Reducing Stigma Among Healthcare Providers to Improve Mental Health Services: RESHAPE-mh Protocol for a Feasibility and Acceptability Pilot Cluster Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change in stigmatizing attitudes, as measured by the Social Distance questionnaire
研究概览
简要总结
A growing number of trials have demonstrated treatment effectiveness for people with mental illness (PWMI) by non-specialist providers, such as primary care and community health workers, in low-resource settings. A barrier to scaling up these evidence-based practices is the limited uptake from trainings into service provision and lack of fidelity to evidence-based practices among non-specialists. This arises, in part, from stigma among non-specialists against PWMI. Therefore, interventions are needed to address attitudes among non-specialists. To address this gap, REducing Stigma among HeAlthcare Providers to improvE Mental Health services (RESHAPE-mh), is an intervention for non-specialists in which social contact with PWMI is added to training and supervision programs. A pilot cluster randomized control trial will address primary objectives including trainees' perspectives on perceived acceptability of PWMI's participation in training and supervision, intervention fidelity and contagion, assessment of randomization, and feasibility and psychometric properties of outcome measures in a cluster design. Secondary objectives are change in provider and patient outcomes. The control condition is existing mental health training and supervision for non-specialists delivered through the Programme for Improving Mental Healthcare (PRIME), which includes the mental health Global Action Programme (mhGAP) and psychosocial treatments. The intervention condition will incorporate social contact with PWMI into existing PRIME training and supervision. Participants in the pilot will be the direct beneficiaries of training and supervision (i.e., primary care workers) and indirect beneficiaries (i.e., their patients). Primary care workers' outcomes include knowledge (mhGAP knowledge scale), explicit attitudes (mhGAP attitudes and social distance scales), implicit attitudes (Implicit Association Test), and clinical competence (Enhancing Assessment of Common Therapeutic factors, ENACT) to be assessed pre-training, post-training, and at 4-month follow-up. Patient outcomes include functioning, stigma experiences in accessing care, and depression/alcohol use symptoms to be assessed at initiation of mental health care and 6 months later. The pilot study will assist in modifying the intervention to inform a larger effectiveness trial of RESHAPE to ultimately improve provider attitudes and clinical competence as a mechanism to improve patient outcomes.
详细描述
Setting The study will take place in primary care health facilities in Chitwan, Nepal. The Department for International Development (DFID)-sponsored Programme for Improving Mental Health Care (PRIME) is being implemented in Chitwan, Nepal. PRIME aims to improve the coverage of treatment for priority mental disorders by implementing and evaluating a comprehensive mental health care package, integrated into primary health care in five low and middle income countries (LMIC) (Nepal, India, South Africa, Ethiopia and Uganda). The care package includes the provision of psychosocial and pharmacological interventions by non-specialized primary health workers (following the World Health Organization mental health Gap Action Programme (mhGAP)-Intervention Guide) and community counselors. Currently, no mental health services are systematically available in primary health care.
The facilities include health posts, primary health centers, and urban clinics. These are all part of the government health center and represent the first portal for care. In these facilities, primary care providers refer to health auxiliaries staff: health assistants, community medical assistants, and auxiliary nurse midwives. PRIME and the RESHAPE component are conducted by Transcultural Psychosocial Organization (TPO) Nepal, a Nepali non-governmental mental health research and training organization.
Design The investigator will use a pilot cluster randomized trial design. Because attitudes and clinical behaviors are influenced by peers (reference), the investigator anticipates a high degree of contagion among providers within a facility. Moreover, clinical care is not restricted to exclusive relationships with a single provider in the government health system. Therefore, patient care will be characterized by seeing a range of providers within a single facility over the course of their treatments. Therefore, a cluster design with the health facility as the unit of clustering is required.
Interventions The control arm will include the standard PRIME training and supervision protocol for Nepal. There are two versions of the PRIME training: one for prescribers and one for non-prescribers. Prescribers refer to health workers who can prescribe medication (health assistants and auxiliary health workers). Non-prescribers cannot prescribe medication and provide community outreach, assist in vaccination within maternal and child health programs, and promote adherence. Non-prescribers are predominantly auxiliary nurse midwives. Training for prescribers is based on mhGAP and includes target disorders of depression, psychosis, epilepsy, and harmful drinking. Psychosocial modules focusing on communication skills, supportive techniques, and health education are included based on prior curriculums and adapted for Nepal. Training is delivered by a psychiatrist and an experienced psychosocial counselor. Following training, the prescriber group participates in monthly supervision sessions with a psychiatrist. Non-prescribers receive training which includes psychosocial basics, a modified behavioral activation module, and a modified motivational interviewing module. These later psychological treatments, known as Healthy Activity Program (HAP) and Counseling for Alcohol Programs (CAP) respectively, have been developed for use in South Asia by non-specialists. Non-prescribers receive monthly supervision from experienced psychosocial counselors.
RESHAPE-mh uses the basic model of PRIME training and supervision. For both the prescriber and non-prescriber training, people with mental illness (PWMI) participate as co-facilitators. PWMI are trained to serve as co-facilitators using "PhotoVoice"-a participatory research approach in which photography is used to develop testimonials and other messaging. PWMI contribute to personal testimonials, ongoing social contact, myth busting, and provide a recovery emphasis. In addition, a health worker who has previously participated in the PRIME program receives training to participate as a co-facilitator and serves as an enthusiastic and aspirational role model. The second component of RESHAPE is ongoing engagement with PWMI through monthly consumer consultation meetings. [Note: In Duke Institutional Review Board (IRB) Pro00055042 and in National Institute of Mental Health (NIMH) grant application K01MH104310, RESHAPE is referred to as "Consumer Engagement Anti-Stigma (CEAS) Training." CEAS has now been renamed as RESHAPE-mh.]
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant Types
- •Primary care workers (primary beneficiary)
- •Patients (indirect beneficiary)
- •Inclusion Criteria:
- •All primary care workers participating in either the prescriber or non-prescriber PRIME trainings will be invited to participate
- •Primary care trainees will need to be 21-65 years of age
- •Recruitment will attempt to balance gender distribution in the recruitment health clusters
- •All participants will need to have Nepali language competency, be actively engaged in care provision in their health cluster, and have a valid certificate of practice from the Ministry of Health
- •Primary care trainees need to have permission from their health supervisor to attend the entire duration of the training.
- •Any patient receiving PRIME services will be invited to participate. This includes persons with diagnoses of depression, psychosis, harmful drinking, or epilepsy. Providers make the diagnosis based on mhGAP criteria.
- •For patients, inclusion criteria will be 21-65 years of age and fluency in Nepali.
排除标准
- •Primary care trainees will be excluded if they have any prior citations on their clinical practice licensure.
- •Patients who cannot provide consent will be excluded.
研究组 & 干预措施
PRIME
The behavioral intervention will be the PRIME/mhGAP training. This is standard mental health training for prescribers (primary care workers who can prescribe psychotropic medication, e.g., health assistants) and non-prescribers (primary care workers who cannot prescribe medications, e.g., auxilliary nurse midwives). For prescribers, training includes introduction to psychosocial techniques and mhGAP. For non-prescribers, training includes psychosocial techniques.
干预措施: PRIME/mhGAP (Behavioral)
PRIME+RESHAPE
The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.
干预措施: RESHAPE (Behavioral)
PRIME+RESHAPE
The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.
干预措施: PRIME/mhGAP (Behavioral)
结局指标
主要结局
Change in stigmatizing attitudes, as measured by the Social Distance questionnaire
时间窗: Baseline, post-training (immediately after 10-day training curriculum), +4 months, + 16 months
Health Provider Outcome: Health providers rate the degree of social distance from persons with mental illness related to 10 domains, e.g., willingness to work together, willingness to be friends, willingness to share meals
Social Distance Scale (SDS) - Baseline
时间窗: Baseline (Pre-Training)
Health Provider Outcome: 12-item scale of willingness to interact with persons with mental illness, minimum = 12, maximum = 72, higher score is worse outcome. Data collected at 3 points: Pre-training , 4 months post-training, 16 months post-training.
Social Distance Scale (SDS) - 4 Months Post-training
时间窗: 4 months Post-Training
Health Provider Outcome: 12-item scale of willingness to interact with persons with mental illness, minimum = 12, maximum = 72, higher score is worse outcome. Data collected at 3 points: Pre-training , 4 months post-training, 16 months post-training.
Social Distance Scale (SDS) - 16 Months Post-training
时间窗: 16 months post-training
Health Provider Outcome: 12-item scale of willingness to interact with persons with mental illness, minimum = 12, maximum = 72, higher score is worse outcome. Data collected at 3 points: Pre-training , 4 months post-training, 16 months post-training.
次要结局
- Change in clinical knowledge, as measured by the mhGAP knowledge assessment(Baseline, post-training (immediately after 10-day training curriculum), +4 months, + 16 months)
- Change in patient functioning, as measured by the World Health Organization Disability Assessment Scale (WHODAS)(Baseline, 6 months)
- Change in patient perceived stigma as a barrier to accessing care, as measured by the Barriers to Access to Care Evaluation (BACE)(Baseline, 6 months)
- Change in implicit attitudes, as measured by the Implicit Association Test (IAT)(Baseline, +4 months, + 16 months)
- Change in patient depression, as measured by the Patient Health Questionnaire (PHQ-9)(Baseline, 6 months)
- Change in stigmatizing attitudes, as measured by the mhGAP Attitudes Questionnaire(Baseline, post-training (immediately after 10-day training curriculum), +4 months, + 16 months)
- Change in clinical competence, as measured by Enhancing Assessment of Common Therapeutic factors(Baseline, +4 months, + 16 months)
- Mental Health Gap Action Programme - Knowledge Test - Baseline(Baseline)
- Mental Health Gap Action Programme - Knowledge Test - 4 Months Post-training(4 months post-training)
- Mental Health Gap Action Programme - Knowledge Test - 16 Months Post-training(16 months post-training)
- Implicit Association Test (IAT) Harmful - Baseline(Baseline)
- Implicit Association Test (IAT) Harmful - 4 Months Post Training(4 months post training)
- Implicit Association Test (IAT) Harmful - 16 Months Post Training(16 months post training)
- Enhancing Assessment of Common Therapeutic Factors - Baseline(Baseline)
- Enhancing Assessment of Common Therapeutic Factors - 4 Months Post-training(4 months post-training)
- Enhancing Assessment of Common Therapeutic Factors - 16 Months Post-training(16 months post-training)
- Mental Health Gap Action Program - Attitudes Questionnaire - Baseline(Baseline)
- Mental Health Gap Action Program - Attitudes Questionnaire - 4 Months Post-training(4 months post-training)
- Mental Health Gap Action Program - Attitudes Questionnaire - 16 Months Post-training(16 months post-training)
研究者
Brandon A Kohrt, MD, PhD
Principal Investigator
George Washington University