Enhancing Post-acute Mental Health Outcomes for Patients With Psychosis in Malawi Through Nurse-delivered Community-based Rehabilitation: The ENHANCE Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Recruitment Rate (Recruitment Feasibility)
研究概览
简要总结
The overall aim of the proposed study is to determine the feasibility, acceptability, fidelity, and preliminary effectiveness of the adapted nurse-led, community-based rehabilitation treatment model for community-dwelling individuals living with psychosis in Blantyre, Malawi using a pilot randomized controlled trial.
详细描述
Psychosis exacts a heavy morbidity and mortality toll worldwide, but especially in low- and middle-income countries (LMICs). Psychotic disorders are one of the most common presenting complaints for individuals admitted to specialty mental health services in many LMICs. Psychotic disorders typically have onset in early adulthood and a chronic course, meaning patients suffer from many years of poor functionality, disability, and lost productivity. Indeed, psychotic disorders remain among the 15 leading causes of disability globally. The chronicity and severity of psychotic disorders exert a heavy burden on family as relatives frequently have to assume caregiver roles in LMIC where access to formal mental health care is limited.
Despite the significant toll of psychosis in LMICs, treatment options are extremely limited and focus heavily on acute, time-limited inpatient stabilization. This focus fails to consider the demonstrated need for long-term post-acute outpatient treatment and community-based rehabilitation to improve outcomes and prevent relapse. Contextual community factors such as reliable continued access to mental health care, stigma and its negative impact on medication adherence, inadequate support, and family conflict are key risk factors for subsequent relapse upon discharge into the community. Research has recommended the need for community interventions to minimize medication non-adherence and limit relapse and readmission.
Community-based rehabilitation (CBR) directly addresses the need for a concerted approach to post-acute community-based care for people with psychosis in low-resource settings. CBR is a general evidence-based approach for the long-term treatment and support of individuals with a broad range of disabilities in resource-constrained settings that is particularly well suited to address the needs of those with psychosis. CBR aims to improve the quality of life of individuals living with disability by supporting medical care engagement, addressing functional goals, and encouraging social inclusion within their families and communities. CBR is amenable to delivery by a range of personnel and involves collaboration between caregivers, community members, and available public sector services to facilitate the rehabilitation of patients.
Accordingly, in this protocol the investigators will pilot-test an adaptation of the evidence-based Community-Based Rehabilitation (CBR) treatment model specifically to address the needs of community-dwelling individuals with psychosis in Malawi. Specifically, investigators will complete a pilot randomized controlled trial to evaluate the feasibility, acceptability, fidelity, and preliminary effectiveness of the adapted CBR treatment model. This work will provide a critical advance in establishing the evidence base for community-based treatment models for people living with psychosis outside of the context of acute inpatient stabilization so as to enhance rehabilitation, functioning, and quality of life.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current outpatient at Queen Elizabeth Central Hospital psychiatry clinic
- •Age 18 or older
- •Diagnosis of schizophrenia spectrum disorder or clinical presentation of symptoms of hallucinations, delusions or thought disorder that persisted for longer than one month and are accompanied by significant functional impairment
- •Resident in Blantyre District
- •Not planning to relocate out of Blantyre District in next 12 months
- •Has a primary caregiver willing to participate in the study
- •Has current elevated symptoms or poor functioning as demonstrated by one or more of:
- •Positive and Negative Symptoms Scale score ≥58
- •WHO Disability Assessment Schedule 2.0 score ≥35
- •Clinical Global Impression Severity score ≥2 (at least mildly ill)
- •Inclusion Criteria for Caregivers:
- •Is a current caregiver for an eligible and consenting patient participant.
- •Age 18 or older
- •Resident in Blantyre District
- •Not planning to relocate out of Blantyre District in next 12 months
排除标准
- •Not a current outpatient at Queen Elizabeth Central Hospital psychiatry clinic
- •Not Age 18 or older
- •No diagnosis of schizophrenia spectrum disorder or clinical presentation of symptoms of hallucinations, delusions or thought disorder that persisted for longer than one month and are accompanied by significant functional impairment
- •Not a resident in Blantyre District
- •Planning to relocate out of Blantyre District in next 12 months
- •Does not have a primary caregiver willing to participate in the study
- •Does not have current elevated symptoms or poor functioning as demonstrated by one or more of:
- •Positive and Negative Symptoms Scale score ≥58
- •WHO Disability Assessment Schedule 2.0 score ≥35
- •Clinical Global Impression Severity score ≥2 (at least mildly ill)
- •Exclusion Criteria for Caregivers:
- •Is not a current caregiver for an eligible and consenting patient participant.
- •Not Age 18 or older
- •Not a resident in Blantyre District
- •Planning to relocate out of Blantyre District in next 12 months
研究组 & 干预措施
Adapted ENHANCE Intervention
Nurse-delivered community-based treatment model for people living with psychosis in the community, coordinated with the usual outpatient care
干预措施: Adapted ENHANCE Intervention (Behavioral)
Enhanced usual care
Continue with usual outpatient care, enhanced with additional feedback and clinical recommendations to the outpatient treatment team
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Recruitment Rate (Recruitment Feasibility)
时间窗: Baseline
This measure is the ability to successfully enroll people with lived experience (PWLE) in the pilot intervention. Feasibility will be evaluated by measuring the recruitment rate (number of patients approached in order to accrue the final sample).
Proportion of participants retained in the study (Retention Feasibility)
时间窗: 12 months
Feasibility will be evaluated by measuring the proportion of participants retained in the study (number of patients enrolled at baseline who are still enrolled in the trial through 12 months).
Number of Participants Who Were Either Very Satisfied or Somewhat Satisfied with the Intervention (Intervention Acceptability)
时间窗: Conclusion of study
The number of patients who were either very satisfied or somewhat satisfied with the intervention among all participants who received the intervention. Satisfaction will be measured on a 4-point Likert scale where 1 indicates high satisfaction and 4 indicates high dissatisfaction.
Proportion of Completed Intervention Sessions (Intervention Attendance Fidelity)
时间窗: 12 months
The total number of intervention sessions completed, out of the number of sessions expected to be completed.
Number of Participants Approached to Meet Enrollment (Recruitment Feasibility)
时间窗: Baseline
This measure is the ability to successfully enroll people with lived experience (PWLE) in the pilot intervention. Feasibility will be evaluated by measuring the number of participants approached in order to accrue the final sample.
Proportion of Participants Retained in the Study (Retention Feasibility)
时间窗: 12 months
Feasibility will be evaluated by measuring the proportion of participants retained in the study (participants enrolled at baseline who are still enrolled in the trial through 12 months).
Number of Participants Who Found the Intervention Helpful (Intervention Acceptability)
时间窗: Conclusion of study, Month 12
A subset of intervention participants were asked if they were willing to participate in a qualitative interview. The 12 who agreed to participant were asked a series of qualitative questions including whether or not the intervention was helpful or unhelpful as a measure of satisfaction to inform intervention acceptability. The number indicating "helpful" as their response are reported.
Number of Intervention Participants Who Completed All Intervention Phases (Intervention Attendance Fidelity)
时间窗: 12 months
The total number of participants who completed all three intervention phases, out of the number of all intervention participants. This outcome does not apply to Enhanced Usual Care and no data were collected.
次要结局
- Internalized stigma(12 months)
- Psychosis Symptom Remission(12 months)
- Quality of Life based on Short-Form 8 measure(12 months)
- Change in psychosis symptoms from baseline(Baseline,12 months)
- Overall Functioning(12 months)
- Psychosis Symptom Response(12 months)
- Clinical Improvement(12 months)
- Quality of Life Based on Short-Form 8 Measure(12 months)
- Change in PANSS Total Score From Baseline(Baseline,12 months)
- Internalized Stigma(12 months)