Engage & Connect: A Psychotherapy for Postpartum Depression
Recruiting · NCT05585164 · Interventional (participants receive a specific treatment) · Lead sponsor: Weill Medical College of Cornell University
View the official record on ClinicalTrials.gov →Interventions studied
Engage & Connect (E&C)Symptom Review and Psychoeducation (SRP)
What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Weill Cornell Medicine - New York, New York, United States