Traditional healers working with primary care and mental health for early intervention in psychosis in young persons

Traditional healers working with primary care and mental health for early intervention in psychosis in young persons: protocol for the development of intervention and feasibility cluster randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN75347421

Enrollment

Registered

2023-01-11

Start date

2023-05-02

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First episode psychosis Mental and Behavioural Disorders Unspecified nonorganic psychosis

Interventions

93 union councils in district Peshawar, Pakistan will be randomised using a 1:1 ratio to either intervention arm (THE HOPE) or Enhanced Treatment as Usual (ETAU) and stratified by urban/rural setting.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 14 to 25 years 2. Residing in one of the union councils in district Peshawar 3. First-ever psychotic (FEP) episode diagnosis made at interview by psychiatrists using a Composite International Diagnostic Interview based on the International Classification of Diseases, 11th revision (ICD-11) criteria for schizophrenia, persistent delusional disorder, acute and transient psychotic disorders, schizoaffective disorder, mood disorders (mania, severe depressive episode, bipolar affective disorder) with psychotic symptoms 4. Have not received antipsychotic medication previously, or if they already have used antipsychotic medications, it was for no longer than 6 weeks.

Exclusion criteria

Exclusion criteria: 1. Evidence of overt learning disability 2. Organic brain damage or pervasive developmental disorder 3. Severe substance abuse (except nicotine dependence) 4. Young person or parent not willing to provide informed consent

Design outcomes

Primary

Measure	Time frame
This will be a feasibility cluster RCT. Key feasibility outcomes will include: 1. The total number of cases recruited in a 12-month period, with a minimum sample size of 90 during the 12-month period 2. Total number of cases referred by TSH and primary care physicians to psychiatrists and the proportion of suspected FEP in the referred cases during the recruitment period 3. The number of FEP cases suspected by TSH and PCPs during the 12-month period 4. The likelihood of the confirmed diagnosis of FEP based on interview diagnosis by a psychiatrist during the 12-month period and Duration of Untreated Psychosis (DUP) in those meeting criteria for FEP during the 12-month recruitment period	—

Measure

Time frame

This will be a feasibility cluster RCT. Key feasibility outcomes will include: 1. The total number of cases recruited in a 12-month period, with a minimum sample size of 90 during the 12-month period 2. Total number of cases referred by TSH and primary care physicians to psychiatrists and the proportion of suspected FEP in the referred cases during the recruitment period 3. The number of FEP cases suspected by TSH and PCPs during the 12-month period 4. The likelihood of the confirmed diagnosis of FEP based on interview diagnosis by a psychiatrist during the 12-month period and Duration of Untreated Psychosis (DUP) in those meeting criteria for FEP during the 12-month recruitment period

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Secondary

Measure	Time frame
In addition to feasibility outcomes, the study will aim to measure the following clinical outcomes: 1. Psychopathology is measured by Brief Psychiatric Rating Scale (BPRS), Young Mania Rating Scale (YMRS), Hamilton Depression Rating Scales (HDRS), Clinical Global Impression Scale (CGI) for measuring improvement in symptoms and remission rates at baseline and 12-week post-baseline 2. Occupational and social functioning is measured using the global assessment of functioning (GAF) at baseline and 12-week post-baseline 3. Duration of untreated psychosis will be measured using the Comprehensive Assessment of At Risk Mental States (CAARMS) at baseline 4. Quality of life is measured using EuroQol-5 at baseline and 12 weeks post-baseline 5. Family burden is measured using the Perceived Family Burden Scale (PFBS) at baseline and 12 weeks post-baseline 6. Stigma measured using the Internalized Stigma of Mental Illness (ISMI) at baseline and 12 weeks post-baseline 7. Physical health is measured by weight and Body Mass Index at baseline and 12 weeks post-baseline 8. Substance abuse is measured using the Drug Abuse Screening Test (DAST-10) at baseline and 12 weeks post-baseline 9. Response to antipsychotics treatment is measured by Change in Psychiatric Rating Scale (BPPRS) from baseline to 4 weeks after starting antipsychotics 10. Adherence to antipsychotic treatment is measured by Medication Adherence Rating Scale (MARS) at 3 months follow up 11. Rates of disengagement defined as a participant's refusal to engage with treatment or not responding to contact requests for a consecutive 4 weeks period during follow-up while still residing within the study site catchment area, will be measured at 3 months follow-up 12. Service utilisation metrics measures will be used as a measure of the acceptability of the intervention at baseline and 12 months follow-up. These will include patients screened for suspected psychosis out of all those presenting at different contact points, the m	—

Measure

Time frame

In addition to feasibility outcomes, the study will aim to measure the following clinical outcomes: 1. Psychopathology is measured by Brief Psychiatric Rating Scale (BPRS), Young Mania Rating Scale (YMRS), Hamilton Depression Rating Scales (HDRS), Clinical Global Impression Scale (CGI) for measuring improvement in symptoms and remission rates at baseline and 12-week post-baseline 2. Occupational and social functioning is measured using the global assessment of functioning (GAF) at baseline and 12-week post-baseline 3. Duration of untreated psychosis will be measured using the Comprehensive Assessment of At Risk Mental States (CAARMS) at baseline 4. Quality of life is measured using EuroQol-5 at baseline and 12 weeks post-baseline 5. Family burden is measured using the Perceived Family Burden Scale (PFBS) at baseline and 12 weeks post-baseline 6. Stigma measured using the Internalized Stigma of Mental Illness (ISMI) at baseline and 12 weeks post-baseline 7. Physical health is measured by weight and Body Mass Index at baseline and 12 weeks post-baseline 8. Substance abuse is measured using the Drug Abuse Screening Test (DAST-10) at baseline and 12 weeks post-baseline 9. Response to antipsychotics treatment is measured by Change in Psychiatric Rating Scale (BPPRS) from baseline to 4 weeks after starting antipsychotics 10. Adherence to antipsychotic treatment is measured by Medication Adherence Rating Scale (MARS) at 3 months follow up 11. Rates of disengagement defined as a participant's refusal to engage with treatment or not responding to contact requests for a consecutive 4 weeks period during follow-up while still residing within the study site catchment area, will be measured at 3 months follow-up 12. Service utilisation metrics measures will be used as a measure of the acceptability of the intervention at baseline and 12 months follow-up. These will include patients screened for suspected psychosis out of all those presenting at different contact points, the m

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Countries

Pakistan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026