NCT02308956

Who might be able to join this trial:

• You must be a current participant in the ongoing Butajira SMD cohort study (people originally enrolled between 1998 and 2001 who were aged 15–49, living in the area, and diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder).
• You still have an ongoing need for mental health care — either because you are currently taking psychiatric medication, you have symptoms even without medication, or you have had a full or partial relapse in the past two years.
• Your mental health condition must be stable — either in remission or with symptoms that have not significantly changed in the past three months.
• You must be planning to stay living in the local area for at least 18 months.
• You must be able to communicate in Amharic (the official language of Ethiopia).
• You must be willing to be randomly assigned to either of the two care approaches being tested in the study.
• You must be able to agree to take part yourself, or have a guardian give permission on your behalf (and you must not be refusing to take part).
• You must live within the catchment area of the TaSCS health centres (not including Butajira health centre itself).

(For Phase 2 only: If not enough participants can be recruited from the existing cohort, the trial may also include people attending the psychiatric outpatient clinic at Butajira hospital who have a diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder, are at least 25 years old, and first had contact with specialist mental health services at least two years before joining the trial.)

Who may not be able to join:

• You have attempted suicide in the past three months.
• You currently have active thoughts of suicide or intent to end your life.
• You are currently prescribed certain specific medications — Thioridazine, Valproate, Lithium, Risperidone, or Olanzapine — as these are not available at the local clinics used in this trial.
• You are currently prescribed a depot injection (a long-acting injectable medication).
• You have a complicated or unstable physical health condition that affects your mental health treatment or requires ongoing care at Butajira hospital.
• You have had a problem with alcohol or khat use (misuse or dependence) in the past 12 months.
• You are currently pregnant or breastfeeding.
• You are being physically restrained at home.
• You do not wish to take part in the study.

(For Phase 2, the exclusion criteria are similar but a suicide attempt in the past three months is not listed as an exclusion — confirm with trial site.)

Important: Always verify eligibility with the trial site directly before applying.