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

NCT04602585 | Unknown DMC

• 1 other identifier: Psycho-education and Psychosis
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Psychosis

Outcome Measures

Primary Outcomes (1)

• Reduction in symptom severity

  The investigators will measure a reduction in symptom severity as measured by the PANSS or YMRS

  6 Months

Study Arms (2)

Experimental

EXPERIMENTAL

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.

Behavioral: Psycho-education

Usual care arm

PLACEBO COMPARATOR

Participants will receive usual care

Behavioral: Psycho-education

Interventions

Psycho-education BEHAVIORAL

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

Experimental; Usual care arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals will be eligible if they have been diagnosed with a FEP and considered (by the attending health care practitioner) to have demonstrable resolution of active symptoms following the use of antipsychotic medications, and deemed clinically stable for a discharge. The diagnosis of FEP will be confirmed through an interview conducted a by a research assistant (RA) using the Mini International Neuropsychiatric Instrument (M.I.N.I). Participants (adults ≥18 years) will be required to provide written informed consent and should reside within a 21 km radius from Kampala.

You may not qualify if:

• individuals will be excluded if they present with a psychosis secondary to a medical or substance use disorder

Sponsors & Collaborators

• Makerere University: lead

Related Publications (1)

• Akena D, Semeere A, Kadama P, Mwesiga EK, Nakku J, Nakasujja N. Feasibility of conducting a pilot randomized control trial of a psycho-education intervention in patients with a first episode psychosis in Uganda-A study protocol. PLoS One. 2022 Jul 29;17(7):e0268493. doi: 10.1371/journal.pone.0268493. eCollection 2022.

  PMID: 35905117 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Dickens Akena, PhD

CONTACT

+256712941009; akenadickens@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: We will mask participants at the point of randomization. They will pick a piece of paper that dictates which arm they will belong
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Dickens Akena

Model Details: Participants will be randomized to one of 2 arms. There will be no cross over

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: September 1, 2021
• Primary Completion: July 30, 2023
• Study Completion: October 30, 2023
• Last Updated: August 10, 2021

Record last verified: 2021-08