Engage & Connect: A Psychotherapy for Postpartum Depression

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05585164

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Depression	Behavioral: Engage & Connect	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Engage & Connect	Behavioral: Engage & Connect 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.

Arm

Intervention/Treatment

Experimental: Engage & Connect

Behavioral: Engage & Connect

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.

Outcome Measures

Primary Outcome Measures

Change in Edinburgh Postnatal Depression Scale (EPDS) [the EPDS will be measured Weekly for 9 weeks]
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) [Baseline, Early Treatment (Week 3), Mid-treatment (Week 6) and Post Treatment (Week 9)]
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 [Baseline, Early Treatment (Week 3), Mid-treatment (Week 6) and Post Treatment (Week 9)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medicine	New York	New York	United States	10022

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator: Nili Solomonov, PhD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT05585164

Other Study ID Numbers:

22-04024696

First Posted:

Oct 18, 2022

Last Update Posted:

Nov 9, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression, Postpartum

Depression

Depressive Disorder

Study Results

No Results Posted as of Nov 9, 2022