Health Condition 1: F321- Major depressive disorder, singleepisode, moderate
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adult pregnant women above 18 years of age Gestational age between 12–26 weeks Singleton pregnancy Patient Health Questionnaire-9 (PHQ-9) score of 10 or more Planning to stay in the study area throughout study duration (approximately four months)
Exclusion criteria
Exclusion criteria: Pregnant women advised rest/restriction of physical activities/laborious tasks by their obstetrician due to medical/obstetric problems History of one or more spontaneous abortions History of cervical stitch/encirclage operation History of pre-term labor/premature rupture of members Receiving treatment for depression or any other mental health condition Presence of suicidal ideation (score of 3 on PHQ-9 item 9) History of hypertension, heart disease, diabetes (including gestational diabetes), respiratory disease, severe anemia, lower respiratory tract infection Inability to communicate in Marathi language Inability to attend in-person yoga sessions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will assess the feasibility and acceptability of the Yoga-Sanskar (YS) intervention and the preliminary efficacy of the intervention on depression in pregnant women. Process data will inform the feasibility of the enrolment, engagement with the intervention, and completion of the intervention. The process indicators are as follows: 1.Number and proportion of eligible participants enrolled per week in the YS and the EUC arm. 2.Number and proportion of enrolled participants in the YS arm who attend the first session, three follow-up training sessions, and the final assessment session. 3.Number and proportion of enrolled participants in both arms who complete the follow-up assessment three months post-randomization. Depression during pregnancy is the primary outcome to assess the efficacy of the intervention. We will assess depression using a culturally adapted and validated Marathi version of PHQ-9. Timepoint: Baseline, three-months post-randomization, post-delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Anxiety Stress Quality of Life Minor ailments in pregnancy Experience of pregnancy Attitude Treatment Expectation Self-Efficacy Competence Awareness Satisfaction Timepoint: Baseline, three-months post-randomization, post-delivery | — |
Countries
India
Contacts
Pravara Institute of Medical Sciences