Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284096
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-21
Brief Title:
The Personal Recovery Based Psychoeducation For Schizophrenia
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
The Effect of Recovery Based Psychoeducation on Personal Recovery in Individuals Diagnosed With Schizophrenia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project aims to introduce a new psychoeducation program that helps individuals with schizophrenia to recover subjectively The programs effectiveness will be evaluated through a randomized controlled research design The goal is not only to emphasize clinical recovery but also to highlight the importance of individual recovery and promote its implementation In this context the following hypotheses have been formulated
Research Question
1 Does recovery-based psychoeducation have an impact on the subjective recovery level in individuals diagnosed with schizophrenia in remission
Hypotheses
H0a Recovery-based psychoeducation does not affect the subjective recovery level in individuals diagnosed with schizophrenia in remission
H0b Recovery-based psychoeducation does not effect on psychological resilience in individuals diagnosed with schizophrenia in remission
H0c Recovery-based psychoeducation does not effect on hope in individuals diagnosed with schizophrenia in remission
H1a Recovery-based psychoeducation affects the subjective recovery level in individuals diagnosed with schizophrenia in remission
H1b Recovery-based psychoeducation has an effect on psychological resilience in individuals diagnosed with schizophrenia in remission
H1c Recovery-based psychoeducation has an effect on hope in individuals diagnosed with schizophrenia in remission
Research Question
1 Does recovery-based psychoeducation have an impact on the subjective recovery level in individuals diagnosed with schizophrenia in remission
Hypotheses
H0a Recovery-based psychoeducation does not affect the subjective recovery level in individuals diagnosed with schizophrenia in remission
H0b Recovery-based psychoeducation does not effect on psychological resilience in individuals diagnosed with schizophrenia in remission
H0c Recovery-based psychoeducation does not effect on hope in individuals diagnosed with schizophrenia in remission
H1a Recovery-based psychoeducation affects the subjective recovery level in individuals diagnosed with schizophrenia in remission
H1b Recovery-based psychoeducation has an effect on psychological resilience in individuals diagnosed with schizophrenia in remission
H1c Recovery-based psychoeducation has an effect on hope in individuals diagnosed with schizophrenia in remission
Detailed Description:
CHIME Connectedness-Hope-Identity-Meaning of Life-Empowerment is a framework conceptualizing subjective recovery in individuals with mental disorders Based on a systematic review involving 97 studies five fundamental principles of recovery were identified in these studies These principles are listed as Empowerment Hope and Optimism Connectedness Social Support Meaning of Life and Identity A psychoeducation program has been developed based on this framework A study examining 115 international English articles conceptualizing personal recovery revealed that most articles reflected all five recovery components supporting its validity In another study evaluating the components of subjective recovery it was found that most components were necessary for the recovery journey of individuals with different psychiatric diagnoses such as bipolar disorder and eating disorders Consequently the recovery framework has gained more importance recently for researchers and clinicians by providing an inclusive consensus model
The psychoeducation program planned based on the Concept of Personal Recovery aims to accelerate recovery make it sustainable and demonstrate the importance of individualized care based on the individuals values and treatment preferences
Research Design Pretest-posttest randomized controlled intervention study Population and Sample of the Study The population of the study consists of 236 individuals diagnosed with schizophrenia registered at the Umraniye Community Mental Health Center affiliated with Erenkoy Mental and Neurological Diseases Training and Research Hospital who meet the Diagnostic and Statistical Manual of Mental Disorders DSM-5 criteria
To calculate the sample for the study a preliminary study will be conducted with a group of 10 individuals Based on the data obtained from this preliminary study the sample size will be calculated using the G-power program
Location and Timing of the Research Approval document with the number 2023391 from Istanbul University-Cerrahpasa Social and Humanities Research Ethics Committee is available The data collection and group sessions for the study scheduled to be conducted between April and June 2024 after obtaining approval from the Ministry of Health Istanbul Provincial Health Directorate will take place in the Umraniye Community Mental Health Center meeting room The meeting room has been designated as a suitable environment for group sessions with the necessary size no entry or exit during sessions and conditions suitable for interaction and sharing in terms of safety In addition a blackboard and a projector are available for use during the sessions Group members will be invited on session days within the time frame determined by common agreement
Data Collection Method
Data will be collected through the participants filling out the scale with the assistance of a research assistant
Data Collection Instruments
Personal Data Form A form created by the researcher in accordance with the literature consisting of a total of 11 questions about participants socio-demographic characteristics and disease conditions
Subjective Recovery Assessment Scale A self-report scale developed by Yildiz and colleagues to assess the subjective recovery status of individuals diagnosed with schizophrenia The scale is a five-point Likert scale and each item is scored from one to five An increase in the score indicates that the individual perceives themselves as improved The scale is evaluated as a single-factor scale without sub-dimensions Psychological Resilience Assessment Scale Developed by Johnson and colleagues and validated with individuals with mental disorders by Duran It is a five-point Likert scale consisting of a total of 12 items and two sub-dimensions These sub-dimensions are named Social Support and Emotional CopingSituational Coping
Schizophrenia Hope Scale Developed by Choe to determine the hope levels of individuals diagnosed with schizophrenia It consists of a total of 9 questions and has a 3-point Likert-type rating 0disagree 1agree 2strongly agree The total score obtained from the scale ranges from 0 to 18 The scale does not have a cutoff point and a high score on the scale indicates high hope in individuals diagnosed with schizophrenia The Turkish validity and reliability study of the scale was conducted by Sahin Altun and colleagues
Data Collection Tool Implementation and Interventions Participants who meet the research criteria and agree to participate in the study will be randomized and divided into intervention and control groups Initial measurements Personal Data Form Subjective Recovery Assessment Scale Psychological Resilience Assessment Scale Schizophrenia Hope Scale will be collected by the researcher through face-to-face interviews While the control group continues to receive routine Community Mental Health Center CMHC the intervention group will receive a recovery-oriented psychoeducation program in addition to routine Community Mental Health Center After the intervention program is completed the final measurements of both the intervention and control groups will be collected Intervention Stage It is planned for the control group to participate only in routine Community Mental Health Center activities craft activities art music computer courses etc The intervention group is aimed to participate in both the psychoeducation program conducted by the researcher and these routine activities in the institution Interventions will be implemented by the researcher personally At the end of the intervention participants will be given an education evaluation form The control group will continue with the routine rehabilitation activities implemented at CMHC during this period The initial meeting with the control group will involve introductions and pre-testing attachmentsabbreviations The final testing will be conducted at the end of the period when the intervention group completes the program
Development of the Recovery-Based Psychoeducation Program The program prepared by the researcher based on relevant literature has been presented to experts for their opinions Psychoeducation programs for individuals diagnosed with schizophrenia in the literature have been determined to consist of 5-10 sessions This study plans to have a total of seven sessions conducted weekly with approximately 60-70 minutes allocated for each session taking into account the attention span of the participants Sessions will be divided into two parts each lasting 30-35 minutes with a 15 minute break
Individuals who voluntarily agree to participate in psychoeducation sessions will be provided with verbal and written consent regarding the group rules The group rules will be collaboratively determined with the participants One day before each psychoeducation session participants will be reminded of the start time through a phone call Before each session participants will be supplied with materials such as pens erasers and notebooks that they may need and use during the session To ensure the participants consistent attendance the instructor will provide snacks and beverages during each session break
Session 1 Introduction Introduction of participants to the educator and each other Purpose duration and frequency of the education Group rules
Session 2 Identity Rebuildingredefining positive identity Overcoming stigma
Session 3 Meaningful Life Meaning of the mental illness experience Spirituality Quality of life Social rolesgoals Rebuilding life
Session 4 Hope and Optimism Belief in the possibility of recovery Motivation for change Relationships that provide hope
Session 5 Empowerment Self-management Control over life Focusing on strengths
Session 6 Social Support Peer support and support groups Friendship relationships Being a part of the community
Session 7 Process Evaluation and Closure Reinforcing what has been learned Program evaluation Receiving feedback Certificate Application of Post-test Measurements
Scope validity of the Psychoeducation Program All items of the session content aimed at ensuring the scope validity of the psychoeducation program prepared in accordance with the relevant literature were presented to a total of 5 experts who are faculty members in the psychiatry and nursing departments A scoring form for all session steps was sent to the experts and they were asked to evaluate the appropriateness of the items in terms of languageculture and content In the evaluation of expert opinions Davis Content Validity Index CVI was used According to the CVI items receiving 1 and 2 points are unacceptable and items receiving 3-4 points are considered acceptable In the analysis the content validity of the second session Identity was calculated as 83 and the content validity of the other sessions was calculated as 100 indicating that the psychoeducation has sufficient scope validity
Randomization The allocation of individuals included in the study to groups will be determined using a simple random sampling method through wwwrandomizerorg
Protection of Participant Confidentiality During the pre-test and post-test application participants will be asked to write their initials and the last two digits of their birth year instead of their full names
Data Analysis The collected data will be analyzed using the Statistical Package for the Social Sciences Statistics for Windows 200 Package Descriptive analyses including counts percentages means standard deviations medians 25th and 75th percentiles minimum and maximum values will be conducted The normal distribution of continuous variables will be checked using the Kolmogorov-Smirnov test and the significance between groups will be compared using parametric tests for those with normal distribution and non-parametric tests for those without normal distribution
Repeated measures analysis of variance ANOVA will be used for the pre-test-post-test evaluation The comparison of categorical variables will be done using Chi-square tests and the relationship between variables will be explored using Pearson correlation tests for continuous variables and Spearman correlation tests for discrete variables Regression analyses will be employed to investigate the impact of independent variables on dependent variables The statistical significance level in the analyses will be accepted as p005
The psychoeducation program planned based on the Concept of Personal Recovery aims to accelerate recovery make it sustainable and demonstrate the importance of individualized care based on the individuals values and treatment preferences
Research Design Pretest-posttest randomized controlled intervention study Population and Sample of the Study The population of the study consists of 236 individuals diagnosed with schizophrenia registered at the Umraniye Community Mental Health Center affiliated with Erenkoy Mental and Neurological Diseases Training and Research Hospital who meet the Diagnostic and Statistical Manual of Mental Disorders DSM-5 criteria
To calculate the sample for the study a preliminary study will be conducted with a group of 10 individuals Based on the data obtained from this preliminary study the sample size will be calculated using the G-power program
Location and Timing of the Research Approval document with the number 2023391 from Istanbul University-Cerrahpasa Social and Humanities Research Ethics Committee is available The data collection and group sessions for the study scheduled to be conducted between April and June 2024 after obtaining approval from the Ministry of Health Istanbul Provincial Health Directorate will take place in the Umraniye Community Mental Health Center meeting room The meeting room has been designated as a suitable environment for group sessions with the necessary size no entry or exit during sessions and conditions suitable for interaction and sharing in terms of safety In addition a blackboard and a projector are available for use during the sessions Group members will be invited on session days within the time frame determined by common agreement
Data Collection Method
Data will be collected through the participants filling out the scale with the assistance of a research assistant
Data Collection Instruments
Personal Data Form A form created by the researcher in accordance with the literature consisting of a total of 11 questions about participants socio-demographic characteristics and disease conditions
Subjective Recovery Assessment Scale A self-report scale developed by Yildiz and colleagues to assess the subjective recovery status of individuals diagnosed with schizophrenia The scale is a five-point Likert scale and each item is scored from one to five An increase in the score indicates that the individual perceives themselves as improved The scale is evaluated as a single-factor scale without sub-dimensions Psychological Resilience Assessment Scale Developed by Johnson and colleagues and validated with individuals with mental disorders by Duran It is a five-point Likert scale consisting of a total of 12 items and two sub-dimensions These sub-dimensions are named Social Support and Emotional CopingSituational Coping
Schizophrenia Hope Scale Developed by Choe to determine the hope levels of individuals diagnosed with schizophrenia It consists of a total of 9 questions and has a 3-point Likert-type rating 0disagree 1agree 2strongly agree The total score obtained from the scale ranges from 0 to 18 The scale does not have a cutoff point and a high score on the scale indicates high hope in individuals diagnosed with schizophrenia The Turkish validity and reliability study of the scale was conducted by Sahin Altun and colleagues
Data Collection Tool Implementation and Interventions Participants who meet the research criteria and agree to participate in the study will be randomized and divided into intervention and control groups Initial measurements Personal Data Form Subjective Recovery Assessment Scale Psychological Resilience Assessment Scale Schizophrenia Hope Scale will be collected by the researcher through face-to-face interviews While the control group continues to receive routine Community Mental Health Center CMHC the intervention group will receive a recovery-oriented psychoeducation program in addition to routine Community Mental Health Center After the intervention program is completed the final measurements of both the intervention and control groups will be collected Intervention Stage It is planned for the control group to participate only in routine Community Mental Health Center activities craft activities art music computer courses etc The intervention group is aimed to participate in both the psychoeducation program conducted by the researcher and these routine activities in the institution Interventions will be implemented by the researcher personally At the end of the intervention participants will be given an education evaluation form The control group will continue with the routine rehabilitation activities implemented at CMHC during this period The initial meeting with the control group will involve introductions and pre-testing attachmentsabbreviations The final testing will be conducted at the end of the period when the intervention group completes the program
Development of the Recovery-Based Psychoeducation Program The program prepared by the researcher based on relevant literature has been presented to experts for their opinions Psychoeducation programs for individuals diagnosed with schizophrenia in the literature have been determined to consist of 5-10 sessions This study plans to have a total of seven sessions conducted weekly with approximately 60-70 minutes allocated for each session taking into account the attention span of the participants Sessions will be divided into two parts each lasting 30-35 minutes with a 15 minute break
Individuals who voluntarily agree to participate in psychoeducation sessions will be provided with verbal and written consent regarding the group rules The group rules will be collaboratively determined with the participants One day before each psychoeducation session participants will be reminded of the start time through a phone call Before each session participants will be supplied with materials such as pens erasers and notebooks that they may need and use during the session To ensure the participants consistent attendance the instructor will provide snacks and beverages during each session break
Session 1 Introduction Introduction of participants to the educator and each other Purpose duration and frequency of the education Group rules
Session 2 Identity Rebuildingredefining positive identity Overcoming stigma
Session 3 Meaningful Life Meaning of the mental illness experience Spirituality Quality of life Social rolesgoals Rebuilding life
Session 4 Hope and Optimism Belief in the possibility of recovery Motivation for change Relationships that provide hope
Session 5 Empowerment Self-management Control over life Focusing on strengths
Session 6 Social Support Peer support and support groups Friendship relationships Being a part of the community
Session 7 Process Evaluation and Closure Reinforcing what has been learned Program evaluation Receiving feedback Certificate Application of Post-test Measurements
Scope validity of the Psychoeducation Program All items of the session content aimed at ensuring the scope validity of the psychoeducation program prepared in accordance with the relevant literature were presented to a total of 5 experts who are faculty members in the psychiatry and nursing departments A scoring form for all session steps was sent to the experts and they were asked to evaluate the appropriateness of the items in terms of languageculture and content In the evaluation of expert opinions Davis Content Validity Index CVI was used According to the CVI items receiving 1 and 2 points are unacceptable and items receiving 3-4 points are considered acceptable In the analysis the content validity of the second session Identity was calculated as 83 and the content validity of the other sessions was calculated as 100 indicating that the psychoeducation has sufficient scope validity
Randomization The allocation of individuals included in the study to groups will be determined using a simple random sampling method through wwwrandomizerorg
Protection of Participant Confidentiality During the pre-test and post-test application participants will be asked to write their initials and the last two digits of their birth year instead of their full names
Data Analysis The collected data will be analyzed using the Statistical Package for the Social Sciences Statistics for Windows 200 Package Descriptive analyses including counts percentages means standard deviations medians 25th and 75th percentiles minimum and maximum values will be conducted The normal distribution of continuous variables will be checked using the Kolmogorov-Smirnov test and the significance between groups will be compared using parametric tests for those with normal distribution and non-parametric tests for those without normal distribution
Repeated measures analysis of variance ANOVA will be used for the pre-test-post-test evaluation The comparison of categorical variables will be done using Chi-square tests and the relationship between variables will be explored using Pearson correlation tests for continuous variables and Spearman correlation tests for discrete variables Regression analyses will be employed to investigate the impact of independent variables on dependent variables The statistical significance level in the analyses will be accepted as p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None