High- versus low-intensity interventions for perinatal depression delivered by non-specialist primary maternal care providers in Nigeria: cluster randomised controlled trial (the EXPONATE trial).

Background: Contextually appropriate interventions delivered by primary maternal care providers (PMCPs) might be effective in reducing the treatment gap for perinatal depression.

Aim: To compare high-intensity treatment (HIT) with low-intensity treatment (LIT) for perinatal depression.

Method: Cluster randomised clinical trial, conducted in Ibadan, Nigeria between 18 June 2013 and 11 December 2015 in 29 maternal care clinics allocated by computed-generated random sequence (15 HIT; 14 LIT). Interventions were delivered individually to antenatal women with DSM-IV (1994) major depression by trained PMCPs. LIT consisted of the basic psychosocial treatment specifications in the World Health Organization Mental Health Gap Action Programme - Intervention Guide. HIT comprised LIT plus eight weekly problem-solving therapy sessions with possible additional sessions determined by scores on the Edinburgh Postnatal Depression Scale (EPDS). The primary outcome was remission of depression at 6 months postpartum (EPDS < 6).

Results: There were 686 participants; 452 and 234 in HIT and LIT arms, respectively, with both groups similar at baseline. Follow-up assessments, completed on 85%, showed remission rates of 70% with HIT and 66% with LIT: risk difference 4% (95% CI -4.1%, 12.0%), adjusted odds ratio 1.12 (95% CI 0.73, 1.72). HIT was more effective for severe depression (odds ratio 2.29; 95% CI 1.01, 5.20; P = 0.047) and resulted in a higher rate of exclusive breastfeeding. Infant outcomes, cost-effectiveness and adverse events were similar.

Conclusions: Except among severely depressed perinatal women, we found no strong evidence to recommend high-intensity in preference to low-intensity psychological intervention in routine primary maternal care.

Declaration Of Interests: None.