Postpartum Depression
Conditions
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.
Interventions
BEHAVIORALEngage & Connect (E&C)
Engage \& Connect, is a remotely-delivered extension of Engage psychotherapy. It is aimed to increase engagement in rewarding social activities and in turn, reduce postpartum depression. In each session, the therapist will work with the patient to develop "action plans" to pursue rewarding social activities of their choice with the goal of reducing social isolation.
BEHAVIORALSymptom Review and Psychoeducation (SRP)
SPR is a remotely-delivered intervention aimed to increase knowledge of postpartum depression and monitor mental health changes. In each session, the therapist will review the participant's symptoms and discuss information related to postpartum depression and changes after birth.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTNili Solomonov, PhD
CONTACTJoohyun Kang
PRINCIPAL_INVESTIGATORNili Solomonov, PhD
Weill Medical College of Cornell University
Outcome results
None listed