Schizophrenia Clinical Trial
Official title:
Efficacy of a Brief Group Psychoeducation Program Aimed at Patients With Schizophrenia and Their Families: A Clinical Controlled Trial
This study evaluates the addition of psychoeducation to treatment as usual in the treatment of adults with schizophrenia for relapse prevention. Half of participants will receive a brief (5 sessions) psychoeducation intervention and treatment as usual in combination, while the other half will receive treatment as usual only.
Schizophrenia is a chronic persistent and disabling psychiatric syndrome whose primary
feature is the presence of delusions, hallucinations, disorganized speech or behavior,
catatonic behavior and negative symptoms (poverty of thought, social isolation, decreased
expression of emotions and motivation for activities). Its incidence in one year is 15.9 per
100,000 inhabitants; its prevalence is 4.3 per 1,000 inhabitants and has been shown to be
more common among men, migrant population, urban area, developed countries and greater
latitude. It is associated with: 1) Increased mortality rates compared to the general
population 2) Disability is one of the top ten causes of years lived with disability in
people between 15 and 44 years old, which can be explained by incomplete remission of up to
80% of affected patients and psychotic relapses (5-7). 3) High economic costs given by
relapses, hospitalizations, decreased labor productivity and financial and emotional burden
for families (8,9). The latter has increased in the last 50 years by changes in the mental
health care systems throughout the world that have left families a greater responsibility in
caring for patients so they would need more knowledge about the disorder, treatment and
rehabilitation (10,11). All this justifies the search for strategies aimed at preventing
psychosis crisis increase the period between crises and decrease disability (12,13,14).
Psychoeducation is one of the strategies that have been raised so far (15).
Psychoeducation is an intervention based on the structured and systematic knowledge
acquisition of a mental disorder, with the aim of improving their clinical prognosis and
reduce care costs (15,16,17). There are various designs of psychoeducative programs, they can
be individual or group, involving only patients, family or both, or short (less than 10
sessions) or longer. There is insufficient evidence to establish whether any of these methods
is most effective, and with respect to the psychoeducation in general, available studies
suggest that it may have beneficial effect on reduction in relapses, adherence, hospital
stay, global functioning and quality of life (19). However, these studies have methodological
limitations such as lack of clarity in the generation and concealment of randomized
allocation sequence, non-blind assessment of outcomes and frequent losses in monitoring,
suggesting that the effects observed for psychoeducation may not be valid and could be
overestimated. Additionally, the cultural characteristics and health system of each country
may limit the applicability of studies, which may be necessary to evaluate the efficacy in
sites with particular conditions (20).
In a private psychiatric clinic in Medellin primarily serving patients who belong to the
contributory scheme of health care, Brief Psychoeducation Group Program was designed (five
sessions) for Patients with Schizophrenia and their Families (PGSF). It was decided to
include both patients and relatives because some studies suggest there may be advantages and
generally patients with this disorder should go out accompanied. It will be group because
some authors have argued that it could have more benefits than individual, to facilitate
meetings with others, by facilitating the encounter with other people with similar
conditions, which could have additional therapeutic effects and be more cost-effective (19).
It will be five sessions because it was considered that they could cover the main issues and
ensure the attendance at all sessions, taking into account the economic conditions and time
restrictions most for most relatives. It is very important to evaluate the effectiveness of
this program because that will allow making informed decisions regarding the implementation
in this and other psychiatric care institutions in the country. In addition, there are not
any controlled clinical trials in Colombia that evaluate the effectiveness of a
psychoeducational intervention for this disorder.
Therefore, the research question is: In a psychiatric clinic of Medellin (Colombia), What is
the effectiveness of a Brief Psychoeducational Group Program for Patients with Schizophrenia
and their Families (PGSF) added to their Outpatient Treatment as Usual (TAU) compared with
TAU to reduce the risk of relapse?
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