Feasibility TRIAL
FEASIBILITY TRIAL
The cluster allocation of the union council determine the treatment path for each participant. Potential participants are verbally informed about the feasibility trial and those who agree to participate are given a full written information sheet about the study by a research assistant (RA) (written information sheets read by RA for those who can’t read). Those willing to participate are requested to complete the baseline sociodemographic data and a suicide risk screen by a RA. The RA refer all suspected cases from TSH and PCP to the psychiatrists assigned to each arm who are independently assess patients within 48 hours of referral, without knowing the diagnosis (by PCP) or impression of TSH. Those diagnosed with FEP started on treatment in collaboration with participating PCPs or TSH (if the patients and family want to continue treatment by TSH) in the intervention arm, while those in the control arm are provided with treatment as usual. The treatment are based on recent guidelines for the treatment of first-ever psychotic episodes adopted for the purpose of the study. Follow-up data are collected 12 weeks later by the RAs.
93 union councils in district Peshawar, Pakistan are randomized using a 1:1 ratio to either intervention arm (THEHOPE) or Enhanced Treatment as Usual (ETAU) and stratified by urban/rural setting. The randomization is done by a statistician who is not part of the study team using computer-generated random numbers.
Feasibility Trial start date: MAY 2023.
INTERVENTION ARM
THEHOPE is an organizational/service-level intervention with the following essential components:
1. A cascade model of training and task shifting from psychiatrists to Primary Care Physicians (PCP), and from PCP to TSH for early detection and treatment of FEP in adolescents.
2. Linking TSH and PCP with mental health professionals for early identification and referral of FEP and establishing community pathways for effective management of FEP. A group of TSH in the intervention arm are linked with one PCP working in the nearest primary health care (PHC) facility who are trained in early identification and referral of FEP in young persons. The TSH and PCPs work collaboratively in establishing care pathways for the optimum management of FEP in young persons.
CONTROL ARM:
Enhanced Treatment as Usual (ETAU)
The Enhanced Treatment As Usual (ETAU) include treatment as usual provided in the local mental health services, enhanced by WHO mhGAP (mental health gap action program) training for primary health care (PHC) physicians. The traditional and spiritual healers (TSH) in the control group are also given generic training about good mental health care. Training are of a similar duration to that for the intervention but the content does not include materials on early intervention in psychosis.
This is a feasibility cluster RCT. Key feasibility outcomes 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.
Primary Outcome Measures
In addition to feasibility outcomes, the study aims 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 are 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, are measured at 3 months follow-up.
12. Service utilization metrics measures are used as a measure of the acceptability of the intervention at baseline and 12 months follow-up. These include patients screened for suspected psychosis out of all those presenting at different contact points, the median time taken in screening, frequency and duration of contacts, median length of time to treatment from assessment to starting treatment and proportion of cases identified as At-Risk Mental State (ARMS) for FEP out of total accepted cases, the willingness of TSH to work with health services (indicated by the number of TSH approached, consented and completing training program).
13. The acceptability of trial procedures also assessed through adherence to trial procedures and completion of the assessments at baseline and 12 weeks.
14. Fidelity of intervention: first-episode psychosis services fidelity scale, modified and adapted for the local settings are used to assess the degree to which mental health teams deliver evidence-based care for FEP, measured at baseline and follow up.
15. The Client Service Receipt Inventory (CSRI) measure direct and indirect costs at baseline and follow up to estimate health economic costs from the payer and provider perspective. The researchers estimate mean, median and quartile costs at each timepoint.
Secondary Outcome Measures
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