Internet-based Treatment for Informal Caregivers in Lithuania LINGI

NCT04052724 | Completed

• 1 other identifier: LINGI
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Distress

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change on Perceived stress scale (PSS-14)

  Pre-treatment, week 8 and 12 months post-treatment

• Change on The Patient Health Questionnaire (PHQ-9)

  Pre-treatment, week 4, week 8 and 12 months post-treatment

• Change on Generalized anxiety disorder (GAD-7)

  Pre-treatment, week 4, week 8 and 12 months post-treatment

• Change on World Health Organisation (WHO-5)

  Pre-treatment, week 8 and 12 months post-treatment

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

  Pre-treatment, week 8 and 12 months post-treatment

Other Outcomes (2)

• Life Events Checklist (LEC)

  Pre-treatment

• The Alcohol Use Disorders Identification Test (AUDIT)

  Pre-treatment

Study Arms (2)

Intervention group LINGI

EXPERIMENTAL

Trans-diagnostic, 8 module, 8 week long internet intervention for reducing informal caregiver burden

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

Interventions

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.

Intervention group LINGI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead
• Vilnius University: collaborator
• University of Groningen: collaborator

Study Sites (1)

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, 58183, Sweden

Location

Related Publications (1)

• 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.

  PMID: 33825687 DERIVED

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Gerhard Andersson, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: August 12, 2019
• Study Start: October 3, 2019
• Primary Completion: April 8, 2020
• Study Completion: March 1, 2021
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)