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Engage & Connect: A Psychotherapy for Postpartum Depression

Primary Purpose

Postpartum Depression

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Engage & Connect

About this trial

This is an interventional treatment trial for Postpartum Depression

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

4-12 weeks post-delivery
Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10.
Mini Mental Status Exam (MMSE) ≤ 1 SD below the mean score for patient's age and education
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:

Ongoing psychotherapy (no more than once every 8 weeks or during the duration of the intervention)
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.

Sites / Locations

Weill Cornell MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Engage & Connect

Arm Description

Outcomes

Primary Outcome Measures

Change in Edinburgh Postnatal Depression Scale (EPDS)

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

Secondary Outcome Measures

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).

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.

Full Information

NCT ID

NCT05585164

First Posted

October 14, 2022

Last Updated

October 19, 2023

Sponsor

Weill Medical College of Cornell University

1. Study Identification

Unique Protocol Identification Number

NCT05585164

Brief Title

Engage & Connect: A Psychotherapy for Postpartum Depression

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2022 (Actual)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study tests a novel psychotherapy, Engage & Connect, tailored to reduce postpartum depression. The study includes 9 weeks of psychotherapy, 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, a 9-week psychotherapy program that focuses on increasing meaningful social activities with significant others. This study will test the treatment benefits of Engage & Connect and changes in thoughts, feelings and behaviors during therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postpartum Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Engage & Connect

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Engage & Connect

Intervention Description

Engage & Connect, is a remotely-delivered extension of Engage psychotherapy. It is aimed to increase engagement in rewarding social activities and in turn, reduce suicidality. In Engage & Connect, depressed middle-aged and older adults with suicidal ideation work with a therapist to develop "action plans" to pursue rewarding social activities of their choice.

Primary Outcome Measure Information:

Title

Change in Edinburgh Postnatal Depression Scale (EPDS)

Description

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 Outcome Measure Information:

Title

Change in Behavioral Activation for Depression Scale (BADS)

Description

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)

Title

Change in Social Reward Processing on STAR task

Description

Time Frame

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

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 4-12 weeks post-delivery Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10. Mini Mental Status Exam (MMSE) ≤ 1 SD below the mean score for patient's age and education 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: Ongoing psychotherapy (no more than once every 8 weeks or during the duration of the intervention) 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nili Solomonov, PhD

Phone

844 999 8746

Ext

718

nis2051@med.cornell.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Dustin Phan

Phone

212-746-2749

dup4001@med.cornell.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nili Solomonov, PhD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Cornell Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10022

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nili Solomonov, PhD

Phone

844-999-8746

Ext

718

nis2051@med.cornell.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Engage & Connect: A Psychotherapy for Postpartum Depression

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