Strengthening Mental Health Care in Chronic Care Patients With Hypertension. A Cluster Randomised Control Trial

NCT02425124 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1052

Last updated 2019-04-17

No results posted yet for this study

Summary

A pragmatic cluster randomized controlled trial (RCT) in 20 public sector primary care clinics in the Dr Kenneth Kaunda district of the North West Province of South Africa to assess mental health and health outcomes for depressed adults receiving hypertensive treatment by measuring the real-world effectiveness of a facility-based stepped care intervention combining stress and depression case detection and management by non-physician clinicians and referral pathways for anti-depressant medication and/or group/individual counselling delivered by lay-health workers for patients with depression. The control condition is enhanced usual primary health care where non-physician clinicians have been equipped with the basic skills to identify stress and depression/anxiety but with limited access to doctors authorized to prescribe antidepressant medication, and with no specific psychosocial interventions.

Conditions

Interventions

BEHAVIORAL

PC101+Mental Health

Facility-based stepped care intervention combining stress and depression case detection and management by non-physician clinicians and referral pathways for anti-depressant medication and/or group/individual counselling delivered by lay-health workers for patients with depression.

Sponsors & Collaborators

  • Department for International Development, United Kingdom

    collaborator OTHER_GOV
  • University of Cape Town

    collaborator OTHER
  • King's College London

    collaborator OTHER
  • University of KwaZulu

    lead OTHER

Principal Investigators

  • Inge Petersen, PhD · University of KwaZulu

  • Lara R Fairall, PhD · University of Cape Town

  • Graham Thornicroft, PhD · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-22
Primary Completion
2016-10-31
Completion
2017-07-31

Countries

  • South Africa

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02425124 on ClinicalTrials.gov