Please select the eligibility criteria that correspond to the clinical trial below.
Title: Task Sharing for the Care of Severe Mental Disorders in a Low-income Country: a Randomised, Controlled Non-inferiority Trial
Brief Summary: Task sharing mental health care through integration of mental health into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. In Ethiopia, it is estimated that only around 10% of people with severe mental disorders (SMDs) ever receive evidence-based treatment for their condition, largely due to scarcity of specialist mental health services. A task-sharing model of mental health care in PHC would be more affordable and accessible to the majority of persons with SMD who do not currently receive evidence-based mental health care. Furthermore, task sharing mental health care with PHC is about to be scaled up in Ethiopia in line with the National Mental Health Strategy. However, the effectiveness of the task sharing model of mental health care for people with SMD has not been evaluated systematically in a low-income country. In this study we propose to investigate non-inferiority of a task sharing model of mental health care in PHC compared to a less accessible, but more specialist, psychiatric nurse-led model of care. The specialist model of care has been demonstrated to be acceptable and associated with improved clinical outcomes for persons with SMD engaged in the service in Ethiopia thus making this an appropriate comparison model against which to evaluate non-inferiority of the task sharing model.


Options:
A: Inclusion Criteria:

* Victims of massive violence from northern Kosovo who reported one or more of the following experiences: 1) torture and other cruel, inhuman or degrading treatment or punishment (TCIDTP); 2) sexual harassment, molestation, rape or insertion of a blunt object into a genital organ and/or the rectum; 3) arrest and detention without warrant or order; or 4) extrajudicial execution of family members, perpetrated by members of law enforcement agency.
* Clinical diagnosis of PTSD and one of following symptoms: depression, anxiety or chronic pain

Exclusion Criteria:

* With mental retardation or significant speech or cognitive impairment that would impede assessments
* With past or present schizophrenia
* With major alcoholic or substance abuse problems
* Having recently undergone chemotherapy or chemo-radiotherapy for cancer or will have these therapy within following 6 months,
* Having had any CBT in the past three years
B: Inclusion criteria for phase 1

* Participant in the ongoing Butajira SMD cohort study (at baseline (between 1998 and 2001), cohort participants were aged between 15 and 49 years, resident in the area for at least six months and had a DSM-IV (SCAN) diagnosis of schizophrenia or schizoaffective disorder, bipolar disorder or major depressive disorder)
* Ongoing need for continuing mental health care due to:

  1. being on psychotropic medication at assessment or,
  2. not on medication but symptomatic at the time of assessment, or
  3. have experienced partial or full relapse within the two years preceding the assessment
* Stable clinical condition: either in remission from SMD or with residual symptoms that have been stable over the preceding three months.
* Planning to stay resident in the area for 18 months.
* Able to communicate in Amharic, the official language of Ethiopia.
* Willing to be randomised to either of the service models as described in the protocol.
* Has capacity to consent to participation or permission given by guardian and not refusing to participate
* Resident in catchment area of TaSCS health centres (excluding Butajira health centre)

Exclusion criteria for phase 1

* Suicide attempt within the preceding three months
* Current active suicide intent
* Prescribed Thioridazine, Valproate, Lithium or second generation antipsychotic medications (Risperidone and Olanzapine), as these medications are not be available in psychiatric nurse-led units or PHC settings in Ethiopia. Within the Butajira SMD cohort, only people who have received care from psychiatrist-led units in the capital city, Addis Ababa, might be receiving these medications. At present, fewer than 10 patients are known to be taking one of these medications.
* Prescribed depot medication
* Complex or unstable medical condition interfering with management of psychiatric disorder or requiring ongoing medical treatment from Butajira hospital
* Alcohol or khat dependence or abuse within the last 12 months
* Pregnant or breast-feeding
* Restrained at home
* Refusing to participate in the study

Inclusion criteria for Phase 2 As for Phase 1, but if we are unable to recruit enough participants from the existing Butajira SMD cohort then we will expand recruitment to people with SMD attending the psychiatric out-patient clinic at Butajira hospital. A semi-structured diagnostic interview will be carried out to determine diagnostic eligibility (DSM-IV diagnosis of schizophrenia or schizoaffective disorder, bipolar disorder or major depressive disorder). For participants recruited from Butajira hospital psychiatric out-patient clinic, the minimum age will be 25 years and the participants should have had their first contact with specialist mental health services at least two years prior to recruitment into the trial to ensure comparability with the Butajira SMD cohort sample.

Exclusion criteria for Phase 2

* Current active suicide intent
* Prescribed Thioridazine, Valproate, Lithium or second generation antipsychotic medications (Risperidone and Olanzapine).
* Pregnant or breast-feeding and prescribed depot
* Refusing to participate in the study
* Medical condition requiring ongoing medical treatment from Butajira hospital
C: Inclusion Criteria:

* Age ≥ 60 years old
* Community-dwelling residences
* Capable of independent communication
* Mini-Mental State Examination (MMSE) score ≥ 18

Exclusion Criteria:

* Incapable of giving written informed consent to this study
* Acute high suicide risk at baseline assessment
* Psychosis
D: Inclusion Criteria:

* clinical diagnosis of PTSD (Post-Traumatic Stress Disorder) derived from expert interviews
* member of the group of formerly abducted people or former child soldiers

Exclusion Criteria:

* current substance dependence
* mental retardation
* psychotic disorder

Answer: B