Health TrialsbyHealthPanel

Engage & Connect: A Psychotherapy for Postpartum Depression

ConditionPostpartum Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorWeill Medical College of Cornell University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Engage & Connect (E&C)

    Behavioral

    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.

  • Symptom Review and Psychoeducation (SRP)

    Behavioral

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Engage & ConnectExperimental treatment 1 intervention
Group B: Symptom Review and PsychoeducationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Edinburgh Postnatal Depression Scale (EPDS)

Measure of depression Severity. Scores range from 0 (no depression severity) to 30 (high depression severity)

Time frame
the EPDS will be measured Weekly for 9 weeks

Secondary outcomes

1

Change in Behavioral Activation for Depression Scale (BADS)

25-item measure self-report measure of behavioral activation. Scores range from 0 (very low behavioral activation) to 150 (high behavioral activation).

Time frame
Baseline, Early Treatment (Week 3), Mid-treatment (Week 6) and Post Treatment (Week 9)
2

Change in Social Reward Processing on STAR task

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.

Time frame
Baseline, Early Treatment (Week 3), Mid-treatment (Week 6) and Post Treatment (Week 9)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

Source ClinicalTrials.gov
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