Engage & Connect: A Psychotherapy for Postpartum Depression

Study Overview
=================
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.

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

Conditions
-----------------
Postpartum Depression

Intervention / Treatment
-----------------
* Behavioral: Engage & Connect


Participation Criteria
=================
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.
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Engage & Connect<br> | Behavioral: Engage & Connect<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) |