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Brief Group Psychoeducation for Schizophrenia

Efficacy of a Brief Group Psychoeducation Program Aimed at Patients With Schizophrenia and Their Families: A Clinical Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02911519
Enrollment
176
Registered
2016-09-22
Start date
2013-08-01
Completion date
2017-02-24
Last updated
2020-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, Patient Education

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.

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?

Interventions

OTHERBrief 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.

OTHERTreatment 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.

Sponsors

Universidad de Antioquia
CollaboratorOTHER
Salud Mental Integral S.A.S.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Relapse12 monthsDefined 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)

Secondary

MeasureTime frameDescription
Symptoms of Schizophrenia12 monthsWill 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
Adherence to Treatment12 monthsWas defined in three categories: 1=Take regularly medication 100% of the time, 2 =Partial adherence 3= Does not take medication.
Insight12 monthsThe 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.
Number of Patients With Hospitalization12 monthsNeed confinement in a hospital or clinic.
Family Burden12 monthsIs 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.
Expressed Emotions12 monthsAre 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.
Quality of Life Measure by WHOQOL-BREF12 monthsFirst 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.

Participant flow

Recruitment details

The participants were selected from the users who attended ambulatory control in the Comprehensive Mental Health Clinic that serves Colombian health care users. Through telephone call and referral by treating psychiatrists, those users who, due to clinical history, were diagnosed with schizophrenia, were invited to participate.

Participants by arm

ArmCount
Brief Group Psychoeducation
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: inform duties and rights of the patient and his family in the Colombian health system and administrative procedures related to patient care. This Brief Group Psychoeducation also received Treatment as Usual.
90
Treatment as Usual Only
The patients in both arms of the intervention received this type of attention. The TAU is the psychiatric care that patients with schizophrenia usually receive in the clinic. Treatment as Usual: 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.
86
Total176

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath02
Overall StudyLost to Follow-up22

Baseline characteristics

CharacteristicBrief Group PsychoeducationTotalTreatment as Usual Only
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
90 Participants176 Participants86 Participants
Age of onset22.5 years22.0 years20.0 years
Duration of disorder16.5 years16.0 years16.0 years
Employment
Employed
35 Participants65 Participants30 Participants
Employment
Unemployed
55 Participants111 Participants56 Participants
Family Emotional Involvement and criticism Scale (FEICS)29.6 units on a scale
STANDARD_DEVIATION 8.9
29.5 units on a scale
STANDARD_DEVIATION 8.8
29.3 units on a scale
STANDARD_DEVIATION 8.6
First domain (physical health) of The World Health Organization Quality of Life WHOQOL-BREF62.4 units on a scale
STANDARD_DEVIATION 16.1
62.9 units on a scale
STANDARD_DEVIATION 15.9
63.5 units on a scale
STANDARD_DEVIATION 15.9
Fourth domain (environment) of The World Health Organization Quality of Life WHOQOL-BREF61.7 units on a scale
STANDARD_DEVIATION 15.3
64.3 units on a scale
STANDARD_DEVIATION 14.7
66.9 units on a scale
STANDARD_DEVIATION 13.7
Marital Status
Civil Union/Married
12 Participants25 Participants13 Participants
Marital Status
Divorced/Widow
8 Participants12 Participants4 Participants
Marital Status
Single
70 Participants139 Participants69 Participants
Number of episodes3.0 psychotic episodes3.0 psychotic episodes3.5 psychotic episodes
Number of hospitalizations2.0 Number of hospitalizations2.0 Number of hospitalizations2.0 Number of hospitalizations
Objective domain of the Family burden self-administered scale0.44 units on a scale
STANDARD_DEVIATION 0.47
0.45 units on a scale
STANDARD_DEVIATION 0.46
0.46 units on a scale
STANDARD_DEVIATION 0.44
Scale for the Assessment of Negative Symptoms (SANS)36.0 units on a scale34.5 units on a scale33.5 units on a scale
Scale for the Assessment of Positive Symptoms (SAPS)19.0 units on a scale14.0 units on a scale11.0 units on a scale
Schedule for the assessment of Insight Scale Expanded version- SAI-E12.4 units on a scale14.0 units on a scale15.0 units on a scale
Second domain (psychological) of The World Health Organization Quality of Life WHOQOL-BREF61.5 units on a scale
STANDARD_DEVIATION 16.6
61.5 units on a scale
STANDARD_DEVIATION 17.2
61.4 units on a scale
STANDARD_DEVIATION 17.8
Sex: Female, Male
Female
28 Participants51 Participants23 Participants
Sex: Female, Male
Male
62 Participants125 Participants63 Participants
Subjective domain of the family burden self-administered scale0.92 units on a scale
STANDARD_DEVIATION 0.42
0.92 units on a scale
STANDARD_DEVIATION 0.44
0.91 units on a scale
STANDARD_DEVIATION 0.45
The Clinical Global Impression - Severity scale (CGI-S)3.0 units on a scale3.0 units on a scale3.0 units on a scale
Third domain (social relationships) of The World Health Organization Quality of Life WHOQOL-BREF52.1 units on a scale
STANDARD_DEVIATION 21.2
52.7 units on a scale
STANDARD_DEVIATION 22.7
53.2 units on a scale
STANDARD_DEVIATION 24.3

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 900 / 86
other
Total, other adverse events
0 / 900 / 86
serious
Total, serious adverse events
0 / 900 / 86

Outcome results

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)

Time frame: 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Brief Group PsychoeducationNumber of Participants With Relapse22 Participants
Treatment as Usual OnlyNumber of Participants With Relapse23 Participants
p-value: 0.5995% CI: [0.77, 1.16]Mixed Models Analysis
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.

Time frame: 12 months

Population: Data was not gathered for all the participants in this outcome.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Brief Group PsychoeducationAdherence to TreatmentTakes regularly medication41 Participants
Brief Group PsychoeducationAdherence to TreatmentPartial adherence21 Participants
Brief Group PsychoeducationAdherence to TreatmentDoes not take medication1 Participants
Treatment as Usual OnlyAdherence to TreatmentTakes regularly medication36 Participants
Treatment as Usual OnlyAdherence to TreatmentPartial adherence16 Participants
Treatment as Usual OnlyAdherence to TreatmentDoes not take medication0 Participants
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.

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
Brief Group PsychoeducationExpressed Emotions31.1 score on a scaleStandard Deviation 5.4
Treatment as Usual OnlyExpressed Emotions30.8 score on a scaleStandard Deviation 6.6
p-value: 0.9795% CI: [-0.19, 0.19]Mixed Models Analysis
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.

Time frame: 12 months

ArmMeasureGroupValue (MEAN)Dispersion
Brief Group PsychoeducationFamily BurdenSSFB objective domain0.66 score on a scaleStandard Deviation 0.4
Brief Group PsychoeducationFamily BurdenSSFB subjective domain0.69 score on a scaleStandard Deviation 0.37
Treatment as Usual OnlyFamily BurdenSSFB objective domain0.68 score on a scaleStandard Deviation 0.37
Treatment as Usual OnlyFamily BurdenSSFB subjective domain0.76 score on a scaleStandard Deviation 0.34
p-value: 0.3395% CI: [-0.01, 0.01]Mixed Models Analysis
p-value: 0.1995% CI: [-0.02, 0.01]Mixed Models Analysis
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.

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
Brief Group PsychoeducationInsight14.9 score on a scaleStandard Deviation 6.9
Treatment as Usual OnlyInsight16.4 score on a scaleStandard Deviation 5.5
p-value: 0.6195% CI: [-0.1, 0.17]Mixed Models Analysis
Secondary

Number of Patients With Hospitalization

Need confinement in a hospital or clinic.

Time frame: 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Brief Group PsychoeducationNumber of Patients With Hospitalization10 Participants
Treatment as Usual OnlyNumber of Patients With Hospitalization9 Participants
p-value: 0.7395% CI: [0.87, 1.1]Mixed Models Analysis
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.

Time frame: 12 months

ArmMeasureGroupValue (MEAN)Dispersion
Brief Group PsychoeducationQuality of Life Measure by WHOQOL-BREFWHOQOL-BREF 2ND DOMAIN61.9 score on a scaleStandard Deviation 16.4
Brief Group PsychoeducationQuality of Life Measure by WHOQOL-BREFWHOQOL-BREF 1ST DOMAIN61.8 score on a scaleStandard Deviation 14
Brief Group PsychoeducationQuality of Life Measure by WHOQOL-BREFWHOQOL-BREF 3RD DOMAIN58.1 score on a scaleStandard Deviation 17.7
Brief Group PsychoeducationQuality of Life Measure by WHOQOL-BREFWHOQOL-BREF 4TH DOMAIN62.5 score on a scaleStandard Deviation 13.9
Treatment as Usual OnlyQuality of Life Measure by WHOQOL-BREFWHOQOL-BREF 4TH DOMAIN65.8 score on a scaleStandard Deviation 14.5
Treatment as Usual OnlyQuality of Life Measure by WHOQOL-BREFWHOQOL-BREF 1ST DOMAIN63.6 score on a scaleStandard Deviation 15.2
Treatment as Usual OnlyQuality of Life Measure by WHOQOL-BREFWHOQOL-BREF 2ND DOMAIN62.6 score on a scaleStandard Deviation 16.4
Treatment as Usual OnlyQuality of Life Measure by WHOQOL-BREFWHOQOL-BREF 3RD DOMAIN57.8 score on a scaleStandard Deviation 23
p-value: 0.8195% CI: [-0.38, 0.3]Mixed Models Analysis
p-value: 0.8195% CI: [-0.38, 0.29]Mixed Models Analysis
p-value: 0.5295% CI: [-0.33, 0.65]Mixed Models Analysis
p-value: 0.2795% CI: [-0.15, 0.53]Mixed Models Analysis
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

Time frame: 12 months

ArmMeasureGroupValue (MEAN)Dispersion
Brief Group PsychoeducationSymptoms of SchizophreniaSAPS scale13.3 score on a scaleStandard Deviation 17.6
Brief Group PsychoeducationSymptoms of SchizophreniaSANS scale34.7 score on a scaleStandard Deviation 18.4
Treatment as Usual OnlySymptoms of SchizophreniaSAPS scale10.9 score on a scaleStandard Deviation 12.4
Treatment as Usual OnlySymptoms of SchizophreniaSANS scale35.6 score on a scaleStandard Deviation 16.5
p-value: 0.9495% CI: [-0.36, 0.39]Mixed Models Analysis
p-value: 0.395% CI: [-0.57, 0.18]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026