Clinical trial NCT05585164: Engage & Connect: A Psychotherapy for Postpartum Depression
Official title: Engage & Connect: A Novel Social Reward Psychotherapy for Postpartum Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Depression
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 (E\&C), a 9-week psychotherapy program that focuses on increasing meaningful social activities with significant others. This study will be a pilot Randomized Controlled Trial that will compare the 9-week E\&C course for mothers with postpartum depression with a Symptom Review and Psychoeducation condition (SRP) for mothers with postpartum depression.

Eligibility criteria: Inclusion Criteria:

1. Up to 1 year post-delivery
2. Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10.
3. 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.
4. Capacity to provide consent for research assessment and treatment.
5. Speaks English proficiently

Exclusion Criteria:

1. Intent or plan to attempt suicide in the near future
2. Ongoing psychotherapy (no more than once every 8 weeks or during the duration of the intervention)
3. Active substance abuse or dependence
4. Severe fetal anomalies, stillbirth or infant death at time of enrollment for index pregnancy
5. History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, persistent depressive disorder, or specific phobia.
6. Use of psychotropic drugs or cholinesterase inhibitors other than use of ≤ 0.5 mg of lorazepam daily up to seven times per week.

Primary outcomes:
measure: Change in Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: the EPDS will be measured Weekly for 9 weeks
Secondary outcomes:
measure: Change in Behavioral Activation for Depression Scale (BADS)
timeFrame: Baseline, Early Treatment (Week 3), Mid-treatment (Week 6) and Post Treatment (Week 9)
measure: Change in Social Reward Processing on STAR task
timeFrame: Baseline, Early Treatment (Week 3), Mid-treatment (Week 6) and Post Treatment (Week 9)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Nili Solomonov, PhD
role: PRINCIPAL_INVESTIGATOR
References: