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STEPped-CARE intervention for depression in primary care

A cluster randomized controlled trial of a STEPped-CARE intervention for depression in primary care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46754188
Enrollment
1800
Registered
2013-09-23
Start date
2013-12-01
Completion date
Unknown
Last updated
2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression Mental and Behavioural Disorders Depressive episode, unspecified

Interventions

Patients are randomised to two arms: an intervention arm in which a manualized stepped-care intervention package is provided and a control arm delivering usual care. The intervention

Sponsors

University of Ibadan (Nigeria)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Consecutive attendees who consent will be screened while waiting to see primary care providers. Those who screen positive will be assessed for inclusion and exclusion, and if eligible, invited to enter the study. Patients much satisfy all of the following to be considered for study entry: 1. Adults, aged 18 years or over, with a score of 11 or more on the Patient Health Questionnaire (PHQ-9) 2. Confirmed 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of depression using the Composite International Diagnostic Interview (CIDI) 3. Provide informed consent

Exclusion criteria

Exclusion criteria: 1. Immediate need for medical attention 2. Pregnant 3. Actively suicidal 4. Presence of bipolar or psychotic disorder or severe substance dependence 5. Unlikely to be in the neighbourhood in the following 12 months

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the proportion of participants recovering from depression at 12 months from entering the trial (who no longer meets the DSM-V criteria for major depression)

Secondary

MeasureTime frame
Secondary outcomes will be conducted at 3, 6 and 9 months and will consist of: 1. PHQ9 scores (in order to address the possibility that even though individuals may have recovered from a major depressive disorder, significant depressive symptoms may still persist 2. Disability as assessed using the WHO Disability Assessment Scale (since there is evidence that disability may follow a different trajectory from that of symptoms among persons with depression) 3. Quality of life as measured by WHO Quality of Life instrument (in view of the evidence that health-related quality of life is a different and important dimension of illness experience other than disability and may more accurately capture personal views of impairment). Service use information, that provides data for computation of cost of care, will be collected using the Service Use Questionnaire.

Countries

Nigeria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 17, 2026