RECRUITING

Engage & Connect: A Psychotherapy for Postpartum Depression

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-11-01
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05585164

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Up to 1 year post-delivery
  2. 2. Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10.
  3. 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. 4. Capacity to provide consent for research assessment and treatment.
  5. 5. Speaks English proficiently
  1. 1. Intent or plan to attempt suicide in the near future
  2. 2. Ongoing psychotherapy (no more than once every 8 weeks or during the duration of the intervention)
  3. 3. Active substance abuse or dependence
  4. 4. Severe fetal anomalies, stillbirth or infant death at time of enrollment for index pregnancy
  5. 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. 6. Use of psychotropic drugs or cholinesterase inhibitors other than use of ≤ 0.5 mg of lorazepam daily up to seven times per week.

Contacts and Locations

Study Contact

Nili Solomonov, PhD
CONTACT
844 999 8746
nis2051@med.cornell.edu
Maddy Schier
CONTACT
646-289-5271
mas4019@med.cornell.edu

Principal Investigator

Nili Solomonov, PhD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine
New York, New York, 10022
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Nili Solomonov, PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-01
Study Completion Date2025-07

Study Record Updates

Study Start Date2022-11-01
Study Completion Date2025-07

Terms related to this study

Additional Relevant MeSH Terms

  • Postpartum Depression