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Trial record 6 of 3692 for:    mental OR mentally OR addiction | Open Studies | Studies updated from 05/01/2016 to 03/10/2017

Reducing Stigma Among Healthcare Providers to Improve Mental Health Services (RESHAPE-mh)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Duke University
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Department for International Development, United Kingdom
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02793271
First received: June 3, 2016
Last updated: June 9, 2016
Last verified: May 2016
  Purpose
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 6-month follow-up. Patient outcomes include functioning, stigma experiences, and depression 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.

Condition Intervention
Mental Disorders
Behavioral: RESHAPE
Behavioral: PRIME/mhGAP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Official Title: Reducing Stigma Among Healthcare Providers to Improve Mental Health Services: RESHAPE-mh Protocol for a Feasibility and Acceptability Pilot Cluster Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in clinical competence, as measured by Enhancing Assessment of Common Therapeutic factors [ Time Frame: Baseline, 3 months, 6 months, and 12 months (12 month time point only if funding allows) ]
    Health Provider Outcome: Clinical competence is assessed with the Enhancing Assessment of Common Therapeutic factors. The ENACT is scored through observed or recorded role plays between primary care workers and standardized patients.

  • Change in stigmatizing attitudes, as measured by the Social Distance questionnaire [ Time Frame: Baseline, 3 months, 6 months, and 12 months (12 month time point only if funding allows) ]
    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


Secondary Outcome Measures:
  • Change in clinical knowledge, as measured by the mhGAP knowledge assessment [ Time Frame: Baseline, 3 months, 6 months, and 12 months (12 month time point only if funding allows) ]
    Health Provider Outcome: Clinical knowledge is assessed with the mhGAP knowledge assessment multiple choice evaluation.

  • Change in patient functioning, as measured by the World Health Organization Disability Assessment Scale (WHODAS) [ Time Frame: Baseline, 6 months ]
    Patient Outcome: Patient functioning is assessed with the World Health Organization Disability Assessment Scale (WHODAS). This is the primary measure of interest for patient outcomes.

  • Change in patient perceived stigma, as measured by the Barriers to Access to Care Evaluation (BACE) [ Time Frame: Baseline, 6 months ]
    Patient Outcome: Patient perceived stigma is assessed with the Barriers to Access to Care Evaluation (BACE)

  • Change in implicit attitudes, as measured by the Implicit Association Test (IAT) [ Time Frame: Baseline, 3 months, 6 months, and 12 months (12 month time point only if funding allows) ]
    Health Provider Outcome: Implicit Association Test (IAT) of implicit biases associating mental disorders versus physical disorders on attributes of harmfulness vs. harmlessness

  • Change in patient depression, as measured by the Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline, 6 months ]
    Patient Outcome: Clinically and culturally validated version of the PHQ-9 to measure depression symptom severity

  • Change in stigmatizing attitudes, as measured by the mhGAP Attitudes Questionnaire [ Time Frame: Baseline, 3 months, 6 months, and 12 months (12 month time point only if funding allows) ]
    Health Provider Outcome: attitudinal questions related to mental illnesses including depression, psychosis, epilepsy, and alcohol use

  • Change in stigmatizing attitudes, as measured by modified items from the Mental Illness Clinicians Attitudes (MICA) [ Time Frame: Baseline, 3 months, 6 months, and 12 months (12 month time point only if funding allows) ]
    Health Provider Outcome: Attitudes toward providing care for persons with mental illness compared to physical illness


Estimated Enrollment: 300
Study Start Date: February 2016
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Behavioral: PRIME/mhGAP
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 Name: Mental health services for primary care
Experimental: 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.
Behavioral: RESHAPE
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.
Other Name: Social contact anti-stigma behavioral intervention
Behavioral: PRIME/mhGAP
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 Name: Mental health services for primary care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02793271

Contacts
Contact: Nagendra P Luital, MA luitelnp@gmail.com
Contact: Manoj Dhakal, MA manojddhakal@gmail.com

Locations
Nepal
Transcultural Psychosocial Organization (TPO) Nepal Recruiting
Bharatpur, Chitwan, Nepal
Contact: Nagendra P Luitel         
Contact: Manoj Dhakal         
Sponsors and Collaborators
Duke University
National Institute of Mental Health (NIMH)
Department for International Development, United Kingdom
Investigators
Principal Investigator: Brandon A Kohrt, MD, PhD Duke Global Health Institute, Duke University
  More Information

Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02793271     History of Changes
Other Study ID Numbers: Pro00055042
K01MH104310 ( US NIH Grant/Contract Award Number )
Study First Received: June 3, 2016
Last Updated: June 9, 2016

Keywords provided by Duke University:
Depression
Primary Health Care
Social Stigma
Stereotyping
Health Care Quality
Access
Evaluation

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders

ClinicalTrials.gov processed this record on March 23, 2017