Feasibility and acceptability of the Problem Management for Moms programme for improving maternal mental health in Zambia: an open-label trial

IF 30.8 1区 医学 Q1 PSYCHIATRY Lancet Psychiatry Pub Date : 2024-11-05 DOI:10.1016/s2215-0366(24)00256-6
Günther Fink, Maria Melero-Dominguez, Mpela Chembe, Daniela de Vernisy-Romero, Thandiwe Tembo, Tamara Billima, Ravi Paul, Margarita Alegria, Doug Parkerson, Peter C Rockers, Zaliwe Banda, Gabriel Lungu, Dorothy Sikazwe, Irene Falgas-Bague
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Abstract

Background

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.

Methods

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.

Findings

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.

Interpretation

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.

Funding

The Eckenstein–Geigy Professorship.
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改善赞比亚孕产妇心理健康的 "妈妈问题管理 "计划的可行性和可接受性:开放标签试验
背景中低收入国家的母亲普遍存在心理困扰,这限制了她们照顾自己和孩子的能力。在这项开放标签试验中,我们招募了生活在赞比亚卢萨卡、有严重心理困扰(20项自我报告问卷[SRQ-20]得分为7分)的妇女和两岁以下的儿童,她们之前都参加了ZamCharts儿童早期营养试验。我们采用随机抽样的方式将参与者(1:1)随机分配到干预组或对照组。干预措施是一项新开发的 "妈妈问题管理"(PM4M)计划:该计划由 "问题管理加强版"(Problem Management Plus)改编而来,为期十节,通过电话或面谈的方式进行。随机分组后,干预组的参与者接受了干预前筛查、干预后评估以及治疗开始 9 个月后的最终随访评估(即最终随访)。对照组在 ZamCharts 基线和最终随访评估时进行评估,这些参与者没有接受任何干预。研究的主要结果是可行性、可接受性和使用 SRQ-20 测量的参与者精神压力。所有主要和次要结果都是在意向治疗人群中估算的,意向治疗人群包括所有被随机分配到干预组并参加最终随访评估的参与者。未收集有关种族的数据。该试验已在 ClinicalTrials.gov 注册,编号为 NCT05627206,并已完成。研究结果在 2021 年 4 月 26 日至 7 月 14 日期间,790 名妇女接受了 ZamCharts 试验的访谈,其中 265 人有严重的精神困扰,并被随机分配到本试验的治疗组(干预组 134 人,对照组 131 人)。在干预组的 134 名妇女中,61 人(46%)接受了 PM4M 干预,73 人(55%)被排除在外;在最后的跟踪评估中,干预组的 103 人和对照组的 106 人成功接受了访谈。ZamCharts 基线参与者的平均年龄为 27-6 岁(SD 7-6)。PM4M 课程于 2022 年 12 月 16 日至 2023 年 5 月 6 日期间进行。经过干预前筛查,61 名被认为符合条件的参与者开始了干预,他们平均完成了 10 次课程中的 7-9 次(标准差为 2-9)。在这 61 名参与者中,有 55 人(77%)对干预措施表示 "比较满意 "或 "非常满意"。在调整后的意向治疗模型中,干预使最终随访时的SRQ-20平均得分降低了2-11分(95% CI -3-50至-0-63),SRQ-20超过7分的调整后几率为0-50(95% CI 0-27至0-93)。没有关于严重不良事件的报告。解释本文介绍的结果表明,PM4M心理健康干预是可行的,而且接受率很高。还需要进一步的研究来评估该干预措施对妇女及其子女的长期疗效,以及将其纳入常规护理的适宜性。
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来源期刊
Lancet Psychiatry
Lancet Psychiatry PSYCHIATRY-
CiteScore
58.30
自引率
0.90%
发文量
0
期刊介绍: The Lancet Psychiatry is a globally renowned and trusted resource for groundbreaking research in the field of psychiatry. We specialize in publishing original studies that contribute to transforming and shedding light on important aspects of psychiatric practice. Our comprehensive coverage extends to diverse topics including psychopharmacology, psychotherapy, and psychosocial approaches that address psychiatric disorders throughout the lifespan. We aim to channel innovative treatments and examine the biological research that forms the foundation of such advancements. Our journal also explores novel service delivery methods and promotes fresh perspectives on mental illness, emphasizing the significant contributions of social psychiatry.
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