Reducing Stigma Among Healthcare Providers to Improve Mental Health Services

NCT02793271 | Completed DMC

• 2 other identifiers: Pro00055042K01MH104310
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Disorders

Keywords

Depression; Primary Health Care; Social Stigma; Stereotyping; Health Care Quality; Access; Evaluation

Outcome Measures

Primary Outcomes (1)

• Change in stigmatizing attitudes, as measured by the Social Distance questionnaire

  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

  Baseline, post-training (immediately after 10-day training curriculum), +4 months, + 16 months

Secondary Outcomes (7)

• 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

Study Arms (2)

PRIME

ACTIVE COMPARATOR

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

PRIME+RESHAPE

EXPERIMENTAL

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; Behavioral: PRIME/mhGAP

Interventions

RESHAPE BEHAVIORAL

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.

Also known as: Social contact anti-stigma behavioral intervention

PRIME+RESHAPE

PRIME/mhGAP BEHAVIORAL

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.

Also known as: Mental health services for primary care

PRIME; PRIME+RESHAPE

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brandon A Kohrt, MD, PhD: lead
• National Institute of Mental Health (NIMH): collaborator
• Department for International Development, United Kingdom: collaborator

Study Sites (1)

Transcultural Psychosocial Organization (TPO) Nepal

Bharatpur, Chitwan, Nepal

Location

Related Publications (15)

• Kohrt BA, Luitel NP, Acharya P, Jordans MJ. Detection of depression in low resource settings: validation of the Patient Health Questionnaire (PHQ-9) and cultural concepts of distress in Nepal. BMC Psychiatry. 2016 Mar 8;16:58. doi: 10.1186/s12888-016-0768-y.

  PMID: 26951403 BACKGROUND

• Jordans MJ, Kohrt BA, Luitel NP, Komproe IH, Lund C. Accuracy of proactive case finding for mental disorders by community informants in Nepal. Br J Psychiatry. 2015 Dec;207(6):501-6. doi: 10.1192/bjp.bp.113.141077. Epub 2015 Oct 8.

  PMID: 26450582 BACKGROUND

• Griffith JL, Kohrt BA. Managing Stigma Effectively: What Social Psychology and Social Neuroscience Can Teach Us. Acad Psychiatry. 2016 Apr;40(2):339-47. doi: 10.1007/s40596-015-0391-0. Epub 2015 Jul 11.

  PMID: 26162463 BACKGROUND

• Kohrt BA, Jordans MJ, Rai S, Shrestha P, Luitel NP, Ramaiya MK, Singla DR, Patel V. Therapist competence in global mental health: Development of the ENhancing Assessment of Common Therapeutic factors (ENACT) rating scale. Behav Res Ther. 2015 Jun;69:11-21. doi: 10.1016/j.brat.2015.03.009. Epub 2015 Mar 24.

  PMID: 25847276 BACKGROUND

• Kohrt BA, Hruschka DJ. Nepali concepts of psychological trauma: the role of idioms of distress, ethnopsychology and ethnophysiology in alleviating suffering and preventing stigma. Cult Med Psychiatry. 2010 Jun;34(2):322-52. doi: 10.1007/s11013-010-9170-2.

  PMID: 20309724 BACKGROUND

• Kohrt BA, Tol WA, Harper I. Reconsidering somatic presentation of generalized anxiety disorder in Nepal. J Nerv Ment Dis. 2007 Jun;195(6):544; author reply 545. doi: 10.1097/NMD.0b013e318064e7eb. No abstract available.

  PMID: 17568305 BACKGROUND

• Kohrt BA, Harper I. Navigating diagnoses: understanding mind-body relations, mental health, and stigma in Nepal. Cult Med Psychiatry. 2008 Dec;32(4):462-91. doi: 10.1007/s11013-008-9110-6.

  PMID: 18784989 BACKGROUND

• Jordans MJ, Luitel NP, Pokhrel P, Patel V. Development and pilot testing of a mental healthcare plan in Nepal. Br J Psychiatry. 2016 Jan;208 Suppl 56(Suppl 56):s21-8. doi: 10.1192/bjp.bp.114.153718. Epub 2015 Oct 7.

  PMID: 26447173 BACKGROUND

• Makan A, Fekadu A, Murhar V, Luitel N, Kathree T, Ssebunya J, Lund C. Stakeholder analysis of the Programme for Improving Mental health carE (PRIME): baseline findings. Int J Ment Health Syst. 2015 Jul 8;9:27. doi: 10.1186/s13033-015-0020-z. eCollection 2015.

  PMID: 26155307 BACKGROUND

• Luitel NP, Jordans MJ, Adhikari A, Upadhaya N, Hanlon C, Lund C, Komproe IH. Mental health care in Nepal: current situation and challenges for development of a district mental health care plan. Confl Health. 2015 Feb 6;9:3. doi: 10.1186/s13031-014-0030-5. eCollection 2015.

  PMID: 25694792 BACKGROUND

• Brenman NF, Luitel NP, Mall S, Jordans MJ. Demand and access to mental health services: a qualitative formative study in Nepal. BMC Int Health Hum Rights. 2014 Aug 2;14:22. doi: 10.1186/1472-698X-14-22.

  PMID: 25084826 BACKGROUND

• Kaiser BN, Gurung D, Rai S, Bhardwaj A, Dhakal M, Cafaro CL, Sikkema KJ, Lund C, Patel V, Jordans MJD, Luitel NP, Kohrt BA. Mechanisms of action for stigma reduction among primary care providers following social contact with service users and aspirational figures in Nepal: an explanatory qualitative design. Int J Ment Health Syst. 2022 Aug 11;16(1):37. doi: 10.1186/s13033-022-00546-7.

  PMID: 35953839 DERIVED

• Kohrt BA, Jordans MJD, Turner EL, Rai S, Gurung D, Dhakal M, Bhardwaj A, Lamichhane J, Singla DR, Lund C, Patel V, Luitel NP, Sikkema KJ. Collaboration With People With Lived Experience of Mental Illness to Reduce Stigma and Improve Primary Care Services: A Pilot Cluster Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2131475. doi: 10.1001/jamanetworkopen.2021.31475.

  PMID: 34730821 DERIVED

• Rai S, Gurung D, Kaiser BN, Sikkema KJ, Dhakal M, Bhardwaj A, Tergesen C, Kohrt BA. A service user co-facilitated intervention to reduce mental illness stigma among primary healthcare workers: Utilizing perspectives of family members and caregivers. Fam Syst Health. 2018 Jun;36(2):198-209. doi: 10.1037/fsh0000338.

  PMID: 29902036 DERIVED

• Kohrt BA, Jordans MJD, Turner EL, Sikkema KJ, Luitel NP, Rai S, Singla DR, Lamichhane J, Lund C, Patel V. Reducing stigma among healthcare providers to improve mental health services (RESHAPE): protocol for a pilot cluster randomized controlled trial of a stigma reduction intervention for training primary healthcare workers in Nepal. Pilot Feasibility Stud. 2018 Jan 24;4:36. doi: 10.1186/s40814-018-0234-3. eCollection 2018.

  PMID: 29403650 DERIVED

MeSH Terms

Conditions

Mental Disorders; Depression; Social Stigma; Stereotyping

Interventions

PRIME protocol; Mental Health Services; Primary Health Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Brandon A Kohrt, MD, PhD

  George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: June 8, 2016
• Study Start: February 1, 2016
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: June 4, 2019

Record last verified: 2019-05

Locations

NE (1)