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Clinical Trials/NCT05585164
NCT05585164
Recruiting
Not Applicable

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

Weill Medical College of Cornell University1 site in 1 country60 target enrollmentNovember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postpartum Depression
Sponsor
Weill Medical College of Cornell University
Enrollment
60
Locations
1
Primary Endpoint
Change in Edinburgh Postnatal Depression Scale (EPDS)
Status
Recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
July 1, 2030
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Up to 1 year post-delivery
  • Edinburgh Postnatal Depression Scale (EPDS) score ≥
  • 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.

Outcomes

Primary Outcomes

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

  • 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 Sites (1)

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