Reducing Stigma Among Healthcare Providers to Improve Mental Health Services
Condition: Mental Disorders
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.]

      Participants Primary care workers are the intended direct beneficiaries of RESHAPE. Their
      patients are the intended indirect beneficiaries. Primary care workers include prescribers
      (health assistants and auxiliary health workers) and non-prescribers (auxiliary nurse
      midwives) both of whom represent the first contact for most care needs. Medical doctors
      (MBBS) are limited to primary health centers and hospitals are usually seen after a person
      has encountered one of the lower level cadre of workers. In the pilot, additional
      participants will include PWMI who will be trained as facilitators for RESHAPE, mental health
      experts (psychiatrists and psychosocial counselors) who serve as facilitators and
      supervisors, and research staff (research assistants, field coordinators, and external
      competency and fidelity raters). For the pilot, the investigator plans to recruit all primary
      care workers (prescribers and non-prescribers) who are participating in the PRIME scale-up
      phase and a subset of their patients.

      Randomization RESHAPE is a pilot cluster randomize trial. As mentioned, the reason for
      cluster randomization is because of the expected contagion at the level of the health
      facility. Health attitudes and behaviors are influenced by co-workers, and therefore the
      investigators expect that an intervention done with one health worker in a facility will
      influence peers. In addition, contagion may occur during other trainings among community
      health workers. Therefore, the health care provider randomization plan is to randomize all
      prescribers and non-prescribers associated with a specific facility.

      Planned analyses

      Qualitative analyses: Focus group discussions (FGD), cognitive interviews, and process
      evaluation notes will be coded in NVIVO (software name) and analyzed using content analysis
      for themes of cultural acceptability, experience of consumers as trainers, relevance to
      clinical care, training duration, structure of training, content of training, and follow-up
      engagement. Coding will be conducted among independent raters, and inter-rater reliability
      will calculated using Kappas. Data analysis will be conducted throughout each step to
      facilitate iterative revision then finalization of the manual.

      Statistical analyses: The quantitative outcomes of interest will be summarized descriptively
      and visually over time for the providers (4 time points: pre- and post-training, then 4
      months later, followed by another 12 months after that assessment point) and patients (2 time
      points: study entry and 6 months later) for both study arms. Total and validated
      domain-specific scores will be obtained for each instrument. Patient (PT)-specific trends
      over time for each score will be plotted to examine between-PT differences and to determine
      the plausible pattern (e.g. linearity) of those trends. This information will be used to
      inform the choice of effect estimate (e.g. difference in slopes or in means at a specific
      follow-up time point) in a subsequent cluster-randomized trial (C-RCT). The profiles will be
      grouped by cluster and by study arm to examine between-cluster and between-arm variation in
      PT outcomes. Using the first PT measurement (i.e. in the absence of intervention),
      preliminary estimates of within- and between-cluster variances, within- and between-primary
      care workers (PCW) variances and the intra-class correlation coefficient (ICC) of PT outcomes
      will be estimated. Such estimates are essential for sample size calculations for the planned
      R01 C-RCT design. Such variances are often guessed or obtained from other studies, whereas
      the investigator will obtain context and design-specific estimates using this pilot data.
      Moreover, the investigator will be able to estimate variance components for other measures of
      interest, such as PT-specific slopes, as appropriate. PCW-specific trends for each PCW-score
      will be examined using the same strategy as for PTs. Preliminary indicative estimates of
      differences in perceptions by arm will be obtained. Because the proposed K01 study is a
      pilot, no hypothesis-based inference testing will be performed. Instead, all quantitative
      analyses will focus on description. Analyses will be used for publication on the C-RCT pilot
      and for modification for full-scale C-RCT.

      Ethics and research governance Consent: Providers will be told in the consent form that there
      are two different training approaches being evaluated. They will not be told about the focus
      regarding stigma as this may bias the outcomes. Nor will they be told that the main
      difference between trainings is the presence of PWMI as co-facilitators as this may
      contribute to attentional biases.

      Harms: The main risk factor is psychological distress among consumers depending on the type
      of interaction with health care trainees in the training. If consumers do not feel that the
      engagement training is comfortable training environment, the investigator has outlined
      contingency plans regarding use of videotaped testimonials. Given a prior training with
      healthcare consumers in Nepal, the investigator anticipates that consumers will find the
      training experience a non-distressing experience. Minimal risk of harm from the treatment is
      anticipated. If patients require medication, hospitalization, or treatment, they will
      continue to be followed. Thus, there is not a disincentive for patients or providers to
      transition to other care if needed. In addition to these risks with greatest likelihood,
      other issues to consider are 1) negative consequences if confidentiality of information
      obtained in the study (including subject identity as a research participant or information
      collected during assessments or abstracted from a medical record review) were compromised.

      Treatment for patients in the study is at the discretion of PCWs. PCW training includes both
      psychotherapy and medication management. At any time, PCWs may decide to initiate medication.
      All patients are expected to be receiving optimal clinical care at the clinical judgment of
      PCWs. PCWs are supervised by psychiatrists in Chitwan who can provide information on
      management and receive referrals for patients with worsening symptoms or other clinical
      concerns. All changes in treatment resulting from Adverse Events or Serious Adverse Events
      will be reported to institutional review boards.

      Research ethics approval: This protocol has been approved by Duke University (Protocol
      Number: Pro00055042) and the Nepal Health Research Council (Regulatory Number: 110/2014).

      Amendments: Amendments will be jointly reviewed by Duke University and Nepal Health Research
      Council, as well submitted to the funder: the National Institute of Mental Health, USA.

      Timescale Trainings for PRIME and PRIME plus RESHAPE will take place in February-June 2016.
      Providers will be followed for two years to evaluate retention, changes in knowledge,
      attitudes, and clinical competence. Patient will be enrolled at facilities approximately 18
      months after training. They will be followed-up six months after initial enrollment
      evaluation. Primary outcome data collection will be completed by the end of June 2018.
    

Intervention name(s): RESHAPE; PRIME/mhGAP
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mental health services users and primary care workers who have previously completed the training are trained using PhotoVoice and other techniques to participate as co-facilitators. They participate in introductions to the intervention, myth busting, recovery stories, psychosocial communication role plays, and collaborative activities addressing challenges and barriers to task sharing/ task shifting mental health services in primary care.; Primary care workers are trained using the mental health Global Action Programme (mhGAP) to identify and treat mental disorders in primary care. Primary care "prescribers" (those who can administer psychotropic medication) are trained to treat disorders including depression, alcohol use disorder, psychosis / schizophrenia, and epilepsy. "Non-prescribers" (primary care workers not authorized to dispense medications) are trained to deliver psychosocial and psychological interventions.
Other intervention name(s): Social contact anti-stigma behavioral intervention; Mental health services for primary care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Keywords: Depression; Primary Health Care; Social Stigma; Stereotyping; Health Care Quality; Access; Evaluation