Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04602585 |
| Other study ID # |
Psycho-education and Psychosis |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
October 30, 2023 |
Study information
| Verified date |
August 2021 |
| Source |
Makerere University |
| Contact |
Dickens Akena, PhD |
| Phone |
+256712941009 |
| Email |
akenadickens[@]yahoo.co.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Methods
1. Study setting: The study will be conducted at the Butabika National Mental Referral
Hospital in Kampala, a 600 bed hospital located 13km east of Kampala city
2. Eligibility criteria: Individuals will be eligible if they have been diagnosed with a
First Episode Psychosis ( 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 (MINI). Participants (adults
≥18 years) will be required to provide written informed consent and should reside within
a 21 km radius from Kampala.
Exclusion criteria: Individuals will be excluded if they present with a psychosis
secondary to a medical or substance use disorder.
3. Sample size and power calculation: The investigators calculated the size of effects that
our sample will be able to detect a clinically significant difference in symptom
severity (primary outcome) between the two arms. A sample size of 80 (n=40 per arm) will
provide sufficient power to detect a 50% difference in mean symptom severity levels
between the two arms using a two-tailed z-test of proportions with 80% power and 95%
confidence interval. Whereas this study is not adequately powered to detect statistical
significance, our findings will provide the investigators with an effect size that can
be used in sample size calculation of a powered randomized control trial (RCT).
4. Data collection methods
i) Training: RAs and VHTs will each undergo 4-day's training in the study procedures.
ii) Random sequence allocation: The investigators will use a simple random technique to
randomize participants. Our biostatistician will write the words intervention, insert them in
40 opaque envelops and seal them, then do the same for controls
iii) Data collection: RAs shall identify potential participants, provide them with
information about the study, obtain written informed consent, then administer the University
of California, San Diego Brief Assessment of Capacity to Consent (UBACC) [40] to assess
participant comprehension of the consent process.
RA's will administer a) standardized questionnaire to collect demographic and clinical
variables (age, gender, address, education, date of symptom onset) b) MINI to confirm a
diagnosis, c) Young Mania Rating Scale (YMRS) [41] for individuals with bipolar illness or
Positive and Negative Symptoms of Schizophrenia Scale (PANSS) [42] for individuals with
schizophrenia spectrum disorders to assess symptom severity d) World Health Organization
Disability Assessment Schedule, e) Internalized Stigma of Mental Illness scale and f) a
medication adherence measure
iv) Blinding participants and RA to the study arm: Participants will then pick an envelope
and open it to see which study arm they belong. VHTs will deliver 6 psycho-education sessions
(1 per month) to participants in intervention arm and their family members at the
participant's residence. The PI and RAs will sit in some of the sessions during the pilot
phase of data collection to ensure fidelity to the manual. RA's will schedule participants
from both arms for an assessment using the same instruments at weeks 4, 12 and 24 at the
clinic
v) Data analysis plans: The investigators will conduct an intention to treat analysis and
compare the groups at baseline, weeks 4, 12 and 24. The investigators will assess the effects
of the intervention on symptom severity (PANSS or YMRS). The investigators will assess for
potential confounders, mediators and effect modifiers using generalized linear estimates.
Participant identification and recruitment:
i) Identification: Health care workers in the different wards and out-patient departments of
Butabika Hospital will be informed about the study. Trained RA shall liaise with the
clinicians to identify potential participants for recruitment at the time of admission to the
wards. RA's will then assess participants who are due for discharge (patients with a clinical
response to medications) for possible enrollment, and provide them with information about the
study. Patients who access care at the out-patient clinic (who may not be admitted) but are
eligible will also be approached by the RA for enrollment.
ii) The informed consent procedure: The RA's will invite potential participants to take part
in the study, and obtain written informed consent. During the consenting process, the purpose
of the study will be described further, the procedures will be explained, and the benefits of
taking part in the study will be outlined. Upon demonstrating understanding and being given a
chance to ask questions, the potential participant will then provide a witnessed, signed or
thumb print consent.
iii) Assessing the capacity to consent: The investigators will administer the University of
California, San Diego Brief Assessment of Capacity to Consent (UBACC) [40] instrument to
assess whether the participants have understood the consent process. The UBACC will be
translated into Luganda, the commonly spoken local language at the study site. The UBACC is a
10-item scale comprised of 3 factors that evaluate understanding, appreciation and reasoning.
It has been used in the Ugandan setting for the Neuro-Genetics of Psychosis in African
Populations (Neuro-GAP) project, although it is yet to be culturally adapted for use in these
settings. A score of less than 14.5 on three separate occasions indicates that the
participant has not understood what the study is all about. Such participants will not be
recruited, but will be given a chance to return at a later date for recruitment (within a
week). The investigators will record the number of participants who fail the UBACC at
baseline and can't be recruited and those who do so after being invited a week later.
The investigators will ask participants to provide the investigators with their demographic
information (age, gender and education level) and examine whether there are significant
differences between participants who are able to consent and those who are not. Participation
in this study is completely voluntary. The patient has the right to withdraw at any time
during the study, including at follow-up. The investigators will document the reasons for
withdrawal. Each interview is anticipated to last a minimum of 120 minutes -there will be 2-3
breaks at 40 minute intervals in between the interviews.
Feasibility of recruitment and delivery of care: The investigators anticipate recruiting the
participants within 6 months. Since The investigators will recruit participants from the
convalescent wards, they will administer the instruments over a 2 day period by conducting
the consenting process a day earlier (takes approximately 30-45min). The rest of the
interview will take approximately an hour and 15min. This is meant to reduce the time taken
during the interviews. Furthermore, not all instruments will be administered in the same
setting
1. The UBACC, Consent MINI, rating scales will be administered at baseline
2. At follow-up, The investigators will administer the MINI, rating scale, Medication
adherence side rating scale (MARS) and WHO-disability adjusted life year scale (WHODAS).
If the patient has Schizophrenia, they only get the PANSS and not the YMRS administered
to them while if they have bipolar, they get the YMRS and not PNASS).
With each village having at least 5 VHTs, The investigators are confident that the
participants will have access to at least one VHT within a 5km radius. The VHTs already play
an integral part of ministry of health efforts including delivery of information during
health campaigns as well as distribution of mosquito nets among many tasks initiated by the
ministry. However, not all of them have received training in delivering mental health care.
The investigators will identify them and train them.
