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The Effect of Psycho-education on Clinical Outcomes Among Patients With a First Episode Psychosis in Central Uganda

NCT04602585 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-08-10

No results posted yet for this study

Summary

Background: Psychotic disorders which the investigators have operationally defined as any of schizophrenia or schizophrenia spectrum disorder, brief psychotic episode, or bipolar affective disorders are severe forms of mental illness that contribute to significant morbidity and mortality primarily due to high rates of relapse. Delivering psycho-education messages about disease etiology, their signs and symptoms, as well as the benefits of adhering to treatment have been shown to reduce relapse among individuals with psychoses in high income countries. However, little has been done to examine the efficacy of this intervention in low resourced settings like Uganda.

Objective: The study objective is to examine the efficacy of psycho-education on symptom severity, stigma and retention in care.

Methods: The Investigators will recruit 80 adult patients (aged ≥18 years) who have been diagnosed with a First Episode Psychosis (FEP) and received antipsychotic medication at Butabika Hospital. Participants should be ready for discharge and reside within a 21km radius from Kampala city. The investigators will use a simple random technique to randomize the 80 participants to either receive 6 sessions of psycho-education from village health team members (VHTs) with a family member (n=40) or routine care (n=40). The investigators will collect symptom severity, stigma and retention in care data over 24 weeks.

Data analysis plans: The investigators will conduct an intention to treat analysis and compare the groups at baseline, weeks 4, 12 and 24. We will assess the effects of the intervention on symptom severity. The investigators will assess for potential confounders, mediators and effect modifiers using generalized linear estimates. Between-subject analysis at week 24 will be used to assess if there is a significant difference in the mean severity scores between the 2 arms.

Conclusion: Findings from this research will throw more light with regards to the preliminary efficacy of the use of psycho-education for individuals with psychosis.

Conditions

Interventions

BEHAVIORAL

Psycho-education

Participants will receive 6 psycho-education sessions as adjunct therapy to the use of antipsychotics

Sponsors & Collaborators

  • Makerere University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2023-07-30
Completion
2023-10-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04602585 on ClinicalTrials.gov