Engage & Connect: A Psychotherapy for Postpartum Depression

Postpartum Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05585164
• Other study ID #: 22-04024696
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: July 2027

Study information

• Verified date: October 2023
• Source: Weill Medical College of Cornell University
• Contact: Nili Solomonov, PhD
• Phone: 844 999 8746
• Email: nis2051[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2027
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. 4-12 weeks post-delivery

2. Edinburgh Postnatal Depression Scale (EPDS) score = 10.

3. Mini Mental Status Exam (MMSE) = 1 SD below the mean score for patient's age and education

4. 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.

5. Capacity to provide consent for research assessment and treatment.

6. Speaks English proficiently

Exclusion Criteria:

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

2. Severe fetal anomalies, stillbirth or infant death at time of enrollment for index pregnancy

3. History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, persistent depressive disorder, or specific phobia.

4. Use of psychotropic drugs or cholinesterase inhibitors other than use of = 0.5 mg of lorazepam daily up to seven times per week.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Edinburgh Postnatal Depression Scale (EPDS)	Measure of depression Severity. Scores range from 0 (no depression severity) to 30 (high depression severity)	the EPDS will be measured Weekly for 9 weeks
Secondary	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).	Baseline, Early Treatment (Week 3), Mid-treatment (Week 6) and Post Treatment (Week 9)
Secondary	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.	Baseline, Early Treatment (Week 3), Mid-treatment (Week 6) and Post Treatment (Week 9)