Implementing and evaluating group interpersonal therapy for postnatal depression in Lebanon and Kenya - individually randomised superiority trial

INTERVENTION: Following the completion of the baseline outcome measures, participants will be randomly allocated to either Group Interpersonal therapy (g‐IPT) or High‐Quality Standard Care (HQ‐SC), using a secure, web‐based platform. Group Interpersonal therapy (g‐IPT): Interpersonal therapy was designed as a structured and time‐limited treatment for depressed adults. The principle of g‐IPT is that depressive episodes are triggered by issues in the patient’s interpersonal relations (e.g. loss of a loved one, disputes, social isolation). It has proven to be an effective treatment for common mental health disorders, and one that can be used as a preventative intervention. For this study, g‐IPT has been adapted for cultural relevance for Kenya and Lebanon and will be further adapted for new mothers with infants. There will be 8 sessions of g‐IPT offered to participants randomised to the intervention arm. High‐Quality Standard Care (HQ‐SC): All participants will receive psychoeducation in the form of a guided introduction to a WHO‐approved self‐help illustrated guide to coping with adversity together with information on nutrition for mothers and babies. This will provide participants with a stress management guide for coping with adversity which equips them with practical skills to cope with stress. CONDITION: Post‐natal depression ; Mental and Behavioural Disorders PRIMARY OUTCOME: Infant’s cognitive development measured using the Malawi Developmental Assessment Tool (MDAT) (Gladstone et al. 2010), at 52 weeks (T6) INCLUSION CRITERIA: 1. Aged 18 years or older 2. Female 3. Postnatal depression as indicated by a score of 12 or more on the PHQ‐9 at baseline 4. Mother with an infant aged 6 ‐ 35 weeks old at the time of screening SECONDARY OUTCOME: 1. Severity of depression measured using the Patient Health Questionnaire – depression module (PHQ‐9) (Kroenke & Spitzer, 2002) at baseline (T1), 8 weeks (T2), 13 weeks(T3), 24 weeks (T4), 36 weeks (T5) and 52 weeks (T6); 2. Family circumstances assessed using the family circumstances questionnaire at baseline (T1), 13 weeks (T3) and 52 weeks (T6); 3. Maternal sensitivity and indicators of family care assessed using the Family Care Indicator (FCI) (Kariger et al., 2012) at baseline (T1), 8 weeks (T2), 13 weeks(T3), 24 weeks (T4), 36 weeks (T5) and 52 weeks (T6); 4. Early childhood development outcomes measured using the Caregiver Reported Early Development Inde X(CREDI) long form (McCoy et al., 2018) at baseline (T1), 13 weeks (T3) and 36 weeks (T5); 5. Anxiety measured using the General Anxiety Disorder‐7 (GAD‐7) (Spitzer et al., 2006) at baseline (T1), 8 weeks (T2), 13 weeks(T3), 24 weeks (T4), 36 weeks (T5) and 52 weeks (T6); 6. Sleep measured using the Sleep Condition Indicator (SCI) (Espie et al., 2014) at baseline (T1), 8 weeks (T2), 13 weeks (T3) and 24 weeks (T4), 36 weeks (T5) and 52 weeks (T6); 7. Infant’s sleep measured using the Brief Infant Sleep Questionnaire – Revised Short form (BISQ) (Mindell et al., 2019) at baseline (T1), 8 weeks (T2), 13 weeks (T3) and 24 weeks (T4), 36 weeks (T5) and 52 weeks (T6); 8. Infant’s physical health measured using the infant physical health questionnaire at baseline (T1), 8 weeks (T2), 13 weeks (T3) and 24 weeks (T4), 36 weeks (T5) and 52 weeks (T6); 9. Breastfeeding assessed using the breastfeeding outcome measure at baseline (T1), 8 weeks (T2), 13 weeks (T3) and 24 weeks (T4), 36 weeks (T5) and 52 weeks (T6); 10. Social isolation assessed using the Lubben Social Network Scale (LSNS‐6) (Lubben & Gironda, 2000) at baseline (T1), 13 weeks (T3) and 52 weeks (T6); 11. Relationship satisfaction measured using the Couple Satisfaction Inde X(CSI‐4) (Funk & Rogge, 2007) at baseline (T1), 13 weeks (T3) and 52 weeks (T6); 12. Health outcome assessed using EQ‐5D (Soeteman et al., 2008) at baseline (T1), 13 weeks (T3), 24 weeks (T4) and 52 weeks (T6); 13. Capability measured using the ICEpop CAPability measure for Adults (ICECAP‐A) (Al‐Janabi et al., 2012) at baseline (T1), 13 weeks (T3), 24 weeks (T4) and 52 weeks (T6); 14. Value of intervention measured using the SUMMIT patient cost questionnaire (Rose‐Clarke et al., 2020) at 13 weeks (T3); 15. Household economic status measured using the Economic House economic questionnaire at baseline (T1) and household shocks measured at 13 weeks (T3); 16. Demographic information covering socio‐economic status, maternal education, maternal parity and teen parent status using the DUMMIT demographic questionnaire at baseline (T1); 17. A brief semi‐structured qualitative interview to explore outcomes such as changes in understanding or, or attitudes towards, post‐natal depression at baseline (T1), 13 weeks (T3) and 52 weeks (T6); ;