Postpartum DepressionNCT05585164
Engage & Connect: A Psychotherapy for Postpartum Depression
A study testing Engage & Connect (E&C) and Symptom Review and Psychoeducation (SRP) in people with Postpartum Depression, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Engage & Connect (E&C) and Symptom Review and Psychoeducation (SRP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Up to 1 year post-delivery
- Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10.
- 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
Who cannot join
- Intent or plan to attempt suicide in the near future
- Ongoing psychotherapy (no more than once every 8 weeks or during the duration of the intervention)
- Active substance abuse or dependence
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10022
Nili Solomonov, PhD, 844 999 8746 ext. 718, nis2051@med.cornell.edu
About this study
Official title: Engage & Connect: A Novel Social Reward Psychotherapy for Postpartum Depression
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.
Read the 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.
- Conditions
- Postpartum Depression
- Being tested
- Engage & Connect (E&C), Symptom Review and Psychoeducation (SRP)
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engage & Connect (E&C)Behavioural
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.
Symptom Review and Psychoeducation (SRP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Engage & Connect | Experimental | Not described Receives: Behavioral: Engage & Connect (E&C) |
| Symptom Review and Psychoeducation | Experimental | Not described Receives: Behavioral: Symptom Review and Psychoeducation (SRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Edinburgh Postnatal Depression Scale (EPDS)
Measure of depression Severity. Scores range from 0 (no depression severity) to 30 (high depression severity)
Measured: the EPDS will be measured Weekly for 9 weeks
Secondary outcomes (2)
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).
Measured: 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.
Measured: Baseline, Early Treatment (Week 3), Mid-treatment (Week 6) and Post Treatment (Week 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Nov 2022
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nili Solomonov, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585164
- Sponsor's protocol ID
- 22-04024696
- Status last verified
- Aug 2026
- First submitted
- 14 Oct 2022
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engage & Connect: A Novel Social Reward Psychotherapy for Postpartum Depression
- ClinicalTrials.gov ID
- NCT05585164
- Acronym / sponsor ID
- 22-04024696
- Conditions
- Postpartum Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Engage & Connect | Experimental | Behavioral: Engage & Connect (E&C) |
| Symptom Review and Psychoeducation | Experimental | Behavioral: Symptom Review and Psychoeducation (SRP) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Up to 1 year post-delivery
- Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10.
- 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
Key exclusion criteria (6 listed)
- Intent or plan to attempt suicide in the near future
- Ongoing psychotherapy (no more than once every 8 weeks or during the duration of the intervention)
- Active substance abuse or dependence
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Engage & 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. | Behavioural | Engage & Connect |
| Symptom 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. | Behavioural | Symptom Review and Psychoeducation |
Primary outcome
Change in Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 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)
2 secondary outcomes
Change in Behavioral Activation for Depression Scale (BADS)
Time frame: Baseline, Early Treatment (Week 3), Mid-treatment (Week 6) and Post Treatment (Week 9)
Change in Social Reward Processing on STAR task
Time frame: Baseline, Early Treatment (Week 3), Mid-treatment (Week 6) and Post Treatment (Week 9)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Postpartum Depression
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Recruiting
Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression
Depression During Pregnancy, Postpartum Depression (PPD)
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
RecruitingEarly Phase 1
A Web-based Intervention Program for Postpartum Depression
Postpartum Depression (PPD), Web-based Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nili Solomonov, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engage & Connect (E&C) and Symptom Review and Psychoeducation (SRP) in people with Postpartum Depression, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nili Solomonov, PhD (212-746-5886, nis2051@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Edinburgh Postnatal Depression Scale (EPDS) (time frame: the EPDS will be measured Weekly for 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.