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

NCT06014476 | Completed

• 1 other identifier: Hangzhou Normal University
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychological Distress; Anxiety Depression; Burden, Caregiver; Disorders of Consciousness

Outcome Measures

Primary Outcomes (6)

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

  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.

  Within 1 days

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

  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.

  Within 1 days

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

  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.

  Within 1 days

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

  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.

  Within 1 days

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

  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.

  Within 1 days

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

  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.

  Within 1 days

Secondary Outcomes (4)

• The diagnoses of patients with disorders of consciousness (DoC)

  Within 10 days

• The relationship between patient diagnoses and caregivers' anxiety

  Within 1 days

• The relationship between patient diagnoses and caregivers' depression

  Within 1 days

• The relationship between patient diagnoses and caregivers' burden

  Within 1 days

Study Arms (2)

Experimental Group

Caregivers of patients with disorders of consciousness, including Coma, Unresponsive Wakefulness Syndrome (UWS), and Minimally Consciousness State (MCS). And caregivers of patients emerge from the minimally conscious state (EMCS)

Other: questionnaires

Control group

caregivers of patients with other disease

Other: questionnaires

Interventions

questionnaires OTHER

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

Also known as: Coma Recovery Scale-Revised (CRS-R)

Control group; Experimental Group

Eligibility Criteria

• Age: 17 Years - 81 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Caregivers of patients with DoC and other diseases

You may qualify if:

• \- (1) Family caregivers without neurological, mental health, or learning disability history.
• (2) Family caregiver with consciousness and capability of independently completing questionnaires.

You may not qualify if:

• Caregivers unwilling to participate
• Not the dominant caregivers

Sponsors & Collaborators

• Hangzhou Normal University: lead

Study Sites (1)

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Caregiver Burden; Consciousness Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Hao YA Wang

  Hangzhou Normal University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 28, 2023
• Study Start: August 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)