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DepressionNCT02425124

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

A study testing PC101+Mental Health in people with Depression and Hypertension, run by University of KwaZulu at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Depression, Hypertension
What is being tested?
PC101+Mental Health
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,052 participants
Where
1 siteSouth Africa
Study dates
22 Apr 2015to 31 Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinics
  • Twenty (20) largest clinics providing chronic care Patients
  • Receiving hypertensive treatment at time of enrolment
  • Depressive symptoms as indicated by total score of 9 or more on PHQ-9
  • Planning to reside in area for the next year
  • Capable of actively engaging in interviewer-administered questionnaire at time of recruitment, 6 months and 12 months later
  • Written consent to participate in the study

Who cannot join

  • Clinics
  • Clinics that do not provide Integrated Chronic Disease Management
  • Small (<10 000 attendances/ year)
  • Mobile or satellite
  • Participated in piloting of intervention \& data collection. Patients
  • Inability to meet the above inclusion criteria

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • Primary Health Care Facilities

    Dr Kenneth Kaunda District, North West, 2577

Other trials in South Africa

About this study

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.

Read the detailed description

Cardiovascular disease (hypertension and stroke) is the leading cause of mortality in the world and the second leading cause of death in Africa. Estimates by the WHO using disability adjusted life years (DALYs) suggest that NCDs were responsible for 28% of the total burden of disease in South Africa in 2004, with heart disease, diabetes and stroke together being responsible for the second most important cause of death in adult South Africans. In the investigators 2014 survey of 3 primary health care facilities in the North West Province where the Department of Health is piloting Integrated Chronic Disease Management the investigators found that of the 1 250 chronic care patients surveyed, 51% reported having hypertension. Spurring the rising burden of NCDs are mental disorders. One in 6 adults experience a common mental disorder (depression, anxiety disorders and substance use disorders) within a 12 month period (Herman et al., 2009), one in four receive treatment of any kind (Seedat et al., 2009). Depression co-exists with NCDs having a mutually reinforcing relationship compromising both prevention and treatment through exacerbating modifiable risk factors and compromising adherence and self-care respectively. Objectives: The investigators propose to strengthen the Primary Care 101 guidelines. This is a set of clinical guidelines and decision support for nurses developed for the identification and management of multiple chronic diseases.

Being tested
PC101+Mental Health
Medical subject headings
Depression, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PC101+Mental HealthBehavioural

    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.

Study groups in NCT02425124
Study groupRoleWhat they receive
ControlActive comparatorPC101 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.
Receives: Behavioral: PC101+Mental Health
InterventionExperimentalPC101 + 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.
Receives: Behavioral: PC101+Mental Health

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depression

    50 % reduction in PHQ-9 score

    Measured: 6 Months

Secondary outcomes (16)

  1. Depression

    50 % reduction in the PHQ-9 score

    Measured: 12 months

  2. Depression

    Remission defined as score of <5 on PHQ9

    Measured: 12 months

  3. Depression

    Mean PHQ9 scores

    Measured: 6 months; 12 months

  4. Blood pressure

    Difference in means

    Measured: 6 months and 12 months

  5. Disability

    Mean score using the Manual for WHO Disability Schedule WHODAS 2.0 schedule

    Measured: 12 Months

  6. Stress

    Mean score using Perceived Stress Scale

    Measured: 12 Months

  7. Antidepressant treatment

    Proportion with antidepressant treatment initiated or intensified

    Measured: 12 months

  8. Counselling

    Proportion receiving counselling by clinic-based counsellor

    Measured: 12 months

  9. Referral to specialist mental health worker/service

    Proportion referred

    Measured: 12 months

  10. Retention in care

    Proportion in care

    Measured: 12 months

  11. Cardiovascular risk factors

    Difference in means

    Measured: 12 months

  12. Diagnosis of other comorbid illnesses

    Proportion diagnosed

    Measured: 12 months

  13. Quality of chronic illness care received

    Mean Patient Assessment of Care for Chronic Conditions (PACIC) score

    Measured: 12 months

  14. Healthcare utilization

    Incidence rate ratio using linkage with hospitalisation databases

    Measured: 12 months

  15. Productivity and economic outcomes

    Productivity and economic outcomes

    Measured: 12 months

  16. All cause mortality

    Proportion died

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2015 (estimated)
  2. Study start22 Apr 2015
  3. Primary completion31 Oct 2016
  4. Study completion31 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,052 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02425124
Sponsor's protocol ID
HRPC10
Status last verified
Apr 2019
First submitted
10 Apr 2015
Last updated
17 Apr 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Petersen I, Fairall L, Zani B, Bhana A, Lombard C, Folb N, Selohilwe O, Georgeu-Pepper D, Petrus R, Mntambo N, Kathree T, Bachmann M, Levitt N, Thornicroft G, Lund C. Effectiveness of a task-sharing collaborative care model for identification and management of depressive symptoms in patients with hypertension attending public sector primary care clinics in South Africa: pragmatic parallel cluster randomised controlled trial. J Affect Disord. 2021 Mar 1;282:112-121. doi: 10.1016/j.jad.2020.12.123. Epub 2020 Dec 28.

    PubMed 33412490

  • Petersen I, Bhana A, Folb N, Thornicroft G, Zani B, Selohilwe O, Petrus R, Mntambo N, Georgeu-Pepper D, Kathree T, Lund C, Lombard C, Bachmann M, Gaziano T, Levitt N, Fairall L; PRIME-SA research team. Collaborative care for the detection and management of depression among adults with hypertension in South Africa: study protocol for the PRIME-SA randomised controlled trial. Trials. 2018 Mar 22;19(1):192. doi: 10.1186/s13063-018-2518-6.

    PubMed 29566730

Questions about this trial

What is this clinical trial studying?

A study testing PC101+Mental Health in people with Depression and Hypertension, run by University of KwaZulu at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02425124, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.

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