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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02793271
Date of registration: 03/06/2016
Prospective Registration: No
Primary sponsor: Brandon A Kohrt, MD, PhD
Public title: Reducing Stigma Among Healthcare Providers to Improve Mental Health Services RESHAPE-mh
Scientific title: Reducing Stigma Among Healthcare Providers to Improve Mental Health Services: RESHAPE-mh Protocol for a Feasibility and Acceptability Pilot Cluster Randomized Control Trial
Date of first enrolment: February 1, 2016
Target sample size: 301
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02793271
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Triple (Participant, Care Provider, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Nepal
Contacts
Name:     Brandon A Kohrt, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  George Washington University
Key inclusion & exclusion 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.



Age minimum: 21 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Mental Disorders
Intervention(s)
Behavioral: PRIME/mhGAP
Behavioral: RESHAPE
Primary Outcome(s)
Change in stigmatizing attitudes, as measured by the Social Distance questionnaire [Time Frame: Baseline, post-training (immediately after 10-day training curriculum), +4 months, + 16 months]
Secondary Outcome(s)
Change in clinical knowledge, as measured by the mhGAP knowledge assessment [Time Frame: 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 [Time Frame: Baseline, +4 months, + 16 months]
Change in implicit attitudes, as measured by the Implicit Association Test (IAT) [Time Frame: Baseline, +4 months, + 16 months]
Change in stigmatizing attitudes, as measured by the mhGAP Attitudes Questionnaire [Time Frame: 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) [Time Frame: Baseline, 6 months]
Change in patient depression, as measured by the Patient Health Questionnaire (PHQ-9) [Time Frame: 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) [Time Frame: Baseline, 6 months]
Secondary ID(s)
Pro00055042
K01MH104310
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Department for International Development, United Kingdom
National Institute of Mental Health (NIMH)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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