Petersen 2018.

Study name	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
Methods	Cluster‐randomised controlled trial
Participants	Inclusion criteria 1. Twenty (20) largest clinics providing chronic care to patients 2. Receiving hypertensive treatment at time of enrolment 3. Depressive symptoms as indicated by total score ≥ 9 on PHQ‐9 4. Planning to reside in area for the next year 5. Capable of actively engaging in interviewer‐administered questionnaire at time of recruitment and 6 months and 12 months later 6. Written consent to participate in the study 7. Participants 18 to 80 years of age 8. Receiving treatment for hypertension 9. Screening positive for depression with total score ≥ 9 on the PHQ‐9 Exclusion criteria 1. Clinics that do not provide integrated chronic disease management 2. Small (< 10,000 attendances/year) 3. Mobile or satellite 4. Participated in piloting of intervention and data collection 5. Inability to meet the above inclusion criteria
Interventions	Intervention PC101 + mental health facility‐based stepped care intervention combining stress and depression case detection and management by non‐physician clinicians and referral pathways for antidepressant medication and/or group/individual counselling delivered by lay health workers for patients with depression Control PC101 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 authorised to prescribe antidepressant medication, and with no specific psychosocial interventions
Outcomes	Primary outcome Reduction in PHQ‐9 score ≥ 50% compared with baseline evaluated at 6 months Secondary outcomes 1. Response at 12 months defined as 50% reduction in score on the PHQ‐9 2. Remission at 12 months defined as score < 5 on the PHQ‐9 3. Mean PHQ‐9 scores at 6 and 12 months 4. Antidepressant treatment, including initiation or intensification of antidepressant medication 5. Referral to a counsellor for depression counselling 6. Referral to a mental health specialist (clinical psychologist, psychiatrist, or secondary care services) 7. Blood pressure at 6 and 12 months 8. Disability measured at 12 months using the WHO Disability Assessment Schedule version 2.0 (WHODAS 2) (12‐item interviewer‐administered version) 9. Stress symptoms measured at 12 months using the Perceived Stress Scale (PSS) 10. Patient assessment of quality of chronic illness care received measured at 12 months using the Patient Assessment of Care for Chronic Conditions (PACIC) Scale (locally adapted 10‐item scale) 11. Health care utilisation including clinic visits and hospital admissions 12. Resource use and economic outcomes measured using a Service Use Questionnaire and 13. All‐cause mortality measured through follow‐up at the clinic and linkage to the South African population register
Starting date	22 April 2015
Contact information	peterseni@ukzn.ac.za
Notes	Completed 31 July 2017