Brief Group Psychoeducation for Schizophrenia

NCT02911519 | Completed Results

• 1 other identifier: SAM001
• Study Type: interventional
• Target: 176
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Patient Education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of Patients With Hospitalization

  12 months

• Symptoms of Schizophrenia

  12 months

• Adherence to Treatment

  12 months

• Insight

  12 months

• Quality of Life Measure by WHOQOL-BREF

  12 months

Study Arms (2)

Brief Group Psychoeducation

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.

Other: Brief Group Psychoeducation; Other: Treatment as Usual

Treatment as Usual Only

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.

Other: Treatment as Usual

Interventions

Brief Group Psychoeducation OTHER

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.

Brief Group Psychoeducation

Treatment as Usual OTHER

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.

Brief Group Psychoeducation; Treatment as Usual Only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Salud Mental Integral S.A.S.: lead
• Universidad de Antioquia: collaborator

MeSH Terms

Conditions

Schizophrenia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Jenny Garcia
• Organization: SAMEIN

jenny.garcia@udea.edu.co

+57 4 219 6014

Study Officials

• Jenny G Valencia, M.D. M.Sc. Ph.D.

  Salud Mental Integral - Samein - SAS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 22, 2016
• Study Start: August 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: February 24, 2017
• Last Updated: May 6, 2020
• Results First Posted: May 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share