Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06264050
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-16
First Post:
2024-02-08
Brief Title:
Psychological Support Group and Its Effects on Mood Anxiety and Coping
Sponsor:
IRCCS San Camillo Venezia Italy
Organization:
IRCCS San Camillo Venezia Italy
Study Overview
Official Title:
The Influence of a Psychological Support Group on Mood Anxiety Coping Skills of Patients Admitted to Neurorehabilitation a Pre-post Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
SUPPORT
Brief Summary:
The aim of this study is to verify the influence that participation in a Psychological Support Group has on anxiety depression and coping skills in patients admitted to the IRCCS San Camillo Hospital
It is therefore an observational study with a pre-post design on a cohort of patients hospitalized at San Camillo IRCCS who attend the Psychological Support Group
The study consists of verifying whether the therapeutic activity of the Psychological Support Group GSP has an influence on the levels of anxiety mood and coping skills in the patients who attend it These purposes will be pursued through the administration to each patient at the beginning pre and at the end post of the period of attendance at the GSP of validated scales Stay Y2 anxiety BDI IIdepressive symptoms COPE NVD 25 coping strategies and the CORE-OM outcomes of psychological activity
It is therefore an observational study with a pre-post design on a cohort of patients hospitalized at San Camillo IRCCS who attend the Psychological Support Group
The study consists of verifying whether the therapeutic activity of the Psychological Support Group GSP has an influence on the levels of anxiety mood and coping skills in the patients who attend it These purposes will be pursued through the administration to each patient at the beginning pre and at the end post of the period of attendance at the GSP of validated scales Stay Y2 anxiety BDI IIdepressive symptoms COPE NVD 25 coping strategies and the CORE-OM outcomes of psychological activity
Detailed Description:
Several neurological pathologies are associated with a decrease in the quality of life for patients In particular previous studies have reported that anxiety and depression are two of the main predictors of this decrease in patients with epilepsy migraine multiple sclerosis Parkinsons disease and stroke Among these pathologies and in general among the populations of patients with neurological diseases belonging to our hospital motor cognitive and communicative impairments negatively impact the quality of life as well as the activities of daily living Often these limitations make it necessary to reconceptualise ones personal identity which passes through experiences of acceptance of the disease as well as consolidation of awareness of the disease and of ones functional outcomes cognitive motor etc with consequent repercussions in terms of the tone of the mood such as experiences of anxiety and depression
A psychological support intervention is therefore necessary after evaluating these aspects in order to outline the critical issues as well as the possible compensation factors that can be provided to the patient in order to strengthen his motivation for the treatment and in general for the rehabilitation process during the hospitalization period favoring the emergence of more functional coping strategies Often in fact the patient is not able to ask for support or help from operators andor family members is not able to appropriately manage their emotional experiences and often experiences incongruent feelings of guilt These aspects negatively influence the rehabilitation services received and generally outline a hospitalization experience that is not entirely functional From this perspective in addition to the individual psychological path the possibility of accessing a psychological support group is configured as a suitable treatment space-time in which to express ones needs and concerns for the future where issues relating to the condition can be explored in depth existential This is undoubtedly the starting point the desire to understand the desire to understand the disease but also the expectations and fears in order to understand the disease and implement more realistic and congruent expectations in view of relational and professional reintegration where possible
The aim of this study is to verify what influence attending the Psychological Support Group has on anxiety depressive symptoms coping styles and what psychological outcomes it leads to in neurorehabilitation patients
Outcomes
For the STAI Y2 Scale a score lower than 50 is indicative of a decrease in state anxiety
For the BDI II an improvement in depressive symptoms is expected which will be expressed with a change in score range for example from moderate to light ie going from the range 20-28 to 14-19 or with a decrease in the score within the same range for example in the severe range
For the CORE OM the total raw scores 0-136 of the entire scale will be analysed also adding the scores of the 4 individual dimensions It is expected that the score at the second post survey will decrease both in the general sum of the 34 items and in the individual dimensions
Subsequently the correlations between the factors will be searched for and analyzed with the Pearson r coefficientFor the COPE NVI 25 Scale the scores of the individual dimensions will be added and given that a higher score corresponds to a better predisposition it is expected that the dimensions Orientation to the problem will increase Positive attitude will increase Transcendent orientation will increase so such as Social support while Avoidance strategies decreases in the score
Subsequently the correlations between the factors will be searched for and analyzed with the Pearson r coefficient
Sample
Patients undergoing neurorehabilitation admitted to the IRCCS San Camillo for whom there is an indication of participation in the Psychological Support Group held by the Neuropsychology Service of the IRCCS San Camillo will be considered eligible for the study
Procedure The patient who receives the indication to be part of the Psychological Support Group and who meets the inclusion and exclusion criteria will be contacted by a researcher who after obtaining consent the day before starting participation in the GSP will ask the patient the rating scales will be administered pre - T1 phase We assume around 30 minutes to compile When the patient finishes participating in the support group the researcherinterviewer will repeat the administration of the same scales according to the methods and precautions described above post-T2 phase the day after discharge from the GSP
The scales will be administered and carried out by specially trained psychological and nursing staff who will not correspond with the staff who will conduct the GSP Patient data will be anonymized
The following information and data will be collected from clinical documentation
Gender age educational qualification current profession or before retirement marital status presence of children or social network
Main pathology cause of entry into neurorehabilitation and types of main pathology eg type of stroke and its location main comorbidities
Duration of hospitalization at T0 duration of the pathology number of hospitalizations whether first hospitalization or not
Barthel Index and FIM Functional Independence Measure scale both at T0 and T2 These two scales are already present in the medical record because they are a routine and mandatory part of hospitalization In addition to the descriptive statistics the Students t test for paired data will be applied or the non-parametric equivalent Wilcoxon signed-rank test The normality of the variables will be tested using the Shapiro-Wilk test
Two-tailed tests with an alpha error of 005 will be used The collected data will be processed using STATA software version 15 or higher
The sample size was calculated on the BDI-II scale due to its clinical relevance in neurorehabilitation treatment Wang Gorestain 2013 Given the scarcity of studies in patients undergoing neurorehabilitation the standard deviation reported by Huang et al 2017 on a sample of patients with Parkinsons disease equal to 84 was used
Assuming a clinically relevant mean difference in the raw scores of 6 effect size 071 19 subjects will be necessary considering a two-tailed test a type I error of 5 and a power of 80 Taking into account a possible dropout rate of 20 the subjects to be enrolled become 24 The calculation was carried out using the G-Power software version 3196 using the Wilcoxon signed-rank test for difference in average for paired data
Expected results
Patients who attend the Psychological Support Group are expected to have a general improvement in their psychological condition related to hospitalization and illness Reduction in anxiety levels fewer depressive symptoms and development of more effective coping strategies
A psychological support intervention is therefore necessary after evaluating these aspects in order to outline the critical issues as well as the possible compensation factors that can be provided to the patient in order to strengthen his motivation for the treatment and in general for the rehabilitation process during the hospitalization period favoring the emergence of more functional coping strategies Often in fact the patient is not able to ask for support or help from operators andor family members is not able to appropriately manage their emotional experiences and often experiences incongruent feelings of guilt These aspects negatively influence the rehabilitation services received and generally outline a hospitalization experience that is not entirely functional From this perspective in addition to the individual psychological path the possibility of accessing a psychological support group is configured as a suitable treatment space-time in which to express ones needs and concerns for the future where issues relating to the condition can be explored in depth existential This is undoubtedly the starting point the desire to understand the desire to understand the disease but also the expectations and fears in order to understand the disease and implement more realistic and congruent expectations in view of relational and professional reintegration where possible
The aim of this study is to verify what influence attending the Psychological Support Group has on anxiety depressive symptoms coping styles and what psychological outcomes it leads to in neurorehabilitation patients
Outcomes
For the STAI Y2 Scale a score lower than 50 is indicative of a decrease in state anxiety
For the BDI II an improvement in depressive symptoms is expected which will be expressed with a change in score range for example from moderate to light ie going from the range 20-28 to 14-19 or with a decrease in the score within the same range for example in the severe range
For the CORE OM the total raw scores 0-136 of the entire scale will be analysed also adding the scores of the 4 individual dimensions It is expected that the score at the second post survey will decrease both in the general sum of the 34 items and in the individual dimensions
Subsequently the correlations between the factors will be searched for and analyzed with the Pearson r coefficientFor the COPE NVI 25 Scale the scores of the individual dimensions will be added and given that a higher score corresponds to a better predisposition it is expected that the dimensions Orientation to the problem will increase Positive attitude will increase Transcendent orientation will increase so such as Social support while Avoidance strategies decreases in the score
Subsequently the correlations between the factors will be searched for and analyzed with the Pearson r coefficient
Sample
Patients undergoing neurorehabilitation admitted to the IRCCS San Camillo for whom there is an indication of participation in the Psychological Support Group held by the Neuropsychology Service of the IRCCS San Camillo will be considered eligible for the study
Procedure The patient who receives the indication to be part of the Psychological Support Group and who meets the inclusion and exclusion criteria will be contacted by a researcher who after obtaining consent the day before starting participation in the GSP will ask the patient the rating scales will be administered pre - T1 phase We assume around 30 minutes to compile When the patient finishes participating in the support group the researcherinterviewer will repeat the administration of the same scales according to the methods and precautions described above post-T2 phase the day after discharge from the GSP
The scales will be administered and carried out by specially trained psychological and nursing staff who will not correspond with the staff who will conduct the GSP Patient data will be anonymized
The following information and data will be collected from clinical documentation
Gender age educational qualification current profession or before retirement marital status presence of children or social network
Main pathology cause of entry into neurorehabilitation and types of main pathology eg type of stroke and its location main comorbidities
Duration of hospitalization at T0 duration of the pathology number of hospitalizations whether first hospitalization or not
Barthel Index and FIM Functional Independence Measure scale both at T0 and T2 These two scales are already present in the medical record because they are a routine and mandatory part of hospitalization In addition to the descriptive statistics the Students t test for paired data will be applied or the non-parametric equivalent Wilcoxon signed-rank test The normality of the variables will be tested using the Shapiro-Wilk test
Two-tailed tests with an alpha error of 005 will be used The collected data will be processed using STATA software version 15 or higher
The sample size was calculated on the BDI-II scale due to its clinical relevance in neurorehabilitation treatment Wang Gorestain 2013 Given the scarcity of studies in patients undergoing neurorehabilitation the standard deviation reported by Huang et al 2017 on a sample of patients with Parkinsons disease equal to 84 was used
Assuming a clinically relevant mean difference in the raw scores of 6 effect size 071 19 subjects will be necessary considering a two-tailed test a type I error of 5 and a power of 80 Taking into account a possible dropout rate of 20 the subjects to be enrolled become 24 The calculation was carried out using the G-Power software version 3196 using the Wilcoxon signed-rank test for difference in average for paired data
Expected results
Patients who attend the Psychological Support Group are expected to have a general improvement in their psychological condition related to hospitalization and illness Reduction in anxiety levels fewer depressive symptoms and development of more effective coping strategies
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