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Completed

NCT Number: NCT04052724

Internet-based Treatment for Informal Caregivers in Lithuania LINGI

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

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Key information

Conditions

Caregiver Distress Behavior Behavioral Symptoms Caregiver Burden Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, 58183, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Intervention group LINGI

Behavioral

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.

Primary outcomes

  1. Change on Caregiver Burden Inventory (CBI)

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

    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.

Secondary outcomes

  1. Change on Perceived stress scale (PSS-14)

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

    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.

  2. Change on The Patient Health Questionnaire (PHQ-9)

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

    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.

  3. Change on Generalized anxiety disorder (GAD-7)

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

    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.

  4. Change on World Health Organisation (WHO-5)

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

    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.

  5. Change on The Brunnsviken Brief Quality of Life Scale (BBQ)

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

    BBQ will be used for evaluating overall quality of life. It contains 12 statements ranging on a Likert scale from 0 - 'Strongly Disagree to 4 - 'Strongly Agree'. Higher score indicates higher quality of life.

Other outcomes

  1. Life Events Checklist (LEC)

    Time frame: Pre-treatment

    This measure will be used for screening for potentially traumatic events in respondent's lifetime. This questionnaire contains 16 questions and a box for mentioning any other stressful events experienced by an individual. There are 6 answer options for: 'Happened to me', 'Witnessed it', 'Learned about it', 'Part of my job', 'Not sure' and 'Doesn't apply'.

  2. The Alcohol Use Disorders Identification Test (AUDIT)

    Time frame: Pre-treatment

    AUDIT will be used for assessing caregiver's alcohol consumption. It contains 10 questions in relation to the alcohol intake. Each question has varying answer options. Higher score indicates higher alcohol consumption and risks associated with it.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • University of Groningen
  • Vilnius University

Registry information

Official study title

Internet-based Treatment for Informal Caregivers in Lithuania LINGI: a Randomized Control Trial

Acronym: LINGI

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Aug 12, 2019
Registry last updated
Nov 15, 2021

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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