N/A
N=176
Brief Group Psychoeducation for Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT02911519 ↗Enrolled (actual)
176
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Number of Participants With Relapse — 22; 23 Participants — p=0.59
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brief Group Psychoeducation (Other); Treatment as Usual (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Salud Mental Integral S.A.S.
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Relapse |
22; 23 | 0.59 |
| SECONDARY Number of Patients With Hospitalization |
10; 9 | 0.73 |
| SECONDARY Symptoms of Schizophrenia |
34.7; 35.6; 13.3; 10.9 | 0.94 |
| SECONDARY Adherence to Treatment |
41; 36; 21; 16; 1; 0 | — |
| SECONDARY Insight |
14.9; 16.4 | 0.61 |
| SECONDARY Quality of Life Measure by WHOQOL-BREF |
61.8; 63.6; 61.9; 62.6; 58.1; 57.8 | 0.81 |
| SECONDARY Family Burden |
0.66; 0.68; 0.69; 0.76 | 0.33 |
| SECONDARY Expressed Emotions |
31.1; 30.8 | 0.97 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02911519). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.