Coping StrategiesSUPPORTNCT06264050
Psychological Support Group and Its Effects on Mood, Anxiety and Coping
A study testing evalutaion scales in people with Coping Strategies and Anxiety, run by IRCCS San Camillo, Venezia, Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coping Strategies, Anxiety, Nurse-Patient Relations
- What is being tested?
- evalutaion scales
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2004to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized at the IRCCS San Camillo. Patients with indication to attend the Psychological Support Group. Patients who have given valid consent. Patients able to understand and read Italian. Patients with any type of neurological pathology for which they are admitted to neurorehabilitation.
- Aphasic patients without comprehension deficits and able to communicate effectively with augmented communication media.
Who cannot join
- Patients unable to give valid consent. Minor patients or patients over 85 years of age. Patients with participation in the Psychological Support Group of less than three sessions.
- Patients with cognitive deficits that prevent them from completing the scales and taking the interview.
- Patients unable to understand and read Italian. Patients with pathologies for which they are not undergoing neurorehabilitation treatment.
About this study
Official title: The Influence of a Psychological Support Group on Mood, Anxiety, Coping Skills of Patients Admitted to Neurorehabilitation: a Pre-post Study
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 II(depressive symptoms), COPE NVD 25 (coping strategies) and the CORE-OM (outcomes of psychological activity).
Read the 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, Parkinson's 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 one's personal identity which passes through experiences of acceptance of the disease as well as consolidation of awareness of the disease and of one's 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 and/or 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 one's 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, i.e. 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 coefficient.For 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 researcher/interviewer 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 (e.g. 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 Student's 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 0.05 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 Parkinson's disease equal to 8.4 was used.
Assuming a clinically relevant mean difference in the raw scores of 6 (effect size 0.71), 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 3.1.9.6) 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.
- Conditions
- Coping Strategies, Anxiety, Nurse-Patient Relations, Psychological, Mood Depressed, Rehabilitation
- Being tested
- evalutaion scales
- Medical subject headings
- Anxiety Disorders, Consciousness Disorders, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evalutaion scalesDiagnostic test
four scales will be administered to whom attend a psychological support group: BDI II (depression); Stai Y2 (trait anxiety); Cope NVI 25 (coping strategies) and Core OM (psychological state)
| Study group | Role | What they receive |
|---|---|---|
| Patients in the psychological support group | Other | Patients in neurorehabilitation attending a psychological support group Receives: Diagnostic Test: evalutaion scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
The State-Trait Anxiety Inventory (STAI) Y2
The Stai Y2 instead measures state anxiety (State-anxiety), i.e. a transitory emotional state of an individual in a particular situation, unlike trait anxiety (Trait-anxiety) which reflects a personality variable that stably characterizes the individual and differentiates him from others in the propensity to respond with high levels of anxiety to situations perceived as dangerous. Trait anxiety is measured by the Stai version Y1
Measured: 10 minutes
The Beck Depression Inventory II (BDI-II)
The Beck Depression Inventory II (BDI-II) has 21 items on a 4-point Likert scale (from 0 to 3) and a total score ranging from 0 to 63. Given that the BDI does not diagnose depression but the presence of depressive symptoms, according the manual scores from 0 to 13 indicate normality, from 14 to 19 mild depression, from 20 to 28 moderate depression, from 29 to 63 severe depression.
Measured: 15 minutes
The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM)
The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a 34-item self-report instrument for measuring outcomes in psychological treatments that has been shown to be reliable, valid, and acceptable in various clinical settings. The items cover four domains: subjective well-being, problems/symptoms, life functioning, and risk. Higher scores in all domains indicate greater psychological problems
Measured: 20 minutes
The Coping Orientations to Problem Experienced NVI - 25
The Coping Orientations to Problem Experienced is a self-report questionnaire that takes into consideration different coping methods. The questionnaire asks you to evaluate how often the subject implements that particular coping process in difficult or stressful situations; There are four answer possibilities, from "I usually don't do it" to "I almost always do it". The short version validated in Italian (NVI) has 25 items instead of the 60 of the original version.
All elements were grouped into 5 subdimensions, namely: Avoidance strategies, Transcendental orientation, Positive attitude, Social support, Problem orientation.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start8 Jan 2004
- Primary completion8 Sep 2024 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Coping StrategiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pre post study on a single cohort
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alberto Camuccio, doctor, Principal investigator, IRCCS San Camillo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264050
- Sponsor's protocol ID
- 2023.04
- Acronym
- SUPPORT
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Castelnuovo G, Giusti EM, Manzoni GM, Saviola D, Gatti A, Gabrielli S, Lacerenza M, Pietrabissa G, Cattivelli R, Spatola CA, Corti S, Novelli M, Villa V, Cottini A, Lai C, Pagnini F, Castelli L, Tavola M, Torta R, Arreghini M, Zanini L, Brunani A, Capodaglio P, D'Aniello GE, Scarpina F, Brioschi A, Priano L, Mauro A, Riva G, Repetto C, Regalia C, Molinari E, Notaro P, Paolucci S, Sandrini G, Simpson SG, Wiederhold B, Tamburin S. Psychological Treatments and Psychotherapies in the Neurorehabilitation of Pain: Evidences and Recommendations from the Italian Consensus Conference on Pain in Neurorehabilitation. Front Psychol. 2016 Feb 19;7:115. doi: 10.3389/fpsyg.2016.00115. eCollection 2016.
PubMed 26924998Chiu EC, Chen YJ, Wu WC, Chou CX, Yu MY. Psychometric Comparisons of Three Depression Measures for Patients With Stroke. Am J Occup Ther. 2022 Jul 1;76(4):7604205140. doi: 10.5014/ajot.2022.049347.
PubMed 35727642Denham AMJ, Baker AL, Spratt N, Guillaumier A, Wynne O, Turner A, Magin P, Bonevski B. The unmet needs of informal carers of stroke survivors: a protocol for a systematic review of quantitative and qualitative studies. BMJ Open. 2018 Jan 31;8(1):e019571. doi: 10.1136/bmjopen-2017-019571.
PubMed 29391371Gregorio GW, Brands I, Stapert S, Verhey FR, van Heugten CM. Assessments of coping after acquired brain injury: a systematic review of instrument conceptualization, feasibility, and psychometric properties. J Head Trauma Rehabil. 2014 May-Jun;29(3):E30-42. doi: 10.1097/HTR.0b013e31828f93db.
PubMed 23640542Huang SL, Hsieh CL, Wu RM, Lu WS. Test-retest reliability and minimal detectable change of the Beck Depression Inventory and the Taiwan Geriatric Depression Scale in patients with Parkinson's disease. PLoS One. 2017 Sep 25;12(9):e0184823. doi: 10.1371/journal.pone.0184823. eCollection 2017.
PubMed 28945776Kampling H, Reese C, Kust J, Mittag O. Systematic development of practice guidelines for psychological interventions in stroke rehabilitation. Disabil Rehabil. 2020 Jun;42(11):1616-1622. doi: 10.1080/09638288.2018.1530308. Epub 2019 Jan 7.
PubMed 30616425Liao B, Liang M, Ouyang Q, Song H, Chen X, Su Y. Psychological Nursing of Patients With Stroke in China: A Systematic Review and Meta-Analysis. Front Psychiatry. 2020 Dec 11;11:569426. doi: 10.3389/fpsyt.2020.569426. eCollection 2020.
PubMed 33362596Palmieri G, Evans C, Hansen V, Brancaleoni G, Ferrari S, Porcelli P, Reitano F, Rigatelli M. Validation of the Italian version of the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM). Clin Psychol Psychother. 2009 Sep-Oct;16(5):444-9. doi: 10.1002/cpp.646.
PubMed 19701881Pearce G, Pinnock H, Epiphaniou E, Parke HL, Heavey E, Griffiths CJ, Greenhalgh T, Sheikh A, Taylor SJ. Experiences of Self-Management Support Following a Stroke: A Meta-Review of Qualitative Systematic Reviews. PLoS One. 2015 Dec 14;10(12):e0141803. doi: 10.1371/journal.pone.0141803. eCollection 2015.
PubMed 26657458Raciti L, Corallo F, Manuli A, Calabro RS. Nursing, Caregiving and Psychological support in Chronic Disorders of Consciousness: a scoping review. Acta Biomed. 2021 Mar 31;92(S2):e2021013. doi: 10.23750/abm.v92iS2.11329.
PubMed 33855992Santangelo G, Sacco R, Siciliano M, Bisecco A, Muzzo G, Docimo R, De Stefano M, Bonavita S, Lavorgna L, Tedeschi G, Trojano L, Gallo A. Anxiety in Multiple Sclerosis: psychometric properties of the State-Trait Anxiety Inventory. Acta Neurol Scand. 2016 Dec;134(6):458-466. doi: 10.1111/ane.12564. Epub 2016 Feb 1.
PubMed 27219913Sarkamo T. Cognitive, emotional, and neural benefits of musical leisure activities in aging and neurological rehabilitation: A critical review. Ann Phys Rehabil Med. 2018 Nov;61(6):414-418. doi: 10.1016/j.rehab.2017.03.006. Epub 2017 Apr 29.
PubMed 28461128Sihvonen AJ, Sarkamo T, Leo V, Tervaniemi M, Altenmuller E, Soinila S. Music-based interventions in neurological rehabilitation. Lancet Neurol. 2017 Aug;16(8):648-660. doi: 10.1016/S1474-4422(17)30168-0. Epub 2017 Jun 26.
PubMed 28663005Soratto J, Pires DEP, Friese S. Thematic content analysis using ATLAS.ti software: Potentialities for researchs in health. Rev Bras Enferm. 2020 Apr 22;73(3):e20190250. doi: 10.1590/0034-7167-2019-0250. eCollection 2020.
PubMed 32321144Starkstein SE, Lischinsky A. The phenomenology of depression after brain injury. NeuroRehabilitation. 2002;17(2):105-13.
PubMed 12082237
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of a Psychological Support Group on Mood, Anxiety, Coping Skills of Patients Admitted to Neurorehabilitation: a Pre-post Study
- ClinicalTrials.gov ID
- NCT06264050
- Acronym / sponsor ID
- SUPPORT / 2023.04
- Conditions
- Coping Strategies, Anxiety, Nurse-Patient Relations, Psychological, Mood Depressed, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (actual)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- 8 Jan 2004 (actual)
- Primary completion
- 8 Sep 2024 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 II(depressive 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, Parkinson's 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 one's personal identity which passes through experiences of acceptance of the disease as well as consolidation of awareness of the disease and of one's 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 and/or 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 one's 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, i.e. 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 coefficient.For 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 researcher/interviewer 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 (e.g. 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 Student's 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 0.05 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 Parkinson's disease equal to 8.4 was used.
Assuming a clinically relevant mean difference in the raw scores of 6 (effect size 0.71), 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 3.1.9.6) 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pre post study on a single cohort
| Arm | Type | Receives |
|---|---|---|
| Patients in the psychological support group | Other | Diagnostic Test: evalutaion scalesPatients in neurorehabilitation attending a psychological support group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients hospitalized at the IRCCS San Camillo. Patients with indication to attend the Psychological Support Group. Patients who have given valid consent. Patients able to understand and read Italian. Patients with any type of neurological pathology for which they are admitted to neurorehabilitation.
- Aphasic patients without comprehension deficits and able to communicate effectively with augmented communication media.
Key exclusion criteria (3 listed)
- Patients unable to give valid consent. Minor patients or patients over 85 years of age. Patients with participation in the Psychological Support Group of less than three sessions.
- Patients with cognitive deficits that prevent them from completing the scales and taking the interview.
- Patients unable to understand and read Italian. Patients with pathologies for which they are not undergoing neurorehabilitation treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evalutaion scalesfour scales will be administered to whom attend a psychological support group: BDI II (depression); Stai Y2 (trait anxiety); Cope NVI 25 (coping strategies) and Core OM (psychological state) | Diagnostic test | Patients in the psychological support group |
Primary outcome
The State-Trait Anxiety Inventory (STAI) Y2
Time frame: 10 minutes
The Stai Y2 instead measures state anxiety (State-anxiety), i.e. a transitory emotional state of an individual in a particular situation, unlike trait anxiety (Trait-anxiety) which reflects a personality variable that stably characterizes the individual and differentiates him from others in the propensity to respond with high levels of anxiety to situations perceived as dangerous. Trait anxiety is measured by the Stai version Y1
The Beck Depression Inventory II (BDI-II)
Time frame: 15 minutes
The Beck Depression Inventory II (BDI-II) has 21 items on a 4-point Likert scale (from 0 to 3) and a total score ranging from 0 to 63. Given that the BDI does not diagnose depression but the presence of depressive symptoms, according the manual scores from 0 to 13 indicate normality, from 14 to 19 mild depression, from 20 to 28 moderate depression, from 29 to 63 severe depression.
The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM)
Time frame: 20 minutes
The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a 34-item self-report instrument for measuring outcomes in psychological treatments that has been shown to be reliable, valid, and acceptable in various clinical settings. The items cover four domains: subjective well-being, problems/symptoms, life functioning, and risk. Higher scores in all domains indicate greater psychological problems
The Coping Orientations to Problem Experienced NVI - 25
Time frame: 15 minutes
The Coping Orientations to Problem Experienced is a self-report questionnaire that takes into consideration different coping methods. The questionnaire asks you to evaluate how often the subject implements that particular coping process in difficult or stressful situations; There are four answer possibilities, from "I usually don't do it" to "I almost always do it". The short version validated in Italian (NVI) has 25 items instead of the 60 of the original version. All elements were grouped into 5 subdimensions, namely: Avoidance strategies, Transcendental orientation, Positive attitude, Social support, Problem orientation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Results publication: PubMed 26924998Castelnuovo G, Giusti EM, Manzoni GM, Saviola D, Gatti A, Gabrielli S, Lacerenza M, Pietrabissa G, Cattivelli R, Spatola CA, Corti S, Novelli M, Villa V, Cottini A, Lai C, Pagnini F, Castelli L, Tavola M, Torta R, Arreghini M, Zanini L, Brunani A, Capodaglio P, D'Aniello GE, Scarpina F, Brioschi A, Priano L, Mauro A, Riva G, Repetto C, Regalia C, Molinari E, Notaro P, Paolucci S, Sandrini G, Simpson SG, Wiederhold B, Tamburin S. Psychological Treatments and Psychotherapies in the Neurorehabilitation of Pain: Evidences and Recommendations from the Italian Consensus Conference on Pain in Neurorehabilitation. Front Psychol. 2016 Feb 19;7:115. doi: 10.3389/fpsyg.2016.00115. eCollection 2016.
- Results publication: PubMed 35727642Chiu EC, Chen YJ, Wu WC, Chou CX, Yu MY. Psychometric Comparisons of Three Depression Measures for Patients With Stroke. Am J Occup Ther. 2022 Jul 1;76(4):7604205140. doi: 10.5014/ajot.2022.049347.
- Results publication: PubMed 29391371Denham AMJ, Baker AL, Spratt N, Guillaumier A, Wynne O, Turner A, Magin P, Bonevski B. The unmet needs of informal carers of stroke survivors: a protocol for a systematic review of quantitative and qualitative studies. BMJ Open. 2018 Jan 31;8(1):e019571. doi: 10.1136/bmjopen-2017-019571.
- Results publication: PubMed 23640542Gregorio GW, Brands I, Stapert S, Verhey FR, van Heugten CM. Assessments of coping after acquired brain injury: a systematic review of instrument conceptualization, feasibility, and psychometric properties. J Head Trauma Rehabil. 2014 May-Jun;29(3):E30-42. doi: 10.1097/HTR.0b013e31828f93db.
- Results publication: PubMed 28945776Huang SL, Hsieh CL, Wu RM, Lu WS. Test-retest reliability and minimal detectable change of the Beck Depression Inventory and the Taiwan Geriatric Depression Scale in patients with Parkinson's disease. PLoS One. 2017 Sep 25;12(9):e0184823. doi: 10.1371/journal.pone.0184823. eCollection 2017.
- Results publication: PubMed 30616425Kampling H, Reese C, Kust J, Mittag O. Systematic development of practice guidelines for psychological interventions in stroke rehabilitation. Disabil Rehabil. 2020 Jun;42(11):1616-1622. doi: 10.1080/09638288.2018.1530308. Epub 2019 Jan 7.
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- Results publication: PubMed 28461128Sarkamo T. Cognitive, emotional, and neural benefits of musical leisure activities in aging and neurological rehabilitation: A critical review. Ann Phys Rehabil Med. 2018 Nov;61(6):414-418. doi: 10.1016/j.rehab.2017.03.006. Epub 2017 Apr 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Camuccio, doctor principal investigator
IRCCS San Camillo
Questions about this trial
What is this clinical trial studying?
A study testing evalutaion scales in people with Coping Strategies and Anxiety, run by IRCCS San Camillo, Venezia, Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The State-Trait Anxiety Inventory (STAI) Y2 (time frame: 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06264050, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.