Caregiver DistressLINGINCT04052724
Internet-based Treatment for Informal Caregivers in Lithuania LINGI
A study testing Intervention group LINGI in people with Caregiver Distress, run by Linkoeping University at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate efficacy of internet intervention for informal caregivers in Lithuania in reducing their care-giving burden. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Distress
- What is being tested?
- Intervention group LINGI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSweden
- Study dates
- 3 Oct 2019to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Behavioral Sciences and Learning, Linköping University
Linköping, Östergötland County, 58183
About this study
Official title: 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.
Read the 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.
- Conditions
- Caregiver Distress
- Being tested
- Intervention group LINGI
- Keywords
- informal caregivers, internet-based cognitive behaviour therapy, culturally adapted psychotherapy, eHealth, caregiver burden
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group LINGIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group LINGI | Experimental | Trans-diagnostic, 8 module, 8 week long internet intervention for reducing informal caregiver burden Receives: Behavioral: Intervention group LINGI |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-treatment, week 4, week 8 and 12 months post-treatment
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-treatment, week 8 and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start3 Oct 2019
- Primary completion8 Apr 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caregiver DistressStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Vilnius University, University of Groningen
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052724
- Sponsor's protocol ID
- LINGI
- Acronym
- LINGI
- Status last verified
- Nov 2021
- First submitted
- 6 Jun 2019
- Last updated
- 15 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Biliunaite I, Kazlauskas E, Sanderman R, Truskauskaite-Kuneviciene I, Dumarkaite A, Andersson G. Internet-Based Cognitive Behavioral Therapy for Informal Caregivers: Randomized Controlled Pilot Trial. J Med Internet Res. 2021 Apr 7;23(4):e21466. doi: 10.2196/21466.
PubMed 33825687
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Treatment for Informal Caregivers in Lithuania LINGI: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04052724
- Acronym / sponsor ID
- LINGI / LINGI
- Conditions
- Caregiver Distress
- Keywords
- informal caregivers, internet-based cognitive behaviour therapy, culturally adapted psychotherapy, eHealth, caregiver burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Vilnius University, University of Groningen
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 12 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group LINGI | Experimental | Behavioral: Intervention group LINGITrans-diagnostic, 8 module, 8 week long internet intervention for reducing informal caregiver burden |
| Control group | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- adverse life experiences as identified by LEC
- alcohol addiction
- having severe physical or mental impairments
- suicide risk
- severe interpersonal violence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention group LINGIIntervention 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. | Behavioural | Intervention group LINGI |
Primary outcome
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.
5 secondary outcomes
Change on Perceived stress scale (PSS-14)
Time frame: 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
Change on Generalized anxiety disorder (GAD-7)
Time frame: 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
Change on The Brunnsviken Brief Quality of Life Scale (BBQ)
Time frame: Pre-treatment, week 8 and 12 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Derived from this study: PubMed 33825687Biliunaite I, Kazlauskas E, Sanderman R, Truskauskaite-Kuneviciene I, Dumarkaite A, Andersson G. Internet-Based Cognitive Behavioral Therapy for Informal Caregivers: Randomized Controlled Pilot Trial. J Med Internet Res. 2021 Apr 7;23(4):e21466. doi: 10.2196/21466.
- Individual participant dataSharing planned: No
Related trials for Caregiver Distress
Not yet recruiting
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Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
RecruitingPhase 4
A Study of Zunveyl on Safety, Tolerability, Neuropsychiatric Symptoms, and Caregiver Distress in Alzheimer's Disease (RESOLVE)
Alzheimer Disease
Recruiting
Project EMPOWER-OCD
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The Breast Cancer Survivors and Partners Online Research Together (SUPORT) Project
Breast Cancer Female, Psychological Distress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Andersson, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group LINGI in people with Caregiver Distress, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on Caregiver Burden Inventory (CBI) (time frame: Pre-treatment, week 4, week 8 and 12 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04052724, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.