Abstract summary 

Psychological distress is common among mothers in low-income and middle-income countries, limiting their capacity to care for themselves and their children. This study aimed to test the feasibility and acceptability of an adapted psychosocial intervention for distressed mothers in low-resource settings.In this open-label trial, we enrolled women living in Lusaka, Zambia, with high mental distress (>7 score on the 20-item Self-Reporting Questionnaire [SRQ-20]) and children younger than 2 years, who had previously enrolled in the ZamCharts early childhood nutrition trial. We randomly assigned participants (1:1) to the intervention or control group using a random number draw. The intervention was a newly developed Problem Management for Moms (PM4M) programme: a ten-session treatment adapted from Problem Management Plus, which was offered by phone or in person. After randomisation, participants in the intervention group underwent pre-intervention screening, a post-intervention assessment, and a final follow-up assessment 9 months after treatment initiation (ie, final follow-up visit). The control group was assessed at the baseline of ZamCharts and at the final follow-up assessment, and these participants did not receive any intervention. The primary study outcomes were feasibility, acceptability, and participant mental distress measured using the SRQ-20. All primary and secondary outcomes were estimated in the intention-to-treat population, which included all participants who were randomised to the intervention group and attended the final follow-up assessment. Data on ethnicity were not collected. The trial is registered at ClinicalTrials.gov, NCT05627206, and has been completed. Women with lived experience of mental health symptoms were involved in this study.Between April 26, and July 14, 2021, 790 women were interviewed in the ZamCharts trial, of whom 265 had high mental distress and were randomly assigned to treatment groups in this trial (134 to the intervention group and 131 to the control group). Of the 134 women in the intervention group, 61 (46%) received the PM4M intervention and 73 (55%) were excluded; 103 in the intervention group and 106 in the control group were successfully interviewed at the final follow-up assessment. The mean age of participants was 27·6 years (SD 7·6) at ZamCharts baseline. PM4M sessions were conducted between Dec 16, 2022, and May 6, 2023. The 61 participants deemed eligible after pre-intervention screening who started the intervention completed a mean of 7·9 (SD 2·9) of ten sessions. 55 (77%) of these 61 participants were somewhat or very satisfied with the intervention. In adjusted intention-to-treat models, the intervention reduced mean SRQ-20 scores by 2·11 points (95% CI -3·50 to -0·63) at the final follow-up, and the adjusted odds ratio of having an SRQ-20 of more than 7 was 0·50 (95% CI 0·27 to 0·93). No serious adverse events were reported.The results presented here suggest that the PM4M mental health intervention is feasible and has high rates of acceptability. Further research is needed to assess the long-term efficacy of this intervention on women and their children, and its suitability for integration into routine care.The Eckenstein-Geigy Professorship.

Authors & Co-authors:  Fink Günther G Melero-Dominguez Maria M Chembe Mpela M de Vernisy-Romero Daniela D Tembo Thandiwe T Billima Tamara T Paul Ravi R Alegria Margarita M Parkerson Doug D Rockers Peter C PC Banda Zaliwe Z Lungu Gabriel G Sikazwe Dorothy D Falgas-Bague Irene I

Study Outcome 

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