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Completed

NCT Number: NCT06014476

Psychological Symptoms and Burden in Caregivers of Patients With Disorders of Consciousness

Caregivers of patients with disorders of consciousness are highly prone to developing mental health issues. The aim of this study is to investigate the psychological symptoms and care burden of caregivers of patients with disorders of consciousness (DoC), and to examine which characteristics of patients were burden predictors to caregivers.

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Key information

Conditions

Psychological Distress Anxiety Depression Behavior Behavioral Symptoms Burden, Caregiver Caregiver Burden Consciousness Disorders Disorders of Consciousness Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress, Psychological

Age range

17 year–81 year

Sex eligibility

All sexes

Study type

Observational

Primary location

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Hangzhou, Zhejiang, China

About this study

This is a multi-center cross-sectional study in China, from August 2021 to October 2022. Patients were assessed by Coma Recovery Scale-Revised (CRS-R), and caregivers' anxiety, depression, and burden were assessed by State-Trait Anxiety Inventory Form Y (STAI), Beck Depression Inventory-II (BDI- II), and Zarit Caregiver Burden scale (ZBI). The comparison with patients' age and caregivers' age-matched subjects who were randomly selected and without DoC; intra-group comparison of caregivers for DoC was conducted. Descriptive statistics were used to illustrate the socio-demographics. One-sample t-test, independent sample t-test, one-way ANOVA, Mann-Whitney U test, and Kruskal-Wallis test were executed to detect the difference between groups due to the distribution of each variable.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (1) Family caregivers without neurological, mental health, or learning disability history.

(2) Family caregiver with consciousness and capability of independently completing questionnaires.

Exclusion criteria

  • Caregivers unwilling to participate
  • Not the dominant caregivers

Treatment and study plan

questionnaires

Other

Sent questionnaires to caregivers and used CRS-R to assess patients with DoC

Other names: Coma Recovery Scale-Revised (CRS-R)

Primary outcomes

  1. The prevalence of anxiety in caregivers of patients with disorders of consciousness.

    Time frame: Within 1 days

    We use the State-Trait Anxiety Inventory Form Y (STAI-Y) to assess the prevalence and severity degree of anxiety for caregivers of patients with disorders of consciousness (DoC)

    STAI was a self-rating scale, consisting of 40 items and divided into two subscales: 1) state anxiety (S-AI) scale includes questions 1-20, state anxiety shows the transitory unpleasant. 2) trait anxiety (T-AI) scale includes questions 21-40, trait anxiety tends to the personality trait. The cumulative score values of state anxiety and trait anxiety scales were calculated respectively, the minimum to maximum value was from 20 to 80, the higher scores mean a worse outcome.

  2. The prevalence and severity degree of depression in caregivers of patients with disorders of consciousness.

    Time frame: Within 1 days

    We use the Beck Depression Inventory-II (BDI-II) to assess the prevalence and severity degree of depression for caregivers of patients with disorders of consciousness (DoC)

    BDI total score: 0-13 as no depression, 14-19 as mild depression, 20-28 as medium depression, and 29-63 as severe depression.

  3. The prevalence and severity degree of burden in caregivers of patients with disorders of consciousness.

    Time frame: Within 1 days

    We use the Zarit Caregiver Burden Scale (ZBI) to assess the prevalence and severity degree of burden for caregivers of patients with disorders of consciousness (DoC)

    ZBI total score: 0-20 indicates no burden, 21-40 mild burden, 41-60 moderate burden, and 61-88 severe burden.

  4. The predictors of anxiety in caregivers of patients with disorders of consciousness.

    Time frame: Within 1 days

    We choose a series of questionnaires to figure out: what are the characteristics of patients and caregivers were caregivers' anxiety predictors?

    The questionnaires include social-demographic questionnaires (including personal information of patients and caregivers e.g., age, gender, etiology, diagnosis, and so on, to record their basic information) and the State-Trait Anxiety Inventory Form Y (STAI-Y).

    We used the Independent-sample T-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and Pearson Correlation to calculate the correlation between the characteristics of patients and caregivers and caregivers' anxiety.

  5. The predictors of depression in caregivers of patients with disorders of consciousness.

    Time frame: Within 1 days

    We choose a series of questionnaires to figure out:

    (1) What are the characteristics of patients and caregivers were caregivers' depression predictors?

    The questionnaires include social-demographic questionnaires (including personal information of patients and caregivers e.g., age, gender, etiology, diagnosis, and so on, to record their basic information), and the Beck Depression Inventory-II (BDI-II).

    We used the Independent-sample T-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and Pearson Correlation to calculate the correlation between the characteristics of patients and caregivers and caregivers' depression.

  6. The predictors of burden in caregivers of patients with disorders of consciousness.

    Time frame: Within 1 days

    We choose a series of questionnaires to figure out:

    (1) What are the characteristics of patients and caregivers were caregivers' burden predictors?

    The questionnaires include social-demographic questionnaires (including personal information of patients and caregivers e.g., age, gender, etiology, diagnosis, and so on, to record their basic information), and the Zarit Caregiver Burden Scale (ZBI).

    We used the Independent-sample T-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and Pearson Correlation to calculate the correlation between the characteristics of patients and caregivers and caregivers' burden.

Secondary outcomes

  1. The diagnoses of patients with disorders of consciousness (DoC)

    Time frame: Within 10 days

    The DoC patients were evaluated 3-5 times Coma Recovery Scale-Revised (CRS-R) within 10 days after questionnaire distribution to determine their current state of consciousness.

  2. The relationship between patient diagnoses and caregivers' anxiety

    Time frame: Within 1 days

    We compare patient diagnoses (assessed by Coma Recovery Scale-Revised (CRS-R) ) and caregivers' anxiety (assessed by the State-Trait Anxiety Inventory Form Y (STAI-Y) )

    We used the one-way ANOVA to calculate the relationship between patient diagnoses and caregivers' anxiety.

  3. The relationship between patient diagnoses and caregivers' depression

    Time frame: Within 1 days

    We compare patient diagnoses (assessed by Coma Recovery Scale-Revised (CRS-R) ) and caregivers' depression (assessed by the Beck Depression Inventory-II (BDI-II) )

    We used the one-way ANOVA to calculate the relationship between patient diagnoses and caregivers' depression.

  4. The relationship between patient diagnoses and caregivers' burden

    Time frame: Within 1 days

    We compare patient diagnoses (assessed by Coma Recovery Scale-Revised (CRS-R) ) and caregivers' depression (assessed by the Zarit Caregiver Burden Scale (ZBI) )

    We used the one-way ANOVA to calculate the relationship between patient diagnoses and caregivers' burden.

Sponsors and collaborators

Lead sponsor

Hangzhou Normal University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2023
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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