A Pilot, Single-blind, Randomized Controlled Trial Evaluating the Implementation Outcomes and Preliminary Efficacy of Problem Management Plus (PM+) Versus Treatment as Usual in Adult Primary Care Users With Symptoms of Depression and/or Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Implementation outcome: Feasibility
研究概览
简要总结
This study aims to evaluate the implementation outcomes of a pilot randomized controlled trial and to assess the preliminary efficacy of Problem Management Plus (PM+) in reducing symptoms of depression and anxiety among users at a Primary Health Care center in Chile.
Two intervention groups will be compared: PM+ versus care as usual (CAU). The process will include an evaluation of the feasibility of the study procedures, as well as the acceptability and fidelity of the PM+ intervention.
详细描述
In Chile, only 19% of the population with mental health conditions has access to primary care services, highlighting the urgent need to expand mental health care availability. Training more healthcare professionals to deliver low-intensity psychological interventions could be a valuable approach to addressing this disparity.
The World Health Organization's Problem Management Plus (PM+) is a low-intensity, transdiagnostic, peer-delivered intervention designed for implementation in resource-limited settings to address common mental health disorders. In this context, PM+ serves as an evidence-based strategy that can help reduce gaps in healthcare services, particularly regarding availability and accessibility.
This study aims to evaluate the implementation outcomes of a pilot randomized clinical trial, including feasibility, acceptability and fidelity and to assess the preliminary efficacy of PM+ in reducing mental health symptoms among users at a primary healthcare center in Chile.
The study design is a single-blind pilot randomized controlled trial with a 1:1 allocation ratio, assessing two intervention arms for participants with depressive and/or anxiety symptoms over five weeks.
The study population consists of adults of 18 years or above with mild to moderate depressive and/or anxiety symptoms, living in the selected study region and enrolled in the primary health care center chosen to conduct the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals over 18 years old.
- •Diagnosed with or presenting depressive and/or anxiety symptoms (through screening).
- •Residents of the selected study region.
- •Part of the population enrolled and validated in the pilot primary health care facilities.
排除标准
- •Suicidal risk requiring immediate or urgent referral to care services.
- •Suffering from severe psychiatric disorders or substance use disorders.
- •Being in situations of declared risk that require protection (e.g., domestic violence).
- •Moderate or severe disability.
- •Incapacitating medical illnesses.
- •Receiving other mental health treatments that could lead to over-intervention.
结局指标
主要结局
Implementation outcome: Feasibility
时间窗: Feasibility outcome component A will be collected once recruitment is completed. Component B will be collected at week 6, starting from the first intervention week.
Measured through components A and B. A. Percentage of participant recruitment: defined as the proportion of participants who consented to enroll in the trial and were subsequently recruited. B. Participant adherence to PM+: defined as the average number of PM+ sessions attended by each participant.
Implementation outcome: Acceptability
时间窗: Acceptability outcomes will be collected during the post-intervention assessment at week 6, starting from the first intervention week.
Indicators of PM+ acceptability among users and trained facilitators, assessed with quantitative scales. For users, an adapted version of the Abbreviated Acceptability Rating Profile (AARP) will be administered. The AARP consists of 8 Likert-scale items, yielding total scores ranging from 8 to 48, with higher scores indicating greater acceptability. For facilitators, an adapted version of the Acceptability of Intervention Measure (AIM) will be used. The AIM comprises 5 Likert-scale items, producing scores ranging from 4 to 20, where higher scores reflect greater acceptability. For both measures, descriptive statistics will be reported using median and interquartile range (IQR), as well as mean and standard deviation (x̄ \[SD\]).
Implementation Outcome: Fidelity
时间窗: Fidelity outcomes will be collected throughout the intervention period, from the first to the final intervention week (week 5).
Indicators of PM+ fidelity will be assessed with a study-specific rubric developed based on expert judgement. The rubric consists of 5 items, each reflecting a component of proper PM+ delivery. Items range from 1 ("low fidelity") to 4 ("high fidelity"), with higher scores indicating greater fidelity. The reported statistics will include the median and interquartile range (IQR) for each item, and the mean and standard deviation (x̄ \[SD\]) for the overall fidelity score per assessed PM+ session.
次要结局
- Preliminary pre-to-post effect of PM+ on depressive symptoms.(Measured through baseline at week 0 and post-intervention assessment at week 6, starting from the first intervention week.)
- Preliminary pre-to-post effect of PM+ on anxiety symptoms.(Measured through baseline at week 0 and post-intervention assessment at week 6, starting from the first intervention week.)
- Preliminary pre-to-post effect of PM+ on self-identified problems.(Measured through baseline at week 0 and post-intervention assessment at week 6, starting from the first intervention week.)