Clinical trial NCT02911519: Brief Group Psychoeducation for Schizophrenia
Official title: Efficacy of a Brief Group Psychoeducation Program Aimed at Patients With Schizophrenia and Their Families: A Clinical Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Patient Education
Lead sponsor: Salud Mental Integral S.A.S.
Sponsor class: OTHER
Collaborators: name: Universidad de Antioquia
First posted: 2016-09-22
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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?

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of schizophrenia according to the International Classification of Diseases in its tenth edition (ICD-10).
2. The relative who attend the PGSF must have lived with the patient in the last year and is preferred to be their primary caregiver.
3. Agree to participate in the investigation.

Exclusion Criteria:

1. Be involved in another group psychoeducation program.
2. Have clinically significant psychotic symptoms that indicate "decompensation" with a score in the Clinical Global Impressions Scale for severity (CGI-S) 3 or greater.
3. Dementia.
4. Moderate mental retardation
5. Drug Addiction. (Consumption of active illegal psychoactive substances or alcohol during the last three months.
6. Medical comorbidity whose life expectancy is less than one year.

Primary outcomes:
measure: Number of Participants With Relapse
timeFrame: 12 months
Secondary outcomes:
measure: Number of Patients With Hospitalization
timeFrame: 12 months
measure: Symptoms of Schizophrenia
timeFrame: 12 months
measure: Adherence to Treatment
timeFrame: 12 months
measure: Insight
timeFrame: 12 months
measure: Quality of Life Measure by WHOQOL-BREF
timeFrame: 12 months
measure: Family Burden
timeFrame: 12 months
measure: Expressed Emotions
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Salud Mental Integral - Samein - SAS
name: Jenny G Valencia, M.D. M.Sc. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: