Pregnancy-related Anxiety
Conditions
Interventions
Study Design:
Open-label, randomized controlled trial (RCT) with parallel design and pre- and post-intervention outcome assessment. Individual participant level 1:1 random assignment will place parti
Sponsors
Faculty of Graduate Studies, University of Colombo.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pregnant women with uncomplicated singleton pregnancies with a period of gestation between 12 and 28 weeks. 2. Pregnant women who can read and comprehend Tamil or Sinhala (since the intervention is bilingual). 3. Pregnant women who scored mild to moderate levels on the Pregnancy-related Anxiety Questionnaire Revised 2, translated and validated through the Delphi process, as well as an additional screening step by a consultant psychiatrist to exclude severe anxiety and depression. 4. Pregnant women who have access to an Android or iOS smartphone or tablet with an internet connection
Exclusion criteria
Exclusion criteria: 1. Pregnant women with a documented diagnosis of a major mental disorder, such as major depression, schizophrenia, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder, and personality disorders. 2. Pregnant women who have previously enrolled in a similar digital mental health intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean scores of anxiety measured through the validated questionnaire (PRAQ-R2). The tool consists of 10 items, divided into three subscales/components. The 3 conponents incude: fear of giving birth, worries about bearing a handicapped child and concerns about own appearance. Participants will be recruited during the end of the first trimester and second trimester of pregnancy (approximately 12–28 weeks of gestation). [Assessed at baseline and at two weeks from the end of the intervention (Week 10). ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in mean scores of breastfeeding efficacy assessed using the Breastfeeding Self-Efficacy Scale – short form (BSES-SF) [Assessed at 1 week and 4 weeks postpartum. ] Reduced neonatal intensive care unit (NICU)admissions assessed through hospital records. [ Assessed after delivery] Reduction in the proportion requiring extra pain relief measured by recording the type and frequency of analgesic methods used during labour (e.g., pethidine, epidural) from labor charts. [ Assessed after delivery] Reduction in mean scores of postnatal depressive symptoms assessed using the Edinburgh Postnatal Depression Scale (EPDS) [ Assessed at 6 weeks postpartum ] Appropriateness, acceptability, and feasibility of the co-developed mHealth intervention as perceived by pregnant women in the intervention group assessed using the three purpose-developed tools: Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) [ Assessed after the completion of the intervention] | — |
Countries
Sri Lanka
Contacts
Public ContactAhamad Salman Amathullah
Principal Investigator
Outcome results
None listed