Internet-based Treatment for Informal Caregivers in Lithuania LINGI (LINGI)

November 12, 2021 updated by: Gerhard Andersson, Linkoeping University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Östergötland
      • Linköping, Östergötland, Sweden, 58183
        • Department of Behavioral Sciences and Learning, Linköping University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group LINGI
Trans-diagnostic, 8 module, 8 week long internet intervention for reducing informal caregiver burden
Behavioral: Intervention group LINGI
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.
No Intervention: Control group
Participants in the control group will be instructed to wait. Once intervention group will be finished, participants in control group will be able to access the same intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-treatment, week 4, week 8 and 12 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-treatment, week 8 and 12 months post-treatment
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.
Pre-treatment, week 4, week 8 and 12 months post-treatment
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.
Pre-treatment, week 4, week 8 and 12 months post-treatment
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.
Pre-treatment, week 8 and 12 months post-treatment
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.
Pre-treatment, week 8 and 12 months post-treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'.
Pre-treatment
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.
Pre-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Collaborators

University of Groningen
Vilnius University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2019

Primary Completion (Actual)

April 8, 2020

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

June 6, 2019

First Submitted That Met QC Criteria

August 9, 2019

First Posted (Actual)

August 12, 2019

Study Record Updates

Last Update Posted (Actual)

November 15, 2021

Last Update Submitted That Met QC Criteria

November 12, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LINGI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Caregiver Distress

Clinical Trials on Intervention group LINGI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe