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New treatment option for Mental Disorders, Severe
Official title Feasibility and Acceptability of an Intervention to Support People With Severe Mental Illness in South Africa
ClinicalTrials.gov ID: NCT07339462
What this study is testing
- What it's testing
- Despite commendable progress in developing mental health systems in low-and-middle income countries, critical gaps remain, particularly the development of community-based systems of support for people living with severe mental illness (SMIs). This application will pilot a co-developed health system strengthening intervention programme in a South African district in order to determine its feasibility, appropriateness and limited efficacy in reducing readmission following discharge from acute psychiatric hospitalization.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Service user
- Adults (aged 18 years and above);
- Being admitted to the psychiatric ward of a hospital for observation and treatment due to an acute psychiatric event, based on ICD diagnosis on...
- F20-29 including schizophrenia, delusional disorders, schizotypal disorders, acute polymorph psychotic disorders, schizoaffective disorders
- F30-39 Mood [affective] disorders with psychoses
You likely can't join if
- Under 18 years of age
- Are indicated by their chart history to have the following conditions:
- Active suicidal ideation
- Substance abuse or dependence as primary diagnosed psychiatric condition
- Personality disorders
- Serious cognitive or other sensorial impairment likely to preclude informed consent and reliable assessment
See the full eligibility criteria
- Service user
- Adults (aged 18 years and above);
- Being admitted to the psychiatric ward of a hospital for observation and treatment due to an acute psychiatric event, based on ICD diagnosis on patient charts according to the following criteria:
- F20-29 including schizophrenia, delusional disorders, schizotypal disorders, acute polymorph psychotic disorders, schizoaffective disorders
- F30-39 Mood [affective] disorders with psychoses
- F30.2 Mania with psychotic symptoms
- F31.2 Bipolar affective disorder, current episode manic with psychotic symptoms
- F31.5 Bipolar affective disorder, current episode severe depression with psychotic symptoms
- F32.3 Severe depressive episode with psychotic symptoms
- F33.3 Recurrent depressive disorder, current episode severe with psychotic symptoms
- Determined by the attending psychiatrist to be discharged into community settings following appropriate recovery from the psychiatric event;
- Willing and able to participate in the intervention programme
- Resides with a caregiver (which could be a family member or member of the household).
- Resides within the geographic boundaries of uMgungundlovu Service user
- Under 18 years of age
- Are indicated by their chart history to have the following conditions:
- Active suicidal ideation
- Substance abuse or dependence as primary diagnosed psychiatric condition
- Personality disorders
- Serious cognitive or other sensorial impairment likely to preclude informed consent and reliable assessment
- Does not reside with a caregiver
- Does not reside within the geographic boundaries of uMgungundlovu Caregiver inclusion criteria
- Adults (aged 18 years and above)
- Willing and able to participate in the intervention programme
- Resides with a caregiver (which could be a family member or member of the household).
- Resides within the geographic boundaries of uMgungundlovu Caregiver exclusion criteria
- Adults (aged 18 years and above)
- Willing and able to participate in the intervention programme
- Resides with a caregiver (which could be a family member or member of the household).
- Resides within the geographic boundaries of uMgungundlovu
The study team makes the final eligibility decision.
Where it's taking place
- Pietermaritzburg, KwaZulu-Natal, South Africa
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pietermaritzburg, KwaZulu-Natal, South Africa. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.