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Internet-based Treatment for Informal Caregivers in Lithuania LINGI

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04052724
Acronym
LINGI
Enrollment
63
Registered
2019-08-12
Start date
2019-10-03
Completion date
2021-03-01
Last updated
2021-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregiver Distress

Keywords

informal caregivers, internet-based cognitive behaviour therapy, culturally adapted psychotherapy, eHealth, caregiver burden

Brief summary

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

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.

Interventions

BEHAVIORALIntervention 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.

Sponsors

Vilnius University
CollaboratorOTHER
University of Groningen
CollaboratorOTHER
Linkoeping University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change on Caregiver Burden Inventory (CBI)Pre-treatment, week 4, week 8 and 12 months post-treatmentThis 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

MeasureTime frameDescription
Change on The Brunnsviken Brief Quality of Life Scale (BBQ)Pre-treatment, week 8 and 12 months post-treatmentBBQ 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.
Change on Generalized anxiety disorder (GAD-7)Pre-treatment, week 4, week 8 and 12 months post-treatmentMeasure 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.
Change on World Health Organisation (WHO-5)Pre-treatment, week 8 and 12 months post-treatmentThis 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.
Change on Perceived stress scale (PSS-14)Pre-treatment, week 8 and 12 months post-treatmentMeasure 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.
Change on The Patient Health Questionnaire (PHQ-9)Pre-treatment, week 4, week 8 and 12 months post-treatmentMeasure 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.

Other

MeasureTime frameDescription
The Alcohol Use Disorders Identification Test (AUDIT)Pre-treatmentAUDIT 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.
Life Events Checklist (LEC)Pre-treatmentThis 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'.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026