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

Evaluating the Impact of Group Interpersonal psychotherapy compared to High Quality Standard Care for mothers with postnatal depression in Lebanon and Kenya on child developmental outcomes, maternal Depression and the mother-child relationship: SUMMIT (SUpporting Mothers’ Mental health with Interpersonal Therapy)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15154316
Enrollment
412
Registered
2023-09-27
Start date
2023-01-02
Completion date
Unknown
Last updated
2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-natal depression Mental and Behavioural Disorders

Interventions

Sponsors

University College London
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Mothers with psychotic conditions including bipolar disorder, anorexia nervosa or substance dependence 2. Mothers whose babies have severe physical health problems or neurodevelopmental problems will also be excluded

Design outcomes

Primary

MeasureTime frame
Infant’s cognitive development measured using the Malawi Developmental Assessment Tool (MDAT) (Gladstone et al. 2010), at 52 weeks (T6)

Secondary

MeasureTime frame
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 Index (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 Index (CSI-4) (Funk & Rogge, 2007) at baseline (T1), 13 weeks (T3) and 52 weeks (T6) 12. Health out

Countries

Kenya, Lebanon

Contacts

Public ContactElizabeth ;Ciara Simes;O'Donnell

;

e.simes@ucl.ac.uk;ciara.o'donnell.16@ucl.ac.uk+44 (0)2031083254;+44 (0)2031083254

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026