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| Name | Class |
|---|---|
| Universidad de Antioquia | OTHER |
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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.
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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Hospitalization | Need confinement in a hospital or clinic. | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jenny G Valencia, M.D. M.Sc. Ph.D. | Salud Mental Integral - Samein - SAS | Principal Investigator |
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The information will be available at the sponsor webpage.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Count of Participants | Participants | 12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jenny Garcia | SAMEIN | +57 4 219 6014 | jenny.garcia@udea.edu.co |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| 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. |
|
| 12 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Age of onset | Median | Inter-Quartile Range | years |
|
| Duration of disorder | Median | Inter-Quartile Range | years |
|
| Number of episodes | Number of psychotic episodes of each patient before the intervention | Median | Inter-Quartile Range | psychotic episodes |
|
| Number of hospitalizations | Number of hospitalizations of each patient before the intervention | Median | Inter-Quartile Range | Number of hospitalizations |
|
| The Clinical Global Impression - Severity scale (CGI-S) | The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The score is between 1 and 7 in which 1 is normal and 7 represents the most extremely ill patients | Median | Inter-Quartile Range | units on a scale |
|
| Scale for the Assessment of Positive Symptoms (SAPS) | 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. | Median | Inter-Quartile Range | units on a scale |
|
| Scale for the Assessment of Negative Symptoms (SANS) | 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. | Median | Inter-Quartile Range | units on a scale |
|
| Schedule for the assessment of Insight Scale Expanded version- SAI-E | 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. | Mean | Inter-Quartile Range | units on a scale |
|
| First domain (physical health) of The World Health Organization Quality of Life 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. | Mean | Standard Deviation | units on a scale |
|
| Second domain (psychological) of The World Health Organization Quality of Life WHOQOL-BREF | Second domain (psychological) 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. | Mean | Standard Deviation | units on a scale |
|
| Third domain (social relationships) of The World Health Organization Quality of Life WHOQOL-BREF | Third domain (social relationships) 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. | Mean | Standard Deviation | units on a scale |
|
| Fourth domain (environment) of The World Health Organization Quality of Life WHOQOL-BREF | Fourth domain (environment) 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. | Mean | Standard Deviation | units on a scale |
|
| Family Emotional Involvement and criticism Scale (FEICS) | Family Emotional Involvement and criticism Scale (FEICS) is a self-report scale to measure expressed emotion. The minimum value is 14 and the maximum value is 70. The higher the score the better expressed emotions. | Mean | Standard Deviation | units on a scale |
|
| Objective domain of the Family burden self-administered scale | Objective domain of the family burden self-administered scale is a scale for assessing caregiver burden. The minimum score is 0 and the maximum score is 2. The higher the score the more family burden. | Mean | Standard Deviation | units on a scale |
|
| Subjective domain of the family burden self-administered scale | Subjective domain of the family burden self-administered scale is a scale for assessing caregiver burden. The minimum score is 0 and the maximum score is 2. The higher the score the more burden. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
|
| Secondary | Number of Patients With Hospitalization | Need confinement in a hospital or clinic. | Posted | Count of Participants | Participants | 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 | Posted | Mean | Standard Deviation | score on a scale | 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. | Data was not gathered for all the participants in this outcome. | Posted | Count of Participants | Participants | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
|
| 0 |
| 90 |
| 0 |
| 90 |
| 0 |
| 90 |
| EG001 | 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. | 0 | 86 | 0 | 86 | 0 | 86 |
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| 0.30 |
| Slope |
| -0.19 |
| 2-Sided |
| 95 |
| -0.57 |
| 0.18 |
This is intention-to-treat analysis. |
| Superiority |
| Does not take medication |
|
| WHOQOL-BREF 3RD DOMAIN |
|
| WHOQOL-BREF 4TH DOMAIN |
|
| Mixed Models Analysis |
| 0.81 |
| Slope |
| -0.04 |
| 2-Sided |
| 95 |
| -0.38 |
| 0.29 |
This is an intention to treat analysis.This statistical Analysis applies to WHOQOL-BREF 2ND DOMAIN (psychological) in the second row. |
| Superiority |
This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 2ND DOMAIN (psychological) in the second row. |
| Mixed Models Analysis | 0.52 | Slope | 0.16 | 2-Sided | 95 | -0.33 | 0.65 | This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 3RD DOMAIN (social relationships) in the third row. | Superiority | This statistical Analysis applies to WHOQOL-BREF 3RD DOMAIN (social relationships) in the third row. |
| Mixed Models Analysis | 0.27 | Slope | 0.19 | 2-Sided | 95 | -0.15 | 0.53 | This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 4TH DOMAIN (environment) in the fourth row. | Superiority | This statistical Analysis applies to WHOQOL-BREF 4TH DOMAIN (environment) in the fourth row. |
| Mixed Models Analysis |
| 0.19 |
| Slope |
| -0.01 |
| 2-Sided |
| 95 |
| -0.02 |
| 0.01 |
This is an intention to treat analysis. This analysis applies to SSFB subjective domain in the second row. |
| Superiority |
This is an intention to treat analysis. This analysis applies to SSFB subjective domain in the second row. |