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Clinical Trials/NCT06661512
NCT06661512Not yet recruitingNot Applicable

Acquired Brain Injury and Neurorehabilitation: the Influence of Psychological Characteristics

Institut Guttmann1 site in 1 country200 target enrollmentStarted: November 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
Illness perception

Study Overview

Brief Summary

Acquired brain damage generates motor, cognitive, behavioral and emotional deficits. Neurorehabilitation aims to reduce these deficits and develop compensatory strategies that increase the person's functionality. However, the success of neurorehabilitation process varies and is influenced by the type of injury, the characteristics of the patient or the treatment received. Despite all the studies about patient characteristics, psychological aspects currently continue to be a field to be explored.

The main objective of the study is to study the psychological characteristics of people with brain damage. Secondary objectives include analyzing its link with other indicators, exploring possible differences depending on the etiology of brain damage, assessing its evolution during neurorehabilitation and exploring its prognostic value.

To carry out this prospective longitudinal observational study, adult patients with acquired brain damage to less than 6 months of evolution who present an objective cognitive alteration will be selected. Patients with a neurological or psychiatric history will be excluded.

Patients included in the study will be administered computerized questionnaires at the beginning of the neurorehabilitation program. The same questionnaires will be administered again 2 months later. In those hospitalized patients who subsequently continue outpatient treatment, a third administration will be performed (2 months after the second administration).

Detailed Description

The neurorehabilitative process can be influenced by different factors. Among the most studied are those related to the characteristics of the patient (age, level of education...), the injury (nature, location, magnitude...) or the treatment received (early, intensive...). In contrast, the possible influence of the patient's psychological characteristics on the neurorehabilitation process has been little studied.

Published research on the role of psychological characteristics in the neurorehabilitation process has focused on populations with mild brain damage, using cross-sectional methodologies. The researchers that use longitudinal methodologies study its influence in the chronic phase or once the intensive neurorehabilitation process is completed. There is, therefore, a field to explore in relation to the psychological characteristics of adult patients with moderate-severe acquired brain damage. Furthermore, longitudinal methodology has not been previously used to analyze possible changes in psychological variables during the neurorehabilitation process, nor the influence it may have on its prognosis.

Research Hypothesis:

Psychological characteristics, such as emotional well-being, self-esteem, and motivation, influence neurorehabilitation outcomes in patients with moderate-severe acquired brain damage.

It is expected that:

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age over 18 years
  • Present acquired brain damage (stroke, head trauma, encephalopathy, brain tumor, or anoxia) after less than 6 months of evolution.
  • Participants must present a cognitive alteration objectified through a neuropsychological examination.
  • Be correctly oriented in person, space and time (assessed by psychometric tests).
  • Have a good command of Spanish.

Exclusion Criteria

  • Presenting a neurological or psychiatric history.
  • Presenting a language disorder or severe visual-perceptive disorder - hemineglect - that prevents participation in the study (does not allow for correct administration of the questionnaire).
  • A posteriori criterion (once the study has begun): Answering incorrectly to any of the validity items included in the questionnaire. This situation leads to automatic exclusion from studies.
  • The initial neuropsychological examination will be used to check whether participants meet inclusion criteria 3 and 4, as well as exclusion criterion
  • This examination includes orientation tests (subtest of the Barcelona Orientation Test), language tests (subtests of the Barcelona Word Repetition Test, Word Naming and Command Comprehension Test) and visual-perception tests (subtests of the Barcelona Superimposed Figures Test). Only those participants who correctly answer all the items will be selected.

Outcomes

Primary Outcomes

Illness perception

Time Frame: 4 months

The Brief Illness Perception Questionnaire (BIPQ) 9 items. 1-10 score range for each item. Higher scores describe a higher degree of accord with the correspondent parameter of perception.

Motivation towards rehabilitation

Time Frame: 4 months

Motivation in stroke patients for rehabilitation scale (MORE) 17 items. 17-119 score range. Higher scores describe a higher degree of motivation towards rehabilitation.

Personal values

Time Frame: 4 months

Valued Living Questionnaire - Adapted (22 items) Part A: 11 items. 1-10 score range for each item. Higher scores describe a higher degree of identification towards the specific value. Part B: 11 items. 1-4 score range for each item. Higher scores describe a worse perceived impact in the specific value described after the brain injury.

Coping strategies

Time Frame: 4 months

Coping Orientation to Problems Experienced Inventory - Abbreviated (Brief COPE) 28 items. 28-112 score range. Higher scores describe a higher use of coping strategies.

Depressive symptomatology

Time Frame: 4 months

Depressive symptomatology measured by Patient Health Questionnaire-9 (PHQ-9) 9 items. 0-27 score range. Higher scores describe higher depressive symptomatology

Anxiety symptomatology

Time Frame: 4 months

Anxiety symptomatology measured by General Anxiety Disorder Questionnaire (GAD-7) 7 items. 0-21 score range. Higher scores describe higher anxiety symptomatology

Anosognosia

Time Frame: 4 months

Ad-hoc Anosognosia Questionnaire. 5 Items. 1-20 score range. Higher scores describe a higher perceived cognitive impairment.

Self-Esteem

Time Frame: 4 months

Rosenberg Self-Esteem scale (RSE) 10 items. 0-30 score range. Higher scores describe a higher degree of Self-Esteem.

Locus of control

Time Frame: 4 months

Sense of Control Scale. 8 items. 4 subscales with a range of -4 to +4. Locus of control refers to the perception of where control lies within their life and the causes of the events. A higher "internal good" subscale describes a higher tendency to attribute success towards oneself. A higher "external good" subscale describes a higher tendency to attribute success towards elements independent of oneself. A higher "internal bad" subscale describes a higher tendency to attribute failure towards oneself. A higher "external bad" subscale describes a higher tendency to attribute failure towards elements independent of oneself.

Self-Compassion

Time Frame: 4 months

Self-Compassion Scale Short Form (SCS-SF) 12 items. 12-60 score range. Higher scores describe a higher degree of Self-Compassion.

Injustice Experience

Time Frame: 4 months

Injustice Experience Questionnaire; IEQ 12 items. 0-48 score range. Higher scores describe a higher perception of injustice.

Dispositional hope

Time Frame: 4 months

Life Orientation Test (LOT-R): 6 items. 0-24 score range. Higher scores describe a higher degree of dispositional hope.

Posttraumatic Growth

Time Frame: 4 months

Posttraumatic Growth Inventory Short Form (PTGI-SF) 8 items. 0-40 score range. Higher scores describe a higher degree of Posttraumatic Growth.

Personality traits

Time Frame: 4 months

Big Five Inventory -2 (BFI-2-S) 30 items. 15 subscales with a 2-10 score range. 5 Personality traits with varying ranges of scores. Higher scores describe a higher intensity in that specific personality trait.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Institut Guttmann
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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