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CODEPAD-III (Collaborative Outcomes of DEpression and Pain Associated With Delivery-III)

Not Yet RecruitingNA

Sponsor: KK Women's and Children's Hospital

Conditions: Depression, Postpartum, Pain, Mental Health

Interventions: Collaborative Psychological Model (CPM), Intervention common to both arms, Telephone-based support (Control)

The childbirth process is associated with increased risk of having depression and persistent pain which may have adverse effects to mothers and their babies. There is a lack of routine effective programs in current healthcare practice to address, risk stratify and reduce depression and persistent pain after childbirth. The study site proposes a Collaborative Psychological Model (CPM) consisting of music listening, customized mobile application on psychological strategies, telephone-based support, with monitoring (mobile electronic surveys, wearable-based vital sign monitoring) to effectively prevent, detect, monitor, and treat depression and persistent pain after childbirth. The study will determine if using the CPM will reduce the risk of having depression associated with childbirth. The study will also find out whether the CPM will reduce the depressive symptoms in women who undergo labor that may have increased depression risk. This clinical study will involve 2042 women undergoing childbirth at KK Hospital. In addition, up to 1428 patients' partners (fathers) will also be recruited for the week 8 postpartum assessment. The study findings will improve healthcare for women in the community by incorporating digital psychological strategies to manage depression and persistent pain after childbirth. The CPM will also guide future directions to customize an individual's healthcare needs and to improve transition from hospital to community care for women after childbirth.

Eligibility overview

Sex: ALL

Age: 21 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria (Mothers):

* Healthy (American Society of Anesthesiologists (ASA) physical status II);
* Parturient women at term (36 weeks' gestation or more, nulliparous and multiparous);
* With a singleton fetus;
* Planning to have childbirth and delivery at study site;
* Patients with prior mental health history, and current active psychiatric care will also be recruited.

Inclusion Criteria (Fathers):

* Identified partner (e.g., husband or significant other) of the enrolled pregnant patient;
* Aged 21 years and above;
* Able to understand the study procedures and willing to participate in the 8 weeks postpartum assessment.

Exclusion Criteria (Mothers):

* History of intravenous drug or opioid abuse;
* Previous history of chronic pain syndrome.

Exclusion Criteria (Fathers):

* Unable to provide informed consent (e.g., cognitive impairment, language barriers without available translation support);
* Any condition that, in the opinion of the investigators, would make participation inappropriate (e.g., severe psychiatric or medical condition).