Trial Outcomes & Findings for Brief Group Psychoeducation for Schizophrenia (NCT NCT02911519)
NCT ID: NCT02911519
Last Updated: 2020-05-06
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
176 participants
Primary outcome timeframe
12 months
Results posted on
2020-05-06
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
86
|
|
Overall Study
COMPLETED
|
88
|
82
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Death
|
0
|
2
|
Baseline Characteristics
Brief Group Psychoeducation for Schizophrenia
Baseline characteristics by cohort
| Measure |
Brief Group Psychoeducation
n=90 Participants
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.
|
Treatment as Usual Only
n=86 Participants
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.
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
90 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Marital Status
Single
|
70 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Marital Status
Civil Union/Married
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Marital Status
Divorced/Widow
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Employment
Employed
|
35 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Employment
Unemployed
|
55 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Age of onset
|
22.5 years
n=5 Participants
|
20.0 years
n=7 Participants
|
22.0 years
n=5 Participants
|
|
Duration of disorder
|
16.5 years
n=5 Participants
|
16.0 years
n=7 Participants
|
16.0 years
n=5 Participants
|
|
Number of episodes
|
3.0 psychotic episodes
n=5 Participants
|
3.5 psychotic episodes
n=7 Participants
|
3.0 psychotic episodes
n=5 Participants
|
|
Number of hospitalizations
|
2.0 Number of hospitalizations
n=5 Participants
|
2.0 Number of hospitalizations
n=7 Participants
|
2.0 Number of hospitalizations
n=5 Participants
|
|
The Clinical Global Impression - Severity scale (CGI-S)
|
3.0 units on a scale
n=5 Participants
|
3.0 units on a scale
n=7 Participants
|
3.0 units on a scale
n=5 Participants
|
|
Scale for the Assessment of Positive Symptoms (SAPS)
|
19.0 units on a scale
n=5 Participants
|
11.0 units on a scale
n=7 Participants
|
14.0 units on a scale
n=5 Participants
|
|
Scale for the Assessment of Negative Symptoms (SANS)
|
36.0 units on a scale
n=5 Participants
|
33.5 units on a scale
n=7 Participants
|
34.5 units on a scale
n=5 Participants
|
|
Schedule for the assessment of Insight Scale Expanded version- SAI-E
|
12.4 units on a scale
n=5 Participants
|
15.0 units on a scale
n=7 Participants
|
14.0 units on a scale
n=5 Participants
|
|
First domain (physical health) of The World Health Organization Quality of Life WHOQOL-BREF
|
62.4 units on a scale
STANDARD_DEVIATION 16.1 • n=5 Participants
|
63.5 units on a scale
STANDARD_DEVIATION 15.9 • n=7 Participants
|
62.9 units on a scale
STANDARD_DEVIATION 15.9 • n=5 Participants
|
|
Second domain (psychological) of The World Health Organization Quality of Life WHOQOL-BREF
|
61.5 units on a scale
STANDARD_DEVIATION 16.6 • n=5 Participants
|
61.4 units on a scale
STANDARD_DEVIATION 17.8 • n=7 Participants
|
61.5 units on a scale
STANDARD_DEVIATION 17.2 • n=5 Participants
|
|
Third domain (social relationships) of The World Health Organization Quality of Life WHOQOL-BREF
|
52.1 units on a scale
STANDARD_DEVIATION 21.2 • n=5 Participants
|
53.2 units on a scale
STANDARD_DEVIATION 24.3 • n=7 Participants
|
52.7 units on a scale
STANDARD_DEVIATION 22.7 • n=5 Participants
|
|
Fourth domain (environment) of The World Health Organization Quality of Life WHOQOL-BREF
|
61.7 units on a scale
STANDARD_DEVIATION 15.3 • n=5 Participants
|
66.9 units on a scale
STANDARD_DEVIATION 13.7 • n=7 Participants
|
64.3 units on a scale
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Family Emotional Involvement and criticism Scale (FEICS)
|
29.6 units on a scale
STANDARD_DEVIATION 8.9 • n=5 Participants
|
29.3 units on a scale
STANDARD_DEVIATION 8.6 • n=7 Participants
|
29.5 units on a scale
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Objective domain of the Family burden self-administered scale
|
0.44 units on a scale
STANDARD_DEVIATION 0.47 • n=5 Participants
|
0.46 units on a scale
STANDARD_DEVIATION 0.44 • n=7 Participants
|
0.45 units on a scale
STANDARD_DEVIATION 0.46 • n=5 Participants
|
|
Subjective domain of the family burden self-administered scale
|
0.92 units on a scale
STANDARD_DEVIATION 0.42 • n=5 Participants
|
0.91 units on a scale
STANDARD_DEVIATION 0.45 • n=7 Participants
|
0.92 units on a scale
STANDARD_DEVIATION 0.44 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 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)
Outcome measures
| Measure |
Brief Group Psychoeducation
n=90 Participants
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.
|
Treatment as Usual Only
n=86 Participants
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.
|
|---|---|---|
|
Number of Participants With Relapse
|
22 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 12 monthsNeed confinement in a hospital or clinic.
Outcome measures
| Measure |
Brief Group Psychoeducation
n=90 Participants
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.
|
Treatment as Usual Only
n=86 Participants
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.
|
|---|---|---|
|
Number of Patients With Hospitalization
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 12 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
Outcome measures
| Measure |
Brief Group Psychoeducation
n=90 Participants
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.
|
Treatment as Usual Only
n=86 Participants
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.
|
|---|---|---|
|
Symptoms of Schizophrenia
SANS scale
|
34.7 score on a scale
Standard Deviation 18.4
|
35.6 score on a scale
Standard Deviation 16.5
|
|
Symptoms of Schizophrenia
SAPS scale
|
13.3 score on a scale
Standard Deviation 17.6
|
10.9 score on a scale
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data was not gathered for all the participants in this outcome.
Was defined in three categories: 1=Take regularly medication 100% of the time, 2 =Partial adherence 3= Does not take medication.
Outcome measures
| Measure |
Brief Group Psychoeducation
n=63 Participants
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.
|
Treatment as Usual Only
n=52 Participants
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.
|
|---|---|---|
|
Adherence to Treatment
Takes regularly medication
|
41 Participants
|
36 Participants
|
|
Adherence to Treatment
Partial adherence
|
21 Participants
|
16 Participants
|
|
Adherence to Treatment
Does not take medication
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 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.
Outcome measures
| Measure |
Brief Group Psychoeducation
n=90 Participants
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.
|
Treatment as Usual Only
n=86 Participants
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.
|
|---|---|---|
|
Insight
|
14.9 score on a scale
Standard Deviation 6.9
|
16.4 score on a scale
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: 12 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.
Outcome measures
| Measure |
Brief Group Psychoeducation
n=90 Participants
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.
|
Treatment as Usual Only
n=86 Participants
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.
|
|---|---|---|
|
Quality of Life Measure by WHOQOL-BREF
WHOQOL-BREF 1ST DOMAIN
|
61.8 score on a scale
Standard Deviation 14.0
|
63.6 score on a scale
Standard Deviation 15.2
|
|
Quality of Life Measure by WHOQOL-BREF
WHOQOL-BREF 2ND DOMAIN
|
61.9 score on a scale
Standard Deviation 16.4
|
62.6 score on a scale
Standard Deviation 16.4
|
|
Quality of Life Measure by WHOQOL-BREF
WHOQOL-BREF 3RD DOMAIN
|
58.1 score on a scale
Standard Deviation 17.7
|
57.8 score on a scale
Standard Deviation 23.0
|
|
Quality of Life Measure by WHOQOL-BREF
WHOQOL-BREF 4TH DOMAIN
|
62.5 score on a scale
Standard Deviation 13.9
|
65.8 score on a scale
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: 12 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.
Outcome measures
| Measure |
Brief Group Psychoeducation
n=90 Participants
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.
|
Treatment as Usual Only
n=86 Participants
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.
|
|---|---|---|
|
Family Burden
SSFB objective domain
|
0.66 score on a scale
Standard Deviation 0.40
|
0.68 score on a scale
Standard Deviation 0.37
|
|
Family Burden
SSFB subjective domain
|
0.69 score on a scale
Standard Deviation 0.37
|
0.76 score on a scale
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: 12 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.
Outcome measures
| Measure |
Brief Group Psychoeducation
n=90 Participants
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.
|
Treatment as Usual Only
n=86 Participants
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.
|
|---|---|---|
|
Expressed Emotions
|
31.1 score on a scale
Standard Deviation 5.4
|
30.8 score on a scale
Standard Deviation 6.6
|
Adverse Events
Brief Group Psychoeducation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place