Background The Thinking Healthy Program (THP) is an evidence based task-shifted low intensity psychosocial intervention, recommended by the World Health Organization for the treatment of perinatal depression. The investigators developed a technology-assisted version of Thinking Healthy Program (THP-TA) which allows peers to deliver the THP, while ensuring minimal resources for training of delivery agents and ensuring adequate fidelity. Method This is a non-inferiority, pragmatic cluster randomized controlled trial designed to test the primary hypothesis that technology assisted delivery of THP is not worse than THP intervention delivered by community health workers, in increasing perinatal depression remission rates at 3 months postnatal. In addition, this study will also test the effectiveness of the THP-TA in improving recovery from perinatal depression at 6 months postpartum, quality of life and social support. This study also aims to evaluate the cost-effectiveness of the THP-TA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
980
A technology adapted version of the Thinking Healthy Program (THP) delivered by peers using multimedia android based app.
This intervention paper-based manual delivered by lady health workers ie government employed community health workers with health training background.
Human Development Research Foundation
Rawalpindi, Punjab Province, Pakistan
Remission rates of perinatal depression
Remission rates from perinatal depression among the trial participants will be based on clinical diagnostic criteria based on the Structured Clinical Interview for the DSM-IV Axis (SCID) module. The SCID will be employed at baseline and 3 months postnatal.
Time frame: 3 months postnatal
Sustained remission rates of perinatal depression
Sustained remission rates from perinatal depression among the trial participants will be based on clinical diagnostic criteria based on the Structured Clinical Interview for the DSM-IV Axis (SCID) module, assessed at baseline, 3 and 6 months postnatal.
Time frame: 3 months and 6 months postnatal
Change in severity of perinatal depressive symptoms
Severity of perinatal depressive symptoms will be measured using the Patient Health Questionnaire-9 items assessed at baseline, 3 months and 6 months postnatal. Score on this scale ranges from 0 to 27, with higher scores indicating increased severity.
Time frame: 3 months and 6 months postnatal
Change in severity of perinatal anxiety symptoms
Severity of perinatal anxiety symptoms will be measured using the Generalized anxiety Disorder-7 scale assessed at baseline, 3 months and 6 months postnatal. Score on this scale ranges from 0 to 21, with higher scores indicating increased severity.
Time frame: 3 months and 6 months postnatal
Change in maternal Quality of Life
Change in maternal quality of life will be measured using the EuroQuality of Life scale (EQ-5D-3L), at baseline, 3 months and 6 months postnatal. It is a valid and reliable scale to quantify health status across 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Time frame: 3 months and 6 months postnatal
Change in disability using the World Health Organization Disability Assessment Schedule 2.0
This World Health Organization Disability Assessment Schedule 2.0 questionnaire assesses disability due to health conditions or illnesses (chronic or acute) including mental and emotional health problems. It is a valid and reliable instrument that generates domain-specific scores for six different functioning domains: i) cognition ii) mobility iii) self-care iv) getting along v) life activities (household and work/school) and vi) participation. It will be employed at baseline, 3 and 6 months postnatal.
Time frame: 3 months and 6 months postnatal
Service use and costs
Service use will be measured using Client Service Receipt Inventory (CSRI), including costs of healthcare services used, details and costs of medications and wider health service utilization and economic costs at 3 months and 6 months postnatal.
Time frame: Pregnancy through to 6 months postnatal
Infant nutrition/breastfeeding
Using 24-hour recall WHO breastfeeding practices tool, we will quantify percentage of infants being exclusively breastfed at 3 months and 6 months postnatal.
Time frame: 3 months and 6 months postnatal
Family planning practices
To ascertain family planning practices, categorical questions will be asked regarding the use of contraception during the postpartum period.
Time frame: 3 months and 6 months postnatal
Infant Immunization Status
Immunization status of the infant will be assessed using a categorical question assessing completely or incompletely immunized as per the Expanded Programme on Immunization program in Pakistan, at 3 months and 6 months postnatal.
Time frame: 3 months and 6 months postnatal
Maternal Social support
Multidimensional Scale of Perceived Social Support (MSPSS) will be used to assess the perceived levels of social support among the intervention recipients at baseline, 3 months and 6 months postnatal, from three sources: family, friends and significant other. It comprises of 12 items, scores on which can be summed together with higher scores corresponding to better social support.
Time frame: 3 months and 6 months postnatal
Parental time spent in play with the infant
Parental time spent in play with the infant will be assessed at 3 months and 6 months postnatal.
Time frame: 3 months and 6 months postnatal
Diarrheal episodes among infants
Number of episodes of diarrheal episodes among infants will be assessed using the WHO criteria and definitions, at 3 months and 6 months postnatal
Time frame: 3 months and 6 months postnatal
Acute upper respiratory tract infections among infants
Number of episodes of acute upper respiratory tract infections among infants will be assessed using the WHO criteria and definitions, at 3 months and 6 months postnatal
Time frame: 3 months and 6 months postnatal
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.