Schizophrenia Clinical Trial
Official title:
Efficacy of a Brief Group Psychoeducation Program Aimed at Patients With Schizophrenia and Their Families: A Clinical Controlled Trial
NCT number | NCT02911519 |
Other study ID # | SAM001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2013 |
Est. completion date | February 24, 2017 |
Verified date | April 2020 |
Source | Salud Mental Integral S.A.S. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 176 |
Est. completion date | February 24, 2017 |
Est. primary completion date | December 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Salud Mental Integral S.A.S. | Universidad de Antioquia |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Relapse | 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 | Number of Patients With Hospitalization | Need confinement in a hospital or clinic. | 12 months | |
Secondary | Symptoms of Schizophrenia | 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 | |
Secondary | Adherence to Treatment | Was defined in three categories: 1=Take regularly medication 100% of the time, 2 =Partial adherence 3= Does not take medication. | 12 months | |
Secondary | Insight | 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 | |
Secondary | Quality of Life Measure by WHOQOL-BREF | 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 | |
Secondary | Family Burden | 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 | |
Secondary | Expressed Emotions | 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 |
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