Overview

This trial is active, not recruiting.

Condition schizophrenia
Treatments brief group psychoeducation, treatment as usual
Sponsor Salud Mental Integral S.A.S.
Collaborator Universidad de Antioquia
Start date August 2013
End date December 2016
Trial size 192 participants
Trial identifier NCT02911519, SAM001

Summary

This study evaluates the addition of psychoeducation to treament as usual in the treatment of adults with schizophrenia for relapse prevention. Half of partipants will receive a brief (5 sessions) psychoeducation intervention and treatment as usual in combination, while the other half will receive treatment as usual only.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
It was designed after a review of the literature on the subject; content and procedures will be written in a manual. They will be five sessions of two hours once a week. Each session will be conducted by a clinical psychologist and a general practitioner trained in group management.
brief group psychoeducation
First session: describe the clinical manifestations of schizophrenia, deny myths, and inform on the biological nature of the disorder. Second session: provide updated information regarding pharmacological treatment, their side effects and the importance of adherence to treatment. Third session: Achieving recognition of personal responsibility for the lifestyle, routine, physical care and the risk of addiction; awareness of the importance of self-monitoring of symptoms and the development of cognitive, behavioral and emotional strategies. Fourth Session: To recognize the role of family members in the treatment, the problem of expressed emotions and communication in times of crisis. Fifth Session: To know the rights and duties of patients and their families in the current health care system.
treatment as usual
The patients in both arms of the intervention will receive this type of attention. The TAU is the psychiatric care that patients with schizophrenia usually receive in the clinic. This is done in consultation of 30 minutes, in which the psychiatrist evaluates the clinical condition of the patient and psychosocial factors that may be affecting, prescribes drugs according to protocols and clinical care and answers questions about the disorder. In the consultation a brochure with information is given about schizophrenia. The frequency of consultations varies depending on severity of symptoms usually split between one and six months.
(Active Comparator)
The patients in both arms of the intervention will receive this type of attention. The TAU is the psychiatric care that patients with schizophrenia usually receive in the clinic. The frequency of consultations varies depending on severity of symptoms usually split between one and six months.
treatment as usual
The patients in both arms of the intervention will receive this type of attention. The TAU is the psychiatric care that patients with schizophrenia usually receive in the clinic. This is done in consultation of 30 minutes, in which the psychiatrist evaluates the clinical condition of the patient and psychosocial factors that may be affecting, prescribes drugs according to protocols and clinical care and answers questions about the disorder. In the consultation a brochure with information is given about schizophrenia. The frequency of consultations varies depending on severity of symptoms usually split between one and six months.

Primary Outcomes

Measure
Relapse
time frame: 12 months

Secondary Outcomes

Measure
Hospitalization
time frame: 12 months
Symptoms of Schizophrenia
time frame: 12 months
Adherence to treatment
time frame: 12 months
Insight
time frame: 12 months
Quality of life
time frame: 12 months
Family Burden
time frame: 12 months
Expressed emotions
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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 you 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.

Additional Information

Official title Efficacy of a Brief Group Psychoeducation Program Aimed at Patients With Schizophrenia and Their Families: A Clinical Controlled Trial
Principal investigator Jenny G Valencia, M.D. M.Sc. Ph.D.
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, we are not aware of any controlled clinical trials in Colombia that evaluate the effectiveness of a psychoeducational intervention for this disorder. Therefore, we propose the following research question: 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?
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Salud Mental Integral S.A.S..