Change in Edinburgh Postnatal Depression Scale (EPDS)	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 Outcome Measures

Name	Time	Method
Change in Behavioral Activation for Depression Scale (BADS)	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).
Change in Social Reward Processing on STAR task	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.

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States