Schizophrenia
Conditions
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
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.
Sponsors
Study design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Relapse | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of Schizophrenia | 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 |
| Adherence to Treatment | 12 months | Was defined in three categories: 1=Take regularly medication 100% of the time, 2 =Partial adherence 3= Does not take medication. |
| Insight | 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. |
| Number of Patients With Hospitalization | 12 months | Need confinement in a hospital or clinic. |
| Family Burden | 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. |
| Expressed Emotions | 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. |
| Quality of Life Measure by WHOQOL-BREF | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 176 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 2 |
| Overall Study | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | Brief Group Psychoeducation | Total | Treatment as Usual Only |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants | 176 Participants | 86 Participants |
| Age of onset | 22.5 years | 22.0 years | 20.0 years |
| Duration of disorder | 16.5 years | 16.0 years | 16.0 years |
| Employment Employed | 35 Participants | 65 Participants | 30 Participants |
| Employment Unemployed | 55 Participants | 111 Participants | 56 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-BREF | 62.4 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-BREF | 61.7 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 Participants | 25 Participants | 13 Participants |
| Marital Status Divorced/Widow | 8 Participants | 12 Participants | 4 Participants |
| Marital Status Single | 70 Participants | 139 Participants | 69 Participants |
| Number of episodes | 3.0 psychotic episodes | 3.0 psychotic episodes | 3.5 psychotic episodes |
| Number of hospitalizations | 2.0 Number of hospitalizations | 2.0 Number of hospitalizations | 2.0 Number of hospitalizations |
| Objective domain of the Family burden self-administered scale | 0.44 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 scale | 34.5 units on a scale | 33.5 units on a scale |
| Scale for the Assessment of Positive Symptoms (SAPS) | 19.0 units on a scale | 14.0 units on a scale | 11.0 units on a scale |
| Schedule for the assessment of Insight Scale Expanded version- SAI-E | 12.4 units on a scale | 14.0 units on a scale | 15.0 units on a scale |
| Second domain (psychological) of The World Health Organization Quality of Life WHOQOL-BREF | 61.5 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 Participants | 51 Participants | 23 Participants |
| Sex: Female, Male Male | 62 Participants | 125 Participants | 63 Participants |
| Subjective domain of the family burden self-administered scale | 0.92 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 scale | 3.0 units on a scale | 3.0 units on a scale |
| Third domain (social relationships) of The World Health Organization Quality of Life WHOQOL-BREF | 52.1 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 type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 86 |
| other Total, other adverse events | 0 / 90 | 0 / 86 |
| serious Total, serious adverse events | 0 / 90 | 0 / 86 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brief Group Psychoeducation | Number of Participants With Relapse | 22 Participants |
| Treatment as Usual Only | Number of Participants With Relapse | 23 Participants |
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brief Group Psychoeducation | Adherence to Treatment | Takes regularly medication | 41 Participants |
| Brief Group Psychoeducation | Adherence to Treatment | Partial adherence | 21 Participants |
| Brief Group Psychoeducation | Adherence to Treatment | Does not take medication | 1 Participants |
| Treatment as Usual Only | Adherence to Treatment | Takes regularly medication | 36 Participants |
| Treatment as Usual Only | Adherence to Treatment | Partial adherence | 16 Participants |
| Treatment as Usual Only | Adherence to Treatment | Does not take medication | 0 Participants |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Group Psychoeducation | Expressed Emotions | 31.1 score on a scale | Standard Deviation 5.4 |
| Treatment as Usual Only | Expressed Emotions | 30.8 score on a scale | Standard Deviation 6.6 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Group Psychoeducation | Family Burden | SSFB objective domain | 0.66 score on a scale | Standard Deviation 0.4 |
| Brief Group Psychoeducation | Family Burden | SSFB subjective domain | 0.69 score on a scale | Standard Deviation 0.37 |
| Treatment as Usual Only | Family Burden | SSFB objective domain | 0.68 score on a scale | Standard Deviation 0.37 |
| Treatment as Usual Only | Family Burden | SSFB subjective domain | 0.76 score on a scale | Standard Deviation 0.34 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Group Psychoeducation | Insight | 14.9 score on a scale | Standard Deviation 6.9 |
| Treatment as Usual Only | Insight | 16.4 score on a scale | Standard Deviation 5.5 |
Number of Patients With Hospitalization
Need confinement in a hospital or clinic.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brief Group Psychoeducation | Number of Patients With Hospitalization | 10 Participants |
| Treatment as Usual Only | Number of Patients With Hospitalization | 9 Participants |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Group Psychoeducation | Quality of Life Measure by WHOQOL-BREF | WHOQOL-BREF 2ND DOMAIN | 61.9 score on a scale | Standard Deviation 16.4 |
| Brief Group Psychoeducation | Quality of Life Measure by WHOQOL-BREF | WHOQOL-BREF 1ST DOMAIN | 61.8 score on a scale | Standard Deviation 14 |
| Brief Group Psychoeducation | Quality of Life Measure by WHOQOL-BREF | WHOQOL-BREF 3RD DOMAIN | 58.1 score on a scale | Standard Deviation 17.7 |
| Brief Group Psychoeducation | Quality of Life Measure by WHOQOL-BREF | WHOQOL-BREF 4TH DOMAIN | 62.5 score on a scale | Standard Deviation 13.9 |
| Treatment as Usual Only | Quality of Life Measure by WHOQOL-BREF | WHOQOL-BREF 4TH DOMAIN | 65.8 score on a scale | Standard Deviation 14.5 |
| Treatment as Usual Only | Quality of Life Measure by WHOQOL-BREF | WHOQOL-BREF 1ST DOMAIN | 63.6 score on a scale | Standard Deviation 15.2 |
| Treatment as Usual Only | Quality of Life Measure by WHOQOL-BREF | WHOQOL-BREF 2ND DOMAIN | 62.6 score on a scale | Standard Deviation 16.4 |
| Treatment as Usual Only | Quality of Life Measure by WHOQOL-BREF | WHOQOL-BREF 3RD DOMAIN | 57.8 score on a scale | Standard Deviation 23 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Group Psychoeducation | Symptoms of Schizophrenia | SAPS scale | 13.3 score on a scale | Standard Deviation 17.6 |
| Brief Group Psychoeducation | Symptoms of Schizophrenia | SANS scale | 34.7 score on a scale | Standard Deviation 18.4 |
| Treatment as Usual Only | Symptoms of Schizophrenia | SAPS scale | 10.9 score on a scale | Standard Deviation 12.4 |
| Treatment as Usual Only | Symptoms of Schizophrenia | SANS scale | 35.6 score on a scale | Standard Deviation 16.5 |