Here is the design of a clinical trial:

Official Title: The Effect of Psycho-education on Clinical Outcomes Among Patients With a First Episode Psychosis in Central Uganda - A Pilot Randomized Control Trial

Included conditions:
- Psychosis

Study Armgroups:
- {'label': 'Experimental', 'type': 'EXPERIMENTAL', 'description': "After discharge, the program manager will link the participants with a VHT nearest to them. The participants (randomized to the intervention arm) will be informed during the consent procedure that they will undergo 6 psycho-education sessions (1 per month) together with a family member at the participant's residence. The VHTs and participants will meet and schedule appointments for the next engagements. This shall be done on a case by case basis. Some psycho-education sessions could take place in the patient's residence, others in the nearest public space (school or church or mosque compounds). The investigators will document where the majority of these sessions happen. This will help the investigators document feasibility. The PI and RAs will sit in some of the sessions during the pilot phase of data collection to ensure fidelity to the manual.", 'interventionNames': ['Behavioral: Psycho-education']}
- {'label': 'Usual care arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants will receive usual care', 'interventionNames': ['Behavioral: Psycho-education']}

Interventions:
- {'type': 'BEHAVIORAL', 'name': 'Psycho-education', 'description': 'Participants will receive 6 psycho-education sessions as adjunct therapy to the use of antipsychotics', 'armGroupLabels': ['Experimental', 'Usual care arm']}

Primary Outcomes:
- {'measure': 'Reduction in symptom severity', 'description': 'The investigators will measure a reduction in symptom severity as measured by the PANSS or YMRS', 'timeFrame': '6 Months'}

Please estimate the sample size based on the assumption: 
No formal sample size and power calculation conducted; recruitment feasibility assessed by recruiting 70% of potentially eligible participants over 20 weeks and retaining 80% of recruited participants.
Sample size estimation
        Being a study assessing feasibility of recruitment as a primary outcome, we have not conduced a formal sample size and power calculation. Rather, we have considered that recruiting 70% of potentially eligible participants over a 20-week period and retaining 80% of recruited participants will provide us with adequate data that will be needed in recruiting participants for a powered RCT.
        In 2018 [41], a total of 43,870 individuals accessed care at the hospital, 60% (26,322) of them were diagnosed with psychotic disorders, approximately 20% (5,264) of the 26,322 patients with psychosis presented for the first time (potential cases of FEP). Thus, the number of participants who are eligible for recruitment is approximate 440 per month. Close to 20% of the Ugandan population lives within the central districts from where we intend to recruit participantsâwe anticipate having 88 patients (with psychosis) eligible for recruitment per week. However, a significant proportion of patients present with a psychosis resulting from substance use. We anticipate that approximately 40% of the 88 patients would be eligible as per criteria described below. Thus, we will have approximately 32 participants eligible for recruitment per week with a recruitment target of 24 of the 32 participants per week. We will document what proportion of this figure is attained.
        With a sample size of 80 participants, we will be able to conduct preliminary analyses to detect modest significant differences (5% increase in mean scores) in illness self-management and adherence as well as a 5% reduction in mean stigma and symptom severity. We will use this data to generate an effect size that can be used in a sample size estimation of a powered RCT.