- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02911519
Brief Group Psychoeducation for Schizophrenia
Efficacy of a Brief Group Psychoeducation Program Aimed at Patients With Schizophrenia and Their Families: A Clinical Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of schizophrenia according to the International Classification of Diseases in its tenth edition (ICD-10).
- The relative who attend the PGSF must have lived with the patient in the last year and is preferred to be their primary caregiver.
- Agree to participate in the investigation.
Exclusion Criteria:
- Be involved in another group psychoeducation program.
- Have clinically significant psychotic symptoms that indicate "decompensation" with a score in the Clinical Global Impressions Scale for severity (CGI-S) 3 or greater.
- Dementia.
- Moderate mental retardation
- Drug Addiction. (Consumption of active illegal psychoactive substances or alcohol during the last three months.
- Medical comorbidity whose life expectancy is less than one year.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brief Group Psychoeducation
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.
|
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.
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: Treatment as Usual Only
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Relapse
Time Frame: 12 months
|
Defined as the reappearance of criteria for an episode of psychosis in a patient who did not or only had residual symptoms.
It can be set in two ways: hospitalization or a score on the CGI-S greater than or equal to 3 in the evaluation and an increase greater than 20% in the Scale for the Assessment of Positive Symptoms (SAPS)
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Hospitalization
Time Frame: 12 months
|
Need confinement in a hospital or clinic.
|
12 months
|
Symptoms of Schizophrenia
Time Frame: 12 months
|
Will be measured with rating Scales for the Assessment of Positive Symptoms (SAPS) and negative symptoms (SANS).
The Scale for the Assessment of Positive Symptoms (SAPS) is a rating scale to measure positive symptoms in schizophrenia.
SAPS is split into 4 domains, and within each domain separate symptoms are rated from 0 (absent) to 5 (severe).
The score is between 0 and 155, a higher score on the scale represents a worse clinical status.The Scale for the Assessment of Negative Symptoms (SANS) is a rating scale to measure negative symptoms in schizophrenia.
The scale is between 0 and 95.
The higher score represents worse clinical status
|
12 months
|
Adherence to Treatment
Time Frame: 12 months
|
Was defined in three categories: 1=Take regularly medication 100% of the time, 2 =Partial adherence 3= Does not take medication.
|
12 months
|
Insight
Time Frame: 12 months
|
The Schedule for the assessment of Insight Scale Expanded version- SAI-E is a scale that measures insight as a multidimensional concept; including awareness of having a mental illness, ability to relabel psychotic phenomena as abnormal and compliance with treatment.
The score is between 1 and 35.
The higher score represents a better insight.
|
12 months
|
Quality of Life Measure by WHOQOL-BREF
Time Frame: 12 months
|
First domain (physical health) of The World Health Organization Quality of Life WHOQOL- BREF which is a short form of the World Health Organization Quality of Life scale.
The minimum score is 0 and the highest is 100.
The higher the score the better quality of life.
Second domain (psychological) the minimum score is 0 and the highest is 100.
The higher the score the better quality of life.Third domain (social relationships) the minimum score is 0 and the highest is 100.
The higher the score the better quality of life.
Fourth domain (environment) the minimum score is 0 and the highest is 100.
The higher the score the better quality of life.
|
12 months
|
Family Burden
Time Frame: 12 months
|
Is defined as the impact it may have on the caregiver who lives with a psychiatric patient.
It is evaluated with the Self-Administered Scale of Family Burden (SSFB) which has 2 domains: Objective domain measures the alterations of daily behavior of the patients family.
The minimum score is 0 and the maximum score is 2. The higher the score the more family burden.
Subjective domain is the stress produced by the patients behavior to the family.
The minimum score is 0 and the maximum score is 2. The higher the score the more burden.
|
12 months
|
Expressed Emotions
Time Frame: 12 months
|
Are the attitudes of family members that interfere in interpersonal relations and it has shown to influence the course of psychiatric disorders, increasing the risk of relapse.
The most studied are criticism and emotional over involvement.
The first one is a negative filter that distorts the perceptions of a person over others.
Over involvement is a lack of appropriate emotional limits among members of a family.
They will be evaluated with the Family Emotional Involvement and Criticism Scale (FEICS).
The minimum value is 14 and the maximum value is 70.
The higher the score the better expressed emotions.
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jenny G Valencia, M.D. M.Sc. Ph.D., Salud Mental Integral - Samein - SAS
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAM001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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