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临床试验/NCT06264050
NCT06264050Unknown不适用

The Influence of a Psychological Support Group on Mood, Anxiety, Coping Skills of Patients Admitted to Neurorehabilitation: a Pre-post Study

IRCCS San Camillo, Venezia, Italy0 个研究点目标入组 19 人开始时间: 2004年1月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
19
主要终点
The State-Trait Anxiety Inventory (STAI) Y2

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Patients in the psychological support group

Other

Patients in neurorehabilitation attending a psychological support group

干预措施: evalutaion scales (Diagnostic Test)

结局指标

主要结局

The State-Trait Anxiety Inventory (STAI) Y2

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
IRCCS San Camillo, Venezia, Italy
申办方类型
Other
责任方
Sponsor

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