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Recruiting NCT05585164

Engage & Connect: A Psychotherapy for Postpartum Depression

No phase Interventional Postpartum Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Engage & Connect (E&C), Symptom Review and Psychoeducation (SRP).
Who it may be relevant to
Registry conditions: Postpartum Depression. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral Engage & Connect (E&C)
    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.
  • Behavioral Symptom Review and Psychoeducation (SRP)
    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 outcome measures

  • Change in Edinburgh Postnatal Depression Scale (EPDS) [Time frame: the EPDS will be measured Weekly for 9 weeks]
Secondary outcome measures (2)
  • Change in Behavioral Activation for Depression Scale (BADS) [Time frame: Baseline, Early Treatment (Week 3), Mid-treatment (Week 6) and Post Treatment (Week 9)]
  • Change in Social Reward Processing on STAR task [Time frame: Baseline, Early Treatment (Week 3), Mid-treatment (Week 6) and Post Treatment (Week 9)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Weill Cornell Medicine — New York

Identifiers

NCT: NCT05585164 · 22-04024696

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗