Evidence map›Paper›PMID 35905117›Full record

ArticlePloS one2022

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.

Dickens Akena, Aggrey Semeere, Philippa Kadama, Emmanuel K Mwesiga, Juliet Nakku, Noeline Nakasujja

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04602585 (The Effect of Psycho-education on Clinical Outcomes Among Patients With a First Episode Psychosis in Central Uganda - A Pilot Randomized Control Trial), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.1field-weighted citation impact, top 52% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04602585 naunknown statusnot on this map

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

TypeinterventionalSponsorMakerere UniversityRan2021 to 2023Enrolled80ConditionsPsychosisArmsPsycho-education
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Dickens AkenaDepartment of Psychiatry, Makerere University College of Health Sciences, Kampala, Uganda.ORCID 0000-0002-8886-4553
Aggrey SemeereInfectious Disease Institute, Makerere University College of Health Sciences, Kampala, Uganda.
Philippa KadamaInfectious Disease Institute, Makerere University College of Health Sciences, Kampala, Uganda.
Emmanuel K MwesigaDepartment of Psychiatry, Makerere University College of Health Sciences, Kampala, Uganda.ORCID 0000-0003-3512-7717
Juliet NakkuButabika National Mental referral Hospital, Kampala, Uganda.ORCID 0000-0002-0611-1102
Noeline NakasujjaDepartment of Psychiatry, Makerere University College of Health Sciences, Kampala, Uganda.
Makerere University · UGButabika Hospital · UG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPsychotic disorders contribute to significant morbidity and mortality partly due to the chronicity of the illness and high relapse rates. Delivering psycho-education messages about disease etiology, their signs and symptoms and the benefits of treatment adherence have been shown to improve clinical outcomes among individuals with psychoses. However, little has been done to examine the feasibility and efficacy of this intervention in low resourced settings.

objectiveOur primary objective will be to determine the feasibility of recruiting and retaining patients with a first episode psychosis (FEP) and for the secondary objective, we will determine the preliminary efficacy of psycho-education on illness self-management, stigma, adherence to medications and symptom severity. HYPOTHESIS: We hypothesize that (i) we will recruit 70% of eligible participants and accrue a sample size of 80 over 20-weeks, retaining 80% of the sample size for 24 weeks, (ii) the intervention will lead to improvement in clinical outcomes (described above).

methodsWe will recruit 80 adult patients who have been diagnosed with a FEP, received antipsychotic medication at Butabika Hospital and reside within 21km from the Hospital. Trained village health team (VHTs) members will deliver 6 psycho-education sessions to 40 participants and their family members (intervention arm). Participants in the control arm (n = 40) will receive routine care. We will document how feasible it will be to recruit and retain participants over 24 weeks and document the preliminary efficacy of the intervention on illness self-management, stigma, adherence to medications and severity of symptoms. DATA ANALYSIS: We will document the proportion of participants who consent and get recruited, the proportion of those who will get retained and reasons for drop out. We will conduct an intention to treat analysis comparing the groups at weeks 4, 12, 24 and assess the effect of the intervention on the clinical outcomes (described above). We will use the Bonferroni approach to correct for multiple comparisons.

trial registrationClinical trials.gov registration number: NCT04602585.

Indexed as

Antipsychotic AgentsPsychotic DisordersAdultFeasibility StudiesHumansPilot ProjectsRandomized Controlled Trials as TopicTreatment OutcomeUgandaAntipsychotic Agents

Identifiers

PMID35905117
PMCPMC9337703
OpenAlexW4288712682

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.