Internet-based Treatment for Informal Caregivers in Lithuania LINGI

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

Detailed Description
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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.

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

Conditions
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Caregiver Distress

Intervention / Treatment
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* Behavioral: Intervention group LINGI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly allocated to either control or intervention group. Participants in the control group will receive the same treatment once the intervention group is finished with the treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group LINGI<br>Trans-diagnostic, 8 module, 8 week long internet intervention for reducing informal caregiver burden | Behavioral: Intervention group LINGI<br>* 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.<br>|
| No Intervention: Control group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 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) | 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) | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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informal caregivers, internet-based cognitive behaviour therapy, culturally adapted psychotherapy, eHealth, caregiver burden