Management of depression by primary care health workers in Lagos, Nigeria

• Register: ISRCTN
• Last refreshed on: 26 August 2019
• Main ID: ISRCTN66243738
• Date of registration: 31/01/2017
• Prospective Registration: No
• Primary sponsor: Lagos State University College of Medicine
• Public title: Management of depression by primary care health workers in Lagos, Nigeria
• Scientific title: Collaborative stepped care intervention with mobile telephone support for primary care workers’ management of depression in Lagos, Nigeria: A cluster randomized controlled trial
• Date of first enrolment: 01/07/2014
• Target sample size: 1350
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN66243738
• Study type: Interventional
• Study design: Three-arm cluster randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Nigeria

Contacts

• Name: Abiodun Adewuya

Key inclusion & exclusion criteria

Inclusion criteria:
1. Adults aged 18-60 years
2. Scoring >10 on PHQ-9 or persistent score of >5 but <10 on PHQ-9 for 2 weeks
3. Intend to stay in the project area for at least 16 months
4. Ready to consent to trial

Exclusion criteria:
1. Children (below 18 years) and the elderly (above 60 years)
2. Patients with serious medical condition or disability necessitating specialist care
3. Patients having presently having any form of psychosis or under psychiatric care or showing suicidal ideation or attempt.
4. Patients with scores 5 or less on PHQ-9 on first visit or 2 weeks repeat screen
5. Patients not intending to stay in the project area for at least 16 months


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Depression
Mental and Behavioural Disorders
Depression

Intervention(s)

Participating centers are randomized to one of the three groups by an independent centre using minimization procedure to ensure even distribution of the PHCs as per their size.

Control group: Participants receive information leaflets about depression, its causes, symptoms and ways of preventing it.

CSC only group: Participants receive the collaborative stepped care (CSC) intervention. This involves the following:
1. Information leaflets about depression, its causes, symptoms and ways of preventing it
2. Psychoeducation focusing on educating the patient about their symptoms, the association of depression with interpersonal difficulties, the need to share emotional symptoms with the doctor and sharing personal difficulties with family members caring for them or other key people in their social network
3. Problem Solving Therapy in Primary Care (PST-PC) consisting of 6 sessions are offered to patients with unresolved mild depression, pregnant women, breastfeeding mothers, elderly, adolescents or those with co-morbid medical conditions and patients with moderate/severe depression not wanting medications
4. Antidepressants for moderate/severe depression, those not responding after 6 sessions of PST-PC or those not wanting PST-PC. Amitriptyline or Fluoxetine are the medications of choice and are given for 6 months.
5. Referral to mental health team for non-responders to antidepressants after 4 months, cases of depression with psychosis or suicidal ideations/attempts

CSC+ Mobile telephony support group: Participants receive the same collaborative stepped care (CSC) intervention as the CSC only group with the addition of mobile telephony support. This involves receiving:
1. Two text messages to remind patient about the next clinic appointment – the first text message delivered three days to the appointment and se

Primary Outcome(s)

Depressive symptoms are measured using the Patient Health Questionnaire (PHQ-9) at 4, 6 and 12 months.

Secondary Outcome(s)

1. Disability due to the illness is measured using the Short form of the WHO Disability Assessment Schedule (WHODAS-S) at baseline, 6 and 12 months
2. Quality of life is measured using the Brief version of the WHO Quality of Life schedule (WHOQOL-Bref) at baseline, 6 and 12 months
3. Adherence to treatment instructions (clinic appointments and drug dosage) is measured using logs of attendance and tablet counts at 6 and 12 months
4. Death from suicide and rate of self-inflicted injuries at 6 and 12 months
5. Health economic cost is calculated using the Client Service Receipt Inventory at 6 and 12 months
6. Stigma experience by the patient will be measured using the 7-item Impact Scale of the Inventory of Stigma Experiences at baseline, 6 and 12 months

Secondary ID(s)

GMH-0084-04

Source(s) of Monetary Support

Grand Challenges Canada (GCC)

Ethics review

Status:
Approval date:
Contact:

Lagos State University Teaching Hospital Health Research and Ethics Committee, 11/06/2013, LREC/10/06/299

Results

• Results available: Yes
• Date Completed: 30/12/2016