Internet-based Treatment for Informal Caregivers in Lithuania LINGI

Linkoeping University63 enrolled

Overview

The purpose of this study is to evaluate efficacy of internet intervention for informal caregivers in Lithuania in reducing their care-giving burden.

Intervention is going to take a form of an Internet based Cognitive Behavioural Treatment program (ICBT) consisting of eight modules. These are the themes, as listed chronologically: Introduction, Thoughts, Stress and relaxation, Problem Solving, Communication, Anxiety, Behavioural Activation, Maintenance. These themes were chosen after considering topics which might be the most useful for someone in a role of an informal caregiver, considering the trans-diagnostic nature of the intervention. Effect of the intervention will be compared against a wait-list control group. Intervention is in Lithuanian.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Caregiver Distress

Interventions

Intervention group LINGIBEHAVIORAL

Intervention based on cognitive behavioural therapy principles and culturally adapted to Lithuanian population. Intervention's main purpose is to reduce caregiver burden and increase quality of life. Intervention contains psycho-educational elements as well as examples and exercises.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * must be 18 years old or over * fluent in comprehending, writing and reading Lithuanian language * score 24 or more points on the Caregiver Burden Inventory * spent at least last couple of months for providing care * must have internet access and ability to use computer or any other compatible device Exclusion Criteria: * adverse life experiences as identified by LEC * alcohol addiction * having severe physical or mental impairments * suicide risk * severe interpersonal violence * the person in need of care has life expectancy below or approximately around 6 months

Locations (1)

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, Sweden

Outcomes

Primary Outcomes

Change on Caregiver Burden Inventory (CBI)

This measure is used to evaluate caregiver burden. CBI contains 24 questions that are distributed within 5 facets - Time Dependency, Emotional Health, Development, Physical Health and Social Relationships. Answer options are presented on a 5-item Likert scale and ranges from from 0 ('Never') to 4 ('Nearly Always'). Total score on CBI is summed up and ranges from 0 to 96, higher score indicating higher levels of burden experienced.

Time frame: Pre-treatment, week 4, week 8 and 12 months post-treatment

Secondary Outcomes

Change on Perceived stress scale (PSS-14)

Measure will be used to evaluate levels of experienced stress. It contains 14 questions on a Likert scale ranging from 0 ('Never') to 4 ('Very Often'). Higher score indicates more severe symptoms.

Time frame: Pre-treatment, week 8 and 12 months post-treatment

Change on The Patient Health Questionnaire (PHQ-9)

Measure will be used to evaluate depressive symptoms. It contains 9 questions that must be responded to by choosing an answer from 4-item Likert scale, where number 0 indicates 'Not at all' and 3 - 'Nearly every day'. Higher score indicates more severe symptoms.

Time frame: Pre-treatment, week 4, week 8 and 12 months post-treatment

Change on Generalized anxiety disorder (GAD-7)

Measure will be used to evaluate caregiver anxiety. GAD-7 contains 7 questions that must be responded to by choosing an answer from 4-item Likert scale, where number 0 indicates 'Not at all' and 3 - 'Nearly every day'. Higher score indicates more severe symptoms.

Time frame: Pre-treatment, week 4, week 8 and 12 months post-treatment

Change on World Health Organisation (WHO-5)

This questionnaire contains 5 statements regarding individual's well-being. Each of the statements must be evaluated using 6-item Likert scale with a score of 0 indicating 'At no time' while a score of 5 - 'All the time'. Higher score indicates higher well-being.

Data from ClinicalTrials.gov

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